Recon: Pfizer Raises 2019 Guidance on Sturdy Cancer, Heart Drug Sales Drugmakers Settle Medicaid Fraud Suit for $248M – Regulatory Concentrate


Posted 29 October 2019 | By Michael Mezher 

Recon: Pfizer Raises 2019 Guidance on Strong Cancer, Heart Drug Sales; Drugmakers Settle Medicaid Fraud Suit for $248M
Welcome to Regulatory Reconnaissance, your each day regulatory news and intelligence briefing.
In Concentrate: US
  • Pfizer raises 2019 forecast as sales of cancer drug, heart medicine surge (Reuters) (Economic Occasions) (WSJ) (Press)
  • Mirati provides a initial appear at its KRAS-blocking cancer drug (STAT) (Endpoints) (Reuters) (Press)
  • Will an FDA panel propose a drug for stopping premature births stay obtainable? (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)
  • Home unanimously clears PBM transparency bills (Politico)
  • Pallone, Guthrie Introduce Legislation To Help Continuous Pharmaceutical Manufacturing (E&C)
  • Pallone and Eshoo on Home Passage of 5 Wellness Bills  (E&C)
  • Greg Walden to retire in most current sign of GOP doubts about retaking Home (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 avoid 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 achievement inspires rivals (Endpoints) (Press)
  • Worldwide Regulators Synergize Horizon Scanning Efforts (Pink Sheet-$)
  • WTO Value Transparency Talks Face Resistance From Created Nations (Pink Sheet-$)
  • Counting down to the MDR date of application, and the legal stuff to get correct just before Could 2020 (MedicalDevicesLegal)

Pharmaceuticals & Biotechnology

  • Realizing the guarantee of prescription digital therapeutics (STAT)
  • Merck’s quarterly Keytruda sales soar previous $three billion, but analysts fret more than future development (Fierce)
  • Pfizer kills off MacroGenics-partnered strong tumor bispecific (Fierce)
  • Quarterly Inactive Ingredient Database (IID) Transform Log (FDA)
  • Generic Version of Xanax Is Recalled by FDA (NYTimes)
  • How to communicate about antimicrobial resistance efficiently (Wellcome Trust)
  • Males With Breast Cancer Require Far more Remedy Selections and Access to Genetic Counseling (FDA)
  • Folks taking blood thinners may possibly threat danger by mixing with OTC meds (Reuters)
  • Agile’s Twirla Suffers Scathing Critique By US FDA Ahead Of Advisory Cmte. (Pink Sheet-$)
  • Manufacturer Communications With Payers Less difficult Beneath US FDA Guidance, But Challenges Stay (Pink Sheet-$)
  • Disc Medicine nabs money, large backers and biopharma drug deal (Fierce)
  • Early cost setting, other industry access arranging is crucial for early-stage drug, device corporations (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 swift OK for a challenging niche (Endpoints)
  • Terns Pharmaceuticals Receives Speedy Track Designation From the FDA for TERN-101, an FXR Agonist for the Remedy of NASH (Press)
  • Navidea Biopharmaceuticals Announces Good 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)

Health-related Devices

  • FDA once more warns of leak threat with Endologix AAA grafts (MedtechDive)
  • Siemens Healthineers closes $1B Corindus Vascular Robotics acquire (MassDevice)
  • Abbott plans $38m Mitraclip plant in Indiana (MassDevice)
  • Medtronic wins FDA breakthrough nod for completely implantable LVAD (MassDevice)
  • Health-related 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-$) (Bloomberg)
  • FTC Sends Warning Letters to Sellers of Cosmetic Contacts: All Speak to Lens Purchases Need a Prescription from a Health-related Skilled (FTC)
  • The really hard alternatives facing ‘Medicare for All’ (Politico)
  • Justice Division challenges grand jury subpoenas in J&J opioid probe: filing (Reuters)
  • Boston jury finds biotech CEO guilty of fleecing investors, obstruction of justice (Endpoints) (Law360-$)
  • FTC Rips Gilead’s ‘Erroneous’ Argument In HIV Drug Rumble (Law360-$)
  • Takeda Hid ‘Dangerously Defective’ Gout Drug’s Dangers (Law360-$)
  • Chinese Distributor Cannot 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 corporations to submit kind I variations for 2019 by finish of November 2019 (EMA)
  • Syringe driver pumps: T34™ 3rd edition models only – quit utilizing the pump till updated directions for use and BodyCommTM V3. software program 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

  • Adjustments to propolis and royal jelly in listed medicine applications (TGA)
  • TGA presentation: How to submit an helpful very good 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)

Common Wellness & Other Intriguing Articles

  • Medicinal cannabis not verified in mental well being, study finds (Reuters)
  • Speedy DNA Sequencing Can Give Diagnostic Clues When Newborns Require Intensive Care (NPR)

Regulatory Reconnaissance is our each day intelligence briefing for the regulatory affairs space, bringing you the major regulatory news stories from about the globe. Every single weekday morning, we aim to bring you the most current highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the most current trends with the possible to influence regulatory affairs pros and the business in which they function.
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