Regulatory Recon: Biotech Leaders Speak Out Against US Immigration Order Teva CEO Resigns (7 February 2017)

Posted 07 February 2017 | By Michael Mezher 

Regulatory Recon: Biotech Leaders Speak Out Against US Immigration Order Teva CEO Resigns (7 February 2017)

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

In Focus: US

  • US immigration order strikes against biotech (Nature)
  • E&C delays vote on drug pricing bill (Politico)
  • Cellectis gets US go-ahead to test 'off-the-shelf' cell therapy (Reuters) (Endpoints) (PMLive) (Press)
  • GOP Sets June Deadline for Completing FDA User Fee Reauthorizations (Focus)
  • Industry Needs To Submit Fewer Safety Reports, US FDA Official Says (Pink Sheet-$)
  • Mylan agreed to pay $96.5 million in Provigil antitrust class action (Reuters) (CNBC)
  • Mylan faces subpoena from lawmakers over EpiPen pricing documents (SNL) (NBC)
  • GPhA In Talks With Trump On Drug Pricing, Lukewarm On Priority Review Voucher Bill (InsideHealthPolicy-$)
  • FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders (FDA)
  • From 'Repeal' to 'Repair': Campaign Talk on Health Law Meets Reality (NYTimes)
  • Conservative Republicans Double Down on Push to Repeal Obamacare (WSJ)
  • FDA proposal on biotech drugs sparks criticism (The Hill)
  • Drugmaker Kaleo Raises Price Of Lifesaving Drug By Thousands (KHN)
  • Trump's 'Two Out, One In' Regulatory Policy May Apply to Some FDA Guidance (Focus)
  • Actelion, take two (BioCentury)
  • Lawyers, drugs and money (BioCentury)
  • Right-to-try bill introduced in House (BioCentury) (Rep. Biggs)
  • A New Day For Oversight Of Human Subjects Research (Health Affairs Blog)
  • Tom Price, Dr. Personal Enrichment (NYTimes)
  • Beyond Bricks And Mortar: Reimagining Infrastructure Investment To Spur Biotechnology Innovation (Forbes)
  • PhRMA CEO goes on Fox to discuss White House meeting (PhRMA)

In Focus: International

  • Carmat withdraws initial request to resume artificial heart implants (Reuters)
  • First Take: New Indian Medical Device Regulations (Emergo) (Economic Times)
  • Teva Loses CEO, Leaving Investors to Guess What's Next (Bloomberg) (Endpoints) (BioCentury) (Pharmafile)
  • MHRA Looks to Increase Medical Device Fees (Focus)
  • Turning the Tide Against Cholera (NYTimes)
  • Health Commissioner awards Prize to NGOs active in reducing the threat of AMR (EC)
  • Sourcing Medical Devices in China: Phase 5 – Quality Inspections (Pacific Bridge Medical)
  • Brazilian Regulators Officially Adjust Medical Device Fees Downward (Emergo)
  • Thomas Cueni named as new IFPMA Director General (Pharmafile) (PharmaLetter-$)
  • Trends in biopharma innovation; report (PharmaLetter-$)
  • Takeda's Planned Emerging Markets Deal: India Yay Or Nay? (SCRIP-$)
  • How does GSK's incoming chief view the Advair generic threat? Stay tuned this week (Fierce) (The Street)
  • Medical devices--Quality management systems--Requirements for regulatory purposes officially released (CFDA)
  • UK launch for world's largest breath-based study into bowel cancer (PharmaTimes)
  • Janssen Pilot Speeds Up African Approvals As Harmonization Project Expands (Pink Sheet-$)
  • GW Pharma's cannabis-derived combo med helps brain cancer patients (Fierce)

