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European regulators are updating the product information for Novartis’ osteoporosis and bone loss treatment Aclasta to include stronger warnings about the risk of severe jaw disease and are introducing a patient reminder card to minimize the risk. Read More
Drugmakers sparred with consumer and patient advocates at a Friday public hearing on the FDA’s proposed rule to give generics makers the ability to update label safety information independently — with generics firms opposing the rule and advocacy groups supporting it. Read More
For the first time, the European Medicines Agency has produced a guideline on clinical trial design for drugmakers developing targeted products to treat lupus — an effort by the EMA to encourage more companies to target the underserved disease. Read More
Drugmakers are being asked to partner with the NIH, academics and biotechnology companies to develop new antibiotics, under a White House plan announced late Friday. Read More
Biosimilars makers are not required to share their applications and manufacturing processes with the biologics company whose product they are copying, the FDA says, rejecting Amgen’s argument that the law that created the biosimilars pathway mandates disclosure of that information. Read More
Consumer and patient advocacy groups made their case for the FDA’s proposed rule to give labeling parity to generic makers, one day ahead of an FDA public hearing to again solicit comment on the plan. Read More
The FDA continues to look into improving generic bioequivalence testing, sponsoring research into BE evaluation of drugs for which doctors are most likely to resist substituting a generic, such as anticoagulants. Read More