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Nine senators — including eight democrats and one independent — have urged the Federal Trade Commission to “closely scrutinize” AbbVie’s proposed $63 billion merger with Allergan and Bristol-Myers Squibb’s proposed $74 billion merger with Celgene. Read More
The FDA released a new plan on Wednesday for using data to help bridge the “persistent gap” between scientific innovations and the technology needed to develop them into therapies. Read More
Novartis announced Wednesday that it is halting distribution of generic Zantac (ranitidine) globally amid ongoing investigations into ranitidine drugs containing a potential carcinogen. Read More
The FDA features the misuse of petitions to stall generic drug applications in a final guidance issued Wednesday — and spells out how the agency will deal with the petitions. Read More
An FDA advisory committee narrowly voted in favor of GSK’s over-the-counter novel Nicotine Mouth Spray as a nicotine replacement therapy on Wednesday. Read More
The FDA hit Laboratorio Reig Jofre for numerous violations at its Barcelona sterile drug manufacturing facility, including inadequate smoke studies and failing to qualify contract service providers. Read More
Cabaret Biotech filed suit on Monday against Gilead and its Kite Pharma subsidiary alleging that Yescarta its CAR-T immunotherapy for non-Hodgkin’s lymphoma, infringed on its patent (7,741,465) targeting chimeric receptor genes. Read More
The FDA on Tuesday unveiled its first joint approval for oncology drugs with regulators in Australia and Canada under an initiative called Project Orbis, granting accelerated approval for a combination treatment for advanced endometrial cancer. Read More
The FDA has laid out a three-stage process for how the agency will handle product development and pre-submission meetings for ANDAs, in a new Manual of Policies and Procedures (MAPP) released on Tuesday. Read More