Regulatory Recon: Kite Teams Up With Pfizer on Lymphoma Combo; Fed Up With Drugmakers, Hospitals Start Their Own (18 January 2018)

Posted 18 January 2018 By Michael Mezher

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

In Focus: US

  • US Doctors Plan to Treat Cancer Patients Using CRISPR (MIT Technology Review)
  • Gilead's Kite Teams up With Pfizer on a Lymphoma Combo (Endpoints) (Press)
  • Fed Up With Drug Companies, Hospitals Decide to Start Their Own (NYTimes) (STAT)
  • How a government shutdown could affect drug safety, flu response, and more (STAT)
  • Senate committee advances Azar nomination as health secretary (Reuters)
  • Pence says that Congress should get right-to-try legislation 'DONE' (STAT)
  • Where the money is: Top 100 VCs investing in US biotechs during 2017 (Endpoints)
  • FDA Adds Overall Survival Data to Kyprolis Label for Multiple Myeloma (Press)
  • Insider trading scam spurred by $11.2B Gilead deal earns a stretch in prison (Endpoints)
  • When the well runs dry, where will unicorns — and biotech — go? (STAT)
  • US court invalidates J&J cancer drug patent, hitting UK's BTG (Reuters) (Endpoints)
  • Judge signals early support for Valeant settlement, company says (Fierce)
  • BIO Report on Innovation in Prevalent Chronic Diseases (BIO)
  • Where is Trump's emergency on opioids? (USA Today) (NYTimes)
  • The Next Emflaza: Acer Therapeutics Looks to Take a Page Out of Marathon's Book (Focus)

In Focus: International

  • China's Great Leap Into Biotech (Bloomberg)
  • Novartis ties a new round of biosimilar development programs to a partnership deal with India's Biocon (Endpoints) (Press)
  • Biotech groups urged to focus more on humans in drug tests (Financial Times) (PharmaLetter-$) (BIA)
  • India plans to raise health spending by 11 percent in budget; less than requested (Reuters)
  • Given Medicine, the Patients Got Better. They Remained in Shackles Anyway. (NYTimes)
  • EMA Begins Publishing Reports on Whether Approved Medicines Still Qualify as Orphans (Focus)
  • Brazilians rush to get yellow fever vaccinations amid fatal cases (Reuters)
  • NPPA fixes retail price of 30 drug formulations (Economic Times)
  • Companies Urged To Tailor Approach To Orphan Drugs In Emerging Markets (SCRIP-$)
  • Another EU fake Velcade alert, this time in Finland (Securing Industry)
  • China's pollution tax to roll out from April; Teva directors undergo pay cut (PharmaCompass)

Pharmaceuticals & Biotechnology

  • More evidence common morning sickness drug may not work (Reuters)
  • Delay of the Revisions to the Federal Policy for the Protection of Human Subjects (Federal Register)
  • With $58M in hand, the startup team at Pandion sets their sights on a next-gen approach to immunology (Endpoints) (Xconomy)
  • FDA Drafts PRV Guidance for Medical Countermeasures (Focus)
  • Research backs blanket screening for breast, ovarian cancer mutations (PharmaTimes)
  • AstraZeneca expands drug discovery collaboration with X-Chem (Pharmafile) (Endpoints) (Press)
  • Kids' Vaccinations Are On The Rise But So Are Parent Refusals (Forbes)
  • CBER Director Marks: Regenerative Medicine Enforcement Will Be 'Notched Up' In 2018 (Pink Sheet-$)
  • RMAT Designation, Gene Therapies Highlight 2017 CBER Transformation (Pink Sheet-$)
  • OTC Monograph Reform Momentum Carries Potential Exclusivity Snag (Pink Sheet-$)
  • CHPA Statement Regarding OTC Monograph Reform and Exclusivity Provisions (CHPA)
  • Inositec names ex-Roche, Novartis staffer as CMO (Fierce)
  • Toothpaste ingredient could fight malaria, research shows (Reuters)
  • Heated abdominal chemo bath improves ovarian cancer survival (Reuters)
  • William Ralph Kincaid; Denial of Hearing; Final Debarment Order (FDA)
  • Retooling drug development with next-generation machine learning, Owkin nabs $11M (Fierce)
  • Alligator lures AstraZeneca exec to its team (PharmaLetter-$)
  • Riding the wave: The FDA and real world evidence (Pharmafile)
  • Real-world data show benefits of long-acting antipsychotics (PharmaLetter)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA approves Avion Pharmaceuticals' Belcontra (DSN)
  • First Chronic Hepatitis B Patient Dosed in China in a Phase 1 Trial of T101 (Transgene's TG1050 Technology) (Press)
  • Ipsen ends P3 trial on liver cancer early due to strong data (Pharmafile)
  • Ipsen to Present Data at ASCO GI 2018, Including New Post-Hoc Analyses from ONIVYDE (irinotecan liposome injection) Phase 3 NAPOLI-1 Trial (Press)
  • GC Pharma Confirms Phase 2/3 Clinical Trial of New Protein Therapy for Hepatitis B (Press)
  • Protalex Doses First Patient in Final and Highest Dose Cohort of European Phase 1b Study of PRTX-100 in Immune Thrombocytopenia (Press)

