Top Regulatory News Stories – Week Ending May 11, 2018

The FDA approved Novartis’ combination treatment dabrafenib (Tafinlar) and trametinib (Mekinist) for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.  http://www.pharmacytimes.com/news/fda-approves-drug-combination-for-treating-brafpositive-anaplastic-thyroid-cancer

The FDA has promised Roche/Genentech a priority review for Tecentriq plus Avastin and chemo for lung cancer, with a PDUFA date of September 5thhttps://endpts.com/fda-promises-roche-a-snap-decision-on-tecentriq-triple-for-frontline-lung-cancer-as-it-falls-even-further-behind-merck-bristol-myers/

An FDA advisory committee voted 12 – 8 in favor of Akcea Therapeutics’ rare disease drug, volanesorsen  https://endpts.com/akcea-ionis-win-over-most-fda-experts-to-its-rare-disease-drug-volanesorsen-vastly-improving-odds-of-success/?utm

Lipocine Inc. announced that it has received a Complete Response Letter from the FDA regarding its NDA for Tlando ™, the Company’s oral testosterone product candidate for testosterone replacement therapy  https://www.drugs.com/nda/tlando_180509.html

SELLAS Life Sciences Group announced that the FDA has granted orphan drug designation to its novel drug candidate, galinpepimut-S, for the treatment of multiple myeloma (MM). http://www.firstwordpharma.com/node/1564157#axzz5F1j5s5H9

The FDA added the EpiPen to its list of drug shortages, citing a disruption with the supply. Along with EpiPens, the FDA added generic versions and Adrenaclick autoinjectors to its drug shortage list. https://www.usnews.com/news/health-care-news/articles/2018-05-09/fda-adds-epipens-to-list-of-drug-shortages

Health Canada is requesting industry input on establishing mandatory requirements for submitting drug master files using the electronic common technical document (eCTD) format. https://www.raps.org/news-and-articles/news-articles/2018/5/health-canada-proposes-mandatory-ectd-requirements?feed=Regulatory-Focus

The Department of Health and Human Services released the spring version of its unified agenda on proposed and final rulemakings, featuring a proposed rule on quality system regulations for medical devices, and a final rule on postmarketing safety reporting regulations for human drugs and biological products, among others.  https://www.raps.org/news-and-articles/news-articles/2018/5/upcoming-fda-rulemakings-device-quality-systems?utm

A Florida-based stem cell clinic and a network of about 100 clinics in California are facing litigation brought on by the FDA to cease the marketing of their products. https://www.raps.org/news-and-articles/news-articles/2018/5/fda-files-injunctions-against-stem-cell-clinics-to?utm

In other news…

Takeda has reached a deal to buy Shire for around $62 billion.  Cuts to the workforce are expected:  https://endpts.com/takeda-ceo-christophe-weber-finally-closes-on-his-62b-deal-to-buy-shire-now-he-has-to-convince-shareholders-and-slash-jobs/?utm

Sarepta Therapeutics announced a partnership with Myonexus Therapeutics for the advancement of multiple gene therapy programs aimed at treating distinct forms of limb-girdle muscular dystrophies  http://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-partnership-myonexus-therapeutics

India’s Aurobindo has bid $1.6B for Novartis‘ U.S. dermatology generics business  https://www.fiercepharma.com/pharma/aurobindo-bids-1-6b-for-novartis-u-s-dermatology-generics-report

Valeant Pharmaceuticals plans to change its name to Bausch Health Cos., as management takes another step toward remaking the company and distancing it from past controversies.  https://www.wsj.com/articles/valeant-pharmaceuticals-to-change-its-name-to-bausch-health-1525752878

Evelo Biosciences raised $85M in their Nasdaq debut: https://endpts.com/evelo-bio-grabs-85m-as-the-latest-early-stage-biotech-debuts-on-nasdaq/?utm_medium=email&utm

Eli Lilly & Co. will buy the immuno-oncology biotech ARMO Biosciences Inc. for about $1.6 billion in an all-cash deal  https://www.marketwatch.com/story/eli-lilly-will-buy-armo-biosciences-for-16-bln-2018-05-10

This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com   You can also visit us on LinkedIn at https://www.linkedin.com/company/dennis-partners/

 

 

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