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Regulatory Recon: Drugmakers say New FDA Commissioner Should Have Medical Experience Pharma Industry Reacts to UK PM May's Brexit Speech (18 January 2017)

Posted 18 January 2017 | By Michael Mezher 

Regulatory Recon: Drugmakers say New FDA Commissioner Should Have Medical Experience Pharma Industry Reacts to UK PM May's Brexit Speech (18 January 2017)

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

In Focus: US

  • New FDA Chief Should Have Medical Experience, Drugmakers Say (Bloomberg)
  • Trump tax cuts could mean more Novartis investment in US (Reuters)
  • Senators on key panel reject Donald Trump's skepticism about vaccines (STAT)
  • Trump could mean new momentum for drug imports (The Hill)
  • The Challenge of Paying for Cost-Effective Cures (AJMC)
  • McKesson to Pay $150 Million for Failing to Report 'Suspicious' Drug Orders (WSJ) (Reuters) (Press) (DoJ)
  • Pharma Money Reaches Guideline Writers, Patient Groups, Even Doctors on Twitter (ProPublica) (Reuters) (STAT-$)
  • Final rule enhances protections for research participants, modernizes oversight system (HHS)
  • Bayer, Monsanto confirm spending plans after meeting Trump (Reuters) (Fierce) (Press)
  • Pfizer chief: Hatred of pharma is 'a problem of perception' (STAT-$)
  • Pfizer warns of 'big challenge' ahead from strong dollar (Financial Times)
  • FDA Issues Long-Awaited Biosimilar Interchangeability Guidance (Focus) (FDA Law Blog)
  • FDA Denies AbbVie Petition on Biosimilar Interchangeability Following Publication of Draft Guidance (FDA)
  • Precision Medicine Gives People With Cancer New Hope In 2017 (Forbes)
  • Trump Can Lower Drug Prices By U.S. Government Purchase Of Drug Companies (Forbes)
  • Health Law Repeal Could Cost 18 Million Their Insurance, Study Finds (NYTimes)
  • More in U.S. Like 'Obamacare,' as Ax Hovers Over It: Poll (WSJ)
  • Obamacare Hasn't Just Made People Healthier, but More Financially Secure (The Atlantic)
  • Second Theranos Lab Failed U.S. Inspection (WSJ)
  • Takeda and NY biotech Ovid ink rare drug development pact (Fierce) (Xconomy) (Press)
  • Tom Price, Nominee for HHS Secretary and a Doctor, Is a Harbinger of Health Care Under Donald Trump (WSJ)
  • Democrats ramp up attack on Tom Price after new ethical questions (Politico)
  • Lilly buys migraine biotech CoLucid, and the drug it outlicensed, for $960M (Fierce) (Lilly)
  • Biogen Reaches Settlement and License Agreement for MS Drug (WSJ)
  • High Prices For Orphan Drugs Strain Families And Insurers (NPR)

In Focus: International

  • Drugmakers in Davos shift focus to chronic diseases of poor (Reuters)
  • PM May announces Brexit plan, Industry Reacts (Pharmafile) (PM Live) (PharmaTimes) (ABPI) (Pink Sheet-$)
  • FDA, EMA Accept Boehringer Ingleheim Humira Biosimilar Candidate for Review (Press)
  • EU approval for Sanofi's diabetes combo (PharmaTimes)
  • Europe's oncologists back biosimilar versions of cancer drugs (Reuters)
  • Novel Vector Control Approaches: The Future for Prevention of Zika Virus Transmission? (PLOS)
  • 22 pharma companies join forces for global non-communicable disease initiative (Pharmafile) (Astellas) (Eisai) (Press)
  • Pharma industry reacts to OECD health committee statement (PharmaLetter-$) (EFPIA) (OECD)
  • SMC OKs four new therapies for NHS use in Scotland (PharmaTimes)
  • Drug companies pledge to improve emerging markets cancer care (Financial Times)
  • Change to IDA from CDSCO will usher in fresh wave of accountability & professionalism: Dr Jagashetty (PharmaBiz)
  • Pharmaceutical market in MENA region forecast to reach $50 billion in 2025 (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Post-Marketing Commitment Trials: Where Do They Belong? (CuttingEdgeInfo)
  • FDA Issues Guidance Regarding Biologic Drug Naming (Patent Docs) (Focus)
  • Few Americans believe pharma places patients over profits: poll (STAT-$)
  • Sound advice: Company aims to make drug packaging easy — and helpful (STAT-$)
  • An Alternative to GMP Quality System Auditing in the Pharma Industry (FDAZilla)
  • Pulmatrix shares soar after winning FDA designation (MassDevice) (Press)
  • Bayer names new head of its pharmaceuticals business in the Americas region (PharmaLetter-$)
  • M&A in 2016: Pause for breath in a shifting market (EP Vantage)
  • Notice of Availability of the Draft Programmatic Environmental Assessment (Draft PEA) for Mosquito Control Activities Funded by HHS/CDC To Combat Zika Virus Transmission in the United States (HHS/CDC)
  • After the San Francisco Rain: Looking On The Bright Side In 2017 (LifeSciVC)
  • US government awarded patent on fake drug detector (Securing Industry)
  • Prostate Cancer Vaccines: What's In The Pipeline? (SCRIP-$)
  • Allergan's Esmya inches closer to U.S. approval, but FDA label is key to its blockbuster fate (Fierce)
  • FDA Allows Use of E.U.-Approved Topical Drug Due to Shortage (MPR)
  • The Bully Pulpit: Trump Versus Drug Prices (Pink Sheet-$)
  • Trump, Congress And The Search For Common Ground On Drug Pricing (Pink Sheet-$)
  • Single-use bioreactors: 2,000L a ceiling, says new BPSA board member (BioPharmaReporter)
  • Horizon to use CRISPR tech to enhance CHO cell lines for biomanufacturing (BioPharmaReporter)
  • GeoVax draws a bead on hep B with therapeutic vaccine deal (Fierce)
  • The rise of 'technology-enabled' clinical research companies (Outsourcing Pharma)

