seeking biotech alpha July 2019 & October 2018 insight

TECENTRIQ (atezolizumab) plus ABRAXANE (nab-paclitaxel)

Roche's Tecentriq extends progression-free survival in first-line TNBC

Results from a Phase 3 clinical trial, IMpassion130, evaluating Roche (OTCQX:RHHBY) unit Genentech's TECENTRIQ (atezolizumab) plus Celgene's (NASDAQ:CELG) ABRAXANE (nab-paclitaxel) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) showed a treatment effect. The data were presented at ESMO in Munich.

Oct. 20, 2018 7:28 PM ET|By: Douglas W. House, SA News Edito

TECENTRIQ is a prescription medicine used to treat: A type of bladder and urinary tract cancer called urothelial carcinoma. And -A type of lung cancer called non-small cell lung cancer (NSCLC)

KEYTRUDA® (pembrolizumab)

TECENTRIQ (atezolizumab) plus ABRAXANE (nab-paclitaxel)

Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Pathological Complete Response (pCR) in Pivotal Phase 3 KEYNOTE-522 Trial in Patients with Triple-Negative Breast Cancer (TNBC)

Mon July 29, 2019 6:55 AM|Business Wire|About: MRK

https://www.businesswire.com/news/home/20190729005182/en/

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.

Opdivo (nivolumab) + Yervoy (ipilimumab)

TECENTRIQ (atezolizumab) plus ABRAXANE (nab-paclitaxel)

Opdivo (nivolumab) + Yervoy (ipilimumab)

Unique combination of Opdivo + Yervoy shows encouraging action in Phase 1/2 bladder cancer study

Oct. 20, 2018 6:09 PM ET|By: Douglas W. House, SA News Editor

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Patients With Untreated Inoperable or Metastatic Urothelial Cancer (CheckMate901)

Filgotinib

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

Opdivo (nivolumab) + Yervoy (ipilimumab)

Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting

Sat October 20, 2018 6:30 PM|Business Wire|About: GILD, GLPG

Filgotinib is a highly selective JAK1 inhibitor, discovered and developed by Galapagos using its target and drug discovery technology platform. In more than 1,600 patient years of rheumatoid arthritis (RA) and Crohn's disease clinical study experience, filgotinib has shown a rapid onset of action, potentially best-in-class efficacy and favorable findings on safety and tolerability.

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma

Mon July 29, 2019 6:30 AM|Business Wire|About: MRK

Opinion Granted Based on Significant Overall Survival Benefit for KEYTRUDA in Combination with Axitinib Compared to Sunitinib in Phase 3 KEYNOTE-426 Trial

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

INLYTA is a prescription medicine used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC) when one prior drug treatment regimen for your RCC has not worked.

IBRANCE (palbociclib) and FASLODEX (fulvestrant)

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

Ibrance + Faslodex extends survival in late-stage breast cancer study

Oct. 20, 2018 6:21 PM ET|By: Douglas W. House, SA News Editor

Pfizer (NYSE:PFE) announces overall survival (OS) data from the Phase 3 PALOMA-3 trial evaluating the combination of IBRANCE (palbociclib) and AstraZeneca's (NYSE:AZN) FASLODEX (fulvestrant) in women with HR+/HER2- metastatic breast cancer who progressed on or after prior endocrine therapy, an indication approved in the U.S. in March.

IBRANCE® (palbociclib) is the first FDA-approved medication in a class of therapy called CDK 4/6 inhibitors. Taken in combination with certain hormonal therapies, IBRANCE works to put the brakes on cell growth and division in hormone receptor positive, HER2- metastatic breast cancer.

seeking biotech alpha July 2019 & October 2018 insight

LYNPARZA

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

Tau Morphomer™ inhibitor ( ACI-3024 )

Solo-1 Phase III Trial Demonstrates Lynparza Maintenance Therapy Cut the Risk of Disease Progression or Death by 70% in Patients with Newly-Diagnosed, Advanced BRCA-Mutated Ovarian Cancer

Sun October 21, 2018 10:33 AM|Business Wire|About: AZN

LYNPARZA is a prescription medicine used to treat adults: who have ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy or who have 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

Tau Morphomer™ inhibitor ( ACI-3024 )

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

Tau Morphomer™ inhibitor ( ACI-3024 )

AC Immune Initiates Phase 1 Study of ACI-3024 Small Molecule Tau Morphomer™, an Investigational Treatment for Alzheimer’s Disease

Wed July 17, 2019 7:00 AM|GlobeNewswire|About: ACIU, LLYGlobeNewswire

LAUSANNE, Switzerland, July 17, 2019 (GLOBE NEWSWIRE) -- AC Immune SA (ACIU) (NASDAQ: ACIU)

AC Immune and Lilly Announce License and Collaboration Agreement December 12, 2018 Multi-year agreement focuses on Morphomer tau aggregation inhibitors, for the potential treatment of Alzheimer's disease and other neurodegenerative diseases. AC Immune to receive an initial upfront payment of CHF80 million and will be eligible for CHF60 million in potential near-term development milestones, up to approximately CHF1.7 billion in other potential development, regulatory and commercial milestones, and low double-digit royalties. Lilly to purchase $50 million note, convertible to equity position in AC Immune. Lausanne, Switzerland, and Indianapolis, IN, USA, December 12, 2018 - AC Immune SA (NASDAQ: ACIU) and Eli Lilly and Company (NYSE:LLY)

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Results in Significantly Longer Treatment-Free Survival in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

CATEGORY:

CORPORATE/FINANCIAL NEWSMONDAY, OCTOBER 22, 2018

6:45 AM EDT

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

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work

LOKELMA™ (sodium zirconium cyclosilicate)

RECARBRIO™ (imipenem, cilastatin, and relebactam)

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

AstraZeneca to Present New Data Demonstrating Breadth of Research Portfolio in Renal Disease at ASN Kidney Week 2018

Mon October 22, 2018 7:00 AM|Business Wire|About: AZN

LOKELMA is indicated for the treatment of hyperkalemia in adults. NOW FDA-APPROVED

RECARBRIO™ (imipenem, cilastatin, and relebactam)

FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) For the Treatment of Adults with Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections Where Limited or No Alternative Treatment Options Are Available

Wed July 17, 2019 6:45 AM|Business Wire|About: MRK

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

AzymetricTM platform

RECARBRIO™ (imipenem, cilastatin, and relebactam)

Celgene Selects Lead Oncology Therapeutic Candidate Under Bispecific Antibody Collaboration with Zymeworks

Tue July 16, 2019 8:30 AM|Business Wire|About: ZYME

First of ten potential products built on Zymeworks’ proprietary AzymetricTMplatform
Zymeworks (ZYME) to receive US$7.5 million commercial license payment

VANCOUVER, British Columbia--(BUSINESS WIRE)

https://www.businesswire.com/news/home/20190716005225/en/

Our proprietary platforms: Azymetric™, ZymeLink™, and EFECT™ can be easily used in combination with each other and with existing approaches without compromising manufacturability. Our platforms enables the development next-generation biotherapeutics to result in superior patient outcomes.

seeking biotech alpha July 2019 insight

MitraClip™ heart valve repair device

Abbott Receives U.S. Approval of Next-Generation MitraClip®, Bringing New Enhancements to Abbott's Leading MitraClip Platform

Mon July 15, 2019 12:46 PM|PR

Newswire|About: ABT

- G4 includes new clip sizes and an enhanced leaflet grasping feature

PR Newswire

ABBOTT PARK, Ill., July 15, 2019 /PRNewswire/ -- Abbott (ABT)

EXPLORE THE ABBOTT PORTFOLIO OF STRUCTURAL HEART SOLUTIONS

Intuitive (ISRG)

MitraClip™ heart valve repair device

Intuitive Surgical acquires Schölly Fiberoptic’s robotic endoscope business

Mon July 15, 2019 4:15 PM|GlobeNewswire|About: ISRG

SUNNYVALE, Calif. and DENZLINGEN, Germany, July 15, 2019 (GLOBE NEWSWIRE) -- Intuitive (ISRG)

15/07/19 | Company INTUITIVE SURGICAL ÜBERNIMMT DAS ROBOTIK-ENDOSKOPIE-GESCHÄFT VON SCHÖLLY FIBEROPTIC GMBH

Emgality® (galcanezumab-gnlm)

MitraClip™ heart valve repair device

Emgality® (galcanezumab-gnlm)

AHS 2019: Post-Hoc Analyses of Phase 3 Pivotal Studies of Emgality® (galcanezumab-gnlm) Show Improvements in Daily Functioning and Reductions in Disability in Patients with Chronic and Episodic Migraine

Fri July 12, 2019 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, July 12, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)

October 31, 2018 AbbVie Announces Positive Results from CLL14, a Phase 3 Trial Evaluating a Venetoclax Combination as First-Line Therapy with a Fixed Duration of Treatment in Patients with Chronic Lymphocytic Leukemia

crizanlizumab (SEG101)

Gilead Sciences and Renown Institute for Health Innovation

Emgality® (galcanezumab-gnlm)

FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101)

Jul 16, 2019

FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease, shortening FDA review to six months from standard ten months
Vaso-occlusive crises (also called sickle cell pain crises) are unpredictable and extremely painful events that can lead to serious life-threatening complications and death[1]

Basel, July 16, 2019 -

https://seekingalpha.com/news/3477970-fda-accepts-novartis-application-sickle-cell-med-crizanlizumab

Crizanlizumab (SEG101) HOME » CRIZANLIZUMAB (SEG101) Crizanlizumab (SEG101, formerly SelG1) is an anti-P-selectin antibody being developed by Novartis as a potential treatment of sickle cell anemia.

