The Canadian pharma is willing to bet $14.5 billion that it can take care of the specialty pharma’s stocking level issues and still pull in $500 million in synergies with in the first six months.
Problems with wholesale inventories made Salix Pharmaceuticals Ltd. an unattractive takeout target to Allergan Inc. last year, but former Allergan suitor Valeant Pharmaceuticals International Inc. doesn’t see the issue as a hindrance and believes it is up for the task of squeezing profits out of the specialty pharma’s gastrointestinal franchises.
With its battle for Allergan firmly in the rearview, Valeant has moved on to acquiring Salix in its largest deal...
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.
The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.
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.
