Regulatory Recon: MyoKardia Plots Course After Phase II Success; How PBMs Maintain EpiPen Market Share Despite Generic Alternatives (7 August 2017)

Posted 07 August 2017 By Michael Mezher

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

In Focus: US

  • Take the Generic Drug, Patients Are Told — Unless Insurers Say No (ProPublica)
  • Behind the Push to Keep Higher-Priced EpiPen in Consumers' Hands (WSJ)
  • Falling US Generic Drug Prices Hurt Manufacturers, Wholesalers (WSJ)
  • Small, groundbreaking cardio study pushes MyoKardia to a pivotal showdown  (Endpoints) (STAT)
  • FDA's Off-Patent, Off-Exclusivity List Draws Few Takers Early On (Pink Sheet-$)
  • NxStage Medical Acquired by Fresenius for $2 Billion (The Street) (Xconomy)
  • Mallinckrodt bags late-stage infantile jaundice drug in $425M InfaCare buyout deal (Endpoints)
  • Zynerba goes into meltdown mode as cannabis-derived drug flops in PhII (Endpoints) (Reuters)
  • Gilead and GSK are sizing up PAH specialist United Therapeutics, report says (Fierce)
  • Allergan ups guidance but shares weighed down by Teva sell-off (Financial Times)
  • FDA rejects second Vernalis cough/cold treatment (PharmaTimes) (Fierce) (Reuters)
  • Lawyers circle America's opioid crisis (Financial Times)
  • DEA proposes cutting production of some opioid painkillers (Reuters)
  • Martin Shkreli is Found Guilty of Fraud (NYTimes) (STAT 1, 2) (NBC) (Endpoints)
  • AstraZeneca is beginning to look a lot like Tesco (Financial Times)
  • Can Pharma Influence Physician Prescribing? Unleashing New Data Using Prostate Cancer Drugs (Forbes)

Sponsored Content: FDA Recommendations for Cybersecurity in Life Sciences

In Focus: International

  • GMO salmon caught in US regulatory net, but Canadians have eaten 5 tons (Washington Post) (Nature)
  • GSK déjà vu: Time for a top-down switch as new CEO tries to conquer old R&D demons (Endpoints) (Financial Times 1, 2)
  • Teva's $6bn loss complicates search for a chief (Financial Times) (Fierce)
  • Just how badly did Teva misstep? Here's what the wags say (STAT)
  • Bids For EMA Show East-West Split Over Principle of Fair Spread Of Agencies (Pink Sheet-$)
  • EMA Calls for Special Approach for Tracking Pediatric Drugs (FDANews-$)
  • Bayer secures one-two treatment for liver cancer after EU approval (Pharmafile)
  • European Commission backs LEO Pharma's Kyntheum (PMLive)
  • NHS England launches trial to assess PrEP (PharmaTimes) (Pharmafile)
  • NICE backs new treatment option for psoriasis (PharmaTimes)
  • Bluebird Bio sees Europe as first market for its gene therapies (Fierce)
  • EPO Applies Doctrine of Plausibility to Small Molecule Pharmaceuticals (Patent Docs)
  • Mylan, Aurobindo End Litigation Over Imaging Agent (Bloomberg)
  • India mulls waiving off clinical trials on humans for critical drugs (Economic Times)
  • Compliance Deadlines Approaching for Malaysian Medical Device Registration (Emergo)
  • Brazilian Regulators Propose Extending Validity Timeframes for Medical Devices (Emergo)

