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Regulatory

Latest Headlines

Latest Headlines

Out with the old, reimburse the new: Merck's Frazier wades into Australia drug debate

Wading into what has become an "argy-bargy" political issue, Merck CEO Ken Frazier gave his two cents on why Australians miss out on new drugs.

Blurred lines in Japan's vision for healthcare in next two decades

Japan's efforts to blend cost savings and innovation are so tied up in broader national goals to revive the deflation-hit economy that a plan had to be drawn up for the next two decades--but the documents and slides to describe the ideas seem to deftly avoid any look at the hard choices needed.

Taiwan's PharmaEngine racks up good news on MM-398

Taiwan's PharmaEngine had a host of good news last week as Merrimack Pharma, its U.S. license holder for pancreatic cancer candidate MM-398 was granted priority review by the U.S. FDA and a subsidiary of Baxter also had a filing accepted by the European Medicines Agency that sparked an $11 million payment.

Sarepta submits its DMD drug for FDA scrutiny, on the heels of BioMarin

Sarepta, ending a protracted process that may have cost its last CEO his job, submitted its treatment for Duchenne muscular dystrophy to the FDA, setting the stage for a possible approval early next year.

TCM-based oncology candidate wins U.S. FDA nod for PhIII, Xinhua says

A traditional Chinese medicine (TCM)-based candidate, Kanglaite, won U.S. FDA approval for a multiregion Phase III trial in pancreatic cancer treatment that uses a derivative of the coix seed, the state-run Xinhua news agency reports.

India's Gujarat state drugmakers speed up biosimilar race

Drug companies in India's leading industrial state of Gujarat, the base of Prime Minister Narendra Modi, are stepping up efforts to crack the domestic market for biosimilars as well as abroad, Business Standard reports.

Australia's CSL's rIX-FP PhIII meets endpoint, firm buys Rapivab rights from BioCryst

Australia's CSL unveiled Phase III trial results for hemophilia B candidate rIX-FP that met the primary endpoint and separately noted it bought exclusive rights to commercialize flu treatment Rapivab from BioCryst Pharmaceuticals last week. The note highlighted the growing reach of the biopharma in a core blood products business and in vaccines following its purchase of a Novartis unit last year.

FDA warns that transdermal patch for ADHD can lead to permanent skin discoloration

The FDA warned that a transdermal patch used to treat ADHD in children and adolescents can lead to chemical leukoderma, or permanent skin discoloration, as a result of the skin's repeated exposure to specific chemical compounds.

FDA issues guidance to help companies meet their first UDI direct marking deadline

Industry is barreling toward its first direct marking requirement under the FDA's unique device identification (UDI) initiative. To help companies comply with the requirements, the agency released a Q&A-style guidance on the topic.

FDA gives nod to newest pelvic mesh product, despite ongoing safety issues

The U.S. Food and Drug Administration has signed off on the latest iteration of a pelvic mesh, despite the ongoing controversy around this type of device and a huge settlement from Medtronic for more than 11,000 vaginal mesh patients earlier this week.