Seeking Biotech Alpha APRIL/MARCH 2020 Insight

https://news.abbvie.com/news/press-releases/imbruvica-ibrutinib-receives-11th-fda-approval.htm

https://www.abbvie.com/

https://www.prnewswire.com/news-releases/imbruvica-ibrutinib-receives-11th-fda-approval-301044668.html

https://seekingalpha.com/symbol/ABBV

IMBRUVICA® (ibrutinib) is a prescription medicine used to treat adults with: Mantle cell lymphoma (MCL) who have received at least one prior treatment Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion Waldenström's macroglobulinemia (WM) Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy

Trodelvy™ (sacituzumab govitecan-hziy)

IMBRUVICA® (ibrutinib) Receives 11th FDA Approval

FDA Grants Accelerated Approval for Immunomedics’ Trodelvy in Previously-Treated Metastatic Triple-Negative Breast Cancer

Wed April 22, 2020 11:47 AM|GlobeNewswire|About: IMMU

First FDA-approved antibody-drug conjugate that targets the Trop-2 antigen

Trodelvy is the first antibody-drug conjugate approved by FDA specifically for the treatment of relapsed or refractory metastatic triple-negative breast cancer

Company to host conference call today at 5:00 p.m. Eastern Time

MORRIS PLAINS, N.J., April 22, 2020 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (IMMU) (NASDAQ: IMMU)

https://www.immunomedics.com/

https://www.immunomedics.com/our-company/news-and-events/fda-grants-accelerated-approval-for-immunomedics-trodelvy-in-previously-treated-metastatic-triple-negative-breast-cancer/

https://seekingalpha.com/symbol/IMMU

Pipeline

https://www.immunomedics.com/our-science/pipeline/

FDA Grants Accelerated Approval for Immunomedics’ Trodelvy in Previously-Treated Metastatic Triple Negative Breast Cancer First FDA-approved antibody-drug conjugate that targets the Trop-2 antigen Trodelvy is the first antibody-drug conjugate approved by FDA specifically for the treatment of relapsed or refractory metastatic triple-negative breast cancer Company to host conference call today at 5:00 p.m. Eastern Time Morris Plains, N.J., April 22, 2020 — Immunomedics, Inc. (NASDAQ: IMMU)

Kymriah® (tisagenlecleucel)

IMBRUVICA® (ibrutinib) Receives 11th FDA Approval

Pfizer and BioNTech on go with COVID-19 vaccine study in Germany

Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma

Wed April 22, 2020 1:29 AM|PR Newswire

- The Regenerative Medicine Advanced Therapy (RMAT) designation reflects the unmet need for patients with r/r follicular lymphoma

- US regulatory filing for Kymriah in r/r follicular lymphoma anticipated in 2021

PR Newswire

EAST HANOVER, N.J., April 22, 2020 /PRNewswire/

https://www.us.kymriah.com/

https://www.novartis.us/

https://www.prnewswire.com/news-releases/novartis-kymriah-receives-fda-regenerative-medicine-advanced-therapy-designation-in-follicular-lymphoma-301044971.html

https://www.novartis.com/news/media-releases/novartis-kymriah-receives-fda-regenerative-medicine-advanced-therapy-designation-follicular-lymphoma

What is KYMRIAH? KYMRIAH is made from your own white blood cells and is a prescription cancer treatment used in patients up to 25 years old who have acute lymphoblastic leukemia (ALL) that is either relapsing (went into remission, then came back) or is refractory (did not go into remission after receiving other leukemia treatments). It is also used in patients with non-Hodgkin lymphoma that has relapsed or is refractory after having at least two other kinds of treatment.

Pfizer and BioNTech on go with COVID-19 vaccine study in Germany

RGX-314 for the treatment of wet age-related macular degeneration (wet AMD)

Pfizer and BioNTech on go with COVID-19 vaccine study in Germany

BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates

Wed April 22, 2020 5:00 AM|GlobeNewswire|About: BNTX, PFE

First COVID-19-related clinical trial to start in Germany
Initial dose escalation phase to target dose range of 1µg to 100µg
Clinical supply from BioNTech’s GMP-certified mRNA production facilities in Europe
Four vaccine candidates to enter clinical development

MAINZ, Germany and NEW YORK, April 22, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (BNTX) and Pfizer Inc. (PFE)

https://biontech.de/

https://biontech.de/science/pipeline

https://www.pfizer.com/news/press-release/press-release-detail/biontech_and_pfizer_announce_regulatory_approval_from_german_authority_paul_ehrlich_institut_to_commence_first_clinical_trial_of_covid_19_vaccine_candidates

https://seekingalpha.com/symbol/BNTX

Pfizer and BioNTech on go with COVID-19 vaccine study in Germany

Apr. 22, 2020 6:37 AM ET|About: BioNTech SE (BNTX)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3562932-pfizer-and-biontech-on-go-covidminus-19-vaccine-study-in-germany

EXPLORE OUR PRODUCT CANDIDATES

RGX-314 for the treatment of wet age-related macular degeneration (wet AMD)

REGENXBIO Announces Additional Positive Long-term and Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD

Wed April 22, 2020 6:30 AM|PR Newswire|About: RGNX

ROCKVILLE, Md., April 22, 2020 /PRNewswire/ --

RGX-314 continues to be well-tolerated at all dose levels
Long-term, durable treatment effect demonstrated over two years in Cohort 3
- Mean improvement in vision (+14 letters) and stable retinal thickness (+2 µm)
- 50% of patients (3/6) remain anti-VEGF injection-free over two years
- 67% of patients (4/6) are anti-VEGF injection-free from nine months to two years
- Stable intraocular RGX-314 protein expression over two years
73% of patients (8/11) in Cohort 5 remain anti-VEGF injection-free over nine months
Intraocular RGX-314 protein levels at six months demonstrate dose-dependent expression across cohorts
Company on track to provide one-year data from Cohorts 4 & 5 in mid-2020 and initiate RGX-314 subretinal delivery pivotal program in 2H 2020
Webcast conference call to be hosted Wednesday, April 22 at 8:30 a.m. ET featuring wet AMD Key Opinion Leaders, Allen C. Ho, M.D., Robert Avery, M.D., and Peter Campochiaro, M.D.

REGENXBIO Inc. (RGNX)

https://www.prnewswire.com/news-releases/regenxbio-announces-additional-positive-long-term-and-interim-phase-iiia-trial-update-for-rgx-314-for-the-treatment-of-wet-amd-301045143.html

https://seekingalpha.com/symbol/RGNX

https://www.regenxbio.com/

https://www.regenxbio.com/wet-amd/

PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx)

RGX-314 for the treatment of wet age-related macular degeneration (wet AMD)

Agilent Receives FDA Approval for PD-L1 Companion Diagnostic on Dako Omnis

Thu April 23, 2020 8:00 AM|Business Wire|About: A

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (A) (NYSE: A)

https://www.agilent.com/

https://www.businesswire.com/news/home/20200423005127/en/

https://www.agilent.com/en/product/dako-omnis-solution-for-ihc-ish/dako-omnis

https://www.agilent.com/about/newsroom/presrel/2020/23apr-ca20014.html

https://seekingalpha.com/symbol/A

Dako Omnis meets the challenges in the modern pathology lab head-on to accommodate an increasing number of diverse, advanced staining methods in an increasingly unpredictable working day. Dako Omnis achieves this by automating advanced staining techniques, while using the simplest of user interfaces with little hands-on time.

quadrivalent vaccine

Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum

FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination

Fri April 24, 2020 1:00 AM|GlobeNewswire|About: SNY

FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination

Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S.
Safety and effectiveness studied in five double-blind, randomized clinical trials with nearly 5,000 individuals
Helps protect an expanded age group and elicits a high immune response across multiple ages
Under regulatory review in Europe and other countries to help support local immunization efforts

PARIS – April 24, 2020

https://www.vaccineshoppe.com/assets/pdf/395-MenQuadfi%E2%80%93USPI-clean-Apr%202020.pdf

https://seekingalpha.com/symbol/SNY

https://www.sanofi.com/

April 24 2020 FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination

Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum

Innovent and Eli Lilly Announce NMPA Acceptance of a Supplemental New Drug Application for Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum as First-Line Therapy in Non-squamous NSCLC

Thu April 23, 2020 7:50 PM|PR Newswire|About: IVBIY, LLY

SUZHOU, China, April 23, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (IVBIY) ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, today jointly announced with Eli Lilly and Company (LLY) ("Lilly", NYSE: LLY)

https://seekingalpha.com/symbol/LLY

Tyvyt® (Sintilimab Injection)

https://investor.lilly.com/news-releases/news-release-details/tyvyt-sintilimab-injection-combined-alimta-pemetrexed-and

http://innoventbio.com/#/

https://seekingalpha.com/symbol/IVBIY

https://www.lilly.com/

https://www.prnewswire.com/news-releases/innovent-and-eli-lilly-announce-nmpa-acceptance-of-a-supplemental-new-drug-application-for-sintilimab-in-combination-with-alimta-pemetrexed-and-platinum-as-first-line-therapy-in-non-squamous-nsclc-301045839.html

Indications for ALIMTA® (pemetrexed for injection)

ALIMTA is indicated in combination with pembrolizumab (pembro) and platinum chemotherapy for the initial treatment of patients with nonsquamous metastatic non-small cell lung cancer (mNSCLC) with no EGFR or ALK genomic tumor aberrations.

ALIMTA is indicated in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).

ALIMTA is indicated as a single agent for the maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

ALIMTA is indicated as a single agent for the treatment of patients with recurrent metastatic nonsquamous non-small cell lung cancer (NSCLC) after prior chemotherapy.

https://www.alimta.com/hcp/

Innovent Biologics, Inc. (IVBIY) ("Innovent") (HKEX: 01801)

Lynparza (olaparib)

Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum

Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For COVID-19 Vaccine

Lynparza demonstrated overall survival benefit in Phase III PROfound trial for BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer

PUBLISHED24 April 2020

24 April 2020 07:00 BST

Only PARP inhibitor to improve overall survival vs. new hormonal agent treatments for this advanced prostate cancer population with high unmet needs

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada)

AstraZeneca's Lynparza extends survival in certain prostate cancer patients

Apr. 24, 2020 7:02 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3564080-astrazenecas-lynparza-extends-survival-in-certain-prostate-cancer-patients

https://seekingalpha.com/news/3488293-astrazeneca-and-mercks-lynparza-shows-treatment-benefit-in-late-stage-prostate-cancer-study

https://www.lynparza.com/ovarian-cancer/recurrent-ovarian-cancer.html

YNPARZA is a prescription medicine used to treat adults who have: advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For COVID-19 Vaccine

Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For its COVID-19 Vaccine Candidate in Support of the Company's Goal to Supply More Than One Billion Vaccine Doses GloballyApr 23, 2020Company Signs Agreement with Emergent BioSolutions in the U.S. As Part of its InvestmentFirst in Series of Anticipated Strategic Collaborations Designed to Further the Company's Goal of Ensuring Global Supply of a Safe and Effective Vaccine for COVID-19

NEW BRUNSWICK, N.J., April 23, 2020 /PRNewswire/ -- Johnson & Johnson (the Company) (NYSE: JNJ) today announced a collaboration between the Janssen Pharmaceutical Companies of Johnson & Johnson and Emergent BioSolutions, Inc

J&J to pay Emergent $135 million as part of COVID-19 vaccine manufacturing deal

Published: April 24, 2020 at 8:32 a.m. ETBy

Jaimy Lee

https://www.marketwatch.com/story/jj-to-pay-emergent-135-million-as-part-of-covid-19-vaccine-manufacturing-deal-2020-04-24

https://www.janssen.com/infectious-diseases-and-vaccines/patented-technologies

https://www.jnj.com/

https://www.janssen.com/infectious-diseases-and-vaccines/patented-technologies

https://www.prnewswire.com/news-releases/johnson--johnson-announces-collaboration-to-expand-manufacturing-capabilities-for-its-covid-19-vaccine-candidate-in-support-of-the-companys-goal-to-supply-more-than-one-billion-vaccine-doses-globally-301046557.html

Patented Vaccine Capabilities & Technologies Cutting-edge technologies are the driving force behind our strong research and vaccine development pipeline to help the global health community better prepare for and combat life-threatening infectious disease outbreaks. LEAD COVID-19 VACCINE CANDIDATE ANNOUNCED On March 30, 2020 Johnson & Johnson announced a lead vaccine candidate for COVID-19

dostarlimab, an investigational anti-programmed death-1 (PD-1) monoclonal antibody,

Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For COVID-19 Vaccine

SIMPONI ARIA® (golimumab)= polyarticular juvenile idiopathic arthritis&juvenile psoriatic arthritis

GSK Presents New Data from the GARNET Study Demonstrating Potential of Dostarlimab to Treat a Subset of Women with Recurrent or Advanced Endometrial Cancer

Thu April 23, 2020 8:03 PM|Business Wire|About: GSK

Data accepted as a late-breaking abstract and presented as a webinar as part of the Society of Gynecologic Oncology 2020 virtual congress
Patients in the updated analysis of GARNET include women with recurrent or advanced endometrial cancer who have progressed on or after platinum-based chemotherapy

