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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
Par Pharmaceuticals has sued the FDA for not granting the company 180 days of marketing exclusivity for its first generic of Takeda Pharmaceutical’s Colcrys, asking a federal court to enjoin the agency from approving any competing generics. Read More
A federal appellate court upheld a district court dismissal of Mylan’s antitrust case against Warner Chilcott and Mayne Pharmaceuticals, which alleged that the name-brand drugmakers modified their acne treatment Doryx to maintain a monopoly on the market. Read More
British drugmaker GlaxoSmithKline will pay $20 million to settle the Security and Exchange Commission’s charges that the company bribed healthcare professionals to boost drug sales in China. Read More
The Department of Justice indicted two executives from separate pharmaceutical companies, alleging that one engaged in a kickback scheme and the other relied on confidential study findings to purchase and sell stock. Read More
The UK’s price watchdog is recommending Bayer’s eye medicine Eylea as a first-line treatment for vision loss due to fluid buildup in the retina, provided the company discounts its price. Read More
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