Despite active M&A activity by conventional standards, 2016 was a fairly quiet year compared to 2015. The U.S. government cracked down on...
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Pharma Year in Review – 2016
As 2016 draws to a close, C&EN takes a look back at 10 stories that shaped the pharmaceutical industry. The year began with the expectation that Pfizer and Allergan...
Oligonucleotide Therapeutics Near Approval
Successful late-stage clinical oligonucleotide therapeutic trials could mark the maturation of a new drug development platform, but the path to commercialization is not...
Pharmacovigilance of Biologics Under Scrutiny
Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from...
Combination Products Challenge Regulators and Manufacturers
Combination drug products are high on everyone’s radar screen, as seen in continuing discussion about appropriate testing and regulation of self-injectors, such as EpiPen,...
Biosimilars Face Repercussions of Drug Pricing Debate
As more biosimilars gain FDA approval for marketing in the United States, and more manufacturers launch programs to develop additional competitive biotech therapies,...