PHILADELPHIA--(BUSINESS WIRE)-- GlaxoSmithKline plc (GSK)

https://www.gsk.com/en-gb/about-us/

Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors (GARNET)

https://clinicaltrials.gov/ct2/show/NCT02715284

https://www.businesswire.com/news/home/20200423005979/en/

https://seekingalpha.com/symbol/GSK

23 April 2020 GSK presents new data from the GARNET study demonstrating potential of dostarlimab to treat a subset of women with recurrent or advanced endometrial cancer Issued: London, UK Data accepted as a late-breaking abstract and presented as a webinar as part of the Society of Gynecologic Oncology 2020 virtual congress Patients in the updated analysis of GARNET include women with recurrent or advanced endometrial cancer who have progressed on or after platinum-based chemotherapy GlaxoSmithKline plc

SIMPONI ARIA® (golimumab)= polyarticular juvenile idiopathic arthritis&juvenile psoriatic arthritis

Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For COVID-19 Vaccine

SIMPONI ARIA® (golimumab)= polyarticular juvenile idiopathic arthritis&juvenile psoriatic arthritis

Janssen Announces Submission of Two Applications to U.S. FDA Seeking Approval of SIMPONI ARIA® (golimumab) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis

Fri April 24, 2020 9:17 AM|PR NewswirePR Newswire

HORSHAM, Pa., April 24, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

https://www.simponiaria.com/

http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI+ARIA-pi.pdf

https://www.janssen.com/

https://www.janssen.com/janssen-announces-submission-two-applications-us-fda-seeking-approval-simponi-aria-golimumab

https://www.jnj.com/

Juvenile idiopathic arthritis

https://www.mayoclinic.org/diseases-conditions/juvenile-idiopathic-arthritis/symptoms-causes/syc-20374082

Juvenile idiopathic arthritis

https://ghr.nlm.nih.gov/condition/juvenile-idiopathic-arthritis

About Juvenile Idiopathic Arthritis

https://creakyjoints.org/education/juvenile-idiopathic-arthritis/

https://www.prnewswire.com/news-releases/janssen-announces-submission-of-two-applications-to-us-fda-seeking-approval-of-simponi-aria-golimumab-for-the-treatment-of-polyarticular-juvenile-idiopathic-arthritis-and-juvenile-psoriatic-arthritis-301046821.html

WHAT IS SIMPONI ARIA®? SIMPONI ARIA® is for adults with: Moderate to severe rheumatoid arthritis, used in combination with methotrexate Active psoriatic arthritis Active ankylosing spondylitis

Seeking Biotech Alpha APRIL/MARCH 2020 Insight

U.S. to Boost Payment for Abbott’s Covid-19 Test to Increase Use

VIR-2218, a small interfering ribonucleic acid (siRNA) that mediates RNA interference

ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab)

U.S. to Boost Payment for Abbott’s Covid-19 Test to Increase Use

By Michelle Fay CortezApril 15, 2020, 2:39 AM EDT

Government will pay $100 per test, up from $51 to spur use
Lack of technicians to run tests accounted for the shortfall

https://www.abbott.com/

https://www.abbott.com/corpnewsroom/product-and-innovation/abbott-launches-novel-coronavirus-test.html

https://seekingalpha.com/symbol/ABT

Find out more

ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab)

VIR-2218, a small interfering ribonucleic acid (siRNA) that mediates RNA interference

ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab)

Merck Announces US Launch of ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab)

Wed April 15, 2020 6:45 AM|Business Wire|About: MRK

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)

https://www.merck.com/product/usa/pi_circulars/o/ontruzant/ontruzant_pi.pdf

https://www.merck.com/index.html

https://www.businesswire.com/news/home/20200415005021/en/

https://www.mrknewsroom.com/news-release/prescription-medicine-news/merck-announces-us-launch-ontruzant-trastuzumab-dttb-biosimi

Merck Announces US Launch of ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab) Wednesday, April 15, 2020 6:45 am EDT

VIR-2218, a small interfering ribonucleic acid (siRNA) that mediates RNA interference

QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib)

VIR-2218 Demonstrates Dose-Dependent and Durable Reductions of Hepatitis B Surface Antigen in Phase 1/2 Trial

Wed April 15, 2020 4:01 PM|GlobeNewswire|About: ALNY, VIRGlobeNewswire

SAN FRANCISCO, April 15, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (VIR)

https://www.vir.bio/

https://www.vir.bio/pipeline/#focus

https://seekingalpha.com/symbol/ALNY

https://seekingalpha.com/symbol/VIR

Study of VIR-2218 in Healthy Volunteers and Patients With Chronic Hepatitis B

https://clinicaltrials.gov/ct2/show/NCT03672188?intr=vir-2218&lead=vir+biotechnology&phase=1&draw=2&rank=1

OUR FOCUS Chronic and acute infections impact hundreds of millions of people every year.

QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib)

QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib) Based Regimen in Metastatic Colorectal Cancer

Wed April 15, 2020 4:05 PM|Business Wire|About: QGEN

U.S. FDA approves therascreen BRAF V600E RGQ PCR assay as companion diagnostic
Test will help identify patients eligible for treatment with the BRAF inhibitor, BRAFTOVI, which the FDA has approved for use in combination with ERBITUX® (cetuximab) in adults with previously treated metastatic colorectal cancer with a BRAF V600E mutation

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)--

QIAGEN N.V. (QGEN)

https://www.qiagen.com/us/products/diagnostics-and-clinical-research/oncology/therascreen-braf-v600e-rgq-pcr-kit/#orderinginformation

https://www.businesswire.com/news/home/20200415005666/en/

https://seekingalpha.com/symbol/QGEN

https://www.braftovimektovi.com/

The therascreen BRAF V600E RGQ PCR Kit is an FDA-approved companion diagnostic (CDx) test to identify patients with cases of metastatic colorectal cancer (mCRC) that harbor the V600E mutation in the BRAF gene, and for whom treatment with BRAFTOVI (encorafenib) + cetuximab may be appropriate. The test uses DNA extracted from formalin-fixed, paraffin-embedded (FFPE) human colorectal cancer (CRC) tumor tissue.

Jelmyto (mitomycin gel)

QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib)

REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection

FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer

Wed April 15, 2020 2:59 PM|PR Newswire

https://www.prnewswire.com/news-releases/fda-approves-first-therapy-for-treatment-of-low-grade-upper-tract-urothelial-cancer-301041332.html

https://www.urogen.com/

https://www.urogen.com/pipeline/

Mitomycin is a chemotherapy drug, specifically, an alkylating agent that interferes with the transcription of DNA into RNA, stopping protein synthesis and stopping cancer cells' ability to proliferate.

https://seekingalpha.com/symbol/URGN

An industry-leading uro-oncology pipeline

REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection

QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib)

REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection

FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola

Thu April 16, 2020 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., April 16, 2020 /PRNewswire/ --

REGN-EB3 developed via same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapy

Regeneron Pharmaceuticals, Inc. (REGN)

https://newsroom.regeneron.com/news-releases/news-release-details/new-england-journal-medicine-publishes-results-ebola-clinical

https://www.prnewswire.com/news-releases/fda-accepts-for-priority-review-biologics-license-application-for-regn-eb3-to-treat-ebola-301041691.html

April 16, 2020 at 7:00 AM EDT Back FDA ACCEPTS FOR PRIORITY REVIEW BIOLOGICS LICENSE APPLICATION FOR REGN-EB3 TO TREAT EBOLA TARRYTOWN, N.Y., April 16, 2020 /PRNewswire/ -- REGN-EB3 developed via same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapy Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available

Lilly launches more low-priced insulin offerings in U.S.

Apr. 16, 2020 6:54 AM ET|About: Eli Lilly and Company (LLY)|By: Douglas W. House, SA News Editor

https://www.lilly.com/

https://seekingalpha.com/symbol/LLY

Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available

04/16/2020

https://investor.lilly.com/news-releases/news-release-details/lower-priced-versions-humalogr-mix7525tm-kwikpenr-and-humalogr

Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available 04/16/2020 Download PDF Non-branded insulins have a 50 percent lower list price than branded versions INDIANAPOLIS, April 16, 2020 /PRNewswire/ -- Non-branded versions of Humalog® Mix75/25™ KwikPen® (insulin lispro protamine and insulin lispro injectable suspension, 100 units/mL) and Humalog® Junior KwikPen® (insulin lispro injection, 100 units/mL) are now available for order by U.S. pharmacies – adding to the broad suite of affordability options offered by Eli Lilly and Company (NYSE: LLY)

KISQALI® (ribociclib)

Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available

Health Canada approves an extended indication for KISQALI® (ribociclib) in combination treatment

Thu April 16, 2020 7:00 AM|Canada Newswire

Breast cancer is the most common female cancer in Canada.1
Advanced breast cancer is the leading cause of cancer death in women 20-59 years old.2,3
While overall 5-year survival rates for female breast cancer are relatively high, at 87%, women with advanced breast cancer face a 22.0% survival rate over 5 years.4

DORVAL, QC, April 16, 2020 /CNW Telbec/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that KISQALI® (ribociclib) is now indicated when used in combination for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer regardless of their menopause status and in combination with various approved hormonal treatment options.

https://www.novartis.ca/en

INDICATIONS KISQALI® (ribociclib) is a prescription medicine used in combination with: an aromatase inhibitor to treat pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic), as the first endocrine-based therapy; or fulvestrant to treat postmenopausal women with HR-positive, HER2-negative metastatic breast cancer as the first endocrine-based therapy or with disease progression following endocrine therapy

TUKYSA™ (tucatinib)

Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available

Pemazyre™ (pemigatinib)

FDA OKs Seattle Genetics' tucatinib for HER+ breast cancer

Apr. 17, 2020 2:27 PM ET|About: Seattle Genetics, Inc. (SGEN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3541692-fda-accepts-seattle-genetics-tucatinib-application-action-date-august-20

https://seekingalpha.com/pr/17778320-seattle-genetics-announces-fda-filing-acceptance-for-priority-review-of-tucatinib-new-drug

https://seekingalpha.com/symbol/SGEN

https://www.seattlegenetics.com/

https://investor.seattlegenetics.com/press-releases/news-details/2020/Seattle-Genetics-Announces-US-FDA-Approval-of-TUKYSA-tucatinib-for-People-with-Advanced-Unresectable-or-Metastatic-HER2-Positive-Breast-Cancer/default.aspx

Tucatinib is an orally bioavailable, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2, a growth factor receptor that is over-expressed in multiple cancers, including breast, colorectal, and gastric cancers. Between 15% and 20% of breast cancers cases worldwide are HER2-positive.

Pemazyre™ (pemigatinib)

Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)

Pemazyre™ (pemigatinib)

FDA Approves Incyte’s Pemazyre™ (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

17 April, 2020

PDF Version

- Pemazyre received Orphan Drug, Breakthrough Therapy and Priority Review designations based on the significant needs of people living with this devastating cancer -

- Investor conference call and webcast scheduled for Monday, April 20, 2020, at 8:00 a.m. ET -

WILMINGTON, Del.--(BUSINESS WIRE)--Apr. 17, 2020-- Incyte (Nasdaq:INCY)

https://www.incyte.com/

Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

https://clinicaltrials.gov/ct2/show/NCT02924376

FDA Approves Incyte’s Pemazyre™ (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

Fri April 17, 2020 8:53 PM|Business Wire|About: INCY

- Pemazyre received Orphan Drug, Breakthrough Therapy and Priority Review designations based on the significant needs of people living with this devastating cancer -

- Investor conference call and webcast scheduled for Monday, April 20, 2020, at 8:00 a.m. ET -

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)

https://seekingalpha.com/pr/17841193-fda-approves-incyte-s-pemazyre-pemigatinib-first-targeted-treatment-for-adults-previously

Cholangiocarcinoma (bile duct cancer)

https://www.mayoclinic.org/diseases-conditions/cholangiocarcinoma/symptoms-causes/syc-20352408

https://seekingalpha.com/symbol/INCY

FDA Approves Incyte’s Pemazyre™ (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma - Pemazyre received Orphan Drug, Breakthrough Therapy and Priority Review designations based on the significant needs of people living with this devastating cancer - - Investor conference call and webcast scheduled for Monday, April 20, 2020, at 8:00 a.m. ET - April 17, 2020 08:53 PM Eastern Daylight Time WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY)

Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)

Bristol Myers Squibb and Exelixis Announce Positive Topline Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Previously Untreated Advanced Renal Cell Carcinoma

Mon April 20, 2020 6:59 AM|Business Wire|About: BMY, EXEL

Study met primary endpoint of significantly improving progression-free survival, and secondary endpoints of overall survival and objective response rate vs. sunitinib

Opdivo in combination with CABOMETYX demonstrates clinically meaningful efficacy results across all endpoints and preliminary assessment showing a favorable safety profile

PRINCETON, N.J. & ALAMEDA, Calif.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (EXEL) (NASDAQ: EXEL)

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER)

https://clinicaltrials.gov/ct2/show/NCT03141177?term=checkmate-9er&draw=2&rank=1

https://www.businesswire.com/news/home/20200420005248/en/

https://www.exelixis.com/

https://cabometyx.com/

https://www.opdivo.com/

https://seekingalpha.com/symbol/EXEL

https://seekingalpha.com/news/3561978-opdivo-cabometyx-combo-successful-in-first-line-kidney-cancer

Opdivo/Cabometyx combo successful in first-line kidney cancer

Apr. 20, 2020 7:19 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor

FULL INDICATIONS For people with previously treated advanced non-small cell lung cancer OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

Ocrevus® (ocrelizumab)

Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)

FDA and EMA Accept Applications for Genentech’s Ocrevus (ocrelizumab) Shorter 2-hour Infusion Time

Mon April 20, 2020 1:00 AM|Business Wire|About: RHHBY

– Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary progressive multiple sclerosis, if approved –

– Applications are based on data from the randomized, double-blind ENSEMBLE PLUS study, showing consistent safety to the currently approved Ocrevus dosing regimen –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://www.gene.com/download/pdf/ocrevus_prescribing.pdf

https://www.ocrevus.com/

https://www.gene.com/media/press-releases/14846/2020-04-19/fda-and-ema-accept-applications-for-gene

Sunday, Apr 19, 2020

FDA and EMA Accept Applications for Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion Time

Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary progressive multiple sclerosis, if approved
Applications are based on data from the randomized, double-blind ENSEMBLE PLUS study, showing consistent safety to the currently approved Ocrevus dosing regimen

South San Francisco, CA -- April 19, 2020 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),

OCREVUS is a prescription medicine used to treat: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults.

