Recon: FDA approves GSK’s Boostrix to prevent whooping cough in infants; EU Commission targets Teva for alleged anticompetitive practices
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA OKs Tdap Vaccine for Whooping Cough Protection Before Birth (MedPage Today) (Fierce) (Reuters)
- U.S. FDA approves ScPharmaceuticals' heart failure therapy (Reuters) (Fierce)
- FDA Expands Label for Alnylam’s Oxlumo for Sickest Patients with Rare Disease PH1 (BioSpace)
- FDA Makes Argument to Withdraw Covis’ Makena from the Market (BioSpace) (Endpoints) (FDAnews)
- Makena Sponsor Covis Seeks To Use FDA Officials’ Words, Actions On Accelerated Approval Against CDER (Pink Sheet)
- Teva Sees Adderall Supply Delays Continuing for 2-3 Months (Bloomberg)
- 'Incorrect' To Assume Interchangeables Are Safer, More Effective Than Biosimilars, Says FDA (Generics Bulletin)
- Alkem’s Fenton, Mo., Plant Slapped with 483 for Equipment, Process Control Issues (FDAnews)
- Covid Shots Saved at Least 330,000 US Seniors’ Lives in 2021 (Bloomberg)
- Advocates petition FDA to make abortion pill accessible to miscarriage patients (Endpoints)
- EU Commission Targets Teva Over Alleged Copaxone Antitrust Breach (Generics Bulletin)
- Surge in Gambia child deaths linked cough syrup under control, president says (Reuters)
- Qdenga: Crunch Time For First Product In Parallel Review Route For EU And Non-EU Markets (Pink Sheet)
- Industry Explains How To Avoid Risks When Using Social Media & Digital Channels (Pink Sheet)
- Pfizer exec denies CEO negotiated EU COVID vaccine contract via text message (Reuters)
- Swiss drugs regulator approves one of Pfizer's COVID-19 booster shots (Reuters)
- CEO of Biotech Lobbying Group BIO on Leave Amid Clash Over Direction (WSJ) (STAT) (Fierce)
- The crown jewel in Merck’s $11.5B Acceleron buyout just cleared a pivotal PhIII (Endpoints) (Fierce) (Reuters) (STAT)
- J&J research vet Mammen a top contender in Biogen’s hunt for a new CEO (STAT)
- Andera Bullish About Prospects For Europe's Biotechs (Scrip)
- BioNTech allies with Australian state, initializing plans to construct new R&D and manufacturing facilities (Endpoints)
- A liver disease upstart with some global connections and a new R&D strategy reaps a $30M launch round (Endpoints)
- Roche breaks ground on expansion at New Jersey manufacturing site — report (Endpoints)
- BioMarin lays off 120 staffers to 'simplify' the company while FDA reviews its big gene therapy (Endpoints)
- Amneal telegraphs 89 layoffs as it prepares to shutter Long Island plant (Fierce)
- Dunkirk retreat: ImmunityBio, aiming to hire 300 in 30 months, lays off staff at new facility (Fierce)
- CSL Seqirus snaps up $30M+ BARDA contract to develop influenza vaccine at its expanded facility in NC (Endpoints) (Fierce)
- An AI, err machine learning, shop lines up Eli Lilly as partner ahead of first in-house clinical trial (Endpoints)
- After Giving Up on Cancer Vaccines, Doctors Start to Find Hope (NYT)
- Guidance For Notified Bodies On How To Review High-Risk IVDs Pending EU Ref Lab Appointments (MedTech Insight)
- Abbott lands FDA emergency authorization for first commercial monkeypox tests (MedTech Dive)
- Becton recalls some sterilization containers due to quality breach (Reuters)
- Progress Of Bayer’s Postmarket Essure Study ‘Inadequate’ Says FDA (MedTech Insight) (MedTech Dive)
- FDA Schedules Meetings On Plastic Surgery Devices, Ophthalmic Dispensers (MedTech Insight)
- Siemens Healthineers elevates corporate focus on China, splitting operations from larger Asia-Pacific region (Fierce)
- Exactech Joint-Replacement Injury Suites Sent to New York Court (Bloomberg)
- Becton Dickinson Unit Beats Catheter Antitrust Case After Trial (Bloomberg)
- Elizabeth Holmes’s Ex Sees Her Bid for New Trail and Antes Up (Bloomberg)
- Quest Settles Ravgen Prenatal Test Patent Suit On Eve Of Trial (Law360)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
