Regulatory Recon: Merck Ends Development of CETP Inhibitor; NIH to Team Up With 11 Drugmakers for Immunotherapy Research (12 October 2017)

Posted 12 October 2017 By Michael Mezher

placeholder+image

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

In Focus: US

  • Merck Drops Development Of Once Promising CETP Inhibitor (CardioBrief) (Reuters) (Endpoints) (Press)
  • To accelerate new cancer treatments, NIH will team up with pharma on immunotherapy research (STAT)
  • 'Double whammy' for Roche as manufacturing patent losses loom (Reuters)
  • Ardelyx's constipation drug succeeds in late-stage trial (Reuters)
  • George Yancopoulos on Threating the Price Needle and Building a Biotech to Last (Timmerman Report)
  • Anti-Vax Message Gets Meaner on Social Media (NBC)
  • Medtronic Says Santa Rosa Buildings Still Standing (Star Tribune)
  • AcelRx Pharma shares sink as FDA rejects its opioid painkiller (Reuters)
  • Experimental Ebola vaccines elicit year-long immune response (NIH) (NEJM)
  • NIH completes atlas of human DNA differences that influence gene expression (NIH)
  • CAR-T cancer therapy is potent, but can be lethal. New research helps explain why (STAT) (Washington Post)
  • Trump healthcare order could face strong legal objections (Reuters)
  • FDA Updates "Least Burdensome" Guidance After 17 Years (FDA Law Blog)
  • Janssen files would-be prostate cancer blockbuster in US (PMLive) (Press)
  • Puerto Rico's Health Care Is in Dire Condition, Three Weeks After Maria (NYTimes)

Preparing for the Spring 2018 RAC Exam?

In Focus: International

  • Sanofi invests 170 million euros in French vaccines facility (Reuters) (Financial Times)
  • NICE gives final draft guidance on two key cancer drugs (Pharmafile) (PharmaTimes)
  • EDQM and Anvisa sign MoU on future use of CEPs in Brazil (InPharmaTechnologist)
  • SGS and Bavarian Nordic developing challenge strain to combat respiratory virus​ (Reuters)
  • Switzerland to streamline approval process for cross-border inspections (InPharmaTechnologist)
  • US FDA approves production at Samsung Biologics 152,000L plant (BiopharmaReporter) (Press)
  • What Korean Pharma Wants To Build On Innovation Momentum (SCRIP-$)
  • Epidemic preparedness: Protecting the world from the next infectious disease (Pharmafile)
  • What EU Governments Need To Do About Access To Affordable Medicines (Pink Sheet-$)
  • Betting On A Brexit Transition Period Is A Gamble: EMA Warning For Industry (Pink Sheet-$)
  • CHMP Readies 'Outstanding Issues' Lists For Products Nearing EU Review End (Pink Sheet-$)
  • The 68th session of the WHO Regional Committee for the Western Pacific (WHO)
  • Seychelles Reports a Case of Plague (NYTimes)
  • Is China's Medtech Market Still Attractive for Foreign Device Companies? (Pacific Bridge Medical)

Pharmaceuticals & Biotechnology

  • A Bit About Biopharma Investing (InThePipeline)
  • Emergent Medical Data (Harvard Bill of Health)
  • PhRMA Names Bradway Chairman-Elect (BioCentury)
  • Ipsen Joins PhRMA to Continue Advancing Research and Innovation (Press)
  • Prostate cancer patients unclear on differences among treatments (Reuters)
  • Elligo to test FDA's real-world data model for immunotherapy safety assessment (Fierce)
  • Trevena to restructure, cut 30% of workforce; shares down 12% after hours (Seeking Alpha)
  • Pfizer sells ex-Hospira API plant in Colorado to CDMO CordenPharma (InPharmaTechnologist)
  • Hot to trot with Zilretta, Flexion rolls $100M-plus stock offering to fund the launch (Fierce)
  • Janssen rolls out trial supply and patient engagement mobile app (Fierce)
  • MilliporeSigma opens $115m life science centre in Massachusetts (BioPharmaReporter)
  • 'We have entered a new era': Cancer researchers no longer follow a single path to discovery (STAT)
  • Seattle Biotech Blaze Bioscience Adds $16M for Clinical Trial Work (Xconomy)
  • Buoyed by new eczema data, AnaptysBio hits the fundraising button (Fierce)
  • Biophytis raises $12M for trials of aging disease duo (Fierce)
  • Genfit seeks €150M to wrap up phase 3 NASH program (Fierce)
  • Guidance: Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA Grants Priority Review for Potential New Indication for Lilly's Verzenio (abemaciclib) as Initial Treatment of Advanced Breast Cancer (Press)
  • Lundbeck and Otsuka start phase III for Rexulti in bipolar (PMLive)
  • FDA Approves LYRICA CR (pregabalin) Extended-Release Tablets CV (Press)
  • Galderma Announces FDA Approval of Restylane Silk as the First HA Dermal Filler Approved for Injection via Cannula (Press)
  • Philogen Announces Authorization from FDA of a Pivotal Registration Trial in USA for the Treatment of Resectable Melanoma (Press)
  • Vidac Pharma Reports Positive Results from Phase 2a Proof-of-Concept Trial of VDA-1102 Ointment in Actinic Keratosis (Press)

Medical Devices

  • FDA clears first 7T magnetic resonance imaging device (FDA)
  • What Matters in Medtech Now? (MDDI)
  • Here's how the diabetes industry's leaders think about patient-centered R&D (Drug Delivery)
  • Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device; Correction (FDA)
  • Covalon Announces FDA Clearance for MediClear PreOp (ICT)
  • NuVasive Receives Expanded FDA 510(k) Clearance For Innovative Magnetic Limb Lengthening Technology (Press)

US: Assorted & Government

  • How Bristol-Myers Squibb May Transform Class Actions (Law360-$)
  • FDA Expert Testifies Of Unparalleled Contamination At NECC (Law360-$)
  • Empty Gestures – Pennsylvania's Right To Try Legislation (Drug & Device Law)
  • BioDelivery Sciences, Teva settle patent fight over opioid dependence treatment (Drug Delivery)
  • The Insufficiency Of Medicaid Block Grants: The Example Of Puerto Rico (Health Affairs Blog)

Upcoming Meetings & Events          

Europe

  • Guidelines on good pharmacovigilance practices (GVP) (EMA)

Asia

  • Going global to meet local needs in China (Novartis)

India

  • Government imposes restrictions on stem cell banking, therapy to curb "rampant" unethical practices (Economic Times)
  • Chennai CDSCO enters into second phase of e-governance, industry and regulators hail high-tech operations (PharmaBiz)
  • Centre plans to frame exclusive policy on bulk drugs, medical devices, formulation parks to address costly imports (PharmaBiz)
  • Pharma cos dumping toxic waste into drains, TSPCB records 4 cases (PharmaBiz)              
  • Indian pharma market clocks growth of 2.8% to Rs.10,420 crore in September 2017 (PharmaBiz)

Australia

  • Prescription medicines minor variations e-form: Frequently asked questions (FAQs) (TGA)
  • Black Triangle Scheme (TGA)
  • Product Information (TGA)

Other International

  • Botswana finds anthrax outbreak after spate of hippo deaths (Reuters)

General Health & Other Interesting Articles

  • Inside the Moonshot Effort to Finally Figure Out the Brain (MIT Technology Review)
  • Tiny, Transparent Worm Challenges Notions About Sex (NPR)
  • Could Making Cancer Screening Simpler Increase Women's Risk? (NPR)

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