Marketwired

International Prix Galien Recognizes SPINRAZA® as Best Biotechnology Product Nov 29, 2018 (BIIB)

CAMBRIDGE, Mass., Nov. 29, 2018 (GLOBE NEWSWIRE) -- Biogen Inc. ( BIIB) has been awarded the 2018 International Prix Galien as Best Biotechnology Product for SPINRAZA (nusinersen), the first and only treatment for spinal muscular atrophy (SMA). The prestigious honor marks the seventh Prix Galien for SPINRAZA, following country recognitions in the U.S., Germany, Italy, Belgium-Luxembourg, the Netherlands and the U.K. The international award was presented at a ceremony in Dakar, Senegal on November 28, 2018. 


 Marketwired  November 29, 2018 

SPINRAZA® (nusinersen)7-10

 Rare disease therapy honored with seven Prix Galien awards, including six independent country recognitions, for innovation in treating spinal muscular atrophy

CAMBRIDGE, Mass., Nov. 29, 2018 (GLOBE NEWSWIRE) -- Biogen Inc. ( BIIB)

 Marketwired 

SPINRAZA is a prescription medicine used to treat spinal muscular atrophy (SMA) in pediatric and adult patients.

seeking biotech alpha October 2018 insight

TruSightTM Oncology 500 (TSO 500)

 Illumina Launches TruSight Oncology 500 to Power Comprehensive, Accurate, Pan-Cancer Tumor Profiling

 SAN DIEGO--(BUSINESS WIRE)--Oct. 30, 2018-- Illumina, Inc. (NASDAQ: ILMN) 

he newest addition to the Illumina oncology portfolio offers researchers the ability to measure Tumor Mutational Burden and Microsatellite Instability, and detect other known and emerging biomarkers October 30, 2018 04:05 PM Eastern Daylight Time SAN DIEGO--(BUSINESS WIRE)--Illumina, Inc. (NASDAQ: ILMN)

Chinese Ministry of Health will issue licenses for 154 new surgical robots

 Intuitive Surgical up 6% on potential upside in China

Oct. 31, 2018 11:08 AM ET|About: Intuitive Surgical, Inc. (ISRG)|By: , SA News Editor 

Da Vinci by Intuitive Enabling surgical care to get patients back to what matters

venetoclax plus obinutuzumab

 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

Wed October 31, 2018 4:14 PM|PR Newswire|About: ABBV 

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

Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab)

 Phase III Data Showed That Venclexta Plus Gazyva Reduced the Risk of Disease Worsening or Death in People With Previously Untreated Chronic Lymphocytic Leukemia With Co-Morbidities

Wed October 31, 2018 4:14 PM|Business Wire|About: RHHBY 

VENCLEXTA is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior treatment.

MYRIMOZ (adalimumab-adaz) HyrimozTM (adalimumab-adaz)

Have you opened a new location, redesigned your shop, or added a new product or service? Don't keep it to yourself, let folks know.

Sandoz receives US FDA approval for biosimilar Hyrimoz(TM) (adalimumab-adaz) Holzkirchen, Germany, October 31, 2018 - Sandoz, a Novartis division

Gilead Sciences, Inc. (GILD) and Tango Therapeutics, Inc.,

 Gilead Sciences and Tango Therapeutics Announce Strategic Collaboration to Develop Next-Generation Targeted Immuno-Oncology Therapies

Wed October 31, 2018 8:30 AM|Business Wire|About: GILD

FOSTER CITY, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and Tango Therapeutics, Inc.

At Tango, we are leveraging the principle of synthetic lethality to develop therapies that take aim at drivers of cancer that have not been approached before.

seeking biotech alpha October 2018 insight

Brolucizumab

 Novartis' brolucizumab shows sustained treatment effect in second year of late-stage wet AMD studies

Oct. 29, 2018 9:32 AM ET|About: Novartis AG (NVS)|By: , SA News Editor  

Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD - Basel, 27 October, 2018

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

 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)

 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)

JNJ- DARZALEX (daratumumab), combined with Celgene's REVLIMID (lenalidomide) and dexamethasone (DRd)

 J & J's Darzalex successful in late-stage study in first-line multiple myeloma

Oct. 30, 2018 6:58 AM ET|By: , SA News Editor 

 Genmab A/S (OTCPK:GNMSF) announces that a Phase 3 clinical trial, MAIA, evaluating licensee Janssen Biotech's (NYSE:JNJ) DARZALEX (daratumumab), combined with Celgene's (NASDAQ:CELG) REVLIMID (lenalidomide) and dexamethasone (DRd), compared to REVLIMID and dexamethasone alone (Rd) in newly diagnosed multiple myeloma patients who are not candidates for high-dose chemo and autologous stem cell transplant (ASCT) met the primary endpoint. 