Dovato (dolutegravir Plus Lamivudine)

Gilead Sciences and Renown Institute for Health Innovation

ViiV Healthcare Announces Phase III Study Meets Primary Endpoint, Demonstrating the Ability to Control HIV-1 With the 2-drug Regimen Dovato (dolutegravir Plus Lamivudine) in Virally Suppressed Patients Switching From a TAF-containing, 3-drug Regimen

Wed July 10, 2019 2:15 AM|Business Wire|About: GSK, PFE

DOVATO is a prescription medicine that is used without other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults who have not received antiretroviral medicines in the past, and without known resistance to the medicines dolutegravir or lamivudine. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS)

Gilead Sciences and Renown Institute for Health Innovation

Gilead Sciences and Renown Institute for Health Innovation Announce Strategic Collaboration to Advance Understanding of Nonalcoholic Steatohepatitis (NASH)

Thu July 11, 2019 8:30 AM|Business Wire|About: GILD

FOSTER CITY, Calif. & RENO, Nev.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and the Renown Institute for Health Innovation (IHI)

Renown is northern Nevada’s healthcare leader and Reno’s only locally owned, not-for-profit health system. We are an entire network of Reno hospitals, urgent care centers, lab services, x-ray and imaging services, primary care doctors and dozens of medical specialties. We help you live a healthier life, and we’re the experts you go to when you are seriously ill or injured. We have more than 6,000 nurses, doctors and care providers dedicated to your health and well-being every day of the year.

seeking biotech alpha July 2019 insight

AbbVie (ABBV) announced today that it has acquired Seattle-based Mavupharma,

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

AbbVie (ABBV) announced today that it has acquired Seattle-based Mavupharma,

AbbVie Enhances Early Stage Oncology Pipeline with Acquisition of Mavupharma

Mon July 15, 2019 8:00 AM|PR Newswire|About: ABBV

NORTH CHICAGO, Ill., July 15, 2019 /PRNewswire/ -- AbbVie (ABBV)

July 15, 2019 AbbVie Enhances Early Stage Oncology Pipeline with Acquisition of Mavupharma

Valoctocogene Roxaparvovec

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

AbbVie (ABBV) announced today that it has acquired Seattle-based Mavupharma,

BioMarin Plans Regulatory Submissions for Marketing Authorization of Valoctocogene Roxaparvovec to Treat Severe Hemophilia A in 4Q 2019 in both U.S. and Europe

Mon July 8, 2019 8:01 AM|PR Newswire|About: BMRN

Late-Breaking Abstract at the 27th International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress Presents 3 Years of Efficacy and Safety of Valoctocogene Roxaparvovec

PR Newswire

SAN RAFAEL, Calif., July 8, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

Valoctocogene Roxaparvovec (BMN 270) for Hemophilia A Valoctocogene roxaparvovec is gene therapy designed for the treatment of Hemophilia A.

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

Array BioPharma Announces Interim Analysis Results from the BEACON CRC Trial of BRAFTOVI + MEKTOVI + Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer at the ESMO 21st World Congress on Gastrointestinal Cancer

Sat July 6, 2019 5:19 AM|PR Newswire|About: ARRY

- Data supports potential to be the first chemotherapy-free, targeted regimen for BRAF-mutant mCRC patients -

- Results were presented in an oral presentation today, July 6, 2019 -

PR Newswire

BOULDER, Colo., July 6, 2019 /PRNewswire/ -- Array BioPharma Inc. (ARRY)

Array Bio's triplet therapy extends survival in late-stage CRC study

Jul. 8, 2019 7:33 AM ET|About: Array BioPharma Inc. (ARRY)|By: Douglas W. House, SA News Editor

BRAFTOVI and MEKTOVI are prescription medicines used together to treat people with a type of skin cancer called melanoma: that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene

Vascepa® (icosapent ethyl)

ALKS 3831 (olanzapine/samidorphan),

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

Amarin Provides Mid-2019 Update, Including Commercialization Plans for Vascepa® and Updates Full Year 2019 Revenue Guidance

Tue July 2, 2019 6:00 AM|GlobeNewswire|About: AMRN

Record Revenue Achieved in 1H19 Primarily Due to Increased Demand for Vascepa
Guidance for Total 2019 Revenue Increased to a Range of $380 to $420 Million from $350 Million Following Unaudited Second Quarter Results Estimated Between $97 and $101 Million, or Between $170 and $174 Million for the First Half of 2019
U.S. Sales Force to Double in Size; Recruiting Commenced
Vascepa sNDA PDUFA Goal Date On-Track for September 28, 2019; Potential for Therapy to Become First Prescription Product Available for Cardiovascular Risk Reduction in Patients with Elevated Triglyceride Levels, Despite Statin Therapy

BEDMINSTER, N.J. and DUBLIN, Ireland, July 02, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

VASCEPA is a prescription medicine used along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults.

ALKS 3831 (olanzapine/samidorphan),

Alkermes Expands Planned New Drug Application for ALKS 3831 to Include Treatment of Bipolar I Disorder

Mon July 15, 2019 7:00 AM|PR Newswire|About: ALKSPR Newswire

DUBLIN, July 15, 2019 /PRNewswire/ -- Alkermes plc (ALKS)

Alkermes Expands Planned New Drug Application for ALKS 3831 to Include Treatment of Bipolar I Disorder -- Following Pre-NDA Meeting With FDA, Company Plans to Submit New Drug Application for Schizophrenia and Bipolar I Disorder Indications in the Fourth Quarter of 2019 -- NEWS PROVIDED BY Alkermes plc Jul 15, 2019, 07:00 ET SHARE THIS ARTICLE DUBLIN, July 15, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS)

XOFLUZA (Baloxavir Marboxil)

ALKS 3831 (olanzapine/samidorphan),

Genentech Announces Positive Results for First Global Phase III Study Investigating One-dose XOFLUZA (Baloxavir Marboxil) in Children With the Flu

Wed July 3, 2019 1:00 AM|Business Wire|About: RHHBY

XOFLUZA is a prescription medicine used to treat the flu (influenza) in people 12 years of age and older who have had flu symptoms for no more than 48 hours.

seeking biotech alpha July 2019 insight

Opicapone

KEYTRUDA® (pembrolizumab)

Alinity™ s System.

Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease

Wed July 10, 2019 4:10 PM|PR Newswire|About: NBIX

- Prescription Drug User Fee Act (PDUFA) Target Action Date Set for April 26, 2020

Opicapone CATECHOL-O-METHYLTRANSFERASE (COMT) INHIBITOR: AN INVESTIGATIONAL TREATMENT FOR PARKINSON’S DISEASE

Alinity™ s System.

KEYTRUDA® (pembrolizumab)

Alinity™ s System.

Abbott Announces FDA Approval of the Alinity™ s System, the Latest Technology for Screening and Protecting the U.S. Blood and Plasma Supply

Thu July 11, 2019 9:00 AM|PR Newswire|About: ABTPR Newswire

ABBOTT PARK, Ill., July 11, 2019 /PRNewswire/ -- Abbott (ABT)

ALINITY SYSTEMS AND PATIENT CARE How diagnostic tests serve as a compass for healthcare

KEYTRUDA® (pembrolizumab)

FDA Accepts Merck’s Supplemental Biologics License Applications for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule for Melanoma and Multiple Other Indications

Tue July 9, 2019 6:45 AM|Business Wire|About: MRK

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

https://www.merck.com/clinical-trials/index.html

KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. 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.

Imfinzi (durvalumab)

ESPEROCT® (Antihemophilic Factor VIII (Recombinant, B-Domain Truncated), PEGylated)

KEYTRUDA® (pembrolizumab)

12 July 2019 07:00 BST

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung cancer (SCLC).

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.

Gilead Sciences, Inc. (GILD) and Galapagos NV (GLPGF)

ESPEROCT® (Antihemophilic Factor VIII (Recombinant, B-Domain Truncated), PEGylated)

Gilead and Galapagos Enter Into Transformative Research and Development Collaboration

Sun July 14, 2019 1:00 PM|Business Wire|About: GILD, GLPG

– Gilead to Make $3.95 Billion Upfront Payment and $1.1 Billion Equity Investment –

– Gilead Gains Access to Galapagos’ Differentiated Drug Discovery Platform and Current and Future Pipeline Outside of Europe –

– Investment Enables Galapagos to Expand and Accelerate Research and Clinical Programs –

– Galapagos Gains Broader Commercialization Role for Filgotinib in Europe and Agrees to Share Equally in Future Development Costs –

– Gilead Agrees to 10-year Standstill –

FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and Galapagos NV (GLPGF)

Gilead to boost Galapagos stake in $5.1B deal Jul. 14, 2019 4:25 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Carl Surran, SA News Editor

ESPEROCT® (Antihemophilic Factor VIII (Recombinant, B-Domain Truncated), PEGylated)

ESPEROCT® is now approved in Canada for the Treatment of Hemophilia A in both Children and Adults

Fri July 12, 2019 7:00 AM|Canada Newswire|About: NVO

New treatment can help Canadians living with hemophilia A better manage their bleeding episodes

TORONTO, July 12, 2019 /CNW/ -

Esperoct®, antihemophilic factor (recombinant), glycopegylated-exei

Seeking biotech alpha July 2019 & October 2018 insight

BMS-986179 With Enhanze®

BAN2401, an anti-amyloid beta protofibril antibody,

BMS-986179 With Enhanze®

Halozyme Announces First Clinical Dosing In Bristol-Myers Squibb's Phase 1 Trial Of BMS-986179 With Enhanze® Technology

Thu October 25, 2018 8:00 AM|PR Newswire|About: BMY, HALO

SAN DIEGO, Oct. 25, 2018 /PRNewswire/ -- Halozyme Therapeutics, Inc. (HALO)

Halozyme’s ENHANZE® drug delivery technology is based on our patented recombinant human hyaluronidase enzyme , rHuPH20 to enable and optimize subcutaneous drug delivery for appropriate co-administered therapies.

