Recon: FDA approves GSK’s Boostrix to prevent whooping cough in infants; EU Commission targets Teva for alleged anticompetitive practices

• 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)