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Despite significant potential savings in time and money, drug and medical device manufacturers have been slow to embrace continuous manufacturing, an FDA technology official said. Read More
Pfizer is pressing the FDA to extend the market exclusivity of its combination drug Duavee, following a judge’s ruling that the FDA had inconsistently interpreted the eligibility criteria. Read More
NICE is endorsing AstraZeneca’s Forxiga as a treatment for Type 2 diabetes in combination with metformin and a sulfonylurea, marking the agency’s third favorable recommendation for the drug. Read More
A European Parliament committee is proposing that the European Commission promote transparency in private research to foster better access to medicines across the EU. Read More
For years, Mylan has dodged paying the appropriate rebates for its epinephrine auto-injector EpiPen through a misclassification, the Centers for Medicare and Medicaid Services confirmed. Read More
Novartis is closing several of its research operations in Switzerland and China and cutting 175 jobs in an effort to centralize control of its drug discovery programs and contain costs. Read More
Amgen is contesting AbbVie’s allegations that its Humira biosimilar, Amjevita, infringes dozens of patents, saying AbbVie failed to raise at least six of those patents in regulatory submissions. Read More
The UK’s price watchdog is recommending the reimbursement of AstraZeneca’s Tagrisso as a second-line treatment for an aggressive form of lung cancer. Read More
Adare Pharmaceuticals and Teva Pharmaceuticals International have sued Apotex, alleging its generic version of Amrix infringes on a patent covering the dosage forms of the drug’s active ingredient. Read More