Home Hemodialysis Device

BAN2401, an anti-amyloid beta protofibril antibody,

BMS-986179 With Enhanze®

CVS Health Announces Start of Clinical Trial for New Home Hemodialysis Device

Wed July 17, 2019 8:00 AM|PR Newswire|About: CVS

Represents next step in company-wide strategy to help improve kidney disease diagnosis and management

PR Newswire

WOONSOCKET, R.I., July 17, 2019 /PRNewswire/ -- CVS Health (CVS)

CVS Health Announces Start of Clinical Trial for New Home Hemodialysis Device Wednesday, July 17, 2019 HemoCare Hemodialysis System designed for home dialysis to enable patients to benefit from longer treatment as compared to in-center treatments Represents next step in company-wide strategy to help improve kidney disease diagnosis and management WOONSOCKET, R.I., July 17, 2019 /PRNewswire/ -- CVS Health (NYSE: CVS)

BAN2401, an anti-amyloid beta protofibril antibody,

Eisai and Biogen Announce Presentation of Additional Data From the Phase II Clinical Trial of BAN2401 in Early Alzheimer’s Disease at the 2018 Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Thu October 25, 2018 8:31 AM|GlobeNewswire|About: BIIB

TOKYO and CAMBRIDGE, Mass., Oct. 25, 2018 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (BIIB) (Headquarters: Cambridge, Massachusetts, United States

October 25, 2018 at 8:31 AM EDT TOKYO and CAMBRIDGE, Mass., Oct. 25, 2018 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB) (Headquarters: Cambridge, Massachusetts, United States, CEO: Michel Vounatsos, “Biogen”) announced that Eisai presented the latest data from the Phase II clinical study (Study 201) of BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer's disease

enfortumab vedotin

Influenza A & B 2 and Strep A 2 molecular assays

BAN2401, an anti-amyloid beta protofibril antibody,

Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer

Tue July 16, 2019 8:00 AM|PR Newswire|About: ALPMY, SGEN

PR Newswire

TOKYO and BOTHELL, Wash., July 16, 2019 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (SGEN)

https://www.businesswire.com/news/home/20190716005265/en/

Enfortumab vedotin is an antibody-drug conjugate (ADC) composed of an anti-Nectin-4 monoclonal antibody attached to our synthetic cell-killing agent, monomethyl auristatin E (MMAE), a microtubule-disrupting agent, using our proprietary linker technology. Enfortumab vedotin is the first agent to target Nectin-4, which is expressed on many solid tumors, with especially uniform expression on bladder cancers. Preclinical studies showed that enfortumab vedotin effectively binds to target cells, internalizes and induces cell-killing activity. We are co-developing enfortumab vedotin with Astellas.

Influenza A & B 2 and Strep A 2 molecular assays

Abbott Introduces the Next Generation of Influenza A & B and Strep A Assays with Fastest-Ever Time to Molecular Results

Thu October 25, 2018 9:00 AM|PR Newswire|About: ABTPR Newswire

ABBOTT PARK, Ill., Oct. 25, 2018 /PRNewswire/ -- Abbott (NYSE: ABT)

Abbott Introduces the Next Generation of Influenza A & B and Strep A Assays with Fastest-Ever Time to Molecular Results NEW ASSAYS EMPOWER CLINICIANS TO MORE QUICKLY MAKE THE RIGHT DIAGNOSIS AT THE POINT-OF-CARE AND PRESCRIBE THE RIGHT TREATMENT

Stivarga® (regorafenib) and Opdivo® (nivolumab)

Influenza A & B 2 and Strep A 2 molecular assays

Thu July 18, 2019 6:30 AM|Business Wire|About: BMY

Combination of regorafenib and nivolumab vs. regorafenib alone to be evaluated in patients with micro-satellite stable metastatic colorectal cancer
Companies plan indication-seeking trial

WHIPPANY, N.J. & PRINCETON, N.J. & OSAKA, Japan--(BUSINESS WIRE)-- Bayer, Bristol-Myers Squibb Company (BMY) (NYSE: BMY)

Bayer, Bristol-Myers Squibb and Ono Pharmaceutical Enter Into a Clinical Collaboration Agreement to Investigate Stivarga® (regorafenib) and Opdivo® (nivolumab) as Combination Therapy in Patients With Metastatic Colorectal Cancer Combination of regorafenib and nivolumab vs. regorafenib alone to be evaluated in patients with micro-satellite stable metastatic colorectal cancer Companies plan indication-seeking trial July 18, 2019 06:30 AM Eastern Daylight Time WHIPPANY, N.J. & PRINCETON, N.J. & OSAKA, Japan--(BUSINESS WIRE)--Bayer, Bristol-Myers Squibb Company (NYSE: BMY) and Ono Pharmaceutical Co., Ltd. (“Ono”

Seeking Biotech Alpha June 2019 Insight

ZIRABEV™ (bevacizumab-bvzr)

Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, ZIRABEV™ (bevacizumab-bvzr)

Fri June 28, 2019 7:33 AM|Business Wire|About: PFE

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

PFIZER RECEIVES U.S. FDA APPROVAL FOR ITS ONCOLOGY BIOSIMILAR, ZIRABEV™ (BEVACIZUMAB-BVZR) Friday, June 28, 2019 - 7:33am EDT

IMFINZI® (durvalumab)

ZIRABEV™ (bevacizumab-bvzr)

IMFINZI® (durvalumab) Improves Overall Survival at Interim Analysis in the Phase III CASPIAN Trial in 1st-Line Extensive-Stage Small Cell Lung Cancer

Thu June 27, 2019 8:56 AM|Business Wire|About: AZN

Trial showed statistically-significant and clinically meaningful benefit in patients with the most aggressive type of lung cancer

WILMINGTON, Del.--(BUSINESS WIRE)-

SOLIRIS® (eculizumab)

ZIRABEV™ (bevacizumab-bvzr)

Darzalex (daratumumab), combined with Celgene's Revlimid (lenalidomide) and dexamethasone

Alexion Receives FDA Approval of SOLIRIS® (eculizumab) for the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are Anti-Aquaporin-4 (AQP4) Antibody Positive

Thu June 27, 2019 2:11 PM|Business Wire|About: ALXN

- At 48 weeks, 98% of patients treated with SOLIRIS were relapse free compared to 63% of patients receiving placebo -

- SOLIRIS is the first and only FDA approved treatment for this rare, severe, condition that attacks the central nervous system without warning -

BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (ALXN)

SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.

Darzalex (daratumumab), combined with Celgene's Revlimid (lenalidomide) and dexamethasone

Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible

Combination regimen reduced the risk of disease progression or death by 44 percent in newly diagnosed patients who are transplant ineligible
Marks the sixth DARZALEX FDA-approved use in multiple myeloma and second for newly diagnosed patients

HORSHAM, Pa., June 27, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson

DARZALEX® is now approved in combination with the medicines lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)

Victoza® (liraglutide)

Darzalex (daratumumab), combined with Celgene's Revlimid (lenalidomide) and dexamethasone

Revatio® (Sildenafil Citrate)

FDA approves Victoza® for the treatment of type 2 diabetes in children and adolescents aged 10-17 years

PLAINSBORO, N.J., June 17, 2019 /PRNewswire/ -- Novo Nordisk

Novo Nordisk A/S (NVO)

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Victoza® (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine for adults with type 2 diabetes that: along with diet and exercise may improve blood sugar (glucose).

Revatio® (Sildenafil Citrate)

Darzalex (daratumumab), combined with Celgene's Revlimid (lenalidomide) and dexamethasone

Revatio® (Sildenafil Citrate)

Pfizer Announces Results from Phase 3 Trial of Revatio® (Sildenafil Citrate) in Newborns with Persistent Pulmonary Hypertension

Fri June 28, 2019 4:05 PM|Business Wire|About: PFE

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

https://www.businesswire.com/news/home/20190628005244/en/

REVATIO is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%).

seeking biotech alpha July 2019 & October 2018 insight

Stelara® (Ustekinumab)

Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF

New Phase 2 Data Show Stelara® (Ustekinumab) Sustained Improvement in Disease Activity in Adults With Systemic Lupus Erythematosus Through One Year

Janssen presents one-year data from continued Phase 2 lupus study during plenary session at ACR/ARHP 2018 Annual Meeting

CHICAGO, October 23, 2018

STELARA® is a prescription medicine used to treat adults 18 years and older with moderately to severely active Crohn’s disease who have already taken other medicine that did not work well enough or they could not tolerate it. STELARA® is a prescription medicine used to treat adults and children 12 years and older with moderate or severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). STELARA® is a prescription medicine approved to treat adults 18 years and older with active psoriatic arthritis, either alone or with methotrexate.

Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF

Gilead Presents New Data on Biktarvy® for the Treatment of HIV in Women and in Virologically Suppressed Patients With Known Resistance

Mon July 22, 2019 12:00 PM|Business Wire|About: GILD

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)

https://www.gilead.com/news-and-press/press-room/press-releases/2019/7/gilead-presents-new-data-on-biktarvy-for-the-treatment-of-hiv-in-women-and-in-virologically-suppressed-patients-with-known-resistance

BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in adults. It can either be used in people who have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.

