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With a mixed bag of results and much at stake for BioMarin’s Duchenne muscular dystrophy treatment drisapersen, FDA reviewers overwhelmingly decided the largest, most complete trial in the drug’s development weakened “promising” findings from earlier studies. Read More
BMS’ Opdivo Wins Expanded Indications Indivior Receives FDA Complete Response Letter for Opioid Overdose Nasal Spray Aduro’s Mesothelioma Candidate Named Orphan Drug in EU EC Grants Expanded Indication to GSK’s PAH Drug Ackman Boosts Stock in Valeant to 9.9 Percent Read More
Eli Lilly scored an FDA approval Tuesday for EGFR inhibitor Portrazza in combination with chemotherapy for second-line treatment in metastatic squamous non-small cell lung cancer. Read More
Two senators are pressing the Department of Health and Human Services to authorize prescription drug importation from Canada to combat price gouging in the marketplace. Read More
On Tuesday, the FDA released the Oct. 22 warning letter issued to Sandoz sites in Kalwe and Turbhe, Maharashtra, India, which Sandoz had earlier hinted at during its third quarter earnings call. With the release of the warning letter, the extent of the data integrity issues are now known. Read More
The FDA has issued a lengthy warning letter to Dr. Reddy’s Laboratories for three India facilities — two in Andhra Pradesh and one in Telangana — for several data integrity and GMP issues that the agency says “represent long-standing failures to adequately resolve significant manufacturing quality problems.” Read More
Pfizer and Allergan announced Monday they have struck an agreement on their rumored merger, joining forces in a massive $160 billion deal that would create the world’s largest drugmaker and combine brand names such as Botox, Lipitor and Viagra. Read More
Two high-profile drugmakers have entered settlement agreements with federal and state justice departments over kickback allegations for prescribing practices. Read More
FDA Grants Cellceutix’s Kevetrin Orphan Drug Designation for Retinoblastoma AGTC Snags Orphan Drug Designation for Achromatopsia Gene Therapy EC Grants Marketing Authorization to Gilead’s HIV-1 Drug EC Grants Two Approvals to Novartis’ Cosentyx Long-Term Survival Benefit Seen in Celldex’s Rintega Read More