Medical Devices

  • IRS Delays Penalty For Excise Tax On Medical Devices (Law360-$)
  • CDRH Looks Ahead to Priorities for 2018 to 2022 (Focus) (FDA Voice) (Report)
  • GAO Calls on FDA to Evaluate its Efforts on Least Burdensome Approach for Devices (Focus)
  • Are Implanted Medical Devices Creating A 'Danger Within Us'? (NPR)
  • What Medical Device Manufacturers Need to Know about FDA's Predictive Toxicology Roadmap (MDDI)
  • Bluegrass Vascular Opens U.S. Clinical Trial for Obstructed Veins (Xconomy)
  • NeuroMetrix, GSK ink development deal for Quell wearable pain-relief tech (Drug Delivery)
  • FDA clears FloPump 32 from International Biophysics (MassDevice)
  • Death prompts warning for Zoll's LifeVest wearable AED (MassDevice)
  • Hologic Brevera Biopsy System Slices and Images Breast Tissue, Now Cleared in Europe (medGadget)
  • Revision rates prompt recalls for Johnson & Johnson's DePuy Synthes, Zimmer Biomet (MassDevice)

US: Assorted & Government

  • Exercise? I get more than people think, Trump says (Reuters)
  • Opioids: Medicare Should Expand Oversight Efforts to Reduce the Risk of Harm (GAO)
  • SEC greenlights AmerisourceBergen shareholder proposals tied to opioid crisis (STAT)
  • Philly Becomes Latest To Sue Drugmakers For Opioid Crisis (Law360-$)
  • Drugmaker Urges Full Fed. Circ. To Kill USPTO Fee Rule (Law360-$)
  • Medtronic logs wins in overcharging lawsuit, defibrillator case fees (MasDevice)
  • Merck, Glenmark Stifled Cholesterol Drug Market, Suit Says (Law360-$)
  • When States Make It Harder to Enroll, Even Eligible People Drop Medicaid (NYTimes)
  • Pa. Court Urged To Resurrect Actiq Off-Label Marketing Suit (Law360-$)
  • J&J Unit Can't Nix FCA Suit Over Hip Implants Yet (Law360-$)

Upcoming Meetings & Events

Europe

  • Committee for Advanced Therapies (CAT) Agenda for 17-19 January 2018 Meeting (EMA)
  • PDCO monthly report of opinions on paediatric investigation plans and other activities (EMA)
  • MHRA issues call to remain 'vigilant' with commonly confused drug names (Pharmaceutical Journal)
  • UK Appoints a Minister for Loneliness (NYTimes)

Asia

  • Mitsubishi Tanabe secures additional indication for Novastan in China (PharmaLetter)
  • Analysts: Japan approves 12 new procedures for Intuitive Surgical's da Vinci (MassDevice)

India

  • Suven gets product patents in China, Sri Lanka (Economic Times)
  • Panacea Biotec partners Serum Institute for hexavalent vaccine (Economic Times)

General Health

  • Pioneering HIV Researcher Mathilde Krim Remembered For Her Activism (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.

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