• PD-L1/PD,EMD Serono,Anti-PD-L1,MSB0010718C

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, today announced the initiation of an international Phase II study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1).

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  • Janssen,IMBRUVICA,Blood Cancer,CHMP,Medicinal

Janssen-Cilag International NV (Janssen) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a marketing authorisation for IMBRUVICA?

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  • GlaxoSmithKline plc,Flonase,Allergy Relief

GlaxoSmithKline plc today announced that the U.S. Food and Drug Administration (FDA) has approved Flonase? Allergy Relief containing the No. 1

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  • Ryanodex,Eagle Pharmaceuticals,dantrolene sodium,Malignant Hyperthermia

Eagle Pharmaceuticals, Inc. today announced that the FDA has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH).

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  • neratinib,Puma,HER2,PB272,Pfizer,ExteNET trial,Herceptin

Puma Biotechnology, Inc. a development stage biopharmaceutical company, announced top line results from the Phase III clinical trial of Puma's investigational drug PB272 (neratinib) for the extended adjuvant treatment of breast cancer (ExteNET Trial).

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  • Gilead Sciences Inc,Sovaldi,$3.5 billion,hepatitis C drug Sovaldi

Gilead Sciences Inc said on Wednesday that its new hepatitis C drug Sovaldi had sales of $3.5 billion in the second quarter, demonstrating that the furor over its price has not curtailed early use.

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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.