Bioinformatics Hub

Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF

Bioinformatics Hub

Intrexon Announces the Formation of Bioinformatics Hub in Munich

Wed October 24, 2018 7:30 AM|PR Newswire|About: XONPR Newswire

GERMANTOWN, Md., Oct. 24, 2018 /PRNewswire/ -- Intrexon Corporation(NASDAQ: XON)

Intrexon Announces the Formation of Bioinformatics Hub in Munich Establishing itself as Intrexon Bioinformatics Germany GmbH (IBG) GERMANTOWN, Md., Oct. 24, 2018 /PRNewswire/ -- Intrexon Corporation (NASDAQ: XON)

Zanubrutinib

F.I.R.S.TTM technology platform

Bioinformatics Hub

BeiGene Announces Acceptance of its New Drug Application in China and Top-Line Pivotal Data for Zanubrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Wed October 24, 2018 7:00 AM|GlobeNewswire|About: BGNE

BEIJING, China, and CAMBRIDGE, Mass., Oct. 24, 2018 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160)

ZANUBRUTINIB: AN INVESTIGATIONAL BTK INHIBITOR Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of BTK that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various lymphomas.

Medtronic SynchroMed™ II pump

F.I.R.S.TTM technology platform

FDA Approves New SynchroMed(TM) II myPTM(TM) Personal Therapy Manager That Enables Patients to Alleviate Unpredictable Pain

(GLOBE NEWSWIRE via COMTEX) --myPTM Allows Patients to Personalize Their Treatment by Delivering On-Demand Boluses, or Drug Doses, Within Therapeutic Limits Set by Their Physician

DUBLIN - October 24, 2018 - Medtronic plc (NYSE:MDT)

The Medtronic SynchroMed™ II pump is part of the SynchroMed II programmable drug infusion system which provides precise drug delivery for chronic therapy for severe spasticity. In addition to the implanted pump, the SynchroMed II infusion system uses a catheter to deliver programmed amounts of Lioresal® Intrathecal (baclofen injection) (a muscle relaxant and antispasticity agent) directly to the intrathecal space and cerebrospinal fluid. The pump and catheter are implanted under the skin.

F.I.R.S.TTM technology platform

BioInvent Announces Selection of First Target Discovered by BioInvent's Proprietary F.I.R.S.TTM Technology Platform Under Collaboration With Pfizer Inc.

Wed July 31, 2019 7:09 AM|PR Newswire|About: PFE

LUND, Sweden, July 31, 2019 /PRNewswire/ -- BioInvent International AB (BOVNF) ("BioInvent" or the "Company") (OMXS: BINV) today announces that Pfizer Inc. (PFE) ("Pfizer") (NYSE: PFE)

https://www.prnewswire.com/news-releases/bioinvent-announces-selection-of-first-target-discovered-by-bioinvents-proprietary-firsttm-technology-platform-under-collaboration-with-pfizer-inc-300893953.html

Pipeline Bioinvent creates value by developing a risk-balanced portfolio of innovative oncology projects

Seeking biotech alpha July 2019 & October 2018 insight

EYLEA® (aflibercept)

Ruxolitinib (Jakafi®)

EYLEA® (aflibercept) Injection Improves Diabetic Retinopathy and Reduces Vision-Threatening Complications in Phase 3 Trial

Thu October 25, 2018 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., Oct. 25, 2018 /PRNewswire/

EYLEA® (aflibercept) Injection is a prescription medicine administered by injection into the eye.

Ruxolitinib (Jakafi®)

FDA Grants Priority Review for Ruxolitinib (Jakafi®) as a Treatment for Patients with Acute Graft-Versus-Host Disease

Thu October 25, 2018 7:30 AM|Business Wire|About: INCY

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

Jakafi is a prescription medicine used to treat people with polycythemia vera who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it. Jakafi is also used to treat certain types of myelofibrosis.

Islatravir (MK-8591)

Ruxolitinib (Jakafi®)

XOFLUZA ™ (BALOXAVIR MARBOXIL)

Merck Announces Presentation of Phase 2b Results for Investigational HIV-1 Therapy Islatravir (MK-8591) at IAS 2019

Wed July 24, 2019 11:00 AM|Business Wire|About: MRK

New Findings from Study Evaluating Islatravir in Combination with Doravirine versus DELSTRIGO™ (doravirine 100 mg/3TC 300 mg/tenofovir disoproxil fumarate 300 mg)

Company Plans to Initiate Phase 3 Trials

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

Merck Announces Presentation of Phase 2b Results for Investigational HIV-1 Therapy Islatravir (MK-8591) at IAS 2019 July 24, 2019 11:00 AM Eastern Daylight Time KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK

XOFLUZA ™ (BALOXAVIR MARBOXIL)

Keytruda (pembrolizumab) and Lenvima (lenvatinib)

XOFLUZA ™ (BALOXAVIR MARBOXIL)

Wednesday, Oct 24, 2018

Genentech Announces FDA Approval of XOFLUZA (Baloxavir Marboxil) for Influenza

First and only single-dose oral medicine approved to treat the flu
XOFLUZA significantly reduced the duration of flu symptoms compared to placebo
First novel proposed mechanism of action to treat the flu in nearly 20 years

South San Francisco, CA -- October 24, 2018 --

XOFLUZA is a prescription medicine used to treat the flu (influenza) in people 12 years of age and older who have had flu symptoms for no more than 48 hours.

Keytruda (pembrolizumab) and Lenvima (lenvatinib)

Merck and Eisai Receive Third Breakthrough Therapy Designation from FDA for KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment

Designation Granted for Potential First-Line Treatment of Patients with Advanced Unresectable Hepatocellular Carcinoma Not Amenable to Locoregional Treatment

Tuesday, July 23, 2019 6:45 am EDT

https://seekingalpha.com/pr/17579041-merck-eisai-receive-third-breakthrough-therapy-designation-fda-keytruda-pembrolizumab-plus

LENVIMA is a prescription medicine that is used to treat certain kinds of cancer. LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing. LENVIMA is used along with another medicine called everolimus to treat advanced renal cell carcinoma (RCC), a type of kidney cancer, after one course of treatment with another anti-cancer medicine. LENVIMA is used by itself as the first treatment for a type of liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery.

Repatha® (Evolocumab)

Keytruda (pembrolizumab) and Lenvima (lenvatinib)

Amgen Makes Repatha® (Evolocumab) Available In The US At A 60 Percent Reduced List Price

THOUSAND OAKS, Calif., Oct. 24, 2018 – Amgen (NASDAQ:AMGN)

Repatha® is a groundbreaking treatment that reduces your risk of having a heart attack or stroke for real. Repatha® is proven to: Dramatically lower your LDL bad cholesterol Significantly drop your risk of having a devastating heart attack or stroke Reduce the need for a stent or open-heart bypass surgery

seeking biotech alpha July 2019 & October 2018 insight

Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pfizer’s Inlyta® (axitinib)

Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pfizer’s Inlyta® (axitinib) Significantly Improved Overall Survival (OS) and Progression-free Survival (PFS) as First-Line Therapy for Advanced or Metastatic Renal Cell Carcinoma

Thu October 18, 2018 6:57 AM|Business Wire|About: MRK

Respiratory and Herpes Antiviral

Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pfizer’s Inlyta® (axitinib)

Gilead Sciences Licenses Respiratory and Herpes Antiviral Research Programs From Novartis

Fri July 19, 2019 8:30 AM|Business Wire|About: GILD

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)

Gilead Sciences Licenses Respiratory and Herpes Antiviral Research Programs From Novartis July 19, 2019 08:30 AM Eastern Daylight Time FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ: GILD

vedolizumab

Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pfizer’s Inlyta® (axitinib)

Alzheimer’s Disease

Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn's Disease

Mon July 22, 2019 1:00 AM|Business Wire|About: TAK

Vedolizumab subcutaneous is currently under review for approval for ulcerative colitis with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA)

OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK) (“Takeda”)

Entyvio (vedolizumab) is indicated for adult patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) who have had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids, or who have had an inadequate response with, lost response to, or were intolerant to an immunomodulator or a tumor necrosis factor (TNF) blocker.1

Alzheimer’s Disease

ZERBAXA® 3g Dose (ceftolozane and tazobactam)

Alzheimer’s Disease

Biogen to Present Data from Alzheimer’s Disease Portfolio at the 2018 Clinical Trials on Alzheimer’s Disease (CTAD) Meeting

Thu October 18, 2018 7:30 AM|GlobeNewswire|About: BIIB

View BIOGEN full pipeline

ZERBAXA® 3g Dose (ceftolozane and tazobactam)

Merck Receives Positive EU CHMP Opinion for ZERBAXA® 3g Dose (ceftolozane and tazobactam) for the Treatment of Adults with Hospital-Acquired Pneumonia (HAP), Including Ventilator-Associated Pneumonia (VAP)

Mon July 29, 2019 4:05 PM|Business Wire|About: MRK

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

ZERBAXA is indicated for the treatment of patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Enterobacter

HUMIRA® (adalimumab)

ZERBAXA® 3g Dose (ceftolozane and tazobactam)

October 18, 2018

AbbVie Announces Global Resolution of HUMIRA® (adalimumab) Patent Disputes with Fresenius Kabi

Adalimumab, sold under the trade name Humira among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis.

seeking biotech alpha July 2019 & October 2018 insight

Tamiflu®

JNJ to open JPOD hub at UPenn’s Pennovation Center in Philadelphia

Kisqali® (ribociclib)

Sanofi signs strategic deal for exclusive US over-the-counter rights to Tamiflu® in Flu Care

Tue July 23, 2019 1:00 AM|GlobeNewswire|About: SNY

Sanofi (SNY) signs strategic deal for exclusive US over-the-counter rights to Tamiflu® in Flu Care

PARIS – July 23, 2019 – Sanofi signed an agreement with Roche for the exclusive over-the-counter (OTC) rights to Tamiflu® for the prevention and treatment of influenza or flu in the US.

