Regulation
• Amgen has won a major legal victory in its patent battle with Sanofi and Regeneron over the companies' competing high cholesterol drugs, likely securing control of the still promising PCSK9 market. In a surprise decision, a federal judge granted Amgen's request for a permanent injunction against Sanofi and Regeneron, effectively banning sales of their drug Praluent – which is currently used by patients – in U.S. markets. Sanofi and Regeneron said they would immediately appeal the ruling and would seek a suspension of the injunction during the appeals process. http://www.forbes.com/sites/matthewherper/2017/01/06/could-amgens-patent-victory-be-bad-for-medicine/#62f848b765fc
• The FDA has awarded a fast-track designation to Astellas’ DNA vaccine candidate for peanut allergies, which is designed to mitigate severe hypersensitivity reactions due to peanut allergy. The news comes alongside the prediction of a senior analysist who has predicted that EpiPen will lose $800M in sales by 2018 due to authorized generic rivals. http://tmm.txp.to/0117-205/fda
• The U.S. Senate Special Committee on Aging has released a report that lays out strategies to prevent pharma companies from buying old, off-patent, drugs and then making huge profits by charging massively inflated prices. The Committee provides a number of potential policies to end the practice, including incentivising generic competition and temporary drug importation. http://www.aging.senate.gov/imo/media/doc/Drug%20Pricing%20Report.pdf
Politics
• Outgoing vice president, Joe Biden, is reportedly set to head up a new non-profit to tackle a broad range of cancer issues – including high oncology drug prices. Biden, who led the Obama administration’s “cancer moonshot” initiative told the Washington Post, “I’m going to begin a national conversation and get Congress and advocacy groups in to make sure these treatments are accessible for everyone … and that we have a more rational way of paying for them while promoting innovation.” http://wapo.st/2k8aNHI
• President Donald Trump is “exploring the possibility of forming a commission on autism,” according to transition spokesperson Hope Hicks. The statement was made following a meeting between the Trump team and Robert F. Kennedy Jr., a proponent of the widely discredited theory that vaccines cause autism. Kennedy told reporters that he had been offered a position heading up a commission analysing vaccine safety. The trump team however denies the claim, stating: “no decisions have been made at this time.” http://wapo.st/2jhd0Ce
Manufacturing
• AstraZenica has opened a £120 million biologics plant in the UK to manufacture oncology drugs. The plant, which was started in 2013, is at the company’s site in Macclesfield, UK. It was officially opened in December by CEO Pascal Soriot. However AstraZenica have said that the plant will not create any new jobs at the site, where the company already employs about 3,000 workers. http://www.signal1.co.uk/news/local/new-manufacturing-plant-for-cancer-medicines-launched-in-macclesfield/
• The European Medicines agency has suspended the manufacturing authority of Danish repackager, EuroPharma, after finding serious breaches of compliance with GMP during an inspection in December. Inspectors said among other problems EuroPharma falsified the expiration dates on products and sold products from contractors whose sites had never been audited for compliance. The regulator has already recalled any products that may have been affected. http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do?ctrl=searchGMPNCResultControlList&action=Drilldown¶m=39443
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