Seeking Biotech Alpha APRIL/MARCH 2020 Insight

Koselugo (selumetinib)

BioCryst launches early-stage study of galidesivir for COVID-19

Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT®

FDA OKs AstraZeneca and Merck's selumetinib for rare nervous system disorder

Apr. 10, 2020 4:55 PM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

https://www.reuters.com/article/brief-fda-approves-first-therapy-for-chi-idUSASA00KGS

https://www.cancer.gov/publications/dictionaries/cancer-drug/def/selumetinib

FDA Approves First Therapy for Children with Debilitating and Disfiguring Rare Disease

Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT®

BioCryst launches early-stage study of galidesivir for COVID-19

Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT®

Lilly Begins Clinical Testing of Therapies for COVID-19

Fri April 10, 2020 5:11 PM|PR Newswire|About: LLY

- Lilly Starts Phase 2 Trial with Anti-Ang2 in COVID-19

PR Newswire

INDIANAPOLIS, April 10, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)

https://www.lilly.com/

https://www.prnewswire.com/news-releases/lilly-begins-clinical-testing-of-therapies-for-covid-19-301038931.html

https://www.olumiant.com/

https://seekingalpha.com/symbol/LLY

Olumiant is a once-daily pill to treat adults with moderately to severely active RA who have tried at least one other medicine called a tumor necrosis factor (TNF) antagonist, such as Humira® (adalimumab), Enbrel® (etanercept), and Remicade® (infliximab), that did not work well or could not be tolerated.

BioCryst launches early-stage study of galidesivir for COVID-19

Apr. 10, 2020 10:40 AM ET|About: BioCryst Pharmaceutica... (BCRX)|By: Douglas W. House, SA News Editor

A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever

https://clinicaltrials.gov/ct2/show/NCT03891420?term=NCT03891420&draw=2&rank=1

https://seekingalpha.com/symbol/BCRX

https://www.biocryst.com/

Structure-Guided Drug Design BioCryst’s structure-guided approach to drug design uses an iterative process to increase selectivity and enable efficient, rapid drug development.

ENHANZE® Technology For Patients With Multiple Myeloma

AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity

BioCryst launches early-stage study of galidesivir for COVID-19

Halozyme Announces Janssen Submits New Drug Application In Japan For Daratumumab Subcutaneous Formulation Utilizing Halozyme's ENHANZE® Technology For Patients With Multiple Myeloma

Sun April 26, 2020 9:40 PM|PR Newswire|About: HALO

SAN DIEGO, April 26, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (HALO)

https://www.halozyme.com/homepage/default.aspx

https://www.prnewswire.com/news-releases/halozyme-announces-janssen-submits-new-drug-application-in-japan-for-daratumumab-subcutaneous-formulation-utilizing-halozymes-enhanze-technology-for-patients-with-multiple-myeloma-301047294.html

https://seekingalpha.com/symbol/HALO

Halozyme’s ENHANZE® drug delivery technology is based on our patented recombinant human hyaluronidase PH20 enzyme, rHuPH20, which locally degrades hyaluronan (HA) in the subcutaneous (SC) space. This allows for increased dispersion and absorption of co-administered therapies.

Libtayo® (cemiplimab)

AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity

Sanofi: Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival

Mon April 27, 2020 7:00 AM|GlobeNewswire|About: SNY

Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival

Libtayo decreased the risk of death by 32.4% compared to chemotherapy
Sanofi (SNY) and Regeneron plan regulatory submissions in 2020

Paris and Tarrytown, N.Y. - April 27, 2020 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

https://www.sanofi.com/

https://newsroom.regeneron.com/news-releases/news-release-details/phase-3-trial-libtayor-cemiplimab-monotherapy-first-line

https://seekingalpha.com/symbol/SNY

LIBTAYO is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that: has spread –or– cannot be cured by surgery or radiation

AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity

Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ADVANCE-1 Pivotal Phase 2/3 Trial in Alzheimer’s Disease Agitation

Mon April 27, 2020 6:00 AM|GlobeNewswire|About: AXSM

Statistically significant improvement in Alzheimer’s disease agitation, as measured by the CMAI total score compared to placebo (p=0.010, primary endpoint)

Demonstrated rapid and substantial improvement in Alzheimer’s disease agitation starting at week 2 with statistical significance at week 3 compared to placebo (p=0.007)

Statistically significant rates of clinical response (p=0.005) on the CMAI and improvement on the modified Alzheimer’s Disease Cooperative Study-CGIC scale for agitation (p=0.036) compared to placebo

Well-tolerated and not associated with cognitive impairment or sedation

No treatments are currently approved for Alzheimer’s disease agitation

Company to host conference call today at 8:00 AM ET

NEW YORK, April 27, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM)

https://axsome.com/

https://seekingalpha.com/symbol/AXSM

https://axsome.com/axs-pipeline/about-axs-05/

Addressing Dementia Via Agitation-Centered Evaluation (ADVANCE)

https://clinicaltrials.gov/ct2/show/NCT03226522?term=alzheimer%27s+disease+agitation&draw=2&rank=34

AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of CNS disorders. AXS-05 consists of a proprietary formulation and dose of bupropion and dextromethorphan, or DM, and utilizes our metabolic inhibition technology

tislelizumab with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) & carboplatin

Roche = FDA approval for cobas HPV test for cobas 6800/8800 Systems to identify cervical cancer

tislelizumab with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) & carboplatin

http://ir.beigene.com/news-releases/news-release-details/beigene-announces-acceptance-supplemental-new-drug-application-1

China authorities accept BeiGene application for expanded use of tislelizumab

Apr. 20, 2020 4:34 PM ET|About: BeiGene, Ltd. (BGNE)|By: Douglas W. House, SA News Editor

https://www.beigene.com/

BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer in China

April 20, 2020 at 4:05 PM EDT

BEIJING, China and CAMBRIDGE, Mass., April 20, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160),

http://ir.beigene.com/news-releases/news-release-details/beigene-announces-acceptance-supplemental-new-drug-application-1

https://seekingalpha.com/symbol/BGNE

https://www.beigene.com/science-and-product-portfolio/pipeline/tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor)

Roche = FDA approval for cobas HPV test for cobas 6800/8800 Systems to identify cervical cancer

tislelizumab with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) & carboplatin

Vertex Announces Innovative Reimbursement Agreement in Switzerland for ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for Eligible Cystic Fibrosis Patients

Tue April 21, 2020 2:00 AM|Business Wire|About: VRTX

Agreement also enables the possibility of rapid patient access to future triple combination regimen (elexacaftor/tezacaftor/ivacaftor and ivacaftor) once approved in Switzerland

LONDON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (VRTX)

https://www.businesswire.com/news/home/20200420005992/en/

https://www.symdeko.com/

https://www.orkambi.com/

https://www.vrtx.com/

https://www.vrtx.com/research-development/pipeline/

https://seekingalpha.com/symbol/VRTX

What is ORKAMBI? ORKAMBI is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene. ORKAMBI should not be used in patients other than those who have two copies of the F508del mutation in their CFTR gene.

Roche = FDA approval for cobas HPV test for cobas 6800/8800 Systems to identify cervical cancer

Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer

More than 99 percent of cervical cancers are caused by persistent high-risk HPV infection1
Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, screening and treatment; expanding access helps reach more women2,3
cobas 6800/8800 Systems deliver full automation, helping laboratories meet the throughput and efficiencies that high-volume, HPV DNA screening programs require

Basel, 21 April 2020 - Roche (SIX: RO, ROG; OTCQX:RHHBY)

https://www.hpv16and18.com/index.html

Roche receives FDA approval for CINtec® PLUS Cytology test to aid clinicians in improving cervical cancer prevention

https://diagnostics.roche.com/global/en/news-listing/2020/roche-receives-FDA-approval-for-CINtec-plus-cytology-test.html

https://diagnostics.roche.com/

https://diagnostics.roche.com/global/en/products/product-category/chlamydia-trachomatis-and-neisseria-gonorrhoeae.html

https://www.roche.com/

FDA OKs Roche HPV test for high-throughput systems

Apr. 21, 2020 6:42 AM ET|About: Roche Holding Ltd ADR (RHHBY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3562411-fda-oks-roche-hpv-test-for-high-throughput-systems

cobas® HPV Test now FDA approved for first-line primary screening.

Tislelizumab

Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic

Roche = FDA approval for cobas HPV test for cobas 6800/8800 Systems to identify cervical cancer

BeiGene Announces that the Phase 3 Trial of Tislelizumab Combined with Chemotherapy in Patients with First-Line Non-Squamous Non-Small Cell Lung Cancer Met the Primary Endpoint of Progression-Free Survival at Interim Analysis

Mon April 13, 2020 4:05 PM|GlobeNewswire|About: BGNE

BEIJING, China, and CAMBRIDGE, Mass., April 13, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

https://www.beigene.com/

http://ir.beigene.com/news-releases/news-release-details/beigene-announces-phase-3-trial-tislelizumab-combined

https://www.beigene.com/science-and-product-portfolio/pipeline

Tislelizumab

https://www.beigene.com/science-and-product-portfolio/pipeline/tislelizumab

https://clinicaltrials.gov/ct2/show/NCT03663205?cond=Nsclc&lead=beigene&phase=2&draw=2&rank=1

https://seekingalpha.com/symbol/BGNE

BeiGene Pipeline We are advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. We have three internally-developed late-stage clinical drug candidates and three marketed products in China.

Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic

Alnylam Receives Fast Track Designation for Vutrisiran for the Treatment of the Polyneuropathy of hATTR Amyloidosis

Tue April 14, 2020 7:00 AM|Business Wire|About: ALNY

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (ALNY) (Nasdaq: ALNY)

https://www.alnylam.com/wp-content/uploads/pdfs/ONPATTRO-Prescribing-Information.pdf

https://www.alnylam.com/

https://www.businesswire.com/news/home/20200414005125/en/

https://www.alnylam.com/alnylam-rnai-pipeline/

https://seekingalpha.com/symbol/ALNY

Familial transthyretin amyloidosis

https://rarediseases.info.nih.gov/diseases/656/familial-transthyretin-amyloidosis

HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

https://clinicaltrials.gov/ct2/show/NCT03759379?term=helios-a&draw=2&rank=1

Alnylam is leading the translation of RNAi (RNA interference) into a whole new class of innovative medicines to potentially address the needs of patients who have limited or inadequate treatment options. Our pipeline of investigational RNAi therapeutics is focused on diseases with high unmet medical need that fall under 4 Strategic Therapeutic Areas (STArs): genetic medicines, cardio-metabolic diseases, hepatic infectious diseases, and central nervous system (CNS) and ocular diseases.

AstraZeneca initiates CALAVI clinical trial with Calquence against COVID-19

Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic

AstraZeneca initiates CALAVI clinical trial with Calquence against COVID-19

PUBLISHED14 April 2020

Trial will assess the effect of Calquence on the exaggerated immune response of patients hospitalised with COVID-19 infection

What is CALQUENCE?

CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer, or adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

It is not known if CALQUENCE is safe and effective in children.

Please see full Prescribing Information, including Patient Information.

https://www.astrazeneca.com/

What is CALQUENCE? CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer, or adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is not known if CALQUENCE is safe and effective in children.

