Regulatory Recon: FDA Approves AZ's Lynparza to Treat Breast Cancer with BRCA Mutation; Roche's MS Drug Ocrevus Wins EU Approval (12 January 2018)

Posted 12 January 2018 By Michael Mezher

placeholder+image

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • In a pioneering first, AstraZeneca scores FDA OK to use its PARP against breast cancer (Endpoints) (Reuters) (GenomeWeb) (FDA)
  • Trump expects medical exam to go well Friday (Reuters)
  • Drugmakers see a pricing blueprint in an $850,000 gene therapy (Reuters)
  • Wait, It Costs How Much? Biotech Balances Optimism, Uncertainty For 2018 (Forbes)
  • Gene therapy comes of age (Science)
  • mRNA vaccines — a new era in vaccinology (Nature)
  • Genentech beefs up its PD-L1 combo pipeline, signing the 'don't eat me' specialists at Forty Seven (Endpoints) (Fierce)
  • Aradigm crashes after FDA panel votes down antibiotic (Fierce) (PMLive)
  • GlaxoSmithKline Gets Expanded FDA Win for Fluarix (BioSpace)
  • Cherokee Can't Sue Opioid Distributors in Tribal Court, Judge Rules (NYTimes)
  • Ex-Insys employee seeks ban on mentioning 'opioid crisis' at trial (Reuters)
  • Philips NV moving HQ to mega-project Cambridge Crossing (Endpoints) (MassDevice)
  • Unified understanding of MS course is required for drug development (Nature)
  • Health Insurer Centene Is Sued Over Lack of Medical Coverage (NYTimes)

In Focus: International

  • Roche's star MS medicine Ocrevus wins EU approval (Reuters) (Endpoints) (Press)
  • India Stalls Plan to Cut Drug Prices as Industry Balks (Bloomberg) (Economic Times)
  • Abuse-Deterrent Opioid No Help in Australia (Medpage)
  • China dings Medtronic over Taiwan reference (MassDevice)
  • Fighting the spread of fake drugs in Africa (DW)
  • An unsurprising case of software qualification with an interesting twist (MedicalDevicesLegal)
  • PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market (EMA, Meeting Highlights)
  • As Rituxan biosimilar competition hots up, Genentech starts legal in action in Japan (PharmaLetter-$)
  • Portuguese doctors back marijuana medicine as bill enters parliament (Reuters)
  • Swedish epilepsy specialist signs deal with UK's CGT Catapult (PharmaLetter-$)
  • Generics applications under review by EMA – January 2018 (GaBI)
  • World's doctor gives WHO a headache (Politico)
  • 'What the hell is going on?' Polio cases are vanishing in Pakistan, yet the virus won't go away (Science)

Pharmaceuticals & Biotechnology

  • We went to #JPM18 with burning questions about biotechs. We got some answers (STAT)
  • Closing JPM18: Winners and losers, brighter days for neuroscience (BioPharmaDive)
  • J.P. Morgan Notebook Day 4: CRISPR's Not Worried; Theratechnologies' HIV Niche; And Is Moderna's IPO Coming Soon? (SCRIP-$)
  • Video: How many PD-1/L1 drugs do we need? Where is immunotherapy headed? Watch Jay Bradner, Hervé Hoppenot, Ellen Sigal, David Berman, Gideon Blumenthal, and Aiman Shalabi discuss with Endpoints at #JPM18 (Endpoints)
  • JP Morgan – Vox pops Global Blood stock ahead of actual data (EPVantage)
  • JP Morgan day three roundup – Editas defends and Novavax fires (EPVantage)
  • Clarification of When Products Made or Derived from Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses"; Proposed Partial Delay of Effective Date (FDA)
  • BRCA mutations don't hurt breast cancer survival (NBC)
  • Genome sequencing turns up new drivers of drug resistance in malaria (STAT)
  • Truffle Primes BioMedtech Fund With $102m, More Financings Planned (SCRIP-$)
  • NIH study supports use of short-term HIV treatment interruption in clinical trials (NIH)
  • NIH researchers report first 3D structure of DHHC enzymes (NIH)
  • Concert rethinks R&D plans after loss in Incyte patent case (Fierce)
  • Why did Ablynx board chairman Peter Fellner resign in wake of Novo's buyout offer?; Amgen vet Richard Paulson tapped to run Ipsen North America (Endpoints)
  • Jumping on anti-aging bandwagon, Y Combinator joins hunt for the $100B pill (Endpoints)
  • New tools for turning genes into drug factories (Fierce)
  • Decoding cancer-linked enzyme could lead to better EGFR cancer drugs (Fierce)
  • Is antacid use during pregnancy tied to childhood asthma? (Reuters)
  • Establishing interchangeability for biosimilars in the US (GaBI)
  • Switching failures with biosimilar etanercept (GaBI)
  • Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability; Extension of Comment Period (FDA)
  • Determining Whether To Submit an Abbreviated New Drug Application or 505(b)(2) Application; Draft Guidance for Industry; Availability; Reopening of the Comment Period (FDA)
  • Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA Grants Fast Track Designation to Concert Pharmaceuticals' CTP-543 for the Treatment of Alopecia Areata (Press)
  • Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-121 Acne Treatment In Lotion Form (Press)

