Former Pfizer employee has joined Sun Pharma as it launches ophthalmic drug and expands its specialty portfolio, which includes Phase III monoclonal antibody for treatment of psoriasis.
Pfizer's former global marketing director Aimee De Blasis Amann has agreed not to disclose or use Pfizer Inc.'s trade secrets and to permit an independent computer forensic specialist to inspect her computers and computer systems, with the exception of a laptop computer she acquired from her new employer, Sun Pharmaceutical Industries Ltd.
On March 27, Eastern District of Pennsylvania Judge Eduardo Robreno issued an order of an injunction agreement between...
The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