Seeking Biotech Alpha APRIL/MARCH 2020 Insight

Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets)

Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine

Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets)

Gilead Canada Submits Supplemental New Drug Submission to Health Canada for Descovy® for HIV Pre-Exposure Prophylaxis

Thu April 9, 2020 8:00 AM|Canada Newswire

-- Submission supported by data from the DISCOVER trial, which evaluated the safety and efficacy of Descovy® compared to Truvada® in people at risk for sexually acquired HIV-1 infection --

MISSISSAUGA, ON, April 9, 2020 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada)

http://www.gilead.ca/

https://www.gilead.com/

https://www.gilead.com/news-and-press/press-room/press-releases/2019/4/gilead-submits-supplemental-new-drug-application-to-us-food-and-drug-administration-for-oncedaily-descovy-for-hiv-preexposure-prophylaxis

https://www.descovy.com/prep

https://seekingalpha.com/symbol/GILD

DESCOVY for PrEP (pre-exposure prophylaxis) is a once-daily prescription medicine for adults and adolescents at risk of HIV. It helps lower the chances of getting HIV through sex. DESCOVY for PrEP is not for everyone: It is not for use in people assigned female at birth who are at risk of getting HIV from vaginal sex, because its effectiveness has not been studied. You must be HIV-negative before and while taking DESCOVY for PrEP.

RYBELSUS® (semaglutide tablets)

Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine

Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets)

Health Canada approves RYBELSUS® (semaglutide tablets) the first and only GLP-1 analogue in a pill for the treatment of adults with type 2 diabetes

Thu April 9, 2020 8:01 AM|Canada Newswire

RYBELSUS® offers convenience to support diabetes management along with diet and exercise for adults1

MISSISSAUGA, ON, April 9, 2020 /CNW/ - Health Canada has approved RYBELSUS® (semaglutide tablets)

https://www.novonordisk.ca/

https://www.rybelsuspro.com/

https://www.novonordisk.ca/our-products.html

https://seekingalpha.com/symbol/NVO

RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Limitations of Use RYBELSUS® is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans RYBELSUS® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis RYBELSUS® is not indicated for use in patients with type 1 diabetes or for the treatment of patients with diabetic ketoacidosis

Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine

Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development

Thu April 9, 2020 7:50 AM|Business Wire|About: BNTX, PFE

Pfizer (PFE) and BioNTech (BNTX) to jointly develop COVID-19 vaccine, initially in the United States and Europe, and scale-up manufacturing capacity to support global supply
Potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and then rapidly scale up capacity to produce hundreds of millions of doses in 2021.
BioNTech will contribute multiple mRNA vaccine candidates as part of its BNT162 COVID-19 vaccine program, which are expected to enter human testing in April 2020
Pfizer will contribute its leading global vaccine clinical research and development, regulatory, manufacturing and distribution infrastructure and capabilities
BioNTech will receive an upfront payment of $185 million, including an equity investment of approximately $113 million, and be eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million

MAINZ, Germany & NEW YORK--(BUSINESS WIRE)-- BioNTech SE, and Pfizer Inc.

https://www.businesswire.com/news/home/20200409005405/en/

https://seekingalpha.com/news/3559589-pfizer-identifies-lead-covidminus-19-candidate

https://biontech.de/

https://seekingalpha.com/symbol/BNTX

https://www.wsj.com/articles/pfizer-identifies-lead-coronavirus-drug-candidate-11586427303?mod=pls_whats_news_us_business_f

Pfizer Identifies Lead Coronavirus Drug Candidate

Experimental medicine to be tested on patients this summer; arthritis therapy Xeljanz considered, too

By Jared S. Hopkins

JAREDSHOPKINS

Updated April 9, 2020 3:56 pm ET

PFIZER AND BIONTECH ANNOUNCE FURTHER DETAILS ON COLLABORATION TO ACCELERATE GLOBAL COVID-19 VACCINE DEVELOPMENT

ONGENTYS® (opicapone)

Mobocertinib (TAK-788)

Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine

Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS® (opicapone) as an Add-On Treatment for Patients with Parkinson's Disease Experiencing "Off" Episodes

Mon April 27, 2020 7:30 AM|PR Newswire|About: NBIX

- Neurocrine Biosciences Plans to Make ONGENTYS Available to Patients Later This Year

PR Newswire

SAN DIEGO, April 27, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX)

https://www.neurocrine.com/

https://seekingalpha.com/symbol/NBIX

https://www.multivu.com/players/English/8719751-neurocrine-biosciences-ongentys/

http://www.neurocrine.com//assets/ongentyspi.pdf

https://www.ninds.nih.gov/Disorders/All-Disorders/Parkinsons-Disease-Challenges-Progress-and-Promise

https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-fda-approval-of-once-daily-ongentys-opicapone-as-an-add-on-treatment-for-patients-with-parkinsons-disease-experiencing-off-episodes-301047469.html

Pipeline Overview

https://www.neurocrine.com/pipeline/pipeline-overview/

Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS® (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes

Mobocertinib (TAK-788)

Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib (TAK-788) for the Treatment of NSCLC Patients with EGFR Exon 20 Insertion Mutations

Mon April 27, 2020 8:00 AM|Business Wire|About: TAK

– Designation Represents Positive Progress for a Unique Patient Population in Need of Targeted Therapy Options

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)

https://www.takeda.com/

https://www.businesswire.com/news/home/20200427005219/en/

https://seekingalpha.com/symbol/TAK

https://www.takeda.com/investors/

Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib (TAK-788) for the Treatment of NSCLC Patients with EGFR Exon 20 Insertion Mutations April 27, 2020 – Designation Represents Positive Progress for a Unique Patient Population in Need of Targeted Therapy Options Cambridge, MASS. & Osaka, JAPAN, April 27, 2020 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)

Actemra (tocilizumab)

Mobocertinib (TAK-788)

Roche's Actemra scores early win in COVID-19 study in France

Apr. 27, 2020 9:51 AM ET|About: Roche Holding Ltd ADR (RHHBY)|By: Douglas W. House, SA News Editor

https://www.aphp.fr/contenu/le-tocilizumab-ameliore-significativement-le-pronostic-des-patients-avec-pneumonie-covid

https://www.actemrahcp.com/

https://www.roche.com/products/product-details.htm?productId=42bf9d08-8573-491a-944a-fdbc030ec44b

https://www.roche.com/

INDICATIONS ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). ACTEMRA is indicated for the treatment of giant cell arteritis (GCA) in adult patients. ACTEMRA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older. ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older. Please see additional Important Safety Information in full Prescribing Information, including BOXED WARNING.

oligomannate

Apr 27, 2020 03:08 PMBUSINESS & TECH

Chinese Alzheimer’s Drug Gets U.S. Approval for Stateside Trial

Shanghai Green Valley Pharmaceutical Co. got clearance on April 8 for the U.S. part of a global trial that seeks to enroll more than 2,000 patients with mild-to-moderate Alzheimer’s across North America, Europe and Asia, according to a company statement Sunday.

https://www.usagainstalzheimers.org/press/usagainstalzheimers-welcomes-chinas-approval-alzheimers-drug-oligomannate

Sodium Oligomannate: First Approval.

Syed YY1.

https://www.ncbi.nlm.nih.gov/pubmed/32020555

Shanghai Institute of Materia Medica

http://english.simm.cas.cn/ns/hd/

https://www.greenvalleypharma.com/En

https://www.greenvalleypharma.com/En/Index/listView/catid/47.html

China Daily | Alzheimer's drug to go on sale this year Date：2019-11-04 Chinese medicine that can improve cognition first to pass clinical trials

oligomannate

TriClip™ Transcatheter Tricuspid Valve Repair System

iBio Expands COVID-19 Vaccine Collaboration to Include the Infectious Disease Research Institute

TriClip™ Transcatheter Tricuspid Valve Repair System

Abbott's TriClip™ Becomes First Device of its Kind to Receive CE Mark for Minimally Invasive Tricuspid Valve Repair

Thu April 9, 2020 9:00 AM|PR Newswire|About: ABT

- New system offers a proven safe and effective minimally invasive non-surgical solution

- The TriClip System leverages Abbott's proven clip-based technology used in its MitraClip™ transcatheter mitral valve therapy

PR Newswire

ABBOTT PARK, Ill., April 9, 2020 /PRNewswire/ -- Abbott (ABT)

Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm stu

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32600-5/fulltext

https://www.abbott.com/

https://www.prnewswire.com/news-releases/abbotts-triclip-becomes-first-device-of-its-kind-to-receive-ce-mark-for-minimally-invasive-tricuspid-valve-repair-301038077.html

https://seekingalpha.com/symbol/ABT

MITRACLIP CLIP DELIVERY SYSTEMS INDICATION FOR USE The MitraClip™ NTR/XTR System

iBio Expands COVID-19 Vaccine Collaboration to Include the Infectious Disease Research Institute

Thu April 9, 2020 7:30 AM|GlobeNewswire|About: IBIOGlobeNewswire

NEW YORK, April 09, 2020 (GLOBE NEWSWIRE) -- iBio, Inc. (IBIO)

https://www.ibioinc.com/

https://www.idri.org/

https://seekingalpha.com/symbol/IBIO

XOSPATA® (gilteritinib)

iBio Expands COVID-19 Vaccine Collaboration to Include the Infectious Disease Research Institute

Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration

Thu April 9, 2020 8:01 PM|PR Newswire|About: ALPMY

TOKYO, April 9, 2020 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (

https://www.astellas.com/en/

https://www.astellas.com/en/science/pipeline

https://www.prnewswire.com/news-releases/astellas-announces-acceptance-of-xospata-gilteritinib-for-regulatory-review-in-china-by-the-national-medical-products-administration-301038645.html

https://seekingalpha.com/symbol/ALPMY

https://www.cancer.gov/news-events/cancer-currents-blog/2019/aml-flt3-gilteritinib-improved-survival

WHAT IS XOSPATA XOSPATA is a prescription medicine used to treat adults with acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation when the disease has come back or has not improved after previous treatment(s). Your healthcare provider will perform a test to make sure XOSPATA is right for you. It is not known if XOSPATA is safe and effective in children.

Seeking Biotech Alpha APRIL/MARCH 2020 Insight

lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO)

Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA

lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO)

Alnylam Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration and Submits Marketing Authorization Application to the European Medicines Agency for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1

Tue April 7, 2020 7:00 AM|Business Wire|About: ALNY

− Lumasiran is the First Potential Therapeutic to Demonstrate Substantial Reduction in Urinary Oxalate Excretion –

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (ALNY) (Nasdaq: ALNY)

https://www.alnylam.com/

Alnylam Reports Positive Topline Results from ILLUMINATE-A Phase 3 Study of Lumasiran for the Treatment of Primary Hyperoxaluria Type 1

Dec 17, 2019

https://investors.alnylam.com/press-release?id=24376

A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1 (ILLUMINATE-A)

https://clinicaltrials.gov/ct2/show/NCT03681184

https://www.businesswire.com/news/home/20200407005239/en/

https://seekingalpha.com/symbol/ALNY

balstilimab (anti-PD-1) for the treatment of cervical cancer.

Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA

lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO)

Agenus Receives Fast Track Designation for Balstilimab in Advanced Cervical Cancer

Tue April 7, 2020 1:04 PM|PR Newswire|About: AGEN

LEXINGTON, Mass., April 7, 2020 /PRNewswire/ -- Agenus Inc. (AGEN)

https://agenusbio.com/

https://agenusbio.com/pipeline/

https://investor.agenusbio.com/2020-04-07-Agenus-Receives-Fast-Track-Designation-for-Balstilimab-in-Advanced-Cervical-Cancer

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

https://www.prnewswire.com/news-releases/agenus-receives-fast-track-designation-for-balstilimab-in-advanced-cervical-cancer-301036879.html

https://seekingalpha.com/symbol/AGEN

BALSTILIMAB (AGEN2034)

PD-1 (programmed cell death protein 1) is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. In 2018, the Nobel Prize in Medicine was awarded for the establishment of PD-1 as a cancer immunotherapy target. Agenus has applied these scientific principles to create a therapy designed to treat cancer, AGEN2034

AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 from interacting with its ligands PD-L1 and PD-L2.

AGEN2034 is clinically active in patients with advanced or refractory cancer.

We are targeting multiple mechanisms to fight cancer with single agent and combination Therapies

Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA

Genentech Provides Regulatory Update on Risdiplam for the Treatment of Spinal Muscular Atrophy (SMA)

Tue April 7, 2020 4:05 PM|Business Wire|About: RHHBY

– U.S. Food and Drug Administration (FDA) extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2 –

– Risdiplam is being investigated in infants, children and adults with Type 1, 2 or 3 SMA –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://www.businesswire.com/news/home/20200407005769/en/

Tuesday, Apr 7, 2020 Genentech Provides Regulatory Update on Risdiplam for the Treatment of Spinal Muscular Atrophy (SMA) U.S. Food and Drug Administration (FDA) extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2 Risdiplam is being investigated in infants, children and adults with Type 1, 2 or 3 SMA South San Francisco, CA -- April 7, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)

BRAFTOVI® (ENCORAFENIB) IN COMBINATION W/ CETUXIMAB = BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER

Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA

Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer

Wed April 8, 2020 6:59 AM|Business Wire|About: BMY

FDA application granted Priority Review designation with PDUFA date of August 6, 2020

Submissions based on results from Phase 3 CheckMate -9LA trial

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY)

https://www.businesswire.com/news/home/20200408005057/en/

https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-announces-acceptance-us-and-eu-regulatory

Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab) This is a summary of important information that you need to know about OPDIVO and OPDIVO + YERVOY. Your healthcare team can work with you to help answer any questions you may have about these medications. Keep this information in a safe place so you can refer to it before and during your treatment.

https://www.opdivo.com/

Indications

YERVOY® (ipilimumab) is a prescription medicine used in adults and children 12 years of age and older to treat melanoma (a kind of skin cancer) that has spread (metastatic) or cannot be removed by surgery (unresectable).