DARZALEX® is a prescription medicine used to treat multiple myeloma: In combination with the medicines bortezomib, melphalan and prednisone, in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).

seeking biotech alpha October 2018 insight

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

 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

 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

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 October 2018 insight

faricimab (RG7716)

 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)

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  

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

Darolutamide

 Wednesday - October 24, 2018 

Not intended for U.S. and UK Media

Phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer 

meets primary endpoint

 Bayer A.G. ADR (BAYRY) 

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Nonmetastatic Castration-resistant Prostate Cancer (ARAMIS)

brolucizumab (RTH258)

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

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

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

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

Clinical Trials Using Capmatinib

seeking biotech alpha October 2018 insight

Thermo Fisher Scientific (TMO)

 Thermo Fisher Scientific Completes Acquisition of Advanced Bioprocessing from BD

Thu October 25, 2018 7:00 PM|PR Newswire|About: BDX, TMO

WALTHAM, Mass., Oct. 25, 2018 /PRNewswire/ -- Thermo Fisher Scientific Inc. (TMO)

Thermo Fisher Scientific

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

 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: , 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)

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

Oct. 25, 2018 4:27 PM ET|About: BioMarin Pharmaceutica... (BMRN)|By: , 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)

 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.

Seeking biotech alpha October 2018 insight

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.

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

ADCETRIS® (brentuximab vedotin)

  Seattle Genetics Announces Multiple Data Presentations Evaluating ADCETRIS® (Brentuximab Vedotin) in Patients with Hodgkin Lymphoma at ISHL 2018

Fri October 26, 2018 8:00 AM|Business Wire|About: SGEN  TKPYY 

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

 Seattle Genetics and Takeda (TKPHF) are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. 

ADCETRIS® (brentuximab vedotin) is approved for the treatment of: Previously untreated Stage 3 or 4 classical Hodgkin lymphoma (cHL): Adult patients with newly diagnosed Stage 3 or 4 cHL in combination with chemotherapy 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 Relapsed systemic anaplastic large cell lymphoma (sALCL): Adult patients with sALCL after at least 1 combination chemotherapy treatment fails

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

Bristol-Myers Squibb (BMY)

 

  • Bristol-Myers Squibb Reports Third Quarter Financial Results
  • Increases Third Quarter Revenues 8% to $5.7 Billion
  • Posts Third Quarter GAAP EPS of $1.16 and Non-GAAP EPS of $1.09
  • Presents Important New Clinical Data on Novel, Oral, Selective TYK2 Inhibitor for Potential Treatment of Patients with Moderate to Severe Plaque Psoriasis
  • Additional Opdivo Approvals Including for Adjuvant Treatment of Adult Patients with Melanoma in the European Union
  • Updates on Ongoing Regulatory Review of Opdivo Plus Low-Dose Yervoy in First-Line Lung Cancer
  • Updates 2018 GAAP and Non-GAAP EPS Guidance

 THURSDAY, OCTOBER 25, 2018 6:59 AM EDT

NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) 

In 2016, we invested $4.9 billion in R&D, which included the discovery and development of new medicines.

Seeking biotech alpha October 2018 insight

EYLEA® (aflibercept)

 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.

Cystic Fibrosis Research

 AbbVie to Assume Full Development and Commercial Control of Cystic Fibrosis Research Program

 NORTH CHICAGO, Ill., Oct. 24, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), 

AbbVie Pipeline Advanced Medicines That Demonstrate Both Strong Clinical Performance And Strong Economic Value

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.

Merck (NYSE:MRK)

 Merck Announces Increased Fourth-Quarter Dividend and $10 Billion Share Repurchase Authorization

Thu October 25, 2018 6:46 AM|Business Wire|About: MRK 

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

Merck Announces Increased Fourth-Quarter Dividend and $10 Billion Share Repurchase Authorization Increases Quarterly Dividend 15% to $0.55 per Outstanding Share Enters Into a $5 Billion Accelerated Share Repurchase Program Under Expanded Authorization Thursday, October 25, 2018 6:46 am EDT

seeking biotech alpha October 2018 insight

Thermo Fisher Scientific (TMO)

 Thermo Fisher Q3 top line up 16%; non-GAAP EPS up 13%; raises guidance

Oct. 24, 2018 6:34 AM ET|About: Thermo Fisher Scientific Inc. (TMO)|By: , SA News Editor 

Thermo Fisher Scientific (TMO) Q3 results: Revenues: $5,920M (+15.7%); Life Sciences Solutions: $1,504M (+8.8%); Analytical Instruments: $1,333M (+12.1%); Specialty Diagnostics: $894M (+5.9%); Laboratory Products and Services: $2,470M (+27.8%).

