Recon: Lilly signs deals to boost India supply of antibody drugs; Inovio says COVID vaccine safe, effective in Ph. 2

• Inovio says COVID-19 vaccine candidate safe, effective in mid-stage trial (Reuters)
• AstraZeneca weighs seeking full approval for Covid shot, skipping EUA (WSJ) (Reuters)
• Novavax not expected to seek COVID vaccine authorization until June at the earliest (Washington Post)
• Biden administration signals that FDA may allow abortion pill access via mail even after the pandemic (Endpoints)
• AbbVie makes a hefty play to boost aesthetics business, paying $550M for non-invasive body sculpting device (Endpoints) (Press)
• White House, state officials scramble to get docs’ help with lagging vaccination effort (Politico)
• Covid response chief has no regrets on Johnson & Johnson pause (Politico)

• BioNTech committed to deliver 1.8 bln doses of COVID-19 vaccine this year (Reuters)
• GAVI in talks with China's Sinopharm, other vaccine makers for COVAX doses (Reuters)
• Eli Lilly signs deals to boost supply of COVID-19 treatment in India (Reuters) (Economic Times)
• EU has not ordered AstraZeneca vaccines beyond June – Commissioner (Reuters)
• First of three S.Korea expert panels recommends approval of Moderna COVID-19 vaccine (Reuters)
• NICE rejects Merck Serono’s Bavencio for urothelial cancer (Pharmafile)

• BioNTech, Fosun Pharma eye 1B doses of COVID-19 vaccine capacity with new China JV (Fierce)
• BioNTech expands mRNA manufacturing to Singapore as clamor for Covid-19 vaccine and boosters swells (Endpoints) (CNBC)
• DCGI approves anti-COVID drug developed by DRDO for emergency use (Economic Times)
• Opinion: Patent Busting Won’t Help Vaccinate the World Faster (WSJ)
• U.S. wants COVID vaccine patent waiver to benefit world, not boost China biotech (Reuters)
• Brazilian firm to produce Russian vaccine without regulatory approval (Reuters)
• Priority COVID-19 test applications: Notice to manufacturers, importers and distributors (Health Canada)

• FDA Priorities for FY 22 (Alliance for a Stronger FDA)
• Ionis scraps CF program in another setback for the disease and the company (Endpoints)
• How the world’s top vaccine maker struggled to meet the moment (FT)
• Characteristics of expedited programmes for cancer drug approval in China (Nature)
• Bayer's near-approval Farxiga rival meets goal in 2nd phase 3 (Fierce)
• Daiichi Sankyo, AstraZeneca's $5B Enhertu follow-up shows early signs of success in breast cancer (Fierce)
• The Number Needed to Prescribe — What Would It Take to Expand Access to Buprenorphine? (NEJM)
• Bringing Harm Reduction into Health Policy — Combating the Overdose Crisis (NEJM)
• Amgen Announces Tezepelumab Biologics License Application Submitted To US FDA (Press)
• Novo Nordisk recalls sales rep samples sunk by Texas power outages (Fierce)
• Astellas’ Xtandi Earns European Approval for HSPC (PharmaJapan)
• The company behind Moderna has a new RNA startup looking to disrupt drugmaking. The goal? 100 new drugs in 10 years (Endpoints)
• Let’s make that $1B-plus: Abingworth gathers more cash, this time for its late-stage poker game. And we learned that even a biotech nuclear winter has its advantages (Endpoints)
• Ex-Harvard professor and serial entrepreneur Omid Farokhzad jumps into the SPAC game with some industry insiders and a certain billionaire scientist (Endpoints)
• Perceptive's $310M US/China play woos new CEO from Eli Lilly's top-speed bamlanivimab team (Endpoints)
• Samantha Du's Quan Capital, Lilly Asia back China's first big kidney play (Endpoints)
• Consultation on the draft Issue Identification Paper: Drug-device combination products (Health Canada)

• BD Expects Alaris Infusion Pump To Return To US Market Next Year (MedtechInsight)
• Lilly Signs Deals With Dexcom, Glooko, myDiabby, Roche For Diabetes Management Solutions (MedtechInsight)
• Viome scores FDA breakthrough label for cancer-screening, microbiome-sequencing AI platform (Fierce)
• Fit For The Future: Industry Gets Involved As UK Medtech And Digital Health Care Regulation Reaches Turning Point (MedtechInsight)

• FDA Dr. Says Stem Cell Clinics' Study 'Just A Bunch Of Words' (Law360)
• Dermatology Case Tapped As Bellwether In Generic Drug MDL (Law360)
• Pharmacies Seek Appeal On Opioid Duties In Tribal Bellwether (Law360)
• Endo Wants Stay Of $2.4B Opioid Baby Trial Pending Appeals (Law360)
• Merck Sued Over Asthma Drug's Alleged Psychiatric Effects (Law360)
• Biden administration reverses Trump-era limits on transgender health protections (The Hill)