It is not known if YERVOY is safe and effective in children less than 12 years of age.

YERVOY® (ipilimumab) is a prescription medicine used in adults to help prevent melanoma (a kind of skin cancer) from coming back after it and lymph nodes that contain cancer have been removed by surgery.

It is not known if YERVOY is safe and effective in children.

YERVOY will not work for every patient. Individual results may vary.

Information provided in this website is not a substitute for talking with your healthcare professional. Your healthcare professional is the best source of information about your disease.

https://www.yervoy.com/

Sotatercept is an investigational product in patients w/ pulmonary arterial hypertension (PAH)

BRAFTOVI® (ENCORAFENIB) IN COMBINATION W/ CETUXIMAB = BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER

Acceleron Receives FDA Breakthrough Therapy Designation for Sotatercept in Pulmonary Arterial Hypertension

Wed April 8, 2020 7:05 AM|Business Wire|About: XLRN

Sotatercept granted first FDA Breakthrough Therapy designation in pulmonary arterial hypertension since the Agency established the designation in 2012

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Acceleron Pharma Inc. (XLRN)

https://www.businesswire.com/news/home/20200408005276/en/

http://acceleronpharma.com/

http://acceleronpharma.com/science-pipeline/sotatercept/

https://seekingalpha.com/symbol/XLRN

Sotatercept Ligand trap in development to rebalance BMPR-II signaling for patients with Pulmonary Arterial Hypertension

BRAFTOVI® (ENCORAFENIB) IN COMBINATION W/ CETUXIMAB = BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER

U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy

Wed April 8, 2020 6:27 PM|Business Wire|About: PFE

BRAFTOVI plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutation

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE

http://labeling.pfizer.com/ShowLabeling.aspx?id=12990

https://www.braftovimektovi.com/hcp/

https://www.businesswire.com/news/home/20200408005791/en/

https://www.nasdaq.com/market-activity/stocks/pfe/dividend-history

INDICATIONS AND USAGE BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) are kinase inhibitors indicated for use in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test.

Seeking Biotech Alpha APRIL/MARCH 2020 Insight

Vosoritide to Treat Children with Achondroplasia

BioMarin Plans Regulatory Submissions for Marketing Authorization of Vosoritide to Treat Children with Achondroplasia in 3Q 2020 in both US and Europe

Mon April 6, 2020 8:31 AM|PR Newswire|About: BMRNPR Newswire

SAN RAFAEL, Calif., April 6, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

https://www.biomarin.com/

https://www.prnewswire.com/news-releases/biomarin-plans-regulatory-submissions-for-marketing-authorization-of-vosoritide-to-treat-children-with-achondroplasia-in-3q-2020-in-both-us-and-europe-301035652.html

https://seekingalpha.com/symbol/BMRN

https://www.biomarin.com/products/pipeline/bmn-111/

https://investors.biomarin.com/2020-04-06-BioMarin-Plans-Regulatory-Submissions-for-Marketing-Authorization-of-Vosoritide-to-Treat-Children-with-Achondroplasia-in-3Q-2020-in-both-US-and-Europe

Achondroplasia

https://ghr.nlm.nih.gov/condition/achondroplasia

Vosoritide (BMN 111) for Achondroplasia Vosoritide is designed for the treatment of achondroplasia, the most common form of dwarfism.

NUSTENDI™ (bempedoic acid and ezetimibe) Tablet

Vosoritide to Treat Children with Achondroplasia

Esperion Announces European Commission Approval of the NUSTENDI™ (bempedoic acid and ezetimibe) Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia

Mon April 6, 2020 7:05 AM|GlobeNewswire|About: ESPR

– First Non-Statin, LDL-C Lowering Combination Medicine Ever Approved in Europe –

– NUSTENDI Is Approved for Patients Who Require Additional LDL-Cholesterol Lowering on a Background Statin, Other Lipid-Lowering Therapies, or Considered Statin Intolerant –

– Daiichi Sankyo Europe to Lead EU Commercialization, Cardiovascular Sales Organization Exceeds 1,000 Professionals –

– Esperion to Receive $150 Million Milestone Payment Upon First Commercial Sale –

ANN ARBOR, Mich., April 06, 2020 (GLOBE NEWSWIRE) -- Esperion (ESPR) announced today the European Commission approved the NUSTENDI™ (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine for hypercholesterolemia and dyslipidemia in Europe. NUSTENDI contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine.

The European Commission approved NUSTENDI for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe,
alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, or
in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.

https://www.esperion.com/

https://www.esperion.com/science/bempedoic-acid-ezetimibe-combo-tablet/

https://seekingalpha.com/symbol/ESPR

Apr 6, 2020 Esperion Announces European Commission Approval of the NUSTENDI™ (bempedoic acid and ezetimibe) Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia

sacituzumab govitecan

Vosoritide to Treat Children with Achondroplasia

sacituzumab govitecan

IMMUNOMEDICS ANNOUNCES ASCENT STUDY TO BE STOPPED FOR COMPELLING EFFICACY

Mon April 6, 2020 8:00 AM|GlobeNewswire|About: IMMU

Decision based on recommendation from DSMC following study data review

Sacituzumab govitecan has the potential to be the first FDA-approved antibody-drug conjugate for the treatment of metastatic triple-negative breast cancer

Conference call and webcast today at 8:00 a.m. Eastern Time

MORRIS PLAINS, N.J., April 06, 2020 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (IMMU)

https://www.immunomedics.com/

https://www.immunomedics.com/our-science/pipeline/

https://clinicaltrials.gov/ct2/show/NCT02574455?term=NCT02574455&rank=1

ASCENT Trial for Metastatic Triple-Negative Breast Cancer

https://www.immunomedics.com/our-science/clinical-trials/

https://seekingalpha.com/symbol/IMMU

ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer (ASCENT)

ALUNBRIG® (brigatinib)

KEYTRUDA® (pembrolizumab) Injection, 100 mg

sacituzumab govitecan

European Commission Approves Takeda’s ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ NSCLC

Mon April 6, 2020 8:00 AM|Business Wire|About: TAK

– Approval Based on Positive Results from the Phase 3 ALTA-1L Trial Showing ALUNBRIG Demonstrated Superior Overall and Intracranial Effectiveness over Crizotinib in the First-line Setting –

– Expanded Indication Provides Additional First-Line Treatment Option for the Approximately 10,000 People with ALK+ NSCLC in Europe –

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)

https://www.businesswire.com/news/home/20200406005146/en/

https://www.takeda.com/

https://www.takedaoncology.com/

Alunbrig

brigatinib

https://www.ema.europa.eu/en/medicines/human/EPAR/alunbrig

https://www.takeda.com/newsroom/newsreleases/2020/european-commission-approves-takedas-alunbrig-brigatinib-as-a-first-line-treatment-for-alk-nsclc/

https://seekingalpha.com/symbol/TAK

ALUNBRIG is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC): that has a certain type of abnormal anaplastic lymphoma kinase (ALK) gene, and that has spread to other parts of your body, and who have taken the medicine crizotinib, but their NSCLC worsened or they cannot tolerate taking crizotinib It is not known if ALUNBRIG is safe and effective in children. There is an ongoing study to learn how ALUNBRIG works over a longer period of time.

ARIES® SARS-CoV-2 Assay

KEYTRUDA® (pembrolizumab) Injection, 100 mg

Luminex Receives FDA Emergency Use Authorization for ARIES® SARS-CoV-2 Assay to Detect Virus Responsible for COVID-19 Disease

Mon April 6, 2020 7:30 AM|PR Newswire|About: LMNXPR Newswire

AUSTIN, Texas, April 6, 2020 /PRNewswire/ -- Luminex Corporation (LMNX)

https://www.prnewswire.com/news-releases/luminex-receives-fda-emergency-use-authorization-for-aries-sars-cov-2-assay-to-detect-virus-responsible-for-covid-19-disease-301035578.html

https://www.luminexcorp.com/

https://seekingalpha.com/symbol/LMNX

In response to the global outbreak of the novel coronavirus disease (COVID-19), Luminex has developed multiple solutions to enhance our NxTAG® and ARIES® offerings in order to automate and facilitate the detection of coronavirus.

KEYTRUDA® (pembrolizumab) Injection, 100 mg

Merck Receives Priority Review from FDA for Second Application for KEYTRUDA® (pembrolizumab) Based on Biomarker, Regardless of Tumor Type

Tue April 7, 2020 6:45 AM|Business Wire|About: MRK

Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada,

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

https://clinicaltrials.gov/ct2/show/NCT02628067

https://www.merck.com/index.html

Merck Announces KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival as First-Line Treatment for Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

First Positive Head-to-Head Phase 3 Trial Comparing a Single-Agent Cancer Medicine to Standard of Care Chemotherapy as First-line Treatment for MSI-H or dMMR Colorectal Cancer

Merck to Share Data from KEYNOTE-177 with Global Regulatory Authorities and at an Upcoming Medical Congress

Thursday, April 2, 2020 6:45 am EDT

https://www.mrknewsroom.com/news-release/oncology/merck-announces-keytruda-pembrolizumab-significantly-improved-progression-free

Merck Receives Priority Review from FDA for Second Application for KEYTRUDA® (pembrolizumab) Based on Biomarker, Regardless of Tumor Type

Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment

Tuesday, April 7, 2020 6:45 am EDT

https://www.mrknewsroom.com/news-release/oncology-newsroom/merck-receives-priority-review-fda-second-application-keytruda-pembro

https://www.businesswire.com/news/home/20200407005141/en/

https://www.keytruda.com/

Advanced microsatellite instability-high cancer THE FIRST APPROVED IMMUNOTHERAPY FOR ADVANCED MSI-H/dMMR CANCERS

Seeking Biotech Alpha APRIL/MARCH 2020 Insight

RUXIENCE™ (rituximab)

oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)

RUXIENCE™ (rituximab)

Pfizer Receives European Approval for Oncology Biosimilar, RUXIENCE™ (rituximab)

Thu April 2, 2020 2:04 PM|Business Wire|About: PFE

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) today announced that the European Commission (EC) has approved RUXIENCE™ (rituximab), a monoclonal antibody (mAb) and biosimilar to MabThera® (rituximab), for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).1,2,3

https://www.businesswire.com/news/home/20200402005733/en/

https://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_european_approval_for_oncology_biosimilar_ruxience_rituximab

PFIZER RECEIVES EUROPEAN APPROVAL FOR ONCOLOGY BIOSIMILAR, RUXIENCE™ (RITUXIMAB)

Thursday, April 2, 2020 - 2:04pmEDT

What does RUXIENCE help treat? INDICATIONS Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids

Dupixent® (dupilumab)

oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)

RUXIENCE™ (rituximab)

Dupixent® (dupilumab) Phase 3 Data at Revolutionizing Atopic Dermatitis Conference Show Significant Improvement in Severe Atopic Dermatitis for Children Aged 6 to 11 Years

Fri April 3, 2020 12:59 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, April 3, 2020 /PRNewswire/

https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf

https://www.prnewswire.com/news-releases/dupixent-dupilumab-phase-3-data-at-revolutionizing-atopic-dermatitis-conference-show-significant-improvement-in-severe-atopic-dermatitis-for-children-aged-6-to-11-years-301034556.html

https://newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-phase-3-data-revolutionizing-atopic

https://seekingalpha.com/symbol/SNY

Indications DUPIXENT is a prescription medicine used: to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 12 years of age. with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT

oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)

Results from Expert Delphi Consensus Survey on Treatment of Pulmonary Arterial Hypertension (PAH) with Oral Prostacyclin Pathway Agents (PPAs) Published in CHEST Journal

Fri April 3, 2020 9:00 AM|PR Newswire|About: JNJPR Newswire

SOUTH SAN FRANCISCO, Calif., April 3, 2020 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson (JNJ)

https://journal.chestnet.org/article/S0012-3692(19)34214-X/fulltext

https://seekingalpha.com/symbol/ALIOF

https://www.janssen.com/

https://www.jnj.com/

https://www.prnewswire.com/news-releases/results-from-expert-delphi-consensus-survey-on-treatment-of-pulmonary-arterial-hypertension-pah-with-oral-prostacyclin-pathway-agents-ppas-published-in-chest-journal-301034862.html

https://www.actelion.us/products/index

https://uptravi.com/

What is UPTRAVI? UPTRAVI® (selexipag) is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the arteries of your lungs. UPTRAVI can help delay (slow down) the progression of your disease and lower your risk of being hospitalized for PAH.

