Posted 29 October 2019 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your every day regulatory news and intelligence briefing.
In Concentrate: US
  • Pfizer raises 2019 forecast as sales of cancer drug, heart medicine surge (Reuters) (Monetary Instances) (WSJ) (Press)
  • Mirati provides a very first appear at its KRAS-blocking cancer drug (STAT) (Endpoints) (Reuters) (Press)
  • Will an FDA panel propose 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)
  • Residence unanimously clears PBM transparency bills (Politico)
  • Pallone, Guthrie Introduce Legislation To Help Continuous Pharmaceutical Manufacturing (E&C)
  • Pallone and Eshoo on Residence Passage of 5 Overall health Bills  (E&C)
  • Greg Walden to retire in newest sign of GOP doubts about retaking Residence (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 avert 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 remedy flops (Reuters) (Endpoints)
  • Boehringer Ingelheim is joining the KRAS crowd as early results inspires rivals (Endpoints) (Press)
  • Worldwide 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 proper ahead of Might 2020 (MedicalDevicesLegal)

Pharmaceuticals & Biotechnology

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

Pharmaceutical & Biotechnology: Study Final results, Filings & Designations

  • TG Therapeutics touts safer PI3Kδ inhibitor as execs tout PhII information, hunt swift OK for a hard niche (Endpoints)
  • Terns Pharmaceuticals Receives Quick Track Designation From the FDA for TERN-101, an FXR Agonist for the Therapy of NASH (Press)
  • Navidea Biopharmaceuticals Announces Good Final results of Initially 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 Final results 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)

Health-related Devices

  • FDA once more warns of leak danger with Endologix AAA grafts (MedtechDive)
  • Siemens Healthineers closes $1B Corindus Vascular Robotics purchase (MassDevice)
  • Abbott plans $38m Mitraclip plant in Indiana (MassDevice)
  • Medtronic wins FDA breakthrough nod for totally implantable LVAD (MassDevice)
  • Health-related Devices Clinical Chemistry and Clinical Toxicology Devices Classification of the Continuous Glucose Monitor Information Management Technique (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-$) (Bloomberg)
  • FTC Sends Warning Letters to Sellers of Cosmetic Contacts: All Get in touch with Lens Purchases Demand a Prescription from a Health-related Specialist (FTC)
  • The difficult alternatives facing ‘Medicare for All’ (Politico)
  • Justice Division troubles grand jury subpoenas in J&J opioid probe: filing (Reuters)
  • Boston jury finds biotech CEO guilty of fleecing investors, obstruction of justice (Endpoints) (Law360-$)
  • 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 Items (FDA Law Weblog)

Upcoming Meetings & Events Europe

  • Early access to medicines scheme applications: pending, refused, granted (MHRA)
  • Regulatory update – EMA encourages businesses to submit sort I variations for 2019 by finish of November 2019 (EMA)
  • Syringe driver pumps: T34™ 3rd edition models only – quit applying the pump till updated directions 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

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

Other International

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

Basic Overall health & Other Exciting Articles

  • Medicinal cannabis not verified in mental overall health, study finds (Reuters)
  • Quick DNA Sequencing Can Provide Diagnostic Clues When Newborns Want Intensive Care (NPR)

Regulatory Reconnaissance is our every day intelligence briefing for the regulatory affairs space, bringing you the prime regulatory news stories from about the globe. Every single weekday morning, we aim to bring you the newest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the newest trends with the possible to effect regulatory affairs pros and the sector in which they function.
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Supply: https://www.raps.org/news-and-articles/news-articles/2019/10/recon-pfizer-raises-2019-guidance-on-sturdy-cance

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