Regulatory Recon: Phase III Cancer Vaccine Trial Fails; EMA’s CHMP Recommends 13 Medicines for Approval (15 September 2017)

Posted 15 September 2017 By Zachary Brennan

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In Focus: US

  • Drug industry on tenterhooks as Maryland price-gouging law nears (Reuters)
  • 100 Years after the Lethal 1918 Flu Pandemic, We Are Still Vulnerable (Scientific American)
  • Bavarian Nordic’s cancer vaccine is a bust in PhIII (Endpoints) (EP Vantage) (Fierce)
  • Rep. Paulsen: Modernize the FDA (The Hill)
  • FDA just approved the first app for treating substance abuse (CNBC)
  • U.S. FDA approves Bayer drug to treat follicular lymphoma (Reuters) (FDA) (Press)
  • Vaccine against four strains of influenza approved for pediatric use in the US (PharmaLetter-$)
  • FDA Approves First Biosimilar Cancer Treatment (Focus)
  • FDA Transparency: Gottlieb Outlines What’s Coming (Focus)
  • FDA Finalizes HPV Diagnostic Study Guidance (Focus)
  • FDA Steps in to Regulate Microneedling Devices (Focus)

In Focus: International

  • European panel recommends approval of J&J's psoriasis drug (Reuters)
  • GSK's three-in-one inhaler gets positive opinion from EU agency (Reuters)
  • Santhera shares plummet after negative CHMP opinion (Reuters) (Pink Sheet-$)
  • South African firm warns of 'pseudo-generics' undermining market for true copycats (PharmaLetter-$)
  • Lord O'Shaughnessy on medical technologies and Brexit (Speech)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 2017 (EMA)
  • Ireland Seeks to Overhaul Biosimilar Drugs Policy (Center for Biosimilars)

Pharmaceuticals & Biotechnology

  • U.S. Congress scrutinizes over-the-counter drugs (C&EN)
  • FDA’s Gottlieb wants drug pricing and drug development costs to come down (C&EN)
  • Spotlight – Medical disclosure farrago hits Esmo 2017 (EP Vantage)
  • Upcoming events – Translarna’s panel decision and targeting RNA in cystic fibrosis (EP Vantage)
  • Snippet roundup: Bad news for Sage and Santhera, good tidings for Glaxo and Bayer (EP Vantage)
  • Challenge of Allergan tribal patent deal in uncharted legal territory (Reuters)
  • Pain Clinic Can't Depose FDA In Meningitis Cases, Feds Say (Law360-$)
  • Industry Attorneys Ask FDA to Narrow Off-Label Communications Guidance (FDANews-$)
  • Medicare Coding Change For Biosimilars Could Save $65bn, Firms Say (Pink Sheet-$)
  • New indication for Briviact (brivaracetam): UCB's newest antiepileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults (Press)
  • Chemist nominated to lead the U.S. National Institute of Standards & Technology (C&EN)
  • Alexion Adds Paul A. Friedman, M.D. to Its Board of Directors (Press)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Stakes are high as Alnylam awaits results from novel rare disease therapy (Stat-$)
  • New data comparing Lucentis efficacy and durability versus aflibercept (PharmaLetter-$)
  • Sandoz psoriasis biosimilar tops reference product Humira in latest Phase 3 data (Pharmafile)
  • Microbiome Connections to Disease Get Stronger (In the Pipeline)
  • How Bacteria Could Protect Tumors From Anticancer Drugs (The Atlantic)
  • Doubts raised over validity of CRISPR-edited human embryo study (C&EN)
  • The Impact of FDA Regulatory Activities on Incident Dispensing of LABA-Containing Medication: 2005-2011 (Study)

Medical Devices

  • Apple to partner with American Well, Stanford to launch heart arrhythmia trial with Apple Watch 3 (Mass Device)
  • Medtronic, Mazor Robotics close $40m round (Mass Device)
  • MiMedx loses appeal in placental allograft tissue patent spat (Mass Device)
  • Abiomed buys Danvers, Mass. HQ for $17m (Mass Device)

US: Assorted & Government

  • FDA Updates 2003 MAPP on Requesting Exemptions From Environmental Assessment Requirements (MAPP)

Upcoming Meetings & Events

Europe

  • Bayer receives positive CHMP opinion for rivaroxaban 10 mg once daily for the extended prevention of venous thromboembolism (Press)
  • GSK’s triple-med COPD inhaler wins recommendation for approval in EU (Mass Device)

General Health & Other Interesting Articles

  • Dr. Vinay Prasad takes on Big Pharma, Big Medicine, and his own colleagues — with glee (Stat)
  • New Product Is First to Claim It May Reduce Peanut Allergies (NY Times-$)
  • Tragedy, Perseverance, and Chance — The Story of CAR-T Therapy (NEJM)
  • 23 and Leave Me Out of It (WSJ-$)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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