Nucala (mepolizumab)

Reblozyl® (luspatercept-aamt)

oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)

Glaxo's Nucala successful in pivotal nasal polyp study

Apr. 3, 2020 9:24 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor
03 April 2020

Nucala (mepolizumab) is the first anti-IL5 biologic to report positive phase 3 results in patients with nasal polyps

https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-is-the-first-anti-il5-biologic-to-report-positive-phase-3-results-in-patients-with-nasal-polyps/
https://www.nucala.com/

Effect of Mepolizumab in Severe Bilateral Nasal Polyps

https://clinicaltrials.gov/ct2/show/NCT03085797?titles=synapse&lead=glaxosmithkline&phase=2&draw=2&rank=1
https://seekingalpha.com/symbol/GSK
https://seekingalpha.com/symbol/BMY

NUCALA is an add-on, prescription maintenance treatment for patients 6 and older with severe eosinophilic asthma. NUCALA is not used to treat sudden breathing problems.

Reblozyl® (luspatercept-aamt)

U.S. Food and Drug Administration (FDA) Approves Reblozyl® (luspatercept-aamt), the First and Only Erythroid Maturation Agent, to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)

Fri April 3, 2020 5:08 PM|Business Wire|About: BMY, XLRN

The FDA approval marks the second indication for Reblozyl and the first new treatment option in over a decade for patients with MDS who require red blood cell (RBC) transfusions and have failed an erythropoiesis stimulating agent

Reblozyl regulates late-stage RBC maturation to relieve patients from the burden of regular RBC transfusions

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Acceleron Pharma Inc. (XLRN) (NASDAQ: XLRN)

http://acceleronpharma.com/

https://media2.celgene.com/content/uploads/reblozyl-pi.pdf

https://www.businesswire.com/news/home/20200403005530/en/

https://seekingalpha.com/symbol/XLRN

Luspatercept-aamt Novel erythroid maturation agent in development for treatment of serious and chronic anemias Luspatercept-aamt is a first-in-class erythroid (red blood cell) maturation agent being developed to treat patients who have serious blood disorders associated with ineffective erythropoiesis.

Ruxolitinib Cream

Reblozyl® (luspatercept-aamt)

Incyte Announces First Presentation of Phase 3 Data from the TRuE-AD Program of Ruxolitinib Cream at the Revolutionizing Atopic Dermatitis Virtual Symposium

Sun April 5, 2020 8:00 AM|Business Wire|About: INCY

- Ruxolitinib cream resulted in a rapid and robust clinical response, with significantly more patients achieving Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS; primary endpoint), defined as an IGA score of 0 (clear) or 1 (almost clear), and EASI75 (key secondary endpoint), defined as the proportion of patients who achieved a ≥ 75% improvement in the Eczema Area and Severity Index Score
- Treatment with ruxolitinib cream also resulted in a rapid, substantial and sustained reduction in itch, a key quality of life measure for patients with atopic dermatitis
- Data support the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration before the end of 2020

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)

https://virtual.revolutionizingad.com/events/6

TRuE AD1 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

https://clinicaltrials.gov/ct2/show/NCT03745638

TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

https://clinicaltrials.gov/ct2/show/NCT03745651

https://www.businesswire.com/news/home/20200405005012/en/

https://seekingalpha.com/symbol/INCY

BRIEF-Incyte Says Phase 3 Data From True-Ad Program Of Ruxolitinib Cream Support Planned Submission Of NDA To US FDA In 2020 April 5 (Reuters) - Incyte Corp:

Seeking Biotech Alpha APRIL/MARCH 2020 Insight

leronlimab (PRO 140)

Sevenfact [coagulation factor VIIa (recombinant)-jncw]

CytoDyn Files a Clinical Trial Protocol with the FDA to Treat Severely Ill COVID-19 Patients with Leronlimab where the Primary Endpoint is Mortality Rate at Two Weeks

Wed April 1, 2020 6:00 AM|GlobeNewswire|About: CYDYGlobeNewswire

VANCOUVER, Washington, April 01, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

https://www.cytodyn.com/

https://www.cytodyn.com/pipeline

https://www.cytodyn.com/newsroom/press-releases/detail/404/cytodyn-files-a-clinical-trial-protocol-with-the-fda-to

https://seekingalpha.com/symbol/CYDY

Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients

Thu April 2, 2020 6:00 AM|GlobeNewswire|About: CYDYGlobeNewswire

VANCOUVER, Washington, April 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

https://seekingalpha.com/pr/17826137-treatment-cytodyns-leronlimab-indicates-significant-trend-toward-immunological-restoration-in

Updates Surrounding Leronlimab Use in Patients With COVID-19 Appear Promising

Apr 09, 2020, 7:51pmDanielle Ternyila

https://www.targetedonc.com/view/updates-surrounding-leronlimab-use-in-patients-with-covid19-appear-promising

Building a Broad Pipeline of Indications

Sevenfact [coagulation factor VIIa (recombinant)-jncw]

FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors

Wed April 1, 2020 1:12 PM|PR NewswirePR Newswire

SILVER SPRING, Md., April 1, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies)

https://www.cdc.gov/ncbddd/hemophilia/data.html

https://www.prnewswire.com/news-releases/fda-approves-additional-treatment-for-adults-and-adolescents-with-hemophilia-a-or-b-and-inhibitors-301033506.html

FDA OKs new hemophilia treatment

Apr. 1, 2020 1:51 PM ET|About: uniQure N.V. (QURE)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3557408-fda-oks-new-hemophilia-treatment

https://www.groupe-lfb.com/en/

MEDICINAL PRODUCTS LFB’s 15 hospital-prescribed biopharmaceuticals are used for treating 80 disorders that are always serious and often rare. LFB has acknowledged expertise in three major therapeutic fields: immunology, intensive care, and haemostasis.

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

Sevenfact [coagulation factor VIIa (recombinant)-jncw]

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

Merck Announces KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival as First-Line Treatment for Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

Thu April 2, 2020 6:45 AM|Business Wire|About: MRK

First Positive Head-to-Head Phase 3 Trial Comparing a Single-Agent Cancer Medicine to Standard of Care Chemotherapy as First-line Treatment for MSI-H or dMMR Colorectal Cancer

Merck (MRK) to Share Data from KEYNOTE-177 with Global Regulatory Authorities and at an Upcoming Medical Congress

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck

Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)

https://clinicaltrials.gov/ct2/show/NCT02563002

https://www.merck.com/index.html

https://www.mrknewsroom.com/news-release/oncology/merck-announces-keytruda-pembrolizumab-significantly-improved-progression-free

https://www.businesswire.com/news/home/20200402005209/en/

How KEYTRUDA works KEYTRUDA is not chemotherapy or radiation therapy—it is an immunotherapy and it works with your immune system to help fight cancer. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

Cologuard® Through Telehealth

Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

Exact Sciences Highlights The Opportunity To Seek Screening With Cologuard® Through Telehealth

Thu April 2, 2020 6:00 AM|PR Newswire|About: EXASPR Newswire

MADISON, Wis., April 2, 2020 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS)

https://www.prnewswire.com/news-releases/exact-sciences-highlights-the-opportunity-to-seek-screening-with-cologuard-through-telehealth-301033897.html

https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html

https://www.exactsciences.com/

https://seekingalpha.com/symbol/EXAS

HOW IT WORKS Cologuard uses a special kind of technology that’s quite innovative. It’s called sDNA (stool DNA) technology and it detects cancer and highest-risk precancers. It makes Cologuard the most accurate, noninvasive colon cancer screening test that you can rely on

PADCEV (enfortumab vedotin-ejfv), combined with Merck's Keytruda (pembrolizumab)

Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®

Seattle Genetics Announces Potential Accelerated Approval Pathway in the U.S. for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Urothelial Cancer

Thu April 2, 2020 8:00 AM|Business Wire|About: SGEN

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN)

https://seekingalpha.com/pr/17826303-seattle-genetics-announces-potential-accelerated-approval-pathway-in-u-s-for-padcev

Seattle Genetics' PADCEV may nab accelerated review for first-line urothelial cancer

Apr. 2, 2020 8:48 AM ET|About: Seattle Genetics, Inc. (SGEN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3557770-seattle-genetics-padcev-may-nab-accelerated-review-for-first-line-urothelial-cancer

https://www.seattlegenetics.com/

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103)

https://clinicaltrials.gov/ct2/show/NCT03288545?term=ev-103&draw=2&rank=1

https://seekingalpha.com/symbol/SGEN

PADCEV Indication PADCEV (enfortumab vedotin-ejfv) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®

Kite Licenses Antibodies and Establishes Collaboration With Teneobio in Multiple Myeloma

Thu April 2, 2020 8:30 AM|Business Wire|About: GILD

-- Kite and Teneobio will Collaborate on Next-Generation Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb® Antibodies --

SANTA MONICA, Calif. & NEWARK, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), and Teneobio, Inc.

https://www.businesswire.com/news/home/20200402005067/en/

https://www.kitepharma.com/

https://www.gilead.com/

https://www.teneobio.com/

https://www.teneobio.com/pipeline/

https://seekingalpha.com/symbol/GILD

NGS-based Discovery of UniAb® and UniDAb®

https://www.teneobio.com/technology/ngs-based-discovery/

April 02, 2020 Kite Licenses Antibodies and Establishes Collaboration With Teneobio in Multiple Myeloma -- Kite and Teneobio will Collaborate on Next-Generation Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb® Antibodies -- SANTA MONICA, Calif. & NEWARK, Calif.--(BUSINESS WIRE)--Apr. 2, 2020-- Kite, a Gilead Company (Nasdaq: GILD), and Teneobio, Inc.

Seeking Biotech Alpha MARCH 2020 Insight

VASCEPA® (Icosapent Ethyl)

Idecabtagene Vicleucel (Ide-cel, bb2121)

XIFAXAN® (rifaximin) 550 mg tablets

Amarin Highlights VASCEPA® (Icosapent Ethyl)-Related Data Presented at American College of Cardiology’s Annual Scientific Session Together With World Congress of Cardiology (ACC.20/WCC)

Tue March 31, 2020 7:00 AM|GlobeNewswire|About: AMRN

DUBLIN, Ireland and BRIDGEWATER, N.J., March 31, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

https://virtual.acc.org/on-demand/acc-videos#nav_jump

https://cslide-us.ctimeetingtech.com/acc2020_eposter/attendee/eposter/poster/157?q=1263-090

https://cslide-us.ctimeetingtech.com/acc2020_eposter/attendee/eposter/poster/367?q=1212-205

https://cslide-us.ctimeetingtech.com/acc2020_eposter/attendee/eposter/poster/388?q=1364-202

https://amarincorp.com/

INDICATION AND IMPORTANT SAFETY INFORMATION

WHAT IS VASCEPA?

VASCEPA is a prescription medicine used:

along with certain medicines (statins) to reduce the risk of heart attack, stroke and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more additional risk factors for heart disease.
along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults.

https://seekingalpha.com/symbol/AMRN

XIFAXAN® (rifaximin) 550 mg tablets

Idecabtagene Vicleucel (Ide-cel, bb2121)

XIFAXAN® (rifaximin) 550 mg tablets

Bausch Health Announces Favorable Topline Results From Study Evaluating Investigative Formulation of Rifaximin SSD IR to Treat Overt Hepatic Encephalopathy

Tue March 31, 2020 7:00 AM|PR Newswire|About: BHC

Study Arm Evaluating 40 MG BID of Rifaximin SSD IR In Combination with Standard of Care Therapy Met Primary Endpoint

LAVAL, Quebec, March 31, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (BHC)

https://www.bauschhealth.com/

https://www.prnewswire.com/news-releases/bausch-health-announces-favorable-topline-results-from-study-evaluating-investigative-formulation-of-rifaximin-ssd-ir-to-treat-overt-hepatic-encephalopathy-301032189.html

https://seekingalpha.com/symbol/BHC

https://www.salix.com/

https://www.bauschhealth.com/news-room/news-releases/news-details/202003310700pr_news_uspr_____ny65880

Idecabtagene Vicleucel (Ide-cel, bb2121)

Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) to FDA

Tue March 31, 2020 6:59 AM|Business Wire|About: BLUE, BMY

BLA submission includes results from pivotal Phase 2 KarMMa study evaluating ide-cel in a heavily pre-treated patient population with relapsed and refractory multiple myeloma

PRINCETON, NJ. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE)

https://www.bluebirdbio.com/

https://www.businesswire.com/news/home/20200331005194/en/

https://seekingalpha.com/symbol/BLUE

In The Pipeline Our pipeline is focused on research in therapeutic areas where we believe we have the best opportunity to deliver transformational medicines to patients.