Tamiflu is a prescription medicine used to treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than 2 days. Tamiflu can also reduce the chance of getting the flu in people 1 year and older.

Kisqali® (ribociclib)

JNJ to open JPOD hub at UPenn’s Pennovation Center in Philadelphia

Kisqali® (ribociclib)

Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct Phase III trials

Jul 31, 2019

Basel, July 31, 2019 – Novartis today announced Kisqali® (ribociclib) achieved statistically significant improvement in overall survival in the Phase III MONALEESA-3 clinical trial.

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

JNJ to open JPOD hub at UPenn’s Pennovation Center in Philadelphia

Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF)

The University of Pennsylvania Announces Agreement with Johnson & Johnson Innovation to Launch JPOD @ Philadelphia

Pennovation Media Contact: Jennifer Rizzi, Director, Communications, Facilities & Real Estate Services, 215.573.6107, rizzi@upenn.edu

July 18, 2018

University of Pennsylvania announces agreement with Johnson & Johnson Innovation to launch JPOD @ Philadelphia Jennifer Rizzi Writer DATE July 18, 2018 - target opening Nov. 1, 2018 at the university’s Pennovation Center in Philadelphia

Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF)

Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy

Tue October 30, 2018 6:36 AM|Business Wire|About: GILD

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)

BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen for ≥3 months with no history of treatment failure and no known resistance to any component of BIKTARVY.

ALKS 5461 (buprenorphine/samidorphan)

Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF)

ALKS 5461 (buprenorphine/samidorphan)

Alkermes Announces Publication of Phase 3 Data for ALKS 5461 for Adjunctive Treatment of Major Depressive Disorder in Molecular Psychiatry

DUBLIN, Oct. 29, 2018 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)

Mon October 29, 2018 1:13 PM|PR Newswire|About: ALKS

ALKS 5461 Demonstrated Consistent Profile of Antidepressant Activity, Safety and Tolerability in Two Phase 3 Studies -- -- New Drug Application for ALKS 5461 Currently Under FDA Review With Target Action Date of Jan. 31, 2019 -- DUBLIN, Oct. 29, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS)

OTEZLA® (apremilast)

Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF)

ALKS 5461 (buprenorphine/samidorphan)

FDA Approves OTEZLA® (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease

Fri July 19, 2019 1:59 PM|Business Wire|About: CELG

OTEZLA reduced the number and pain of oral ulcers in the 12-week placebo-controlled Phase 3 RELIEF™ study

With this third indication in the U.S., OTEZLA is the first and only treatment approved for oral ulcers associated with Behçet’s Disease

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (CELG)

Otezla® (apremilast) is a prescription medicine approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Otezla is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis.

seeking biotech alpha July 2019 & October 2018 insight

LUTATHERA® (lutetium Lu 177 dotatate)

Novartis' Lutathera showed treatment benefit regardless of liver tumor burden in late-stage study;

Oct. 19, 2018 7:10 AM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor

LUTATHERA® (lutetium Lu 177 dotatate) is a prescription medicine used to treat adults with a type of cancer known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that are positive for the hormone receptor somatostatin, including GEP-NETs in the foregut, midgut, and hindgut.

Kevzara® (sarilumab)

LUTATHERA® (lutetium Lu 177 dotatate)

Kevzara® (sarilumab) Data at the 2018 ACR/ARHP Annual Meeting Provide Additional Insight on Safety and Efficacy in Rheumatoid Arthritis

Fri October 19, 2018 7:00 AM|PR Newswire|About: REGN

KEVZARA® (sarilumab) is an injectable prescription medicine called an interleukin-6 (IL-6) receptor blocker. KEVZARA is used to treat adult patients with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease-modifying antirheumatic drug (DMARD) has been used and did not work well or could not be tolerated.

Bimatoprost Sustained-Release (SR)

LUTATHERA® (lutetium Lu 177 dotatate)

Bimatoprost Sustained-Release (SR)

U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension

Wed July 17, 2019 7:30 AM|PR Newswire|About: AGN

-- Allergan continues advancement in eye care innovation, developing specialized treatments for patients --

PR Newswire

DUBLIN, July 17, 2019 /PRNewswire/ -- Allergan plc (AGN)

U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension -- Filing included data from the Phase 3 ARTEMIS studies, which demonstrated that the majority of patients remained treatment free for at least 1 year following 3 treatments with Bimatoprost Sustained-Release -- -- Allergan continues advancement in eye care innovation, developing specialized treatments for patients --

Intuitive Surgical, Inc. (ISRG)

Bimatoprost Sustained-Release (SR)

Oct. 18, 2018 4:18 PM ET|About: Intuitive Surgical, Inc. (ISRG)|By: Douglas W. House, SA News Editor

Intuitive Surgical (NASDAQ:ISRG) Q3 results ($M): Revenue: 920.9 (+14.0%); Instruments & accessories: 486.3 (+21.2%); Systems: 274.6 (+4.8%); Services: 160.0 (+10.7%).

Net income: 292.5 (-2.0%); non-GAAP net income: 337.0 (+3.7%); EPS: 2.45 (-4.3%); non-GAAP EPS: 2.83 (+1.8%).

da Vinci system shipments: 231 (+36.7%).

Fourth generation da Vinci® Surgical Systems continue to advance Minimally Invasive Surgery (MIS) across a wide spectrum of surgical procedures.1 Flexible configurations, upgradable architecture and a consistent interface distinguish our family of da Vinci systems. Standardization of instruments and components can help manage inventory and improve overall OR efficiency.

Intuitive Surgical, Inc. (ISRG)

Intuitive Surgical raises procedure growth outlook

Oct. 19, 2018 6:50 AM ET|About: Intuitive Surgical, Inc. (ISRG)|By: Douglas W. House, SA News Editor

Intuitive, maker of the da Vinci® Surgical System, was founded with a simple belief: People needing medical intervention should recover as quickly and completely as possible. We’ve dedicated two decades to pioneering an integrated family of minimally invasive, robotic-assisted platforms and services with the goal of helping doctors and hospitals deliver the best outcomes possible to those in their care. Five million da Vinci procedures. 44,000 da Vinci surgeons trained worldwide. And a passion to keep innovating.

Temozolomide

Intuitive Surgical, Inc. (ISRG)

BeiGene Presents Preliminary Clinical Data on PARP Inhibitor Pamiparib in Combination with Low-Dose Temozolomide in Patients with Solid Tumors at European Society for Medical Oncology (ESMO) 2018 Congress

Mon October 22, 2018 7:15 AM|GlobeNewswire|About: BGNE

Temozolomide is used for the treatment of anaplastic astrocytoma and glioblastoma multiforme (GBM), a type of brain tumor. Temozolomide belongs to a class of drugs known as alkylating agents, and is a “pro-drug,” which means it is converted into its cancer-fighting form once inside the body. Temozolomide works by stopping or slowing the growth of cancer cells.

seeking biotech alpha July 2019 & October 2018 insight

IMFINZI® (durvalumab)

Valiant Navion thoracic stent graft

Upadacitinib (ABT-494)

IMFINZI® (durvalumab) US Label Updated With Overall Survival Data in Unresectable, Stage III Non-small Cell Lung Cancer

Mon July 22, 2019 8:00 AM|Business Wire|About: AZN

IMFINZI is the only immunotherapy approved to treat patients in this curative-intent setting following chemoradiation therapy

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

Upadacitinib (ABT-494)

Valiant Navion thoracic stent graft

Upadacitinib (ABT-494)

AbbVie's Upadacitinib Shows Significant Improvements in Physical Function, Pain and Quality of Life as a Monotherapy in Patients with Rheumatoid Arthritis in Phase 3 Patient-Reported Outcomes Data

Tue October 23, 2018 9:00 AM|PR Newswire|About: ABBV

Upadacitinib (ABT-494) is a JAK1 selective inhibitor being investigated to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, atopic dermatitis, psoriatic arthritis and axial SpA.

Valiant Navion thoracic stent graft

EPIDYOLEX™ (cannabidiol oral solution)

FDA OK's Medtronic's Valiant Navion TEVAR device

Oct. 23, 2018 9:20 AM ET|About: Medtronic plc (MDT)|By: Douglas W. House, SA News Editor

Valiant Navion thoracic stent graft receives FDA approval 23rd October 2018 - The US Food and Drug Administration (FDA) has approved Valiant Navion thoracic stent graft system (Medtronic) for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural haematomas, and aortic type B dissections.

