Recon: EMA backs J&J booster; Califf on track for confirmation with GOP support

• Manchin, Sanders will oppose Biden FDA nominee Califf (The Hill)
• Biden’s FDA pick on track for confirmation with GOP help (Politico)
• Bristol Myers drug wins first U.S. approval for Graft versus Host Disease prevention (Reuters) (FDA)
• HHS secretary hints that more federal funds may be needed to fight an Omicron surge. (NYTimes)
• Opioid Makers Cement Calif. Win As Judge Spurns Objections (Law360)
• Two Moderna doses provide substantially low neutralizing effect against Omicron (Reuters)
• J&J Shot Loses Antibody Protection Against Omicron in Study (Bloomberg)
• In a Bad Year for Biotech Stocks, Deals and Vaccines Were Winners (WSJ)
• #JPM22 goes virtual, caving to pressure after a wave of big drugmakers pull out due to Omicron fears (Endpoints) (STAT)
• US pauses distribution of GSK/Vir's Covid mAb not due to Omicron, but greater supply of Eli Lilly mAbs (Endpoints)

• EU regulator backs J&J COVID-19 booster dose for adults (Reuters) (EMA)
• EMA launches the Regulatory Science Research Needs initiative (EMA)
• China’s Sinovac offers inadequate protection against Omicron, study shows (FT)
• Japan government panel clears Moderna COVID vaccine for booster shots (Reuters)
• Vaccine effectiveness against severe COVID drops slightly, still 'significant protection'-WHO (Reuters)
• European Union starts drive to vaccinate children against COVID (Reuters)
• Germany spends additional 2.2 bln euros to buy more COVID vaccines (Reuters)
• Pfizer set to oust AstraZeneca as top supplier of COVID-19 shots to poor nations (Reuters)

• Two Pfizer doses give 70% protection against hospitalisation from Omicron, study shows (FT)
• US study suggests vaccines may be ineffective against Omicron without booster (Reuters)
• Majority of breakthrough COVID-19 hospitalizations involve seniors: analysis (The Hill)
• COVID-19 can be a disability, says EEOC (The Hill)
• What New FDA Policy Means For COVID Tests And Beyond (Law360)
• Sanofi, GSK delay data on COVID-19 vaccine booster candidate until 2022 (Reuters)

• Man whose wife won legal ruling dies one week after receiving ivermectin (Fierce)
• HHS Asked to Take Up March-in Request of Prostate Cancer Drug Xtandi (KEI)
• AbbVie's Rinvoq, Pfizer's Xeljanz win new uses after extended reviews as JAK safety woes linger (Fierce)
• Amid safety concerns, FDA grants two new JAK approvals — but with added warnings and a key label change (Endpoints)
• New Eye Drops Offer an Alternative to Reading Glasses (NYTimes)
• BeiGene slides on Shanghai debut as US preps to blacklist some Chinese biotechs (Endpoints)
• Hopes for non-viral gene therapy take a blow as Generation Bio announces significant setback (Endpoints)
• Could the next gene therapy manufacturing hub be Cincinnati? A $100M bet says yes (Endpoints)
• Mesoblast shares tank after Novartis abandons a partnership for the biotech's potential Covid-19 treatment (Endpoints)

• 3 medtech markets poised to thrive in 2022 despite renewed COVID-19 pressures (MedtechDive)
• Medtronic receives FDA warning letter over quality control issues at diabetes HQ (Fierce)
• NuVasive resumes global sales of scoliosis system with reinstated CE mark and new labeling (Fierce)
• AdvaMed Asks US FDA To Add Causality, RWE To Safety-Reporting Draft Guidance (MedtechInsight)
• Boston Scientific to lay off 170 workers, close Silicon Valley manufacturing plant (Fierce)
• Riding an ADC hot streak, a new biotech bets a megaround that a better version of those therapies isn't a myth (Endpoints)
• A new eye-focused biotech is out of stealth, with plans to barrel toward PhII studies (Endpoints)

• Viatris gets shot to shed infringement claims in long-running patent kerfuffle on AstraZeneca's Symbicort (Fierce)
• Ex-Vyera CEO Criticizes Shkreli At Drug-Pricing Bench Trial (Law360)
• Looming abortion pill rules could recast reproductive rights battle (Politico)