Recon: Eli Lilly to buy Prevail for $1B; Regeneron halts enrollment in two lymphoma trials

• Moderna nears US authorization for COVID-19 shot with FDA staff endorsement (Reuters) (FT) (Politico) (NYTimes) (STAT)
• Moderna says its COVID-19 vaccine may prevent asymptomatic infection (Reuters)
• Regeneron pauses patient enrollment in lymphoma drug trials (Reuters)
• Eli Lilly to buy gene therapy developer Prevail in $1.04 billion deal (Reuters)
• 2 more vaccine developers could seek FDA's green light by February (Politico)
• US plans to ship 6M Moderna Covid vaccine doses once FDA gives OK (CNBC)
• Senate Democrats press Trump on possible vaccine shortage (Politico)
• Trump's drug cards clear key hurdle following pressure from White House (Politico)
• PhRMA took in a record $527 million in 2019, new records show (STAT)

• Dec. 23 is new target date for EU vaccine approval (Reuters 1, 2, 3)
• With First Dibs on Vaccines, Rich Countries Have ‘Cleared the Shelves’ (NYTimes)
• Canada pledges C$485 million in COVID-19 aid for other nations (Reuters)
• Canada expects 168,000 Moderna vaccine doses by year end, PM Trudeau says (Reuters)
• WHO sees "strong commitment" from Pfizer on affordable COVID vaccine (Reuters)
• S.Korea Celltrion's candidate COVID-19 drug gets approval for special-case use (Reuters)
• Sanofi renews deal with WHO to fight tropical diseases, sleeping sickness (Reuters)
• Takeda’s gene editing partner is snapped up for $250M cash as sector continues to heat up (Endpoints)

• ‘I haven’t even told my wife’: Inside the frantic and secretive sprint to name the Covid-19 vaccines (STAT)
• The Next Vaccine Challenge: Reassuring Older Americans (NYTimes)
• How COVID-19 is changing the cold and flu season (Nature)
• Mexico weighing vaccine proposals from Moderna, four other companies (Reuters)
• Spain's Reig Jofre to manufacture J&J's COVID-19 vaccine, shares soar (Reuters)
• Lebanon to get first batch of COVID-19 vaccines in two months, minister says (Reuters)
• Brazil's mass vaccination will not start until March, says health official (Reuters)
• Brazil says China 'not transparent' on COVID-19 vaccine emergency use (Reuters)
• AbbVie pulls the trigger on a Covid-19 antibody, going all in on a drug discovered by research alliance (Endpoints)

• 1st Patients To Get CRISPR Gene-Editing Treatment Continue To Thrive (NPR)
• Roche's MS blockbuster Ocrevus, facing new Novartis competition, scores FDA nod for more-convenient infusion (Fierce)
• Japan Weighs Drug Cost Cut of around 400 Billion Yen in Off-Year Re-Pricing, Expanded Coverage Including Products with Smaller-than-Average Price Gap Too (PharmaJapan)
• Allogene, broadening its reach, helps start a biotech in China (BioPharmaDive)
• MinervaX raises $57M for Group B streptococcus vaccine race with Pfizer (Fierce)
• Novartis MS Drug Kesimpta Quick Out Of The Blocks (Scrip)
• Mesoblast spins a PhIII cell therapy miss in heart failure as a win, highlighting positive mortality data (Endpoints)
• Vectura leans into new role as inhalation CDMO post-asthma flop with plant expansion (Endpoints)
• Allogene, Overland plot speedy Asia play for off-the-shelf CAR-T with $117M joint venture (Endpoints)
• U.S. Food and Drug Administration Accepts New Drug Application for Review, Grants Priority Review for Takeda’s TAK-721 (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis (Press)
• Novartis reports positive topline results from second Phase III trial of Beovu® in patients with diabetic macular edema (Press)

• EU launches 1st Eudamed module, but MDR-IVDR bottleneck persists (MedtechDive)
• Roche launches new breast cancer test, seeking out PIK3CA mutations (Fierce)
• BD calls for 'Zero Trust' to combat rising healthcare hacking amid pandemic (MedtechDive)
• Coyle exits Medtronic to run iRhythm as diabetes lead Salmon takes over cardiovascular unit (Fierce)
• Hearing Aids Could Use Some Help (NYTimes)

• Drug Pricing Program: HHS Uses Multiple Mechanisms to Help Ensure Compliance with 340B Requirements (GAO)
• Substance Use Disorder: Reliable Data Needed for Substance Abuse Prevention and Treatment Block Grant Program (GAO)
• Attorneys general ask HHS to punish 340B program bilkers — but pharma claims it's fighting 'waste and abuse' (Endpoints) (STAT)
• Justices Won't Review Cochlear's $268M Hearing Aid IP Loss (Law360)
• J&J Prevails In Tenn. Woman's Pelvic Mesh Suit At 6th Circ. (Law360)
• Walgreens Goes After Generic Cos. Over Alleged Price-Fixing (Law360)
• Drugmakers Call Zantac MDL 'Shotgun Pleadings' (Law360)
• Mallinckrodt's Ch. 11 Fee Payout Proposal Rejected (Law360)