EPIDYOLEX™ (cannabidiol oral solution)

GW Pharmaceuticals receives positive CHMP opinion for EPIDYOLEX™ (cannabidiol oral solution) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy

Fri July 26, 2019 6:37 AM|GlobeNewswire|About: GWPH

If approved cannabidiol oral solution will be the first plant-derived cannabis-based medicine to be approved in Europe for the treatment of any form of epilepsy

GW’s cannabidiol oral solution contains highly purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the “high” associated with cannabis

LONDON and CARLSBAD, Calif., July 26, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPRF) (Nasdaq: GWPH)

EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

RUXIENCE™ (RITUXIMAB-PVVR)

EPIDYOLEX™ (cannabidiol oral solution)

Medtronic Partners with Viz.ai

FDA APPROVES PFIZER’S BIOSIMILAR, RUXIENCE™ (RITUXIMAB-PVVR), FOR CERTAIN CANCERS AND AUTOIMMUNE CONDITIONS

Tuesday, July 23, 2019 - 1:48pmEDT

Pfizer Inc. (NYSE:PFE) t

RUXIENCE™ (RITUXIMAB-PVVR)

Medtronic Partners with Viz.ai

EPIDYOLEX™ (cannabidiol oral solution)

Medtronic Partners with Viz.ai

Medtronic Partners with Viz.ai to Accelerate Adoption of New Artificial Intelligence Software in U.S. Stroke Centers

July 22, 2019 | About: MDT +0%

Technology Has the Potential to Save Crucial Time and Increase Access to Lifesaving Stroke Treatments

DUBLIN and SAN FRANCISCO, July 22, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (:MDT)

http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2404287

LVO Stroke Management

seeking biotech alpha July 2919 & October 2018 insight

Rubraca® (rucaparib)

ALUNBRIG® (brigatinib)

Clovis' Rubraca shows positive action in late-stage prostate cancer study

Oct. 19, 2018 7:32 AM ET|About: Clovis Oncology (CLVS)|By: Douglas W. House, SA News Editor

Rubraca® (rucaparib) tablets are a prescription medicine used for: the maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy the treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have certain “BRCA” gene mutations, either inherited (germline) or acquired (somatic), and who have been treated with 2 or more chemotherapy medicines for their cancer.

ALUNBRIG® (brigatinib)

Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer

Fri October 19, 2018 8:00 AM|Business Wire|About: TKPYY

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

HEARTMATE 3™ LVAD

ALUNBRIG® (brigatinib)

Rituxan (Rituximab)

Abbott's HeartMate 3 Heart Pump Now FDA Approved for Advanced Heart Failure Patients Not Eligible for a Heart Transplant

Fri October 19, 2018 9:00 AM|PR Newswire|About: ABT

WITH THE HEARTMATE 3™ LVAD, YOU CAN MAKE A MEANINGFUL DIFFERENCE IN PATIENT LIVES. How your patients live their lives depends on the LVAD you choose. The HeartMate 3 LVAD can now be used for advanced heart failure patients needing short- or long-term mechanical circulatory support (e.g., bridge to transplant (BTT) or myocardial recovery, or destination therapy (DT)).

Rituxan (Rituximab)

VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen.

Rituxan (Rituximab)

FDA Approves Label Update for Genentech’s Rituxan (Rituximab) in Two Rare Forms of Vasculitis

Fri October 19, 2018 11:35 AM|Business Wire|About: RHHBY

Rituxan is a prescription medicine used to treat adults with: Low-grade or follicular CD20-positive Non-Hodgkin's lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment Follicular CD20-positive Non-Hodgkin's lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy Low-grade CD20-positive Non-Hodgkin's lymphoma as a single agent follow-up therapy for patients who did not progress on initial treatment with CVP chemotherapy CD20-positive diffuse large B-cell Non-Hodgkin's lymphoma as an initial treatment in combination with CHOP chemotherapy

Dengvaxia

VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen.

Sanofi receives positive CHMP opinion for dengue vaccine

Paris, France - October 19, 2018 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Sanofi's dengue vaccine, recommending its approval in Europe.

Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur, is a live recombinant tetravalent dengue vaccine, based on the yellow fever 17D vaccine strain, given as a 3-dose series with 6 months between each dose.

VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen.

Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis

Mon July 22, 2019 8:00 AM|Business Wire|About: VRTX

-Application supported by positive results from two global Phase 3 studies in people with CF ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations-

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

https://www.businesswire.com/news/home/20190722005202/en/

SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with SYMDEKO.

seeking biotech alpha October 2018 insight

XIFAXAN® (rifaximin)

ActoBiotics® Lactococcus lactis

XIFAXAN® (rifaximin)

Salix And Alfasigma Will Initiate Late-Stage Program To Study Rifaximin In Patients With Postoperative Crohn's Disease

Mon October 29, 2018 7:00 AM|PR Newswire|About: BHC

Companies Announce Resolution of Outstanding Arbitration

BRIDGEWATER, N.J., Oct. 29, 2018 /PRNewswire/ -- Salix Pharmaceuticals, Inc. ("Salix")

Salix And Alfasigma Will Initiate Late-Stage Program To Study Rifaximin In Patients With Postoperative Crohn's Disease OCTOBER 29, 2018 Companies Announce Resolution of Outstanding Arbitration BRIDGEWATER, N.J., Oct. 29, 2018 /PRNewswire/ -- Salix Pharmaceuticals, Inc. ("Salix")

tropifexor

ActoBiotics® Lactococcus lactis

XIFAXAN® (rifaximin)

Pfizer Announces Clinical Development Agreement with Novartis to Advance the Treatment of NASH

Mon October 29, 2018 2:15 AM|Business Wire|About: NVS, PFE

Pfizer’s investigational therapies, including an Acetyl CoA-Carboxylase (ACC) Inhibitor (PF-05221304, currently in Phase 2), a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor (PF-06865571, Phase 1) and a Ketohexokinase (KHK) Inhibitor (PF-06835919, Phase 2), together with Novartis’s tropifexor, a non-bile acid, Farnesoid X receptor (FXR) agonist.

Joint studies will evaluate one or more of Pfizer’s investigational NASH therapies in combination with Novartis’s FXR agonist for the treatment of the progressive liver disease October 29, 2018 02:15 AM EDT

ActoBiotics® Lactococcus lactis

ActoBio Therapeutics™ Doses First Patient in Phase Ib/IIa Clinical Study of AG019 for the Treatment of Type 1 Diabetes

Mon October 29, 2018 7:30 AM|PR Newswire|About: XONPR Newswire

GHENT, Belgium, Oct. 29, 2018 /PRNewswire/ -- ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation (NASDAQ: XON)

GHENT, Belgium, Oct. 29, 2018 /PRNewswire/ -- ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation (NASDAQ: XON) ActoBio Therapeutics™ Doses First Patient in Phase Ib/IIa Clinical Study of AG019 for the Treatment of Type 1 Diabetes A unique approach to induce immune tolerance using specifically targeted and designed ActoBiotics® Lactococcus lactis engineered to express therapeutic agents.

GalXC™ RNAi technology

Thermo Fisher Scientific Inc. TMO

ActoBiotics® Lactococcus lactis

Lilly and Dicerna Announce RNAi Licensing and Research Collaboration

Mon October 29, 2018 6:00 AM|PR Newswire|About: DRNA, LLY

INDIANAPOLIS and CAMBRIDGE, Mass., Oct. 29, 2018 /PRNewswire/ -- Eli Lilly and Company (LLY) and Dicerna Pharmaceuticals (DRNA)

Lilly and Dicerna Announce RNAi Licensing and Research Collaboration

cabotegravir and rilpivirine

Thermo Fisher Scientific Inc. TMO

ViiV Healthcare's cabotegravir and rilpivirine regimen shows durable treatment effect in mid-stage HIV study

Oct. 29, 2018 7:27 AM ET|By: Douglas W. House, SA News Editor

ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY).

We are an independent, global specialist HIV company that are committed to delivering innovative new options for the care and treatment of people living with HIV/AIDS. Established in 2009 through a unique partnership between GSK and Pfizer, ViiV Healthcare combines the HIV expertise of GSK, Pfizer and Shionogi, who joined in 2012 following a long-term collaboration on the joint development of several novel integrase inhibitors.

Thermo Fisher Scientific Inc. TMO

Thermo Fisher Scientific Opens Newly Expanded Facility in Frederick, Md.

Mon October 29, 2018 8:30 AM|PR Newswire|About: TMOPR Newswire

FREDERICK, Md., Oct. 29, 2018 /PRNewswire/ -- Thermo Fisher Scientific Inc.,

Thermo Fisher Scientific Opens Newly Expanded Facility in Frederick, Md. FREDERICK, Md., Oct. 29, 2018 /PRNewswire/ -- Thermo Fisher Scientific Inc.,

seeking biotech alpha July 2019 & October 2018 insight

faricimab (RG7716)

Nubeqa® (darolutamide)

Repatha® (Evolocumab)

New STAIRWAY Study Data Shows Potential for Extended Durability With Faricimab in Wet Age-Related Macular Degeneration (AMD)

South San Francisco, CA -- October 27, 2018 --

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

RHHBY

Genentech has multiple products on the market for serious or life-threatening medical conditions.

Repatha® (Evolocumab)

Nubeqa® (darolutamide)

Repatha® (Evolocumab)

Amgen Announces New FOURIER Analysis Showing Benefit With Repatha® (Evolocumab) In High-Risk Patients With Established Cardiovascular Disease And Chronic Kidney Disease

THOUSAND OAKS, Calif., Oct. 26, 2018

/PRNewswire/ -- Amgen (NASDAQ:AMGN)

Repatha Results in Consistent

Reductions in LDL-C Levels and Cardiovascular Events in Patients Independent of Kidney Function
Results Presented at American Society of Nephrology Kidney Week 2018

AMGN

Nubeqa® (darolutamide)

FDA approves Bayer's Nubeqa® (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer

- Nubeqa was approved under the FDA's Priority Review designation; approval granted three months ahead of target FDA action date

- Approval based on Phase III ARAMIS trial evaluating the efficacy and safety of Nubeqa plus androgen deprivation therapy (ADT) compared to placebo plus ADT(1)

A prescription medicine used to treat men with prostate cancer that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone, such as androgen deprivation therapy (ADT).

brolucizumab (RTH258)

ZYTIGA® (abiraterone acetate)

Nubeqa® (darolutamide)

Novartis is going after a $5 billion market with a new treatment for vision loss. That's a big threat to Regeneron

Lydia Ramsey 20h - Business Insider
(NVS)

New Novartis Phase III data for brolucizumab demonstrate reliability of 12-week treatment interval - Basel, April 30, 2018

ZYTIGA® (abiraterone acetate)

Court Issues Ruling in ZYTIGA® Patent Infringement Litigation

Fri October 26, 2018 5:48 PM|PR Newswire|About: JNJ

NEW BRUNSWICK, N.J., Oct. 26, 2018 /PRNewswire

ZYTIGA® (abiraterone acetate) is a prescription medicine that is used along with prednisone. ZYTIGA® is used to treat men with prostate cancer that has spread to other parts of the body.

capmatinib

ZYTIGA® (abiraterone acetate)

Novartis' capmatinib shows positive effect in mid-stage lung cancer study

Oct. 22, 2018 10:37 AM ET|By: Douglas W. House, SA News Editor

Novartis in-licensed capmatinib, an oral MET inhibitor, from Incyte (INCY) in 2009.

