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Recon: FDA approves GSK’s Boostrix to prevent whooping cough in infants; European Commission targets Teva for alleged anti-competitive practices

Acknowledgement | October 10, 2022 | By

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

In brief: United States

  • FDA approves Tdap vaccine for protection against pertussis before birth (MedPage today) (Fierce) (Reuters)
  • US FDA Approves ScPharmaceuticals Heart Failure Treatment (Reuters) (Fierce)
  • FDA expands Alnylam’s Oxlumo label for sickest patients with rare PH1 disease (BioSpace)
  • FDA calls for Covis’ Makena to be removed from market (BioSpace) (Endpoints) (FDA News)
  • Makena’s sponsor, Covis, is seeking to use the words and actions of FDA officials regarding the fast-track approval against CDER (pink sheet)
  • Teva sees Adderall supply delays continuing for 2-3 months (Bloomberg)
  • “Incorrect” to Assume Interchangeables Are Safer and More Effective Than Biosimilars, Says FDA (Generics Bulletin)
  • Alkem’s Fenton, Mo. plant slapped with 483 equipment and process control issues (FDA News)
  • Covid Shots saved at least 330,000 American elderly lives in 2021 (Bloomberg)
  • Advocates are calling on the FDA to make the abortion pill available to patients who miscarry (Endpoints)

Focus: International

  • European Commission targets Teva for alleged violation of Copaxone antitrust rules (Generics Bulletin)
  • Gambia’s spike in child deaths linked to cough syrup under control, president says (Reuters)
  • Qdenga: critical time for first product in parallel review track for EU and non-EU markets (pink sheet)
  • The industry explains how to avoid risks when using social media and digital channels (pink sheet)
  • Pfizer executive denies CEO negotiated COVID vaccine deal with EU via text message (Reuters)
  • Swiss medicines regulator approves one of Pfizer’s COVID-19 recalls (Reuters)

Pharmaceuticals and biotechnology

  • CEO of Biotech Lobbying Group BIO on furlough amid clash over leadership (WSJ) (STAT) (Fierce)
  • The crown jewel of Merck’s $11.5 billion Acceleron takeover just passed a pivotal PhIII (Endpoints) (Fierce) (Reuters) (STAT)
  • J&J seeks vet Mammen one of the top candidates in Biogen’s hunt for a new CEO (STAT)
  • Andera optimistic about the prospects for European biotechnology (Certificate)
  • BioNTech partners with the Australian state, initiating plans to build new R&D and manufacturing facilities (Endpoints)
  • Liver disease newcomer with global connections and new R&D strategy rakes in $30 million seed round (Endpoints)
  • Roche inaugurates expansion of its manufacturing site in New Jersey – report (Endpoints)
  • BioMarin is laying off 120 employees to ‘simplify’ the company as the FDA reviews its big gene therapy (Endpoints)
  • Amneal telegraphs 89 layoffs as it prepares to close Long Island plant (Fierce)
  • Retirement from Dunkirk: ImmunityBio, which aims to hire 300 people in 30 months, is laying off staff in a new establishment (Fierce)
  • CSL Seqirus Wins $30M+BARDA Contract to Develop Influenza Vaccine at Its Expanded North Carolina Facility (Endpoints) (Fierce)
  • Artificial intelligence, machine learning boutique lines up Eli Lilly as partner ahead of first in-house clinical trial (Endpoints)
  • After abandoning cancer vaccines, doctors begin to find hope (NYT)

medical technology

  • Guidance to Notified Bodies on how to review high-risk IVDs pending nominations from EU Reference Laboratories (Overview of medical technologies)
  • Abbott obtains emergency clearance from the FDA for the first commercial tests of monkeypox (MedTech diving)
  • Becton is recalling certain sterilization containers due to a quality deficiency (Reuters)
  • Bayer’s post-marketing Essure study progress ‘insufficient’, FDA says (Overview of medical technologies) (MedTech Diving)
  • The FDA holds meetings on plastic surgery devices and ophthalmic dispensers (Overview of medical technologies)
  • Siemens Healthineers is putting more of a focus on China, separating operations from the wider Asia-Pacific region (Fierce)

Government, regulation and legal

  • Exactech Joint-Replacement Injury Suites Sent to New York Court (Bloomberg)
  • Becton Dickinson unit defeats Catheter antitrust case after trial (Bloomberg)
  • Elizabeth Holmes’ ex sees his offer for a new trail and Antes Up (Bloomberg)
  • Quest settles Ravgen’s prenatal test patent lawsuit on eve of trial (Law360)

Regulatory Recon is our daily intelligence briefing for regulatory affairs, bringing you top regulatory, biopharma and medtech news from around the world.

Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

© 2022 Society of Regulatory Affairs Professionals.

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