Recon: FDA panel recommends withdrawing Makena; Merck affiliate under investigation in France over reformulation of thyroid drug

ReconRecon | 20 October 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close (Pink Sheet) (NYT) (Endpoints) (Reuters) (Bloomberg) (STAT)
  • FDA’s Peter Stein And Lessons From Makena: There Are Limits To Regulatory Flexibility (The Pink Sheet)
  • U.S. FDA authorizes Novavax's COVID vaccine as booster for adults (Reuters) (STAT) (Bloomberg)
  • U.S. committee recommends COVID shot for CDC's free vaccine program (Reuters)
  • FDA pauses PTC’s phase 2 Huntington’s trial despite green light from regulators abroad (Fierce)
  • Clinical trial coordinators sentenced to prison after data falsification scheme (Endpoints) (DOJ)
  • RWE Program Offers Sponsors Chance At Novel Uses, But In Exchange For Disclosing Proposals (The Pink Sheet)
  • Better Antibiotic Trials Sought as Congress Weighs Funding Bill (Bloomberg)
  • Analysis: Falling demand for COVID boosters puts price hikes on the table  (Reuters)
  • Unsanitary conditions and other QC issues raised by FDA in a warning to contract packager (Endpoints)
  • Alembic hit with Form 483, citing 4 observations at Panelav plant in India (Fierce)
  • New Torrent Pharmaceuticals Form 483 highlights cleaning and other quality issues (Endpoints)
In Focus: International
  • EMA recommends Moderna's updated Omicron-tailored vaccine (Reuters
  • Merck KGaA's French affiliate indicted over investigation into reformulation case (Endpoints) (Reuters) (Fierce)
  • Rx Drug DTC Advertising: ‘Europe Is A Minefield’ With LinkedIn Posts Triggering Slew Of Complaints (Pink Sheet)
  • UK sees steep fall in new clinical trials over past five years (Reuters)
  • Novartis Allows Generic Cancer Drug Licenses in World First (Bloomberg) (Pink Sheet)
  • Indonesia finds medicines with ingredients linked to fatal child kidney injury (Reuters)
  • TGA Gives Companies Deadline To Complete Australian Pharmacovigilance Risk Survey (Pink Sheet)
  • Swiss to destroy 9 million expired Moderna COVID-19 jabs (Reuters)
  • WHO says COVID-19 is still a global health emergency (Reuters)
  • WHO to switch to one dose of two-dose cholera vaccine amid rising outbreaks (Reuters)
  • Ebola outbreak in Uganda still a manageable risk - Africa CDC (Reuters)
  • Experimental Ebola shots to be used in Uganda outbreak: reports (Fierce)
Pharma & Biotech
  • J&J and Corning put more than 100 New York jobs on the chopping block in latest pharma layoff round (Fierce)
  • Talaris Cleared to Continue Kidney Transplant Trial after Patient Death (Biospace) (Fierce)
  • Bristol Myers spells out Opdivo win in melanoma — how does it stack up against Keytruda? (Endpoints)
  • Roche and Hookipa Tie Up in KRAS Inhibitor Deal Valued at Potential $950M (Biospace)  (Fierce)
  • BMS’ Opdivo Notches Phase III Win in Advanced Melanoma (Biospace)
  • AM-Pharma, once a Pfizer takeover target, flunks phase 3 kidney injury trial (Fierce)
  • ACRO unveils Q&A toolkit to speed adoption of decentralized clinical trials (Fierce)
  • Biotech layoffs continue as Ambrx cuts staff and part of its pipeline to extend its cash (Endpoints) (Fierce)
  • After matching Comirnaty, Providence plans phase 3 booster study for COVID-19 vaccine candidate (Fierce)
  • Buy now, pay later: Jazz hands over $50M for Zymeworks’ phase 3 HER2-directed bispecific (Fierce)
  • A pair of storied neuroscience biotechs looks to raise nearly $450M combined (and maybe more) via public offerings (Endpoints)
  • FDA seeks feedback on plans to draft and finalize medical device guidance in 2023 (MedTech Dive) (MedTech Insight)
  • Coloplast told by FDA to keep transvaginal mesh off market after 36-month surveillance study (MedTech Dive)
  • ‘Project Glass Box’ - UK Reveals Roadmap For AI Medtech Regulation (MedTech Insight)
  • UK Diagnostic Capacity And Spending Below European Average (MedTech Insight)
  • Philips’ CPAP and BiPAP mask recall stretches to 22M devices, lands Class I FDA label (Fierce)
  • ‘Stickier than most have assumed’: Abbott upends COVID forecasts yet again with $1.7B in test sales  (Fierce)
  • NIH study finds Black patients receive end-stage heart failure treatments at half the rate of white patients (Fierce)
Government, Regulatory & Legal
  • Whistleblowers Eye Clearer Path Following Supreme Court Denials (Bloomberg)
  • FDA, DOJ sue 6 vape shops for ignoring warnings about selling illegal products (STAT)
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.


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