• Amgen,blinatumomab,cancer

Amgen ($AMGN) is following through with a new drug application for its leukemia drug blinatumomab, hoping that promising Phase II data will be enough to push this program past the goal line on a greatly accelerated development schedule.

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  • Eylea,Bayer,Ministry of Health

Bayer announced Monday that the approval by Japan's Ministry of Health, Labour and Welfare was based on positive data from the Phase III MYRROR study in myopic CNV in which patients' vision improved markedly in 24 weeks.

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  • Gilead,Zydelig,Europe

The approval puts Gilead well on track to meet analyst expectations that Zydelig (idelalisib) will be hauling in $1.2 billion in annual sales by 2020, though there's little doubt Gilead will face pressure from European health agencies to keep a lid on the new drug's price.

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  • Merck & Co., Inc.,Merck,Tildrakizumab

Merck & Co., Inc. announced an exclusive worldwide licensing agreement for Merck’s investigational therapeutic antibody candidate, tildrakizumab, (MK-3222), which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment.

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  • Amgen,SHIFT,heart failure

Amgen (NASDAQ:AMGN) today announced data from the Phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study evaluating ivabradine in patients with chronic heart failure (HF) were presented at the 18th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Las Vegas.

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  • Gilead,Sovaldi,license

Gilead Sciences has reached a deal with several generic drugmakers to produce a cheaper version of its popular, $1,000-per-pill hepatitis C drug Sovaldi for use in developing countries.

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  • RNA,Allied,RNAi,Market Research

Market research firm Allied Market Research forecasts that RNA-based therapies will generate $1.2 billion in revenue by 2020, a compounded annual growth rate of 28.4%, according to a recent report.

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  • Johnson & Johnson,J&J,Zytiga,Medivation

The FDA has approved Medivation and Astellas' rival, Xtandi, for use in prostate cancer patients before chemo, giving the pill a head-to-head shot at J&J's blockbuster.

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Recent News

Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence

Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.

Sanofi and Regeneron Announce Sarilumab Biologics License Application Accepted for Review by US FDA

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab.

First data backs efficacy of BMS' novel HIV drug

A Bristol-Myers Squibb (BMS) drug that causes immature HIV particles to be released from cells early, interrupting their lifecycle, has cleared a proof-of-concept study.

EU Rules Could Restrict Genetic Testing

Genetic testing describes the application of laboratory methods to look at a person’s genes (the inherited DNA instructions). Genetic tests can be used to diagnose a genetic condition; screen for a risk of developing a particular health problems; for the selection of treatments; or to assess responses to treatments.

CHMP adopts positive opinion of Edurant in adolescents with HIV-1

The CHMP has adopted a positive opinion recommending a change to the terms of the marketing authorisation for Janssen’s Edurant (rilpivirine) in the EU to extend the indication to adolescent patients aged 12 to <18 years with human immunodeficiency virus-1 (HIV-1) infection

FDA finds mystery 'deficiencies' with Neos' long-acting Ritalin on the eve of approval

Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.

Pfizer's once-failed cancer drug wins the FDA's 'breakthrough' tag

Pfizer has found new hope for a former pipeline standout, picking up the FDA's coveted breakthrough therapy designation for a Phase III reclamation project in oncology.