Pharmaceuticals & Biotechnology

  • University of Minnesota bioethicist takes on clinics touting stem-cell studies (Star Tribune)
  • Statins are still controversial (Financial Times)
  • Ted Stanley, Whose Fentanyl Lollipop Treated Chronic Pain, Dies at 77 (NYTimes)
  • Importation a cliché, not a CAPA (BioWorld)
  • Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions (FDA)
  • FDA Links Naturopathic Turmeric Death To Contaminated Product (Forbes) (FDA)
  • Moderna appoint Novartis vet to scale-up manufacturing (Pharmafile)
  • A Dose Of Innovation: Does FDA Have More Appetite For Innovation In Dose-Finding Trials Than Companies Do? (BioCentury)
  • Building trust-based relationships in pharma (McKinsey)
  • FDA Law SSRN Reading List (July 2017) (Objective Intent)
  • What To Watch As FDA Begins To Fight Rising Drug Prices (Law360-$)
  • States get $200 million funding boost to fight infectious diseases (Modern Healthcare)
  • Acorda shares surge as a big investor pushes it to the auction block (Endpoints)
  • Earnings Preview: What To Expect From Valeant Pharmaceuticals On Tuesday (Forbes)
  • HP&M Attorney Co-Authors Recommendations and "Rules of Engagement" for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials (FDA Law Blog)
  • PCSK9 Sales Still Slow, But May Get Boost From Label, Guideline Changes (SCRIP-$)
  • Gemphire shares crater after its LDL drug comes up short in PhIIb (Endpoints) (Fierce)
  • New Rapamycin CEO Hired to Handle Funding, FDA Inflection Points (Xconomy)
  • FDA Hits Fusion IV for Incomplete Labeling, Environmental Monitoring (FDANews-$)
  • Stomach acid drugs do not increase Alzheimer's risk, study confirms (Pharmafile)
  • DSCSA Red Light Green Light: Verification Responses (RxTrace)
  • Houston Biotech Oncolix Announces Reverse Merger, Goes Public (Xconomy)
  • Prospective Grant of Exclusive Patent License: MicroRNA Therapeutics for Treating Squamous Cell Carcinomas (NIH)
  • Prospective Grant of Exclusive Patent License: The Development of a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the Treatment of Human Liver Cancers (NIH)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; CINQAIR (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; VONVENDI (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA Grants Priority Review and Breakthrough Therapy Designation for Zelboraf (vemurafenib) in Erdheim-Chester Disease with BRAF V600 Mutation (Press)
  • Polaryx Therapeutics Receives Orphan Drug Designation From the U.S. FDA for PLX-200 for Rare Pediatric Disease (Press)
  • FDA Grants Orphan Drug Designation to Omeros' OMS721 for Treatment of IgA Nephropathy (Press)
  • FDA Grants Orphan Drug Designation to Kadmon's Tesevatinib for the Treatment of EGFR-Mutated Non-Small Cell Lung Cancer (Press)
  • Teva Announces FDA Approval of QVAR® RediHaler™ (Beclomethasone Dipropionate HFA) Inhalation Aerosol (Press)
  • Starpharma: Successful VivaGel® Phase 3 Results and NDA Planned for rBV (Press)
  • FDA Approves Medicines360's sNDA for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Four Years (Press)
  • Kite Announces Initiation of Axicabtagene Ciloleucel CAR-T Clinical Program in the European Union (Press)

Medical Devices

  • When It Comes to Software As A Medical Device (SAMD), FDA Acknowledges that New Technology No Longer Fits The Old Regulatory Paradigm  (FDA Law Blog)
  • GE Healthcare wins FDA 510(k) for Signa Premier MRI (MassDevice)
  • FDA updates on Getinge/Datascope IABP recall, labels as Class I (MassDevice)
  • Who Will Win the 2017 Best Medical Technology Award? (MDDI)
  • U.S. Export Opportunities in France's Healthcare Market (MDDI)
  • Want to sell your medtech startup? Be one of these three things (Medical Design & Outsourcing)
  • Laminate Medical's VasQ Fistula Supporting Device Gets FDA Investigational Device Exemption (MedGadget)

US: Assorted & Government

  • For Cosmetics, Let the Buyer Beware (NYTimes)
  • Republican Senator Is on a Mission to Rescue the Health Care Law (NYTimes)
  • Hedge Funds Sue Teva Over Generic Drug Price-Fixing (Law360-$)
  • With Trump in the White House, Obama science experts operate shadow network to press their positions (STAT)
  • Maryland overdose deaths continued to soar in the first part of the year (Baltimore Sun) (Washington Post)
  • Roche faces more than 2K Accutane liability cases as appeals panels reverse rulings (Fierce)
  • In Praise of Brevity (Drug & Device Law)
  • Philips wins $7m in mixed-bag patent spat ruling with Zoll Medical (MassDevice)
  • GOP Leans Toward Funding Obamacare Subsidies With A Catch (Forbes)

Upcoming Meetings & Events

Europe

  • EMA Reduces Parallel Distribution Fees For Malta & Latvia To Improve Medicines Availability (Pink Sheet-$)
  • Romania fights worst outbreak of measles for decades (Financial Times)
  • Out-of-Stock – Xifaxan 550 mg, Filmtabletten (SwissMedic)

India

  • CDSCO trains 100 drug inspectors, to train 85 assistant drug inspectors to implement GMP (PharmaBiz)
  • Pharmacovigilance needs to be strengthened in India: SV Veeramani (PharmaBiz)
  • Wockhardt's antibiotic injection gets USFDA nod (Economic Times)
  • Indian pharma needs to strengthen its know-how in regulations to include cyber security & anti-bribery: French Caldwell (PharmaBiz)
  • Pharma industry, trade concerned over issue of growing expired drugs with no set rules (PharmaBiz)
  • NPPA issues Addendum on its Order on ceiling price fixation of coronary stents to redefine 'manufacturer' (PharmaBiz)
  • Indian government outlines policies on drug pricing to favor poorer patients, and increase clinical trials (PharmaLetter-$)
  • India targeting a $40 billion domestic biosimilars market by 2030 (PharmaLetter-$)

Australia

  • Australia Updates Licensing & Certification Guidance (Pink Sheet-$)

Other International

  • Yellow Fever Outbreak That Threatened Brazil's Megacities Ends (NYTimes)

General Health & Other Interesting Articles

  • Gene editing found biological breakthroughs in unexpected places (Financial Times)
  • A New Way to Reproduce (MIT Technology Review)
  • High-fat diet linked to lung cancer risk (Reuters)
  • For older breast cancer survivors, unclear when to stop mammograms (Reuters)
  • Cleaning a Dirty Sponge Only Helps Its Worst Bacteria, Study Says (NYTimes)

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.

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