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AstraZeneca (AZ) rebuffed a new $106 billion merger bid from Pfizer on Friday, saying that even after Pfizer added $6 billion to the offer it still “substantially” undervalues the company. Read More
The pharmaceutical industry is worried the FDA will hinder the distribution of valid scientific information on off-label drug uses in its new proposal detailing what literature sales reps can distribute to physicians. Read More
Indian drugmaker Wockhardt has received the regulatory green light to resume manufacturing and selling its combination drug to treat pain, the company said April 28. Read More
The European Medicines Agency (EMA) is recommending clinical trial sponsors evaluate local tolerance of medicinal products — i.e., both the active substance and excipient — at contact sites of the body as part of a clinical trial’s general toxicity studies, according to new draft guidance. Read More
Pfizer is receiving blowback from UK scientists, lawmakers and a top company executive for its proposed multi-billion dollar merger with London-based AstraZeneca (AZ). Read More
Drugmakers should implement and maintain security procedures for electronic safety-and-acknowledgement messages over the internet, according to a European draft guidance that provides technical requirements around online data protection. Read More