Thermo Fisher Scientific Reports Third Quarter 2018 Results. WALTHAM, Mass., Oct. 24, 2018 /PRNewswire/ -- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the third quarter ended September 29, 2018.

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

 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

 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.

Johnson & Johnson Vision

 Johnson & Johnson Vision Supports Patients, Ophthalmology Community Through New Products, Data, Educational Opportunities, and Charitable Giving at the 2018 AAO Annual Meeting

Tue October 23, 2018 1:06 PM|PR Newswire|About: JNJ 

Nearly 285 million people around the world face impaired vision, and 80% of those cases are preventable with early diagnosis and treatment. We are committed to changing these statistics.

seeking biotech alpha 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).

Illumina (ILMN)

 Illumina Q3 top line up 20%; earnings up 22%; guidance raised

Oct. 23, 2018 4:15 PM ET|By: , SA News Editor 

Illumina (NASDAQ:ILMN) Q3 results ($M): Revenue: 853 (+19.5%); Product sales: 710 (+19.1%).

Net income: 199 (+22.1%); non-GAAP net income: 227 (+39.3%); EPS: 1.33 (+19.8%); non-GAAP EPS: 1.52 (+36.9%); cash flow ops: 292 (+24.3%).

Illumina Reports Financial Results for Third Quarter of Fiscal Year 2018 SAN DIEGO--(BUSINESS WIRE)--Oct. 23, 2018-- Illumina, Inc. (NASDAQ: ILMN) today announced its financial results for the third quarter of fiscal year 2018.

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).

seeking biotech alpha October 2018 insight

Innate Pharma (OTCPK:IPHYF)

 AstraZeneca to acquire 9.8% of Innate Pharma

Oct. 23, 2018 7:30 AM ET|About: AstraZeneca Group plc (AZN)|By: , SA News Editor 

Reuters reports that AstraZeneca (NYSE:AZN) will acquire a 9.8% stake in French outfit Innate Pharma (OTCPK:IPHYF) via the purchase of ~6.26M newly issued shares at 10 euros per share.

PIPELINE & TECHNOLOGIES DEVELOPING FIRST-IN-CLASS MONOCLONAL ANTIBODIES FOR CANCER TREATMENTS

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.

CoolSculpting®

 CoolSculpting® And Kristin Davis Partner To Overcome Denim Denial Blues

Tue October 23, 2018 7:30 AM|

PR Newswire|About: AGNPR Newswire

DUBLIN, Oct. 23, 2018 /PRNewswire/ 

The CoolSculpting fat-freezing procedure is the only FDA-cleared,* non-surgical fat-reduction treatment that uses controlled cooling to eliminate stubborn fat that resists all efforts through diet and exercise.

Parkinson’s Disease

 Bain Capital and Pfizer Create Cerevel Therapeutics, New CNS Company

Tue October 23, 2018 8:30 AM|Business Wire|About: PFE

  • Continues Development of Neuroscience Portfolio, Aiming to Bring New Therapies to Patients
  • Company Prepared to Move Lead Asset to Phase 3 in Parkinson’s Disease in 2019

Bain Capital and Pfizer Create Cerevel Therapeutics, New CNS Company

Medopad Global Digital

 Information Mediary Corp Joins Medopad Global Digital Health Platform

Tue October 23, 2018 9:31 AM|PR Newswire|About: AAPL, MDT

LONDON and OTTAWA, Oct. 23, 2018 /PRNewswire/ - Medopad, a health technology company with partners such as Apple (AAPL) and Tencent, is today announcing partnerships with leading health tech companies, including Medtronic (MDT), Information Mediary Corp. and FibriCheck, to unite the fragmented digital health ecosystem.

Medopad apps lead the way to improving every stage of the patient treatment process.

seeking biotech alpha 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)

Upadacitinib (ABT-494)

 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.

Taltz® (ixekizumab)

 ACR 2018: Lilly Announces Positive Results for Two Phase 3 Studies of Taltz® (ixekizumab) in Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

Mon October 22, 2018 3:30 PM|PR Newswire|About: LLY 

Taltz is a prescription medicine used to treat adults with active psoriatic arthritis. Taltz is also a treatment for adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).

