Regulatory Recon: French Regulators Halt ALS Trial; FDA Revisits Opioid Prescriber Training (12 May 2017)

Posted 12 May 2017 By Zachary Brennan

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Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                      

  • FDA Revisits Mandatory Opioid Prescriber Training (MedPage Today)
  • Heroin Epidemic Is Driving A Spike In Hepatitis C Cases, CDC Says (NPR) (Reuters) (AP)
  • HELP Committee Sends PDUFA Reauthorization Bill for Vote (Focus) (MedPage Today) (Pink Sheet-$) (Lachman Consultants)
  • FDA-Centric Alternative To 'Right To Try' Laws Attached To User Fee Bill (InsideHealthPolicy-$)
  • Pediatric Cancer Amendment Pulled From User Fee Markup, Talks Ensue (InsideHealthPolicy-$)
  • Isakson Hopes To Attach OTC Fees, Exclusivity To Final User Fee Package (InsideHealthPolicy-$)
  • Efficient Trial Design — FDA Approval of Valbenazine for Tardive Dyskinesia (NEJM Perspective)
  • What I Told HHS Secretary Tom Price About the 340B Drug Pricing Program (Drug Channels)
  • CSL Behring Beats Back Whistle-Blower’s Drug Pricing Fraud Claims (Bloomberg)
  • ICER Posts Briefing Paper on Assessing the Value of Drugs for Rare Conditions (ICER)
  • 10 Issues Gottlieb Will Face as FDA Commissioner (Focus)
  • Meet Scott Gottlieb, M.D., Commissioner of Food and Drugs (FDA)
  • FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects (FDA)
  • Turmoil in Immuno-oncology (In the Pipeline)

In Focus: International

  • French regulators order AB Science to halt trial work on PhIII ALS drug, demanding proof it’s cleaned up (Endpoints) (TheStreet)
  • China cracks down on fake data in drug trials (Nature News)
  • Person infected with Ebola in Congo has died -U.N. health agency (Reuters)
  • Interviews with candidates of WHO Director General (UN)
  • China H7N9 bird flu death toll fell to 24 in April: health authority (Reuters)
  • Top-10 Glaxo investor Woodford sells out, criticises board (Reuters) (BioSpace)
  • EMA Issues Increasing Number of GMP Non-Compliance Statements in India (Focus)
  • UK NICE public meeting May 17 (NICE)
  • Unused €107m pilot plant in France to be demolished, says Sanofi (In-Pharmatechnologist)

Pharmaceuticals and Biotechnology

  • The True Believer: An Interview With New IFPMA Director General Thomas Cueni (IP-Watch)
  • Breast cancer treatment costs higher for younger women (Reuters)
  • Avastin Redux? Genentech’s Tecentriq Trial Failure Puts Bladder Cancer Claim At Risk (Pink Sheet-$)
  • Capricor to Cut Jobs as Cardiac Cell Therapy Falters in Heart Attack Study (GEN)
  • A biosimilar company uses a citizen’s petition in a new way to seek approval standards (Stat-$)
  • Daiichi Sankyo sweeps out Pieris drug, 5 others in a Q1 pipeline cleanup (Endpoints)
  • Financial climate for biotechs reduces the urgency to go public (BioWorld-$)
  • Market watch: Trends in pharmaceutical company R&D spending: 2005–2015 (Nature Reviews Drug Discovery-$)
  • Glaxo scores again as FDA strikes down would-be Advair copycats Hikma, Vectura (Fierce)
  • Ono takes a long look at Seikagaku arthritis candidate (Fierce)
  • Astellas names SVP and head of medical affairs Americas (PharmaLetter-$)
  • Intuniv Buyers Fight Actavis Bid To Nix Pay-For-Delay Suit (Law360-$)
  • 96% cheaper, Avastin is just as effective as Eylea against eye disorder (PharmaLetter-$)
  • Drug Wholesaler Gets 5 Years In Prescription Meds Fraud (Law360-$)
  • The antifungal pipeline: a reality check (Nature Reviews Drug Discovery-$)
  • UK’s MHRA marketing authorisations granted in April (MHRA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Key AstraZeneca drug shown to reduce risk of death from lung cancer (Reuters)
  • GSK's Nucala posts mixed results in COPD (PMLive)
  • Lilly Announces Positive Results for Three Phase 3 Studies of Galcanezumab for the Prevention of Episodic and Chronic Migraine (Press Release) (Fierce)
  • ImmusanT Announces Publication of Positive Data from Phase 1 Trials of Nexvax2 in Celiac Disease Patients (Press Release)

Medical Devices

  • Over-allotments take BD offering to nearly $5B (Mass Device)
  • Med device, drug delivery companies join J&J’s Toronto JLABS incubator (Mass Device)
  • Covalon Announces $2.6 Million Private Placement and Warrant Exercise (Press Release)
  • Research shows the Apple Watch can detect an early sign of heart disease (Macworld)

US: Assorted and Government

  • US may be severely underestimating Zika's potential impact; costs could be in the billions (CNBC) (TheScientist)
  • Bird flu: USDA Has Taken Actions to Reduce Risks but Needs a Plan to Evaluate Its Efforts (GAO Report) (House E&C)
  • Trump’s pick to run mental health is poised to shake things up. Even some liberals can’t wait (Stat)
  • Communities Key To Fighting Opioid Crisis, HHS Secretary Says (NPR)
  • Feinstein, Collins Introduce Bill to Strengthen Oversight of Personal Care Products, Protect Consumer Safety (Press Release)
  • DeLauro Statement on New Study Highlighting Safety of Approved Drugs (Press Release)
  • Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule; Guidance for Industry; Availability (Federal Register)

Upcoming Meetings and Events             

General Health and Other Interesting Articles

  • Bioengineered ‘Pancreas’ Effective in First Patient (TheScientist)
  • Scientists Study Ancient Bacteria for Clues to Drug Resistance (VOA)

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? Send him an email at news@raps.org.

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