Medical Devices

  • Indiana Sen. Donnelly stumps for medtech tax repeal on Senate floor (MassDevice)
  • Insulet's Insulin Pump Gets Medicare Coverage (Bloomberg) (AdvaMed)
  • Mass. Dems file Senate medical device tax repeal bill (MassDevice)
  • Sensor glitch prompts Boston Scientific warning on pacemakers (MassDevice)
  • Class 1 Device Recall LIFEPAK 20e DEFIBRILLATOR/MONITOR (FDA)
  • Edwards Lifesciences recalls Certitude delivery device for Sapien 3 valve (MassDevice)
  • FDA Panel: Self-Collection Pap Tests Must Meet Current Standards (Medpage)
  • How medtech could stop the drug overdose crisis in the US (Medical Design & Outsourcing)
  • LivaNova launches post-market study of bioprosthetic aortic heart valves (MassDevice)
  • CMS May Cover MRI With Cardiac Devices Across the Board (Medpage)
  • Medtronic touts therapy delivered via SynchroMed pump in patients with post-stroke spasticity (Drug Delivery)
  • Cordis, Medinol tout first commercial implants of Elunir drug-eluting stent in US (Drug Delivery)

US: Assorted & Government

  • Sen. Casey Obtains HHS Secret Roadmap to Sabotage the ACA (Casey)
  • US judge pushing for opioid settlement reaches out to states: Ohio (Reuters)
  • Amgen, Genentech Await Del. Ruling In Biosimilar IP Row (Law360-$)
  • Novartis' Zortress Patent Survives PTAB Challenge (Law360-$)
  • Murky FDA Device Guidance Kills Sanofi Antitrust Suit (Law360-$)
  • Axing 'Cadillac' health plan tax may be part of spending deal: House chairman (Reuters)
  • Aptalis Fails to "Surround' Apotex's Generic ER Tablet (National Law Review)
  • Will New York Finally Consider Legalizing Cannabis This Week? (Forbes)
  • California Court of Appeal Limits Duty of Clinical Study Sponsor to Intervene in Treaters' Care of Study Participants (Drug & Device Law)
  • How to Lose $350 million (FDA Law Blog)
  • DEA Administrative Decisions: 2017 in Review (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • France blames Lactalis, retailers in deepening baby food scare (Reuters)
  • Swissmedic Journal – 12/2017 (Swissmedic)

Asia

  • Takeda deals, blockbuster China nods, Sanofi European generics suitors (Fierce)
  • Repatha® SC Injection 420 mg Auto Mini Doser Launched in Japan (Astellas)

India

  • Cipla Revs Up In US, Newer Markets To Cushion Against Volatility (SCRIP-$)

Australia

  • Implementation of the NEW Uniform Recall Procedure for Therapeutic Goods (URPTG) (TGA)
  • Prescription medicines: new or extended uses, or new combinations of registered medicines (TGA)

Other International

  • Zambian army enters slum after riots over cholera controls: state radio (Reuters)

General Health

  • Baltimore hospital probes release of thinly clad patient in cold (Reuters)
  • A New Kidney, a New Life (NYTimes)
  • 12-year-old girl dies after flu misdiagnosis, family says (CBS)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Share this article:

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Exchange: Latest Updates From the Community