Biogen Inc. (BIIB)

 Biogen Q3 revenues up 12%; non-GAAP EPS up 17%

Oct. 23, 2018 6:57 AM ET|About: Biogen Inc. (BIIB)|By: , SA News Editor 

Biogen (BIIB) Q3 results: Revenues: $3,439M (+11.7%); Product Sales: $2,780.1M (+6.0%); Anti-CD20 Revenues: $511.7M (+25.9%); Other: $147.2M.

Net Income: $1,444.4M (+17.8%); Non-GAAP Net Income: $1,494.5M (+11.8%); EPS: $7.15 (+23.5%); Non-GAAP EPS: $7.40 (+17.3%); CF Flow Ops: $1.7B.

BIOGEN Q3 2018 REVENUES INCREASED 12% TO $3.4 BILLION

Johnson & Johnson (JNJ)

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

Oct. 23, 2018 4:58 AM ET|By: , 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

Olumiant® (baricitinib)

 ACR 2018: Lilly Shares Updated Safety Analysis of OLUMIANT® (baricitinib) in Patients with Moderately-to-Severely Active Rheumatoid Arthritis

Sun October 21, 2018 6:30 PM|PR Newswire|About: INCY, LLY 

Olumiant® (baricitinib) is an oral prescription medicine called a Janus kinase (JAK) inhibitor used to treat adults with moderate to severe rheumatoid arthritis (RA) who have not responded well enough to or could not tolerate at least one medicine called a tumor necrosis factor (TNF) antagonist.

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)

 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

seeking biotech alpha October 2018 insight

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 

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.

Entrectinib

 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

DUPIXENT®

 Oct. 20, 2018 5:31 PM ET|About: Regeneron Pharmaceutic... (REGN)|By: , 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

 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 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: , 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)

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: , 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)

IBRANCE (palbociclib) and FASLODEX (fulvestrant)

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

Oct. 20, 2018 6:21 PM ET|By: , 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 October 2018 insight

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

Dengvaxia

 

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.

SYMDEKO® (tezacaftor/ivacaftor and ivacaftor)

 Vertex Data Presented at North American Cystic Fibrosis Conference (NACFC) Demonstrate Rapid Progress Toward Expanding and Enhancing Options for Treating the Underlying Cause of Cystic Fibrosis

Thu October 18, 2018 11:45 AM|Business Wire|About: VRTX 

SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 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

Eye Care Innovation

 Allergan to Showcase Continued Eye Care Innovation with New Data on Investigational Medicines at the American Academy of Ophthalmology Annual Meeting

Fri October 19, 2018 7:30 AM|PR Newswire|About: AGN 


Allergan Product Prescribing and Labeling Information

Intuitive Surgical, Inc. (ISRG)

 Oct. 18, 2018 4:18 PM ET|About: Intuitive Surgical, Inc. (ISRG)|By: , 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.

Temozolomide

 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 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 

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.

Novartis AG (NVS)

 Novartis to Buy Cancer-Drug Maker Endocyte for $2.1 Billion 

Deal is latest by new chief executive to reshape Swiss pharmaceutical giant

By Denise Roland and Donato Paolo ManciniUpdated Oct. 18, 2018 8:20 a.m. ET 

Novartis to Buy Cancer Drugmaker Endocyte for $2.1 Billion By James Paton October 18, 2018, 1:28 AM EDT Updated on October 18, 2018, 1:59 AM EDT

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

Novartis AG (NVS)

 Novartis Q3 top line and non-gaap EPS up 2%

Oct. 18, 2018 6:29 AM ET|About: Novartis AG (NVS)|By: , SA News Editor  

 

Novartis (NVS) Q3 results: Revenues: $12,779M (+2.9%); Innovative Medicines: $8,802M (+6.2%); Sandoz: $2,469M (-5.2%); Alcon: $1,763M (+2.9%).

Net Income: $1,624M (-22.0%); Non-GAAP Net Income: $3,063M (+1.6%); EPS: $0.70 (-21.3%); Non-GAAP EPS: $1.32 (+2.3%); CF Flow Ops: $4,050M (+12.9%).

