Markets & regulatory news

API manufacturing for drugs in India: APPCB

Indian API production takes hit as APPCB shuts 12 plants

By Natalie Morrison

API production in India will take a hit this week with plant closures for Aurobindo, Hetero Drugs, Divis Pharmaceuticals, and Sri Krishna Pharmaceuticals following allegations of environmental wrongdoing.

GSK buys HGS and TGS buys Par

GSK buys HGS and TGS buys Par

Two major takeovers dominate the headlines this week with GSK finally securing its takeover of HGS and Par Pharmaceutical agreeing to be bought by private-equity firm TGS.

FDA publishes Celltex Therapeutics inspection 483

FDA publishes Celltex Therapeutics inspection 483

By Gareth Macdonald

The US FDA has published a 483 detailing the violations it observed during an inspection of stem cell firm Celltex Therapeutics in April and the document does not make for comfortable reading.

India launches 'similar biologics' guidelines at BIO2012

India launches 'similar biologics' guidelines at BIO2012

By Gareth Macdonald

New 'similar biologics' guidelines will curb the rising cost of innovation, attract overseas investment and ensure patients have access to drugs according to the Indian Government team which launched them at BIO 2012.

SGS cell based assay lab biopharmaceutical

SGS opens assay lab in France

By Gareth Macdonald

SGS’ has opened a new cell-based assay laboratory in Poitiers, France in its latest European, biopharma-focused investment.

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