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Posted 29 October 2019 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your everyday 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 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)
  • Home unanimously clears PBM transparency bills (Politico)
  • Pallone, Guthrie Introduce Legislation To Assistance Continuous Pharmaceutical Manufacturing (E&C)
  • Pallone and Eshoo on Home Passage of 5 Overall health 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 immediately after dermatitis therapy flops (Reuters) (Endpoints)
  • Boehringer Ingelheim is joining the KRAS crowd as early achievement inspires rivals (Endpoints) (Press)
  • International Regulators Synergize Horizon Scanning Efforts (Pink Sheet-$)
  • WTO Price tag Transparency Talks Face Resistance From Created Nations (Pink Sheet-$)
  • Counting down to the MDR date of application, and the legal stuff to get proper prior to May possibly 2020 (MedicalDevicesLegal)

Pharmaceuticals & Biotechnology

  • Realizing the guarantee of prescription digital therapeutics (STAT)
  • Merck’s quarterly Keytruda sales soar previous $three billion, but analysts fret more than future development (Fierce)
  • Pfizer kills off MacroGenics-partnered strong tumor bispecific (Fierce)
  • Quarterly Inactive Ingredient Database (IID) Alter Log (FDA)
  • Generic Version of Xanax Is Recalled by FDA (NYTimes)
  • How to communicate about antimicrobial resistance proficiently (Wellcome Trust)
  • Guys With Breast Cancer Require Far more Remedy Alternatives and Access to Genetic Counseling (FDA)
  • Men and women taking blood thinners might danger danger by mixing with OTC meds (Reuters)
  • Agile’s Twirla Suffers Scathing Critique By US FDA Ahead Of Advisory Cmte. (Pink Sheet-$)
  • Manufacturer Communications With Payers A lot easier Beneath US FDA Guidance, But Challenges Stay (Pink Sheet-$)
  • Disc Medicine nabs money, massive backers and biopharma drug deal (Fierce)
  • Early price tag setting, other market place access arranging is important for early-stage drug, device firms (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 fast OK for a hard 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 Good Outcomes of 1st 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 Sufferers 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 completely implantable LVAD (MassDevice)
  • Health-related Devices Clinical Chemistry and Clinical Toxicology Devices Classification of the Continuous Glucose Monitor Information Management Method (FDA)
  • The Surmodics Sundance Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status (Press)
  • FDA clears HeartVista’s 1 Click AI-assisted cardiac MRI (MassDevice) (Press)

US: Assorted & Government

  • Lady Desires New Trial In Sanofi Chemo Drug Bellwether (Law360-$) (Bloomberg)
  • FTC Sends Warning Letters to Sellers of Cosmetic Contacts: All Speak to Lens Purchases Call for a Prescription from a Health-related Qualified (FTC)
  • The difficult selections facing ‘Medicare for All’ (Politico)
  • Justice Division troubles grand jury subpoenas in J&J opioid probe: filing (Reuters)
  • Boston jury finds biotech CEO guilty of fleecing investors, obstruction of justice (Endpoints) (Law360-$)
  • 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 Goods (FDA Law Weblog)

Upcoming Meetings & Events Europe

  • Early access to medicines scheme applications: pending, refused, granted (MHRA)
  • Regulatory update – EMA encourages firms to submit form 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. application 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

  • 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 powerful 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 quit 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 Require Intensive Care (NPR)

Regulatory Reconnaissance is our everyday intelligence briefing for the regulatory affairs space, bringing you the top rated regulatory news stories from about the globe. Each and every 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 prospective to effect regulatory affairs specialists and the business in which they operate.
 
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A story’s inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Concentrate or RAPS.


Supply: https://www.raps.org/news-and-articles/news-articles/2019/10/recon-pfizer-raises-2019-guidance-on-robust-cance

The post Recon: Pfizer Raises 2019 Guidance on Sturdy Cancer, Heart Drug Sales Drugmakers Settle Medicaid Fraud Suit for $248M – Regulatory Concentrate appeared initially on CBD Oil Headlines.

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