ADCETRIS® (brentuximab vedotin)

CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate

Idecabtagene Vicleucel (Ide-cel, bb2121)

Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) in Combination with CHP (Cyclophosphamide, Doxorubicin and Prednisone) for Treatment of Adult Patients with Previously Untreated Systemic Anaplastic Large Cell Lymphoma

Tue March 31, 2020 8:00 AM|Business Wire|About: TAK

– Opinion Based on Phase 3 ECHELON-2 Study Which Demonstrated ADCETRIS Plus Chemotherapy Resulted in a Statistically Significant Improvement in Progression-Free Survival Compared to a Standard of Care –

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--

Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)

https://www.adcetris.com/

https://www.takeda.com/investors/

https://www.takeda.com/

https://www.takedaoncology.com/

https://www.businesswire.com/news/home/20200331005020/en/

https://seekingalpha.com/symbol/TAK

What is ADCETRIS? ADCETRIS is a prescription medicine used for the treatment of: Previously untreated Stage 3 or 4 cHL: Adult patients with newly diagnosed Stage 3 or 4 classical Hodgkin lymphoma (cHL) in combination with chemotherapy (adriamycin, vinblastine, and dacarbazine) Consolidation therapy in cHL: Adult patients with cHL at high risk of coming back or becoming worse after a stem cell transplant (SCT) Relapsed cHL: Adult patients with cHL after an SCT fails or after at least 2 combination chemotherapy treatments fail and SCT is not an option Previously untreated sALCL or other CD30-expressing PTCL: Adult patients with newly diagnosed systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with chemotherapy (cyclophosphamide, doxorubicin, and prednisone) Relapsed sALCL: Adult patients with sALCL after at least 1 combination chemotherapy treatment fails Relapsed pcALCL or CD30-expressing MF: Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy (treatment that reaches and affects the entire body)

CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate

FDA Accepts Investigational New Drug Application for CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate Developed Under Collaboration with Intellia Therapeutics

Tue March 31, 2020 7:30 AM|GlobeNewswire|About: NTLA

CAMBRIDGE, Mass., March 31, 2020 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NTLA)

https://www.intelliatx.com/

https://www.intelliatx.com/pipeline-2/

https://www.intelliatx.com/publications-and-presentations-2/

All News 2020 2019 2018 2017 2016 2015 2014

MAR 31, 2020
FDA Accepts Investigational New Drug Application for CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate Developed Under Collaboration with Intellia Therapeutics
CAMBRIDGE, Mass. , March 31, 2020 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA),

https://ir.intelliatx.com/news-releases

https://seekingalpha.com/symbol/NTLA

FDA signs off on study of CRISPR drug for sickle cell disease

Mar. 31, 2020 10:19 AM ET|About: Intellia Therapeutics,... (NTLA)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3556807-fda-signs-off-on-study-of-crispr-drug-for-sickle-cell-disease

What’s CRISPR/Cas9? How CRISPR/Cas9 Works Types of Edits

remdesivir for the treatment of COVID-19

CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate

01-Apr-2020

GILEAD SCIENCES ANNOUNCES TWO PHASE 3 RANDOMISED STUDIES TO EVALUATE THE SAFETY AND ANTIVIRAL ACTIVITY OF REMDESIVIR (GS-5734™) IN PARTICIPANTS WITH MODERATE TO SEVERE COVID-19

Remdesivir is an investigational agent – it is not approved anywhere globally and has not been demonstrated to be safe or effective for any use.
The UK is one of the countries where Gilead is running clinical trials to evaluate remdesivir for the treatment of COVID-19

London, April 1st 2020 – Gilead Sciences

Gilead Sciences launches two remdesivir studies in UK

Apr. 1, 2020 7:57 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3557138-gilead-sciences-launches-two-remdesivir-studies-in-uk

Gilead begins UK trials of COVID-19 drug remdesivir -April 1, 2020 Gilead has begun testing its COVID-19 coronavirus antiviral remdesivir in the UK, announcing plans to trial the drug in patients in England and Scotland.

Seeking Biotech Alpha MARCH 2020 Insight

Evinacumab

NEXLETOL™ (bempedoic acid) Tablet

Taltz® (ixekizumab)

Regeneron Announces American College of Cardiology Presentation of Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol

Mon March 30, 2020 11:46 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., March 30, 2020 /PRNewswire/ --

Results from separate positive Phase 3 trial of Praluent® (alirocumab) in patients with HoFH also presented; FDA regulatory submission planned for Q2 2020

Regeneron Pharmaceuticals, Inc. (REGN) (NASDAQ: REGN)

https://www.nejm.org/doi/full/10.1056/NEJMoa1612790

https://www.prnewswire.com/news-releases/regeneron-announces-american-college-of-cardiology-presentation-of-positive-phase-3-evinacumab-results-in-patients-with-severe-inherited-form-of-high-cholesterol-301031790.html

Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Taltz® (ixekizumab)

NEXLETOL™ (bempedoic acid) Tablet

Taltz® (ixekizumab)

Lilly's Taltz® (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

Mon March 30, 2020 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, March 30, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)

http://pi.lilly.com/us/taltz-uspi.pdf

https://investor.lilly.com/news-releases/news-release-details/lillys-taltzr-ixekizumab-receives-us-fda-approval-treatment-1

https://www.psoriasis.org/content/statistics

https://www.prnewswire.com/news-releases/lillys-taltz-ixekizumab-receives-us-fda-approval-for-the-treatment-of-pediatric-patients-with-moderate-to-severe-plaque-psoriasis-301031305.html

Important Facts About Taltz® (tȯl-ts). It is a prescription medicine also known as ixekizumab. Taltz is an injectable medicine used to treat adults: With moderate to severe plaque psoriasis. It is for people who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). With active psoriatic arthritis. With active ankylosing spondylitis.

NEXLETOL™ (bempedoic acid) Tablet

QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, Detection of SARS-CoV-2 Coronavirus

Esperion Announces Commercial Availability of the NEXLETOL™ (bempedoic acid) Tablet and Pledges a Conscientious Launch During Unprecedented Moment in Healthcare

Mon March 30, 2020 4:15 PM|GlobeNewswire|About: ESPR

– First Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine in the U.S. in Nearly 20 Years for Indicated Patients Awaiting a New Option –
– Esperion Aims to Set New Industry Standard by Pricing NEXLETOL for Patient Affordability and Access –
– Company Repurposes Healthcare Provider Education and Support Material Encouraging Remote Education and Virtual Visits with our Lipid Experts During This Extraordinary Time –

ANN ARBOR, Mich., March 30, 2020 (GLOBE NEWSWIRE) -- Esperion (ESPR)

https://www.esperion.com/

https://pi.esperion.com/nexletol/nexletol-pi.pdf

https://www.esperion.com/product/nexletol/

https://www.esperion.com/investors-media/press-releases/?request=aHR0cHM6Ly9lc3Blcmlvbi5nY3Mtd2ViLmNvbS8vbmV3cy1yZWxlYXNlcy9uZXdzLXJlbGVhc2UtZGV0YWlscy9lc3Blcmlvbi1hbm5vdW5jZXMtY29tbWVyY2lhbC1hdmFpbGFiaWxpdHktbmV4bGV0b2x0bS1iZW1wZWRvaWM=

https://seekingalpha.com/symbol/ESPR

NEXLETOL

QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, Detection of SARS-CoV-2 Coronavirus

FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients

QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, Detection of SARS-CoV-2 Coronavirus

QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, First and Only Syndromic Solution Integrating Detection of SARS-CoV-2 Coronavirus

Tue March 31, 2020 4:05 AM|Business Wire|About: QGEN

First syndromic testing solution to be deployed in epidemic can differentiate novel coronavirus from 21 other serious respiratory infections
QIAstat-Dx Respiratory SARS-CoV-2 Panel delivers results in about one hour
Adds an important tool for clinicians as part of QIAGEN’s global mobilization to scale up testing supplies for the COVID-19 response

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA)

https://www.businesswire.com/news/home/20200331005294/en/

https://www.qiagen.com/us/

https://seekingalpha.com/symbol/QGEN

FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients

FDA Clears CytoDyn’s Phase 2 Randomized Trial to Treat Mild-to-Moderately Ill Coronavirus Patients with Leronlimab; Enrollment to Begin Immediately

Tue March 31, 2020 6:00 AM|GlobeNewswire|About: CYDY

VANCOUVER, Washington, March 31, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

https://www.cytodyn.com/

https://www.cytodyn.com/pipeline

https://seekingalpha.com/symbol/CYDY

Mechanism of Action: Leronlimab as a CCR5 antagonist

EPIDIOLEX® (cannabidiol)

FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients

GW Pharmaceuticals and Greenwich Biosciences Announce FDA Acceptance of sNDA Filing with Priority Review for EPIDIOLEX® (cannabidiol) in the Treatment of Seizures Associated with Tuberous Sclerosis Complex

Tue March 31, 2020 7:00 AM|GlobeNewswire|About: GWPHGlobeNewswire

CARLSBAD, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPRF) (Nasdaq: GWPH)

https://www.gwpharm.com/

https://www.epidiolex.com/

https://seekingalpha.com/symbol/GWPH

https://www.greenwichbiosciences.com/

https://ghr.nlm.nih.gov/condition/tuberous-sclerosis-complex

Seeking Biotech Alpha MARCH 2020 Insight

BRILINTA

Dual-Antiplatelet Therapy

Imfinzi (durvalumab)

BRILINTA reduced bleeding vs dual therapy in high-risk coronary patients in sub-analyses from Phase IV TWILIGHT trial

Mon March 30, 2020 9:16 AM|Business Wire|About: AZN

BRILINTA monotherapy reduced bleeding complications with no increased risk of ischemic events in patients with diabetes undergoing percutaneous coronary intervention

Consistent results were also observed in patients undergoing complex percutaneous coronary intervention

WILMINGTON, Del.--(BUSINESS WIRE)

https://www.azpicentral.com/brilinta/brilinta.pdf#page=1

https://www.astrazeneca-us.com/

https://www.businesswire.com/news/home/20200330005412/en/

Brilinta reduced bleeding vs dual therapy in high-risk coronary patients in sub-analyses from Phase IV TWILIGHT trial

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/brilinta-reduced-bleeding-vs-dual-therapy-in-high-risk-coronary-patients-in-sub-analyses-from-phase-iv-twilight-trial.html

https://www.astrazeneca.com/

Imfinzi (durvalumab)

Dual-Antiplatelet Therapy

Imfinzi (durvalumab)

Imfinzi approved in the US for extensive-stage small cell lung cancer

PUBLISHED30 March 2020

30 March 2020 07:00 BST

Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit in combination with etoposide and a choice of carboplatin or cisplatin chemotherapy

AstraZeneca’s Imfinzi (durvalumab

https://www.astrazeneca.com/our-therapy-areas/oncology.html

Our approach to Oncology

IMFINZI® (durvalumab) is a prescription medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.

Dual-Antiplatelet Therapy

March 30, 2020 10:00 ET | Source: Medtronic plc

Medtronic Onyx ONE Clear Study of One-Month Dual-Antiplatelet Therapy in High Bleeding Risk Stent Patients Beats Performance Goal

DUBLIN, March 30, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT

https://www.medtronic.com/uk-en/index.html

http://newsroom.medtronic.com/news-releases/news-release-details/medtronic-onyx-one-clear-study-one-month-dual-antiplatelet

https://seekingalpha.com/symbol/MDT

WHAT IS BALLOON ANGIOPLASTY AND STENTING? CORONARY ARTERY DISEASE (CAD)

soticlestat (OV935/TAK935)

Agilent Announces New Class 1 Triple Quadrupole LC/MS System

Dual-Antiplatelet Therapy

Ovid Therapeutics Announces Initial Data with Soticlestat in CDKL5 Deficiency Disorder and Dup15q Syndrome

Mon March 30, 2020 8:00 AM|GlobeNewswire|About: OVID

Soticlestat continues to appear to be safe and well-tolerated; the majority of the 11 patients showed a reduction in seizures

All patients that have completed the Phase 2 ARCADE study to date have opted to enroll in the ENDYMION open-label extension study

NEW YORK, March 30, 2020 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (OVID)

https://seekingalpha.com/symbol/TKPHF

https://ovidrx.com/

https://seekingalpha.com/symbol/OVID

A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Participants With 15Q Duplication Syndrome or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)

https://clinicaltrials.gov/ct2/show/NCT03694275?cond=CDKL5+Deficiency+Disorder&phase=1&draw=2&rank=2

A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy (Endymion)

https://clinicaltrials.gov/ct2/show/NCT03635073?cond=CDKL5+Deficiency+Disorder&phase=1&draw=2&rank=1

our pipeline Our deep understanding of human genetics and cellular function enables us to link basic biology to clinical symptoms. In doing so we translate scientific discoveries into meaningful therapies. The Ovid pipeline includes several candidates that would potentially be the first to make a meaningful impact in the lives of individuals with certain rare neurological diseases, and all address significant markets.

Agilent Announces New Class 1 Triple Quadrupole LC/MS System

Mon March 30, 2020 8:00 AM|Business Wire|About: A

Purpose-built and validated for clinical laboratories

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (A) (NYSE: A) today introduced the Agilent K6460S Clinical Edition TQ LC/MS system, designed to improve in vitro diagnostic workflows in clinical labs.

https://www.agilent.com/cs/library/brochures/brochure-clinical-diagnostics-k6460s-lcms-5994-1680en-agilent.pdf

https://www.agilent.com/

https://www.businesswire.com/news/home/20200330005195/en/

https://seekingalpha.com/symbol/A

Agilent Announces New Class 1 Triple Quadrupole LC/MS System Purpose-built and validated for clinical laboratories SANTA CLARA, Calif., March 30, 2020 Agilent Technologies Inc. (NYSE: A) today introduced the Agilent K6460S Clinical Edition TQ LC/MS system, designed to improve in vitro diagnostic workflows in clinical labs.

