Recon: FDA Rejects Merck’s Chronic Cough Drug, Growth Hormone Deficiency Treatment Pfizer-OPKO; EMA

Posted on January 24, 2022 | Through Joanne S. Eglovitch

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

In brief: United States

  • Califf on track to win FDA chief role despite expected ‘no’ votes (Bloomberg)
  • FDA approves use of antiviral drug remdesivir as outpatient treatment for people with covid-19 (Washington Post) (BioPharma Dive)
  • Merck’s drug for chronic cough rejected by FDA (BioPharma Dive) (Reuters) (Endpoints)
  • FDA expected to sharply restrict use of two monoclonal antibodies, halting federal shipments of covid-19 treatments (Washington Post) (Reuters)
  • Lab study shows omicron-blocking antibodies persist four months after Pfizer-BioNTech booster (Washington Post)
  • FDA refuses to approve Pfizer-OPKO growth hormone deficiency treatment (Reuters) (Endpoints)
  • The US FDA’s median new drug review time remained stable at eight months in 2021 (pink sheet)
  • FBI searches beleaguered COVID test lab headquarters (The Hill)
  • ‘CDC alone can’t solve this problem’: Walensky calls for overhaul of US public health system (Politico)
  • Accutane scripts blocked for weeks after security system overhaul (Bloomberg)
  • Failing to confirm clinical benefit, Gilead withdraws 2 accelerated approval indications for an anti-cancer drug (endpoints)

Focus: International

  • EU regulator expected to rule on Pfizer’s COVID pill by end of January, ahead of Merck (Reuters)
  • Advocacy group urges Pfizer to sell more COVID pills to developing countries (Reuters)
  • Sinovac diet gets big boost from Pfizer, AstraZeneca or J&J COVID injections – study (Reuters)
  • European Medicines Agency expert panel approves AstraZeneca COVID vaccine production scale-up (Reuters)
  • Pharmaceutical industry chiefs hope the trust built during the pandemic with policymakers will endure (Scrip)
  • Lupin’s Foncoo partnership Beginning of the Chinese challenge to AZ, Cipla? (Securities)

Coronavirus pandemic

  • Spread of Omicron could end ’emergency phase’ of pandemic, senior WHO official says (NYT)
  • Don’t assume the COVID pandemic is reaching ‘endgame’, WHO warns (Reuters)
  • Pfizer CEO sees annual COVID vaccine rather than frequent boosters (Reuters)
  • US cases ‘heading in the right direction,’ says Fauci (Washington Post)
  • Beijing 2022 eases COVID restrictions for Games; China warns of pollution (Reuters)
  • Japan to expand COVID restrictions amid Omicron push (Reuters)
  • Russia reports record daily cases of COVID-19 (Reuters)

Pharmaceuticals and biotechnology

  • Timelines for expedited approvals? FDA oncology chief Rick Pazdur considers potential reforms via international approaches (Endpoints)
  • Medicare’s final decision on Alzheimer’s drug coverage: Thoughts from a former CMS chief (pink sheet)
  • Roche sees reason to be optimistic about the failure of the Huntington’s disease drug. Others are not so sure. (BioPharma Diving)
  • Alnylam, awaiting key data from the study, is preparing the dossier for its next drug against rare diseases (BioPharma Dive)
  • Eli Casdin co-leads $250m infusion into microfluidics player that landed NIH funding for Covid-19 testing (Endpoints)
  • Months after pulling lone drug from US, Oncopeptides withdraws pull request – but doesn’t say why (Endpoints)
  • New nonprofit wants to design cheap drug trials, aiming to build on massively successful Covid-19 study (Endpoints)

medical technology

  • European Commission 2022 calendar: major focus on the Eudamed database (MedTech Intelligence)
  • Medtech earnings season shows bumpy end to 2021 for some, boon for others (MedTech Dive)
  • Philips targets end of recall in Q4 2022 as supply chain issues slow results (MedTech Dive)
  • Medtronic’s HawkOne recall labeled Class I, adding to medtech’s product safety concerns (MedTech Dive)
  • Boston Scientific and Sterigenics Begin Tracking Ethylene Oxide Emissions Under New EPA Rules (MedTech Dive)

Government, regulation and legal

  • DOJ’s dismissal of whistleblower’s fraud case against drugmakers upheld (Reuters)
  • Florida man found guilty of falsifying clinical trial results sentenced to more than 2 years in prison (Endpoints)
  • Critics rebuff Alzheimer’s Association publicity blitz to get Medicare to change its Aduhelm decision: ‘Dead false’ (Endpoints)
  • Texas judge blocks vaccination mandate for federal workers (Bill 360)

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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