Posted 29 October 2019 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your day-to-day regulatory news and intelligence briefing.
In Concentrate: US
  • Pfizer raises 2019 forecast as sales of cancer drug, heart medicine surge (Reuters) (Monetary Occasions) (WSJ) (Press)
  • Mirati offers a initially appear at its KRAS-blocking cancer drug (STAT) (Endpoints) (Reuters) (Press)
  • Will an FDA panel advocate a drug for stopping premature births stay accessible? (STAT)
  • Drugmakers Ink $242M Settlement In Ill. Medicaid Fraud Case (Law360-$) (Fierce)
  • Roche — surprise — delays $four.3B Spark buyout once more as regulators hover (Endpoints) (Press)
  • Property unanimously clears PBM transparency bills (Politico)
  • Pallone, Guthrie Introduce Legislation To Assistance Continuous Pharmaceutical Manufacturing (E&C)
  • Pallone and Eshoo on Property Passage of 5 Overall health Bills  (E&C)
  • Greg Walden to retire in most recent sign of GOP doubts about retaking Property (Politico) (E&C)
  • Senate Democrats to vote this week to overturn Trump ObamaCare moves (The Hill)
  • Is Crispr the Subsequent Antibiotic? (NYTimes)

In Concentrate: International

  • GSK TB vaccine could protect against millions of deaths (PMLive) (Endpoints) (NYTimes) (AP) (NEJM)
  • EU ‘yes’ for Bavencio (PharmaTimes)
  • Eudamed reportedly delayed two years, IVDR gets 2nd notified physique (MedtechDive)
  • Morphosys shares fall just after dermatitis therapy flops (Reuters) (Endpoints)
  • Boehringer Ingelheim is joining the KRAS crowd as early accomplishment inspires rivals (Endpoints) (Press)
  • International Regulators Synergize Horizon Scanning Efforts (Pink Sheet-$)
  • WTO Cost Transparency Talks Face Resistance From Created Nations (Pink Sheet-$)
  • Counting down to the MDR date of application, and the legal stuff to get correct ahead of May well 2020 (MedicalDevicesLegal)

Pharmaceuticals & Biotechnology

  • Realizing the guarantee of prescription digital therapeutics (STAT)
  • Merck’s quarterly Keytruda sales soar previous $three billion, but analysts fret more than future development (Fierce)
  • Pfizer kills off MacroGenics-partnered strong tumor bispecific (Fierce)
  • Quarterly Inactive Ingredient Database (IID) Transform Log (FDA)
  • Generic Version of Xanax Is Recalled by FDA (NYTimes)
  • How to communicate about antimicrobial resistance efficiently (Wellcome Trust)
  • Males With Breast Cancer Want A lot more Remedy Possibilities and Access to Genetic Counseling (FDA)
  • Individuals taking blood thinners may perhaps danger danger by mixing with OTC meds (Reuters)
  • Agile’s Twirla Suffers Scathing Critique By US FDA Ahead Of Advisory Cmte. (Pink Sheet-$)
  • Manufacturer Communications With Payers A lot easier Below US FDA Guidance, But Challenges Stay (Pink Sheet-$)
  • Disc Medicine nabs money, huge backers and biopharma drug deal (Fierce)
  • Early cost setting, other market place access preparing is essential for early-stage drug, device providers (STAT)
  • Atlas, Novo-backed biotech reels in ex-Nimbus CEO Don Nicholson as exec chairman, hooks $50M to conquer anemia (Endpoints)

Pharmaceutical & Biotechnology: Study Outcomes, Filings & Designations

  • TG Therapeutics touts safer PI3Kδ inhibitor as execs tout PhII information, hunt rapid OK for a challenging niche (Endpoints)
  • Terns Pharmaceuticals Receives Rapid Track Designation From the FDA for TERN-101, an FXR Agonist for the Remedy of NASH (Press)
  • Navidea Biopharmaceuticals Announces Constructive Outcomes of Very first Interim Evaluation of Ongoing Phase 2B Study in Rheumatoid Arthritis (Press)
  • Themis Bioscience and CEPI Announce Initiation of Phase 1 Clinical Trial with Lassa Fever Vaccine (Press)
  • Vapogenix Reports Encouraging Phase II Outcomes of Topical Non-Opioid Discomfort Medication (Press)
  • Novus Therapeutics Receives FDA Guidance on OP0201 Phase 2a Study in Individuals with Chronic Otitis Media with Effusion (Press)