Clinical Trials Using Capmatinib

seeking biotech alpha July 2019 & October 2018 insight

diroximel fumarate

Aducanumab (BIIB037)

Diroximel Fumarate Demonstrated Significantly Improved Gastrointestinal Tolerability Profile Compared to Dimethyl Fumarate in Patients with Multiple Sclerosis

Tue July 30, 2019 7:30 AM|PR Newswire|About: ALKS, BIIB

PR Newswire

DUBLIN and CAMBRIDGE, Mass., July 30, 2019 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS) and Biogen Inc. (BIIB)

ALKERMES AND BIOGEN ANNOUNCE U.S. FOOD AND DRUG ADMINISTRATION ACCEPTANCE OF DIROXIMEL FUMARATE NEW DRUG APPLICATION FOR MULTIPLE SCLEROSIS February 25, 2019 at 7:30 AM EST DUBLIN, Ireland and CAMBRIDGE, Mass., Feb. 25, 2019 (GLOBE NEWSWIRE) -- Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB)

Aducanumab (BIIB037)

Biogen and Eisai Announce Presentation of Detailed Analyses from the Phase 1b Long-Term Extension Study of Aducanumab at Clinical Trials on Alzheimer’s Disease (CTAD)

Fri October 26, 2018 9:15 AM|GlobeNewswire|About: BIIB

Aducanumab (BIIB037) is being developed by Biogen as a possible Alzheimer’s disease therapy. Alzheimer’s News Today

Oral Semaglutide

Aducanumab (BIIB037)

BioMarin Pharmaceutica (BMRN)

Novo Nordisk's oral semaglutide successful in late-state T2D study

Oct. 26, 2018 9:14 AM ET|About: Novo Nordisk A/S (NVO)|By: Douglas W. House, SA News Editor

Novo Nordisk Pioneer 8 Trial Of Oral Semaglutide Achieved Primary Objective by Reuters Friday, 26 October 2018 12:57 GMT

BioMarin Pharmaceutica (BMRN)

TLR7 agonists vesatolimod (GS-9620) and GS-986

BioMarin Pharmaceutica (BMRN)

BioMarin Pharma Q3 top line up 17%; Vimizim sales up 37%

Oct. 25, 2018 4:27 PM ET|About: BioMarin Pharmaceutica... (BMRN)|By: Douglas W. House, SA News Editor

BioMarin Pharmaceutical (NASDAQ:BMRN) Q3 results ($M): Revenues: 391.7 (+17.2%); Product sales: 386.3 (+29.3%).

VIMIZIM® (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

Regeneron Pharmaceuticals, Inc. (REGN)

TLR7 agonists vesatolimod (GS-9620) and GS-986

October 26, 2018 at 7:00 AM EDT REGENERON RANKED #1 BIOPHARMA EMPLOYER FOR SIXTH TIME BY SCIENCE MAGAZINE

TARRYTOWN, N.Y., Oct. 26, 2018 /PRNewswire/ --

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN

Regeneron Pharmaceuticals, Inc. (REGN)

Our goal is to address serious medical conditions, across multiple and diverse therapeutic areas. Our FDA-approved medicines are only the beginning of our long-term commitment to solve the human body's most complex mysteries.

TLR7 agonists vesatolimod (GS-9620) and GS-986

July 23, 2019

Gilead Announces Latest Data in Ongoing HIV Cure Research Program

– New Studies Evaluate Agents with Potential Role in Eliminating HIV Viral Reservoir –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 23, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD)

Gilead Announces Latest Data in Ongoing HIV Cure Research Program July 23, 2019, 4:00 PM EDT

seeking biotech alpha July 2019 & October 2018 insight

REVLIMID® (lenalidomide)

REVLIMID® (lenalidomide) Demonstrated a Significant Improvement in Progression-Free Survival (PFS) Compared with Observation in a Randomized Study in Patients with Smoldering Multiple Myeloma

Tue October 23, 2018 4:30 PM|Business Wire|About: CELG

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (CELG)

REVLIMID® (lenalidomide) is a prescription medicine, used to treat people with multiple myeloma (MM) in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells).

Verzenio® (abemaciclib)

REVLIMID® (lenalidomide)

Lilly's Verzenio® (abemaciclib) Significantly Extended Life in Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2

07/30/2019

Verzenio is the first and only CDK4 & 6 inhibitor in combination with fulvestrant to achieve statistically significant improvement in overall survival
MONARCH 2 was a Phase 3 study including both pre/peri- and postmenopausal women whose cancer progressed following endocrine therapy

INDIANAPOLIS, July 30, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

Verzenio is a prescription medicine used to treat a type of breast cancer. It is a medicine you can take if: You have a type of breast cancer called HR+/HER2− (hormone receptor positive/human epidermal growth factor receptor 2 negative) and the cancer has spread to other parts of the body (metastasized) Verzenio is given in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, in combination with fulvestrant in women whose disease has progressed after hormonal therapy, or alone in women whose disease has progressed after hormone therapy and prior chemotherapy

TANEZUMAB

REVLIMID® (lenalidomide)

Vedolizumab

Pfizer, Eli Lilly say their non-opioid drug helps reduce osteoarthritis pain

Oct. 23, 2018 7:13 PM ET|About: Eli Lilly and Company (LLY)|By: Carl Surran, SA News Editor

Pfizer (NYSE:PFE) and Eli Lilly (NYSE:LLY) say their jointly developed non-opioid drug met all three primary endpoints of a Phase 3 study in which more than half of osteoarthritis patients reported a significant improvement in pain and function of the knee or hip.

COMPLETE RESULTS FROM FIRST STUDY IN ONGOING PHASE 3 PROGRAM FOR TANEZUMAB DEMONSTRATED SIGNIFICANT IMPROVEMENT IN PAIN AND FUNCTION IN OSTEOARTHRITIS PATIENTS OVER HALF OF PATIENTS TREATED WITH TANEZUMAB REPORTED A 50 PERCENT OR GREATER REDUCTION IN OSTEOARTHRITIS PAIN OF THE KNEE OR HIP PFIZER AND LILLY PRESENT LATE-BREAKING DATA AT 2018 ACR/ARHP ANNUAL MEETING Tuesday, October 23, 2018 - 6:40pm EDT NEW YORK & INDIANAPOLIS-- Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY)

Vedolizumab

INGREZZA® (valbenazine)

Vedolizumab

Investigational Subcutaneous Formulation of Vedolizumab Achieves and Maintains Clinical Remission and Mucosal Healing at Week 52 in Patients with Moderately to Severely Active Ulcerative Colitis

October 22, 2018 Osaka, Japan

Vedolizumab (trade name Entyvio) is a monoclonal antibody developed by Millennium Pharmaceuticals, Inc (a subsidiary of Takeda Pharmaceuticals) for the treatment of ulcerative colitis and Crohn's disease.

INGREZZA® (valbenazine)

Neurocrine Biosciences to Present New Data Analyses on the Long-Term Effects of INGREZZA® (valbenazine) in Tardive Dyskinesia Patients with Mood Disorders at the 2018 Annual Psych Congress

Tue October 23, 2018 4:01 PM|PR Newswire|About: NBIXPR Newswire

SAN DIEGO, Oct. 23, 2018 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX)

INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

Takeda (TKPYY)

INGREZZA® (valbenazine)

Takeda signs $50m Crohn’s deal with French biotech Enterome

Takeda Pharmaceutical Co., which has a major presence in Massachusetts, is based in Japan.

By Jonathan Saltzman GLOBE STAFF OCTOBER 23, 2018

23RD OCTOBER 2018 PRESS RELEASES 2018 EB8018, the lead investigational candidate, targets Crohn’s disease with potential for other GI disorders Paris, France and Cambridge, MA, USA – October 23, 2018 ENTEROME SA, a clinical-stage biotech company developing innovative therapies to treat microbiome-associated diseases with a focus on auto-immune disease and cancer, has entered into a global licensing, co-development and co-promotion agreement with Takeda Pharmaceutical Company Limited (“Takeda”). The agreement covers Enterome’s lead investigational drug candidate EB8018 in patients with Crohn’s disease, with the potential to expand to other gastrointestinal (GI) disorders and liver diseases.

seeking biotech alpha July 2019 & October 2018 insight

dapirolizumab pegol (DZP)

BRUSSELS, Belgium and CAMBRIDGE, Mass., Oct. 23, 2018 (GLOBE NEWSWIRE) -- Today UCB (Euronext Brussels: UCB) and Biogen Inc (BIIB). (Nasdaq: BIIB) announced top-line results from a Phase 2b study evaluating the safety and efficacy of dapirolizumab pegol (DZP), an anti-CD40L pegylated Fab, in adults with moderately-to-severely active systemic lupus erythematosus (SLE) despite receiving standard-of-care treatment such as corticosteroids, anti-malarials and non-biological immunosuppressants.

