We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Baxalta has rejected Shire’s $30 billion hostile takeover bid, saying it significantly undervalues the company, which makes treatments for hemophilia and other blood disorders. Read More
Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
The European Commission has cleared the way for Pfizer to acquire Hospira, pending the divestiture of its Remicade biosimilar and certain sterile injectable drugs. Read More
United Therapeutics claims Allergan’s Paragraph IV ANDA for a generic version of its hypertension drug Tyvaso violates three of the drug’s patents. Read More
Indian drugmaker Hetero has launched a biosimilar version of Roche’s Rituxan on the subcontinent, with plans to introduce it in key markets outside India through strategic partners. Read More
Pfizer has acquired exclusive rights to market potential generic versions of Teva’s multiple sclerosis drug Copaxone, under an agreement with Synthon. Read More
The Federal Circuit appeals court has denied AstraZeneca’s effort to block Mylan’s launch of a generic version of the acid reflux blockbuster Nexium, paving the way for additional competition for the drug. Read More
Genzyme received a 16-observation Form 483 from the FDA for not conducting risk assessments and other quality lapses at a facility where bulk drug substances are made. Read More