Healthcare Devices

  • FDA once more warns of leak danger with Endologix AAA grafts (MedtechDive)
  • Siemens Healthineers closes $1B Corindus Vascular Robotics get (MassDevice)
  • Abbott plans $38m Mitraclip plant in Indiana (MassDevice)
  • Medtronic wins FDA breakthrough nod for completely implantable LVAD (MassDevice)
  • Healthcare Devices Clinical Chemistry and Clinical Toxicology Devices Classification of the Continuous Glucose Monitor Information Management Program (FDA)
  • The Surmodics Sundance Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status (Press)
  • FDA clears HeartVista’s A single Click AI-assisted cardiac MRI (MassDevice) (Press)

US: Assorted & Government

  • Lady Desires New Trial In Sanofi Chemo Drug Bellwether (Law360-$) (Bloomberg)
  • FTC Sends Warning Letters to Sellers of Cosmetic Contacts: All Make contact with Lens Purchases Need a Prescription from a Healthcare Specialist (FTC)
  • The tough selections facing ‘Medicare for All’ (Politico)
  • Justice Division concerns grand jury subpoenas in J&J opioid probe: filing (Reuters)
  • Boston jury finds biotech CEO guilty of fleecing investors, obstruction of justice (Endpoints) (Law360-$)
  • FTC Rips Gilead’s ‘Erroneous’ Argument In HIV Drug Rumble (Law360-$)
  • Takeda Hid ‘Dangerously Defective’ Gout Drug’s Dangers (Law360-$)
  • Chinese Distributor Can’t Pause US Co.’s Trade Secrets Suit (Law360-$)
  • CBD Guidelines In Limbo As FDA Grapples With New Cannabis Era (Law360-$)
  • Supreme Court Preemption Teaser (Drug & Device Law)
  • FDA Does Away with the Compliance Policy Guide for Homeopathic Drug Merchandise (FDA Law Weblog)

Upcoming Meetings & Events Europe

  • Early access to medicines scheme applications: pending, refused, granted (MHRA)
  • Regulatory update – EMA encourages providers to submit variety I variations for 2019 by finish of November 2019 (EMA)
  • Syringe driver pumps: T34™ 3rd edition models only – cease employing the pump till updated guidelines for use and BodyCommTM V3. computer software are released (MDA/2019/038) (MHRA)
  • France’s Servier aims to accelerate Russian expansion (PharmaLetter-$)
  • Germany’s Stada Arz to transfer production of 4 drugs to Russia (PharmaLetter-$)


  • Asia Deal Watch: Qpex Partners Its Experimental Antibiotics With Brii In Higher China (Scrip-$)

India Australia

  • Modifications to propolis and royal jelly in listed medicine applications (TGA)
  • TGA presentation: How to submit an productive fantastic manufacturing practice clearance application (TGA)
  • Advertisers of complementary medicines (TGA)
  • Introduction to medicinal cannabis regulation in Australia (TGA)

Other International

  • Kenyan group aim to cease fatal snake bites (Reuters)

Common Overall health & Other Exciting Articles

  • Medicinal cannabis not established in mental well being, study finds (Reuters)
  • Rapid DNA Sequencing Can Supply Diagnostic Clues When Newborns Want Intensive Care (NPR)

Regulatory Reconnaissance is our day-to-day intelligence briefing for the regulatory affairs space, bringing you the leading regulatory news stories from about the globe. Every single weekday morning, we aim to bring you the most recent highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the most recent trends with the prospective to influence regulatory affairs pros and the business in which they perform.
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Supply: https://www.raps.org/news-and-articles/news-articles/2019/10/recon-pfizer-raises-2019-guidance-on-powerful-cance

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