UCB AND BIOGEN ANNOUNCE TOPLINE RESULTS FROM A PHASE 2B STUDY OF DAPIROLIZUMAB PEGOL IN SYSTEMIC LUPUS ERYTHEMATOSUS October 23, 2018 at 1:00 AM EDT BRUSSELS, Belgium and CAMBRIDGE, Mass., Oct. 23, 2018 (GLOBE NEWSWIRE)

LYNPARZA

dapirolizumab pegol (DZP)

AstraZeneca's Lynparza shows positive effect in late-stage ovarian cancer study;

Oct. 22, 2018 3:41 PM ET|About: AstraZeneca Group plc (AZN)|By: Douglas W. House, SA News Editor

LYNPARZA is a type of targeted therapy called a PARP inhibitor. LYNPARZA can be used to help keep recurrent ovarian cancer from coming back or getting worse after it has responded to chemotherapy. This is called maintenance treatment.

Upadacitinib (ABT-494)

dapirolizumab pegol (DZP)

BAQSIMI™ (glucagon) Nasal Powder 3 mg

Positive Phase 2b Data for AbbVie's Upadacitinib Show Significant Induction of Clinical Remission and Response in Patients with Ulcerative Colitis

Mon October 22, 2018 6:01 PM|PR Newswire|About: ABBV

Upadacitinib (ABT-494) is a JAK1 selective inhibitor being investigated to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, atopic dermatitis, psoriatic arthritis and axial SpA.

BAQSIMI™ (glucagon) Nasal Powder 3 mg

BAQSIMI™ (glucagon) Nasal Powder 3 mg, the First and Only Nasally Administered Glucagon to Treat Severe Hypoglycemia in Adults and Children with Diabetes Ages Four Years and Older, Approved by FDA

Wed July 24, 2019 11:19 PM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, July 24, 2019 /PRNewswire/ -

FDA NEWS RELEASE July 24, 2019 FDA approves first treatment for severe hypoglycemia that can be administered without an injection

Biogen Inc. (BIIB)

BAQSIMI™ (glucagon) Nasal Powder 3 mg

Johnson & Johnson (JNJ)

Biogen Inc. 2019 Q2 - Results - Earnings Call Slides

Jul. 23, 2019 12:39 PM ET|1 comment | About: Biogen Inc. (BIIB)

BIOGEN Q2 2019 REVENUES INCREASED 8% TO $3.6 BILLION GAAP diluted EPS increased 88%; Non-GAAP diluted EPS increased 58% Company raises full year 2019 financial guidance New results from NURTURE study demonstrated compelling efficacy of SPINRAZA Company completed acquisition of Nightstar Therapeutics Cambridge, Mass., July 23, 2019 -- Biogen Inc. (Nasdaq: BIIB)

Johnson & Johnson (JNJ)

BAQSIMI™ (glucagon) Nasal Powder 3 mg

Johnson & Johnson (JNJ)

J&J makes $2.1B offer to buy out Ci:z

Oct. 23, 2018 4:58 AM ET|By: Yoel Minkoff, SA News Editor

JNJ

Ci:z Holdings Co., Ltd. Conception, development, manufacture and sale of cosmetics, health food, beauty care devices and other products

seeking biotech alpha October 2018 insight

IBRANCE® (palbociclib)

pemigatinib (INCB54828)

IBRANCE® (palbociclib)

Pfizer Presents Overall Survival Data From PALOMA-3 Trial of IBRANCE® (palbociclib) in Patients With HR+, HER2- Metastatic Breast Cancer

Sat October 20, 2018 10:30 AM|Business Wire|About: PFE

Entrectinib

pemigatinib (INCB54828)

IBRANCE® (palbociclib)

Genentech’s Investigational Personalized Medicine Entrectinib Shrank Tumors in People with NTRK Fusion-Positive Solid Tumors

Sun October 21, 2018 5:00 AM|Business Wire|About: RHHBY

Genentech’s Investigational Personalized Medicine Entrectinib Shrank Tumors in People with NTRK Fusion-Positive Solid Tumors

pemigatinib (INCB54828)

Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma

Sun October 21, 2018 6:45 AM|Business Wire|About: INCY

WILMINGTON, Del.--(BUSINESS WIRE)--Oct 21, 2018--Incyte Corporation (Nasdaq:INCY) announces updated data from its ongoing Phase 2 FIGHT-202 trial evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) who failed at least one previous treatment. In patients with FGFR2 translocations who were followed for at least eight months, interim study results demonstrated an overall response rate (ORR) of 40 percent, the primary endpoint, and a median progression free survival (PFS) of 9.2 months, a key secondary endpoint.

DUPIXENT®

Larotrectinib

pemigatinib (INCB54828)

Oct. 20, 2018 5:31 PM ET|About: Regeneron Pharmaceutic... (REGN)|By: Douglas W. House, SA News Editor

The FDA approves Regeneron Pharmaceuticals (NASDAQ:REGN) and development partner Sanofi's (NYSE:SNY) DUPIXENT (dupilumab) as add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

DUPIXENT is a prescription medicine used to treat adult patients 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.

Larotrectinib

Larotrectinib Delivers 81% Overall Response Rate in an Expanded Dataset of 109 TRK Fusion Cancer Patients Across Ages and Tumor Types

Sun October 21, 2018 5:12 AM|PR Newswire|About: LOXO

Our lead therapy in clinical development, larotrectinib, is an oral and selective inhibitor of tropomyosin receptor kinases (TRK), a family of signaling proteins that play an important role in cellular communication and tumor growth.

TEVA

Larotrectinib

Sun October 21, 2018 8:23 AM|Business Wire|About: TEVA

PARSIPPANY, N.J.--(BUSINESS WIRE)-

Teva and New Jersey Governor Murphy Formalize North America Headquarters Move with Ceremony in Israel

Teva Specialty Pipeline -Pipeline is current as of April 2018

seeking biotech alpha is biotecMAX 生物技术最大 8/14/2020 the heart of biotech

seeking biotech alpha July 2019 & October 2018 insight

TECENTRIQ (atezolizumab) plus ABRAXANE (nab-paclitaxel)

TECENTRIQ (atezolizumab) plus ABRAXANE (nab-paclitaxel)

TECENTRIQ (atezolizumab) plus ABRAXANE (nab-paclitaxel)

KEYTRUDA® (pembrolizumab)

TECENTRIQ (atezolizumab) plus ABRAXANE (nab-paclitaxel)

TECENTRIQ (atezolizumab) plus ABRAXANE (nab-paclitaxel)

Opdivo (nivolumab) + Yervoy (ipilimumab)

TECENTRIQ (atezolizumab) plus ABRAXANE (nab-paclitaxel)

Opdivo (nivolumab) + Yervoy (ipilimumab)

Filgotinib

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

Opdivo (nivolumab) + Yervoy (ipilimumab)

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

IBRANCE (palbociclib) and FASLODEX (fulvestrant)

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

seeking biotech alpha July 2019 & October 2018 insight

LYNPARZA

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

Tau Morphomer™ inhibitor ( ACI-3024 )

Tau Morphomer™ inhibitor ( ACI-3024 )

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

Tau Morphomer™ inhibitor ( ACI-3024 )

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

LOKELMA™ (sodium zirconium cyclosilicate)

RECARBRIO™ (imipenem, cilastatin, and relebactam)

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

RECARBRIO™ (imipenem, cilastatin, and relebactam)

RECARBRIO™ (imipenem, cilastatin, and relebactam)

RECARBRIO™ (imipenem, cilastatin, and relebactam)

AzymetricTM platform

RECARBRIO™ (imipenem, cilastatin, and relebactam)

RECARBRIO™ (imipenem, cilastatin, and relebactam)

seeking biotech alpha July 2019 insight

MitraClip™ heart valve repair device

MitraClip™ heart valve repair device

MitraClip™ heart valve repair device

Intuitive (ISRG)

MitraClip™ heart valve repair device

MitraClip™ heart valve repair device

Emgality® (galcanezumab-gnlm)

MitraClip™ heart valve repair device

Emgality® (galcanezumab-gnlm)

crizanlizumab (SEG101)

Gilead Sciences and Renown Institute for Health Innovation

Emgality® (galcanezumab-gnlm)

Dovato (dolutegravir Plus Lamivudine)

Gilead Sciences and Renown Institute for Health Innovation

Gilead Sciences and Renown Institute for Health Innovation

Gilead Sciences and Renown Institute for Health Innovation

Gilead Sciences and Renown Institute for Health Innovation

Gilead Sciences and Renown Institute for Health Innovation

seeking biotech alpha July 2019 insight

AbbVie (ABBV) announced today that it has acquired Seattle-based Mavupharma,

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

AbbVie (ABBV) announced today that it has acquired Seattle-based Mavupharma,

Valoctocogene Roxaparvovec

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

AbbVie (ABBV) announced today that it has acquired Seattle-based Mavupharma,

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

Vascepa® (icosapent ethyl)

ALKS 3831 (olanzapine/samidorphan),

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

ALKS 3831 (olanzapine/samidorphan),

ALKS 3831 (olanzapine/samidorphan),

ALKS 3831 (olanzapine/samidorphan),

XOFLUZA (Baloxavir Marboxil)

ALKS 3831 (olanzapine/samidorphan),

ALKS 3831 (olanzapine/samidorphan),

seeking biotech alpha July 2019 insight

Opicapone

KEYTRUDA® (pembrolizumab)