Regulatory Focus™ > News Articles > 2021 > 10 > Recon: J&J will reportedly seek authorization for boosters this week; Pfizer loses suit over copay a

Recon: J&J will reportedly seek authorization for boosters this week; Pfizer loses suit over copay assistance programs

Posted 04 October 2021 | By Michael Mezher 

Recon: J&J will reportedly seek authorization for boosters this week; Pfizer loses suit over copay assistance programs

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • McKinsey Never Told the FDA It Was Working for Opioid Makers While Also Working for the Agency (ProPublica)
  • Gilead and Kite nab another approval for Tecartus, as leading CAR-T portfolio continues to grow (Endpoints)
  • U.S. Supreme Court rejects challenge to New York tax on opioid companies (Reuters)
  • Pharmacy chains face first trial over US opioid epidemic (Reuters)
  • Johnson & Johnson to Seek FDA Authorization for Booster Shot (NYTimes) (Reuters)
  • U.S. eyes Israeli military data for Pfizer COVID-19 booster safety (Reuters)
  • Three generic drug makers to pay $450 million to settle civil price fixing charges (STAT)
  • Pfizer loses a lawsuit alleging the U.S. illegally limits use of patient copay assistance programs (STAT)
  • Elizabeth Holmes knew machines weren’t working, former Theranos lab director testifies (CNBC)
  • FDA won't extend shelf life of J&J Covid vaccine doses, may extend life of millions of Moderna shots (NBC)
In Focus: International
  • Thailand joins Asian nations in rush to buy Merck's COVID-19 pill (Reuters)
  • Amid COVID-19 booster data dilemma, EU nations' plans diverge (Reuters)
  • Russia sees no hurdles for WHO approval of Sputnik V vaccine (Reuters)
  • India's Divi's Labs hits record high on Merck's positive trial data for COVID-19 drug (Reuters)
  • Cipla to sell Lilly's Trulicity, Humalog diabetes treatments in India (Reuters)
    UK pharmacies seeing some disruption to medicine deliveries (Reuters)
  • EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19 (EMA)
Coronavirus Pandemic
  • Italian studies show COVID-19 shots less effective in immunocompromised (Reuters)
  • FDA greenlights combination at-home test for COVID and influenza in children as flu season approaches (Fierce)
Pharma & Biotech
  • For the first time, WHO committee recommends action on high-priced essential medicines (STAT)
  • Merck shakes hands with Acceleron; Finally, a pill for Covid-19; The past and future of contract research; and more (Endpoints)
  • IPOs get back into gear with filings from LianBio and Xilio, and Cormorant's SPAC has a deal (Endpoints)
  • Sarepta embarks on late-stage clinical trial of Duchenne gene therapy (BioPharmaDive)
  • How a busy year for biotech IPOs measures up at the three-quarter mark (BioPharmaDive)
  • J&J releases the first big data cut in the RSV vaccine race, setting bar for GlaxoSmithKline and Pfizer (Endpoints)
  • J&J signs on Xencor for a $100M licensing deal targeting CD20, looking to press its advantage in bispecifics (Endpoints)
  • Canada's Xenon touts out-of-the-blue win for its daily epilepsy pill, sending investors into a frenzy (Endpoints)
  • Enanta culls internal NASH work, betting on an out-licensing strategy in the disaster-strewn field (Endpoints)
  • BioMarin recruits Vertex's translational chief to head up clinical trial ops (Endpoints)
  • Teva temporarily padlocks a plant after FDA cites it for contamination (Endpoints)
  • AstraZeneca's Enhertu gets BTD for breast cancer; Centessa nabs $300M loan (Endpoints)
  • Thermo Fisher expands into Switzerland as part of CSL collaboration (Endpoints)
  • In research first, jolts from a customized brain implant provided immediate relief to a severely depressed patient, scientists say (STAT)
  • FDA hits nearly all MDUFA IV commitments despite pandemic disruptions (MedtechDive)
  • FDA approves Abbott's latest implant for closing holes in the heart leftover from childbirth (Fierce)
  • FDA's real-world evidence push hampered by data challenges, 'million-dollar question' (MedtechIDive)
Government, Regulatory & Legal
  • Merck Accuses Bayer Of Ducking Product Liability Claims (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.