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

  • Neurocrine misses endpoint in phase 2 Tourette trial (Fierce) (Press) (The Street)
  • FDA Grants Fast Track Designation for aTyr's Resolaris to Treat Limb Girdle Muscular Dystrophy 2B and Removes Partial Clinical Hold for Resolaris (Press)
  • Remedy Pharmaceuticals' CIRARA Granted Orphan Drug Designation For Treatment of Severe Cerebral Edema Caused By Acute Ischemic Stroke (Press)
  • Teva Receives FDA Approval for VANTRELATM ER (Hydrocodone Bitartrate) Extended-Release Tablets [CII] Formulated with Proprietary Abuse Deterrence Technology (Press)
  • Lysogene Receives Rare Pediatric Disease Designation from FDA for LYS-GM101 for Treatment of GM1 Gangliosidosis (Press)
  • ARCA biopharma Announces 150th Patient Randomized into the GENETIC-AF Phase 2B/3 Clinical Trial (Press)

US: Medical Devices

  • Built for the Future. Study Shows Wearable Devices Can Help Detect Illness Early (NIH)
  • What You Need To Know About the FDA's Guidance on Postmarket Cybersecurity (Drug & Device Law) (Focus)
  • NIOSH launches hearing loss prevention app (CDC)
  • Promenade Software Launches MedISAO – Sharing Cybersecurity Information within the Medical Device Community (Press)
  • FDA warns again on Pentax duodenoscopes (MassDevice) (FDA 1, 2)
  • Abbott touts dorsal root ganglion stim study (MassDevice)
  • FDA Releases Discussion Paper on LDT Regulation After Gathering Stakeholder Feedback (GenomeWeb) (Focus)
  • CyMedica Orthopedics announces FDA clearance for e-vive™, the first app-driven muscle activation therapy and patient engagement solution for pre and post-operative knee surgery rehabilitation (Press)
  • Could Apple's upcoming regulated cardiac device be headphone-based? (mobihealthnews)

US: Assorted & Government

  • Trump's health: What we could expect with the oldest incoming president (Washington Post)
  • FDA and EPA issue final fish consumption advice (FDA)
  • Birth-Control Repeal May Cost Women $1.4B A Year In Copays (For Starters) (Forbes)
  • Allergan pays $15m for failing to disclose Actavis 'white knight' offer (MassDevice)
  • Defibrillator Decision Does Not Shock The Conscience (Law360-$)
  • Justices Decline J&J Patent Appeal Over Expert Misconduct (Law360-$)

Upcoming Meetings & Events

Europe

  • Medtronic wins CE Mark for large-size CoreValve Evolut R replacement heart valve (MassDevice) (Medtronic)
  • Intact Vascular wins CE Mark for Tack blood vessel repair device (MassDevice)
  • Eyewear giants Essilor, Luxottica to merge (MassDevice)
  • DH invests £35m in vaccines for global epidemics (PharmaTimes)

Asia

  • Novel Anti-IL-6 Antibody for Rheumatoid Arthritis from WuXi-MedImmune Joint Venture Receives Clinical Trial Permit (CTP) from CFDA (Press)

India

  • Gujarat FDCA trains 50 drug inspectors on GMP in line with the training imparted to US FDA inspectors (PharmaBiz)
  • Pharmacies continue to sell banned drugs in remote and far-flung areas of Hyderabad (PharmaBiz)
  • Telengana govt identifies 3,100 acres of land on the outskirts of Hyderabad to shift polluting pharma units (PharmaBiz)
  • Zydus Cadila gets USFDA nod for chemotherapy drug (Economic Times)
  • NPPA seeks info about pricing, products from stent makers (Economic Times)
  • Panacea inks pact with UNICEF,gets USFDA nod for migraine drug (Economic Times)

Australia

  • Mainstay Medical seeks Australian approval to sell ReActiv8  (BioSpectrum)
  • TGA statutory advisory committees (TGA)

General Health & Other Interesting Articles

  • Delayed umbilical cord clamping tied to lower anemia risk in babies (Reuters)
  • Asthma may be misdiagnosed in many adults (Reuters)
  • Food As Medicine: It's Not Just A Fringe Idea Anymore (NPR)
  • These paper-airplane drones may one day save your life (Recode)

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.


Categories: Recon, Regulatory News

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