Recon: US FDA joins global regulators investigating contaminated cough syrup; AstraZeneca’s Evusheld no longer authorized in the US

ReconRecon | 26 January 2023 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • U.S. FDA joins global regulators probing tainted overseas cough syrup (Reuters) (CBS News)
  • AstraZeneca’s Covid Drug No Longer Authorized for Use in the US (Bloomberg) (STAT)
  • Live blog: Tracking the meeting of the FDA advisory panel on Covid vaccines (STAT)
  • Inhibikase, FDA find common ground to lift hold on Parkinson’s drug (Fierce)
  • Updated COVID vaccines prevented illness from latest variants – CDC (Reuters)
  • The 4 biggest questions about the FDA’s forthcoming changes to accelerated approvals (STAT)
  • FDA Shuts Down Bids Asking for CBD Products as Diet Supplements (Bloomberg)
  • FDA identifies recall of Emergent’s decontamination kits as most serious (Reuters)
  • FDA sends warning letter to community hospital review board over research concerns (Endpoints)
  • US FDA Has History Of Pushing Sponsors On Confirmatory Trials … Sometimes (Pink Sheet)
  • ‘We Don’t Hold Regulatory Actions For Press’ – Inside FDA’s Communications Difficulties And Misinformation Fights (Pink Sheet)
  • Lilly turns to nonprofit, not the FDA, to resolve dispute with Novartis over a prescription drug ad (STAT)
  • CDC chief to create new offices to boost public health response – Bloomberg News (Reuters)
  • NIH associate director announces departure to private sector, joining anti-aging biotech (Endpoints)
In Focus: International
  • Requests For EMA PRIME Designation Fall But Improvements Are On The Way (Pink Sheet)
  • EU  drug regulator decides ongoing antibiotic shortage not a ‘major event’ (Reuters)
  • EMA changes orphan designation policy for certain eye drugs to expand access (Endpoints)
  • EMA gives nod to Critical Path Institute’s trial simulation platform for DMD (Fierce)
  • Proposals On EU-Wide Joint Clinical Assessments Fall Short, Warn German Industry Groups (Pink Sheet)
Pharma & Biotech
  • After dose de-escalation, death drives Magenta to pause antibody-drug conjugate leukemia trial (Fierce) (BioSpace)
  • Merck halts prostate cancer study while reporting positive readout in biliary tract cancer (Endpoints)
  • Sanofi dives deeper into phase 3 data for Hemlibra rival as FDA decision approaches (Fierce)
  • Investor 'misalignment' leads to tRNA biotech's shuttering (Endpoints)
  • Bristol Myers CMO, other still skeptical about cancer vaccines as BioNTech, Moderna march ahead with I-O partners (Fierce)
  • Aridis' monoclonal antibody fails PhIII, but plans for second trial anyway (Endpoints)
  • Early data from AC Immune Alzheimer’s vaccine suggests a response, setting up next phase of study (Fierce)
  • 2 deals in 2 weeks: GenKOre signs pacts worth up to $650M biobucks for gene-editing tech (Fierce)
  • Lonza posts full 2022 results as it looks to buy back $2B+ in shares (Endpoints)
  • Grey Wolf reels in $49M to enter the clinic for new immunotherapy target (Endpoints)
  • Abzena lays off more than 60 employees in California (Endpoints)
  • Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore (MedTech Dive)
  • Moves For Go Ahead For MDR Proposal To Be Discussed At European Parliament (MedTech Insight)
  • FDA tacks Class I rating to Getinge recall of a decade’s worth of cardiac balloon pumps (MedTech Dive)
  • FDA Approves Abbott’s Spinal Cord Stimulation for People Living with Neuropathy (Biospace)
  • Abbott’s soaring FreeStyle Libre sales temper COVID testing drop-off in 2022 results (Fierce)
  • Abbott sees ‘signs of stability’ for 2023 as hospital staffing, supply chain improves (MedTech Dive)
  • Researchers Suggest More Care In Using Abbott’s MitraClip (MedTech Insight)
  • 3M to cut 2,500 jobs, forecasts downbeat Q1 as demand weakens (Reuters)
Government, Regulatory & Legal
  • Soldiers Urge Action in Terror Support Suit Against Drugmakers (Bloomberg)
  • Lawsuits filed over U.S. state restrictions on abortion pills (Reuters)
  • MetLife Accused of Wrongly Pocketing $65 Million in Drug Rebates (Bloomberg)
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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