PharmTech News

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

After Valsartan Recalls, Regulators Grapple with Nitrosamine Contamination in APIs

Emergent BioSolutions is set to acquire Adapt Pharma, a pharmaceutical company focused on addressing the opioid overdose and addiction crisis, in a deal worth up to $735 million.

Emergent to Acquire Opioid-Focused Adapt Pharma in Deal Worth $735 Million

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.

Novartis to Sell Parts of Sandoz in $1-Billion Deal

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

FDA Expands NDMA Investigation to All ARB Class Drugs

Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.

UK Outlines Potential Pharma Changes Post-Brexit

As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.

DHSC Directs Pharma to Stockpile Medicines

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA Approves First-of-its-Kind RNA Therapy

The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.

EMA Scales Back Activities to Prepare for Brexit

The acquisition will place Cambrex into the finished dosage form CDMO market.

Cambrex to Acquire Halo Pharma for $425 Million

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

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