Recon: Merck signs €900M deal for Debiopharm for cancer drug; Perrigo to sell generic business for $1.55B

• FDA authorizes Johnson & Johnson’s single-dose Covid-19 vaccine (STAT) (Reuters) (Politico) (FDA)
• Single-dose Covid vaccine recommended by CDC advisory panel (Politico)
• J&J CEO sees COVID-19 shots in American arms in 1-2 days as shipping starts (Reuters 1, 2)
• Johnson & Johnson has planned trials of its vaccine that will include infants (NYTimes)
• Novavax closes in on Covid triumph after 33 years of failure (FT)
• New Mexico attorney general accuses Gilead of blocking competition to its HIV medicines (STAT)
• 'Hub-and-spoke' biotech BridgeBio scores first FDA approval with Alexion castoff (Fierce)
• Scheduling COVID vaccinations is still too tough in certain places: White House (Reuters)
• FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test (FDA)

• Perrigo to sell generic drugs business for $1.55 billion (Reuters)
• EU audits Indian vaccine maker as AstraZeneca looks to boost supplies to the bloc (Reuters)
• Merck agrees $1 billion deal with Debiopharm for head and neck cancer drug (Reuters) (Endpoints)
• AstraZeneca sells stake in vaccine maker Moderna for nearly $1 billion (Reuters)
• South Korea launches review of Johnson & Johnson's COVID-19 vaccine (Reuters)
• Six-week sprint got Indian-made AstraZeneca vaccine approved in Canada (Reuters)
• COVID-19 vaccine vial maker Stevanato preps IPO valuing it at up to $5 billion: sources (Reuters)
• China’s Covid vaccination programme beset by delay and reluctance (FT)
• Congo confirms three new Ebola cases (Reuters)

• Turning COVID-19 Vaccine EUA Into A BLA Will Require Six Months Of Additional Data (Pink Sheet)
• EU to propose vaccine certificates in time for summer holidays (Reuters)
• Amid scramble for COVID-19 vaccine, Latin America turns to Russia (Reuters)
• Fraudsters offer 1 billion COVID-19 doses across EU, agency warns (Reuters)
• German health advisers signal end of Oxford/AstraZeneca age restrictions (FT)
• Russian scientists say Sputnik V performs well against COVID mutations (Reuters)
• Moldova approves Russia's Sputnik V vaccine as political row simmers (Reuters)
• China's CanSino says first vaccines packaged in Mexico will be ready in March (Reuters)
• Ivory Coast launches first vaccination drive with COVAX shots (Reuters)
• Australia receives AstraZeneca vials as it ramps up vaccination drive (Reuters)
• Eurofins launches prescription-free COVID-19 test, eyes further growth (Reuters)
• Flowserve supplying pumps, valves for Pfizer vaccine production (Reuters)
• Over 60% of Russians don't want Sputnik V vaccine, see coronavirus as biological weapon: Reuters poll (Reuters)
• Roche SARS-CoV-2 Rapid Antigen Test receives special approval for at-home patient self-testing using nasal swabs in Germany (Reuters)

• Janet Woodcock revolutionized the way the FDA reviews cancer drugs, inspiring her supporters and raising concerns for detractors (STAT)
• Covid-19 Vaccines Yield Breakthroughs in Long-Term Fight Against Infectious Disease (WSJ)
• Gilead to cut 178 California jobs and move some to North Carolina (SF Chronicle)
• UCB Files Psoriasis Med Bimekizumab for Japan Approval (PharmaJapan)
• Roche, Genentech partner with The Weill Neurohub on ten-year neuroscience collaboration (PMLive)
• FDA accepts gefapixant for review in cough, positioning Merck to get head start on Bayer and Bellus (Fierce)
• Four IPOs and a SPAC pitch a new slate of microbiome, cancer and inflammatory drugs to Wall Street (Endpoints)
• Merck gets a PDUFA date for its chronic cough contender; Morphic shares skyrocket on the heels of PhI data rollout in IBD (Endpoints)
• With new $106M crossover round, Tenaya preps heart failure programs for the clinic — and maybe an IPO (Endpoints)
• Biotech's shares routed after the FDA demands new trial, raises safety and endpoint issues in surprise CRL (Endpoints)
• Looking to take advantage of 'silenced' enzymes, SalioGen emerges from stealth with eyes set on gene therapy 3.0 (Endpoints)
• Angling Pfizer, AstraZeneca jumps into commercial PD-(L)1 fight in China (Endpoints)

• Signs Of Hope But Obstacles Remain For Swiss Device MRA With EU (MedtechInsight)
• FDA Misses Fifth Target Date For Issuing Draft Harmonized Quality System Reg (MedtechInsight)
• FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts (FDA)
• FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy (FDA)
• Axonics adds incontinence device to portfolio in $200M Contura takeover (MedtechDive)
• NuVasive buys Simplify Medical in play for $2.6B cervical spine market (MedtechDive)

• Meet The Supreme Court Heavyweights Arguing Arthrex (Law360)
• 4 Paths The Justices Could Take In Arthrex (Law360)
• Walgreens Relieved Of Claims It Mislabeled Infant Pain Med (Law360)
• March Trial Set For Patent Battle Over Glaucoma Treatment (Law360)
• Arbor Hits FDA With Suit Over Neurological Drug (Law360)
• 1st Circ. Upholds 3 Ex-NECC Workers' Drug Fraud Convictions (Law360)