VASCEPA® (Icosapent Ethyl)

Agilent Announces New Class 1 Triple Quadrupole LC/MS System

Eicosapentaenoic Acid (EPA) Levels From VASCEPA® (Icosapent Ethyl) in REDUCE-IT® Strongly Correlated with Cardiovascular Outcomes

Mon March 30, 2020 11:45 AM|GlobeNewswire|About: AMRN

Serum EPA Levels Showed Approximately 400% Increase Following Administration of VASCEPA
High EPA Levels Associated with Substantial Reductions in Multiple Cardiovascular Endpoints Including Heart Failure and Total Mortality

Amarin to Webcast Discussion of Presented Data March 30, 5:30 - 6:30 p.m., Eastern Time

DUBLIN, Ireland and BRIDGEWATER, N.J., March 30, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

https://amarincorp.com/

https://virtual.acc.org/

https://www.vascepa.com/assets/pdf/Vascepa_PI.pdf

https://seekingalpha.com/symbol/AMRN

INDICATIONS AND LIMITATIONS OF USE VASCEPA® (icosapent ethyl) is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease VASCEPA is indicated as an adjunct to diet to reduce TG levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Seeking Biotech Alpha MARCH 2020 Insight

ZEPOSIA® (ozanimod)

Zolgensma® (onasemnogene abeparvovec)

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of ZEPOSIA® (ozanimod) for the Treatment of Adult Patients with Relapsing Remitting Multiple Sclerosis with Active Disease

Fri March 27, 2020 11:05 AM|Business Wire|About: BMY

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY)

https://www.businesswire.com/news/home/20200327005326/en/

https://packageinserts.bms.com/pi/pi_zeposia.pdf

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of ZEPOSIA® (ozanimod) for the Treatment of Adult Patients with Relapsing Remitting Multiple Sclerosis with Active Disease CATEGORY: CORPORATE/FINANCIAL NEWS FRIDAY, MARCH 27, 2020 11:05 AM EDT

Zolgensma® (onasemnogene abeparvovec)

Zolgensmaonasemnogene abeparvovec

On 26 March 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zolgensma1, intended for the treatment of babies and young children who have a rare, serious inherited condition called spinal muscular atrophy (SMA).

European advisory group backs Novartis gene therapy for SMA

Mar. 27, 2020 9:49 AM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3555880-european-advisory-group-backs-novartis-gene-therapy-for-sma

AveXis receives positive CHMP opinion for Zolgensma®, the only gene therapy for spinal muscular atrophy (SMA) Mar 27, 2020

Cosentyx® (secukinumab)

Zolgensma® (onasemnogene abeparvovec)

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in Five Minutes

Novartis Cosentyx® gains positive CHMP opinion for new indication in the axial spondyloarthritis spectrum

Mar 27, 2020

EMA CHMP positive opinion in non-radiographic axial spondyloarthritis (nr-axSpA) paves way for fourth indication in Europe, and is based on Phase III PREVENT data1
If approved, Cosentyx would become the first fully-human IL-17A inhibitor indicated for patients in Europe with nr-axSpA
There are approximately 1.7 million patients with nr-axSpA in the top five EU countries and US, which forms part of the axial spondyloarthritis (axSpA) disease spectrum2
Cosentyx is backed by five years of clinical data supporting long-term safety and efficacy across ankylosing spondylitis (AS), psoriatic arthritis (PsA) and moderate-to-severe plaque psoriasis (PsO)3-6

Basel, March 27, 2020

COSENTYX® (secukinumab) is a prescription medicine used to treat adults: with moderate to severe plaque psoriasis that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light, alone or with systemic therapy) with active psoriatic arthritis with active ankylosing spondylitis

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in Five Minutes

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in as Little as Five Minutes

Fri March 27, 2020 7:20 PM|PR Newswire|About: ABT

- Test to run on Abbott's point-of-care ID NOW platform - a portable instrument that can be deployed where testing is needed most

- ID NOW has the largest molecular point-of-care installed base in the U.S. and is available in a wide range of healthcare settings

- Abbott will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day

- This is the company's second test to receive Emergency Use Authorization by the FDA for COVID-19 detection; combined, Abbott expects to produce about 5 million tests per month

PR Newswire

ABBOTT PARK, Ill., March 27, 2020 /PRNewswire/ -- Abbott (ABT)

https://www.abbott.com/

https://www.prnewswire.com/news-releases/abbott-launches-molecular-point-of-care-test-to-detect-novel-coronavirus-in-as-little-as-five-minutes-301031213.html

https://seekingalpha.com/symbol/ABT

The test will run on the company's ID NOW™ platform

Abbott Launches 5-Minute Virus Test for Use Almost Anywhere

By Michelle Fay CortezMarch 27, 2020, 7:21 PM EDT Updated on March 28, 2020, 8:28 AM EDT

https://www.bloomberg.com/news/articles/2020-03-27/abbott-launches-5-minute-covid-19-test-for-use-almost-anywhere

ABBOTT LAUNCHES MOLECULAR POINT-OF-CARE TEST TO DETECT NOVEL CORONAVIRUS IN AS LITTLE AS FIVE MINUTES - The Abbott ID NOW™ COVID-19 test brings rapid testing to the front lines - Test to run on Abbott's point-of-care ID NOW platform - a portable instrument that can be deployed where testing is needed most - ID NOW has the largest molecular point-of-care installed base in the U.S. and is available in a wide range of healthcare settings - Abbott will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day - This is the company's second test to receive Emergency Use Authorization by the FDA for COVID-19 detection; combined, Abbott expects to produce about 5 million tests per month

vericiguat

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in Five Minutes

Repatha® (Evolocumab)

Investigational Drug Vericiguat Significantly Reduced the Risk of the Composite Endpoint of Heart Failure Hospitalization or Cardiovascular Death, Compared to Placebo, When Given in Combination with Available Heart Failure Therapies

Sat March 28, 2020 10:00 AM|Business Wire|About: MRK

Phase 3 VICTORIA Trial is the First Contemporary Outcomes Study Focused Exclusively on a Chronic Heart Failure Patient Population Following a Worsening Event

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK),

https://seekingalpha.com/pr/17821566-investigational-drug-vericiguat-significantly-reduced-risk-of-composite-endpoint-of-heart

Merck's vericiguat shows positive effect in large-scale CV outcomes study

Mar. 28, 2020 11:21 AM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor

Merck (NYSE:MRK)

https://seekingalpha.com/news/3520021-merck-and-bayers-vericiguat-successful-in-late-stage-heart-failure-study

https://www.businesswire.com/news/home/20200328005001/en/

A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001) (VICTORIA)

Repatha® (Evolocumab)

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in Five Minutes

Repatha® (Evolocumab)

Amgen Announces Positive Results At ACC.20/WCC From Phase 3B Study Of Repatha® (Evolocumab) In People Living With HIV Who Have High LDL-Cholesterol

Sat March 28, 2020 10:00 AM|PR Newswire|About: AMGN

Repatha is the First PCSK9 Inhibitor to Demonstrate LDL-C Lowering Results in People Living with HIV

PR Newswire

THOUSAND OAKS, Calif., March 28, 2020 /PRNewswire/ -- Amgen (AMGN)

https://www.prnewswire.com/news-releases/amgen-announces-positive-results-at-acc20wcc-from-phase-3b-study-of-repatha-evolocumab-in-people-living-with-hiv-who-have-high-ldl-cholesterol-301031307.html

https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/repatha/repatha_pi_hcp_english.ashx

https://www.amgen.com/

https://www.amgen.com/media/news-releases/2020/03/amgen-announces-positive-results-at-acc20wcc-from-phase-3b-study-of-repatha-evolocumab-in-people-living-with-hiv-who-have-high-ldlcholesterol/

HOW DOES REPATHA® WORK? Repatha® helps the liver clear LDL bad cholesterol by limiting the actions of a protein called PCSK9—and less PCSK9 means less LDL in your blood.

Seeking Biotech Alpha MARCH 2020 Insight

ZEPOSIA® (ozanimod)

Reblozyl® (luspatercept-aamt)

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s ZEPOSIA® (ozanimod), a New Oral Treatment for Relapsing Forms of Multiple Sclerosis

Thu March 26, 2020 6:30 AM|Business Wire|About: BMY

In clinical trials, ZEPOSIA demonstrated efficacy on a key clinical marker of disease activity – annualized relapse rate (ARR) – as compared to AVONEX® (interferon beta-1a)1,2,3

ZEPOSIA is a sphingosine-1-phosphate (S1P) receptor modulator that requires no label-based first dose observation1

ZEPOSIA adds to Bristol Myers Squibb’s legacy immunology franchise and marks the first FDA-approved New Drug Application since the Celgene acquisition

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)

https://packageinserts.bms.com/pi/pi_zeposia.pdf

To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

https://www.clinicaltrials.gov/ct2/show/NCT03915769

https://www.businesswire.com/news/home/20200326005222/en/

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s ZEPOSIA® (ozanimod), a New Oral Treatment for Relapsing Forms of Multiple Sclerosis In clinical trials, ZEPOSIA demonstrated efficacy on a key clinical marker of disease activity – annualized relapse rate (ARR) – as compared to AVONEX® (interferon beta-1a)1,2,3 ZEPOSIA is a sphingosine-1-phosphate (S1P) receptor modulator that requires no label-based first dose observation1 ZEPOSIA adds to Bristol Myers Squibb’s legacy immunology franchise and marks the first FDA-approved New Drug Application since the Celgene acquisition March 26, 2020 06:30 AM Eastern Daylight Time PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY

Reblozyl® (luspatercept-aamt)

New England Journal of Medicine Publishes Results from Pivotal Phase 3 BELIEVE Trial of Reblozyl (luspatercept-aamt) in Adult Patients With Beta Thalassemia

Thu March 26, 2020 6:59 AM|Business Wire|About: BMY, XLRN

Results demonstrate that treatment with Reblozyl provides significant reduction in transfusion burden for patients with beta thalassemia-associated anemia compared to placebo

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE:BMY) and Acceleron Pharma Inc. (XLRN)

https://media.celgene.com/content/uploads/reblozyl-pi.pdf

http://acceleronpharma.com/

A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia (BEYOND)

https://www.clinicaltrials.gov/ct2/show/NCT03342404?term=BEYOND&cond=Beta-Thalassemia

Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Subjects Who Require Regular RBC Transfusions Due to Beta (β)-Thalassemia.

https://clinicaltrials.gov/ct2/show/NCT04143724?term=luspatercept%2C+beta+thalassemia%2C+pediatric&draw=2&rank=1

Efficacy and Safety Study of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions (COMMANDS)

https://www.clinicaltrials.gov/ct2/show/NCT03682536?term=COMMANDS+luspatercept&rank=1

https://www.businesswire.com/news/home/20200326005054/en/

https://seekingalpha.com/symbol/XLRN

New England Journal of Medicine Publishes Results from Pivotal Phase 3 BELIEVE Trial of Reblozyl (luspatercept-aamt) in Adult Patients With Beta Thalassemia Results demonstrate that treatment with Reblozyl provides significant reduction in transfusion burden for patients with beta thalassemia-associated anemia compared to placebo CATEGORY: R&D NEWS THURSDAY, MARCH 26, 2020 6:59 AM EDT

XARACOLL®

Reblozyl® (luspatercept-aamt)

Xofluza® (baloxavir marboxil)

Innocoll Holdings Limited Announces FDA Acceptance of New Drug Application for XARACOLL® for the Management of Postsurgical Pain after Open Inguinal Hernia Surgery

Thu March 26, 2020 12:49 PM|PR NewswirePR Newswire

ATHLONE, Ireland, March 26, 2020 /PRNewswire/ -- Innocoll Holdings Limited,

https://www.prnewswire.com/news-releases/innocoll-holdings-limited-announces-fda-acceptance-of-new-drug-application-for-xaracoll-for-the-management-of-postsurgical-pain-after-open-inguinal-hernia-surgery-301030493.html

https://www.gurnetpointcapital.com/

https://www.innocoll.com/xaracoll/

https://seekingalpha.com/symbol/DRRX

XARACOLL is a novel collagen-matrix implant in late-stage development designed to deliver bupivacaine HCl to the surgical site. XARACOLL has been studied in two Phase III clinical trials for postsurgical analgesia in patients undergoing open inguinal hernioplasty.

Xofluza® (baloxavir marboxil)

FDA Accepts Genentech’s New Drug Application for Xofluza for the Treatment of Influenza in Children

Fri March 27, 2020 2:00 AM|Business Wire|About: RHHBY

– The application seeks approval of a new, additional formulation of Xofluza as granules for oral suspension for people one year of age and older with influenza –

– The FDA also accepts a supplemental New Drug Application for the use of Xofluza for post-exposure prophylaxis, potentially offering Xofluza as a preventive treatment for influenza after exposure to an infected individual –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://www.gene.com/download/pdf/xofluza_prescribing.pdf

https://www.businesswire.com/news/home/20200326005826/en/