Q3 2018 Results

seeking biotech alpha October 2018 insight

IMBRUVICA® (ibrutinib) in Combination with Obinutuzumab (GAZYVA®)

 October 17, 2018

AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA® (ibrutinib) in Combination with Obinutuzumab (GAZYVA®) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

IMBRUVICA® works by blocking the activity of a protein called Bruton's tyrosine kinase, or BTK. BTK is a protein involved in communication signals within B cells. By blocking BTK, IMBRUVICA® may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs. BTK is also found in normal B cells, so blocking it may cause side effects.

Talzenna® (Talazoparib)

 BioMarin Receives Milestone Payments from Pfizer for Talzenna® (Talazoparib) for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

FDA Approval Triggers $15 Million Payment

BioMarin Entitled to Earn Mid-Single Digit Royalties on Future Sales

Oct 16, 2018

FDA approves Talzenna for specific breast cancer

DUPIXENT® (DUPILUMAB)

 October 16, 2018 at 12:59 AM EDT Back

DUPIXENT® (DUPILUMAB) SHOWED POSITIVE TOPLINE RESULTS IN TWO PHASE 3 TRIALS OF PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS

TARRYTOWN, N.Y. and PARIS, Oct. 16, 2018 /PRNewswire/ -- 

DUPIXENT is the first biologic for adults with uncontrolled moderate‑to‑severe atopic dermatitis. It is the first treatment of its kind and targets the signaling of IL-4 and IL-13, two of the cytokines involved in the underlying inflammatory process.1,4

Lynparza (olaparib)

 16 October 2018 07:00 BST
Fourth Orphan Drug Designation in the US for AstraZeneca and MSD’s Lynparza
 

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that they were granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for Lynparza (olaparib) for the treatment of pancreatic cancer.

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. Your health care provider will perform a test to make sure that LYNPARZA is right for you

AMGEVITA™ (Biosimilar Adalimumab)

 Amgen Launches AMGEVITA™ (Biosimilar Adalimumab) In Markets Across Europe

Tue October 16, 2018 12:00 AM|PR Newswire|About: AMGN 

Amgen Launches AMGEVITA™ (Biosimilar Adalimumab) In Markets Across Europe Published: Oct 16, 2018

seeking biotech alpha October 2018 insight

Axiom Genotyping Solution

 SANTA CLARA, Calif., Oct. 16, 2018 /PRNewswire/ -- Thermo Fisher Scientific   

Thermo Fisher Scientific Custom Microarrays Drive Large-Scale Genotyping Study of Finnish Population FinnGen, a first-of-its-kind study of 500,000 individuals, combines genomics and health record data to better understand disease origins and improve human health

The Axiom Genotyping Solution is the platform of choice for large-scale genotyping studies

High Sensitive Troponin-I

 ABBOTT PARK, Ill., Oct. 17, 2018 /PRNewswire/  

 New Study Shows Abbott's Novel 

Diagnostic Test has the Potential to Demonstrate Gold Standard Accuracy and Speed, Which Could Help Rule Out Heart Attacks Earlier at the Point of Care

ARCHITECT High Sensitive Troponin-I results may enable an easier management of patients with suspect Acute Myocardial Infarction (AMI)

Taltz® (ixekizumab)

 PR Newswire

INDIANAPOLIS, Oct. 15, 2018 /PRNewswire/ -- Eli Lilly and Company (LLY) announced that it will present new data for Taltz® (ixekizumab) and Olumiant®(baricitinib) at the American College of Rheumatology (ACR)/Association of  

New Data Showcasing Lilly's Growing Commitment in Rheumatology to be Featured at the ACR/ARHP Annual Meeting

Mon October 15, 2018 6:45 AM|PR Newswire|About: LLY 

Taltz is a biologic (injection) prescription medication used to treat adults with active psoriatic arthritis.

Abbott Laboratories (ABT)

 Abbott Laboratories Q3 revenues up 12%; non-GAAP EPS up 14%; narrows guidance

Oct. 17, 2018 8:08 AM ET|About: Abbott Laboratories (ABT)|By: , SA News Editor  

ABBOTT PARK, Ill., Oct. 17, 2018 /PRNewswire/ -- Abbott (NYSE: ABT) today announced financial results for the third quarter ended Sept. 30, 2018.

Jardiance (empagliflozin)

 Oct. 15, 2018 3:26 PM ET|About: CVS Health Corporation (CVS)|By: , SA News Editor 

CVS Health's (CVS -1.5%) Caremark PBM will include Boehringer Ingelheim and Eli Lilly's (LLY +0.8%) type 2 diabetes med Jardiance (empagliflozin) in its 2019 commercial formulary, providing access to its ~94M members.

JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and also to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease. JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine)