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The top business, scientific and regulatory news from the pharmaceutical and biotechnology industries.

Novartis Personalized Cell Therapy Receives FDA Breakthrough Therapy Designation

July 9, 2014

FDA grants breakthrough therapy designation to Novartis chimeric antigen receptor therapy.

Roche to Acquire Seragon Pharmaceuticals

July 2, 2014

Genentech's $1.7 billion acquisition of Seargon Pharmaceutical includes portfolio of investigational next-generation oral selective estrogen receptor degraders.

FDA Urged to Preserve Biosimilar Naming Conventions

July 2, 2014

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

BMS Recalls Coumadin Vials Due to Particulate Matter

July 1, 2014

Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.

Kentucky Oncology Practice Pleads Guilty to Buying and Selling Unapproved Drugs

July 1, 2014

The oncology center and its manager were charged with obtaining and selling unapproved, potentially counterfeit, cancer-treatment drugs.

EMA Revises Guidance on Advanced Therapies

July 1, 2014

European Medicines Agency clarifies advanced-therapy medicinal products classification.

Merck Collaborates with Bionomics on Alzheimer's Treatments

July 1, 2014

Merck funds Bionomics with $20 million to progress therapies for cognitive impairment caused by central nervous system disorders

EMD Serono and Mersana to Develop Next-Generation Antibody-Drug Conjugates

July 1, 2014

The collaboration will use Mersana Therapeutics Fleximer technology for antibody-drug conjugates.

FDA Outlines Guidance and Rules for Compounding Drug Products

July 1, 2014

FDA releases guidance documents and rules on requirements for compounding human drug products.

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What impact do mega-mergers of biopharmaceutical companies have on the development of new drugs?
Improves the quality and number of innovative drugs available to patients.
Restricts innovation and the development of new drugs.
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Improves the quality and number of innovative drugs available to patients.
29%
Restricts innovation and the development of new drugs.
54%
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4%
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13%
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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerSeeking Alternative Catalyst Solutions
Jill Wechsler Regulatory Watch Jill Wechsler Global Expansion Shapes Drug Oversight
Chris Burgess Statistical Solutions Chris BurgessIs a Sample Size of n=6 a Magic Number?
Sean Milmo European Regulatory WatchSean MilmoRegulating the Environmental Impact of Pharmaceuticals
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