US: Pharmaceuticals & Biotechnology

  • In Last Gasps of the Obama Administration, FDA Attempts to Clarify Role of Government in Regulation of Genome Editing (FDA Law Blog)
  • Foreign Inspection Program Feels the Freeze (Lachman Consultants)
  • Priced like an automaker, sputtering Gilead shares lure value bets (Reuters)
  • AstraZeneca: faith healer (Financial Times)
  • No Easy Road to Getting Rid of PAINS (In The Pipeline)
  • What will be "the Trump effect"? (PharmaLetter-$)
  • Pharma Execs Like Gottlieb for FDA Commissioner (MedPage)
  • Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers (Health Affairs)
  • More Than 25% of New Molecular Entities Approved in 2016 Are Personalized Medicines (National Law Review)
  • Picking the Right Over-the-Counter Pain Reliever (NYTimes)
  • Aspirin may help prevent pregnancy loss in women with high inflammation, NIH study finds (NIH)
  • Pet medicines pose poison risk for kids (Reuters)
  • FDA lifts clinical hold on Northwest Bio cancer vax trial (Fierce) (Press)
  • Renova takes over Janssen's rights to heart failure candidate stresscopin (Fierce)
  • Generic Versions Of Rytary Should Meet 3 Extra Standards, Impax Says (Pink Sheet-$)
  • US FDA's 'Within Label' Definition Allows Companies To Elaborate On Indications (Pink Sheet-$)
  • GMP Requirement Guidance For Combination Products Satisfies Industry (Pink Sheet-$)
  • FDA Delays Implementation of Rule Clarifying When Products Made or Derived from Tobacco are Regulated as Drugs, Devices or Combination Products (FDA)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Phase III results show 80% lesion clearance in sun-induced skin cancer (PharmaLetter-$)
  • Vyome Biosciences Announces Top-Line Results from Phase 1 Study of VB-1953 for Patients with Facial Acne Vulgaris (Press)
  • Aura Biosciences wins FDA nod for light-activated ocular melanoma treatment IND (Drug Delivery)
  • Pivotal Phase 3 Data Results for TRULANCE (plecanatide) in the Treatment of Chronic Idiopathic Constipation (CIC) Published in American Journal of Gastroenterology (Press)

US: Medical Devices

  • FDA Monthly PMA Approvals – Janurary 2017 (FDA)
  • Medtronic gets FDA clearance for cardiac-mapping vest (MobiHealthNews)
  • Boston Scientific Feeling Good on Lotus Edge (MDDI)
  • Four pivotal NIH-funded artificial pancreas research efforts begin (NIH)
  • Abiomed gains after Abbott tables HeartMate PHP program (MassDevice)
  • FDA Releases Draft Guidance on Manufacturers' Communications with Payors (Inside Medical Devices)
  • Baebies Receives FDA de novo Clearance for First Lysosomal Storage Disease Newborn Screening Platform, SEEKER (Press)
  • First automated ANCA IFA assays cleared by FDA (Press)

US: Assorted & Government

  • USPTO Releases Performance and Accountability Report for FY 2016 (Patent Docs)
  • Despite Judge's Order, a Cleveland Clinic Doctor Still Can't Come Back to U.S. (ProPublica)
  • Deadly Drugs Shipped Before Test Results Came In, Jury Told (Law360-$)
  • Investors Sue Over Lilly's $960M Buy Of Migraine Drug Co. (Law360-$)
  • GSK Nabs $40M Arbitral Award In Migraine Drug Row (Law360-$)

Upcoming Meetings & Events


  • Banned wholesaler Europharma DK hires repackager Abacus Medicine and replaces CEO (InPharmaTechnologist)
  • Roche: 'Largest biomanufacturing capacity across the industry' to get bigger (BioPharmaReporter)
  • Serono spinout raises €29M for phase 2 Parkinson's trials (Fierce)
  • Spanish Regulator Suspends Vaccine Company for Quality Violations (Focus)
  • Ablynx files rare blood disorder drug, raising prospect of first commercial product next year (Fierce) (PharmaLetter-$)
  • CE Mark Approval for Shift Labs' DripAssist Infusion Rate Monitor (Medgadget)


  • Dipharma and Alvogen launch Diterin in South Korea (PharmaLetter-$)
  • This Is How Trump's U.S. Protectionism Has Actually Helped Asian Healthcare (Forbes)
  • GE Healthcare's 'Cell line agnostic' FlexFactory to boost Turkish biosimilars business (BioPharmaReporter)


  • Panel recommends portal to monitor online sale of drugs (Economic Times)
  • Gujarat FDCA lab tested maximum number of drug samples as part of health ministry's pan India spurious drugs survey (PharmaBiz)
  • DoP quashes ceiling price fixation of amlodipine 5 mg tablets by NPPA for deviation of DPCO, 2013 (PharmaBiz)


  • Publication of TGA laboratory testing outcomes (TGA)
  • A $125 million in grants to help Australian researchers 'make next great medical discovery' (PharmaLetter-$)

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

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

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