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

• 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)

• 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)

• 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)