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Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington, D.C. Read More
The FDA’s Pediatric Advisory Committee voted overwhelmingly that the risks outweigh the benefits of using opioids to treat coughs in children. Read More
FDA commissioner Scott Gottlieb highlighted the agency’s efforts to improve clinical trials during a keynote address Monday at the RAPS’ 2017 Regulatory Conference. Read More
Biocon plans to re-submit applications for European approval of two biosimilars as soon as it corrects serious GMP deficiencies found at a Bangalore manufacturing plant. Read More
The FDA finalized 48 guidances for generics manufacturers, outlining the recommended studies for demonstrating bioequivalence for dozens of active ingredients and combinations, to assist the industry with generating evidence to support ANDA approvals. Read More
The PTO’s Patent Trial and Appeal Board will evaluate the validity of three Genentech patents covering its blockbuster breast cancer treatment Herceptin, following petitions for inter partes review filed by Hospira. Read More
Coherus BioSciences filed a petition with the PTO for an inter partes review of a patent on production methods for Amgen’s Enbrel (etanercept), saying the claims are obvious and unpatentable. Read More
Hedge fund investors are suing generics manufacturer Teva for not being forthcoming about a federal price-fixing investigation — saying the company’s false statements before the eventual reveal of a subpoena resulted in losses of billions in shareholder value. Read More
A Pennsylvania district court refused to certify a group of corporate and institutional drug purchasers as plaintiffs in a class-action antitrust suit against several drugmakers — saying the approximately two-dozen organizations in the class was relatively small and did not meet legal class-action requirements. Read More
The state of Maryland defended its law against generic drug price gouging in court, moving to dismiss a complaint brought by the industry’s trade group, the Association for Accessible Medicines. Read More
AbbVie filed a federal lawsuit in Delaware claiming Boehringer Ingelheim is illegally infringing on patents in its development of a Humira biosimilar. Read More