Recon: Moderna begins pediatric COVID vaccine trial; Eli Lilly bowel disease drug succeeds in Phase 3

• US drug distributors urge govt to boost COVID-19 vaccine supply network (Reuters)
• Moderna begins study of COVID-19 vaccine in kids (Reuters)
• AstraZeneca, US agree 500,000 more supplies of COVID-19 antibody cocktail (Reuters)
• Purdue Pharma to use public trusts, Sackler cash to settle opioid litigation (Reuters) (NYTimes)
• Eli Lilly bowel disease treatment succeeds in late-stage study (Reuters)
• Vaccinated Americans have been getting their second doses on time, the CDC says. (NYTimes)
• AbbVie in talks to sell $5 billion women's drugs portfolio – sources (Reuters)

• EMA: Benefits of AstraZeneca vaccine continue to outweigh the risks (Reuters)
• EU regulator to meet on Thursday to discuss AstraZeneca vaccine (Reuters)
• WHO urges world not to halt vaccinations as AstraZeneca shot divides Europe (Reuters)
• WHO vaccine safety panel may issue statement on AstraZeneca on Tuesday – spokesman (Reuters)
• Dutch regulator says it is not bypassing EMA with AstraZeneca halt (Reuters)
• Pfizer to delivery 200 million vaccine doses to EU in second quarter (Reuters)
• Canada's Medicago begins late-stage study of COVID-19 vaccine (Reuters)
• Lonza gets licence to make ingredients for Moderna vaccine (Reuters)
• Takeda grants J&J German production capacity for COVID-19 shot (Reuters)
• Roche launches COVID-19 variant test to help monitor mutations (Reuters)

• FDA requires Regeneron, Lilly to monitor variants as a condition of mAb EUAs (Endpoints)
• WHO Points To Wildlife Farms In Southern China As Likely Source Of Pandemic (NPR)
• World's top vaccine maker India criticised at home for exports as infections rise (Reuters)
• Ocugen seeks to sell 100 million Indian vaccine doses in US in 2021 (Reuters)
• India's Gland Pharma to make up to 252 million Sputnik V vaccine doses (Reuters)
• Mexico focuses vaccine loan request on U.S. stockpile of AstraZeneca doses (Reuters)
• Kremlin says pressure on countries to reject Russia's Sputnik V vaccine is unprecedented (Reuters)
• Canada to recommend use of AstraZeneca COVID-19 vaccine for those over 65: CBC News (Reuters)
• Brazil signs Pfizer deal for 100 million vaccine doses: source (Reuters)
• Sweden pauses AstraZeneca COVID-19 vaccinations (Reuters)
• Latvia suspends use of AstraZeneca's COVID-19 vaccine (Reuters)
• Portugal temporarily suspends AstraZeneca COVID-19 shots (Reuters)
• Spain joins countries halting AstraZeneca COVID-19 vaccine (Reuters)
• Cyprus suspends AstraZeneca vaccine pending EU agency review (Reuters)
• Slovenia temporarily halts AstraZeneca vaccine use (Reuters)

• US FDA Mulls Possibility Of Preannouncing Post-COVID Domestic Surveillance Inspections (Pink Sheet)
• Pharma mergers face fresh scrutiny by a new international antitrust group (STAT)
• Opinion: The Drugs at the Heart of Our Pricing Crisis (NYTimes)
• Once again, the viability of the U.S. biosimilar market is thrown into question (STAT)
• Takeda, Sarepta double down on a biotech partner's platform to engineer better AAV capsids by mapping out their structure (Endpoints)
• BIO chair slams Trump’s HHS, calls to stop Russian disinformation campaign on vaccines (Endpoints)
• What’s in a (drug) name? FDA to study how they affect efficacy perceptions (Endpoints)
• US FDA Exclusivity Battles Continue: Alvogen and Sandoz Challenge Buprenorphine, Aubagio Awards (Pink Sheet)
• In restarted study, Solid Bio reports no serious toxicity in Duchenne patient given ‘safer’ gene therapy (STAT)
• With all the buzz in gene therapy, Sanofi offloads two small molecule sickle cell programs from $11.6B buyout to Global Blood Therapeutics (Endpoints)
• Merck wins priority review for rare carcinoma drug belzutifan, the centerpiece of $1B+ Peloton buyout (Endpoints)
• GSK, German Merck's $4.2B bintrafusp alfa drug flops again, but companies squint to see glimmers of hope (Fierce)
• Specialty drugmaker ANI to boost CDMO work, generics portfolio with $210M Novitium buyout (Fierce)
• Can a CRISPR startup succeed where Pfizer, GlaxoSmithKline, Biogen and Genentech failed and cure chronic pain? (Endpoints)
• Record funding flowed into cell, gene therapy companies last year: report (BioPharmaDive)
• No quick redemption for GlaxoSmithKline’s $4B alliance with Merck KGaA as bispecific cancer drug flunks a second trial (Endpoints)
• A Rubius drug derived from red blood cells produces anti-tumor responses — and more questions (STAT)
• Johnson & Johnson’s arthritis drug shows promising results in Phase III trial (Pharmafile)
• Melinta Therapeutics nabs FDA nod for more convenient rework of antibiotic Orbactiv, a former Eli Lilly candidate (Endpoints)
• Daphne Koller lines up $400M for a global shopping spree to vault forward on AI drug discovery (Endpoints)
• Taiwan's Acepodia closes Series B with the promise of conjugating antibodies and off-the-shelf NK cells (Endpoints)
•  

• FDA issues safety alert for plastic breaks in Stryker-made STAR ankle replacements (Fierce) (FDA)
• All eyes on elective care after a rollercoaster year for medtech (MedtechDive)
• 1 year after COVID-19 hit: What's next for FDA, electives, testing and robotics (MedtechDive)
• 5 things medtech can expect from FDA in 2021 (MedtechDive)
• Australia will develop UDI system for medical devices following new regulatory amendment (Emergo)
• FDA Activities Related to Essure (FDA)

• Insulin makers win a significant round in Minnesota lawsuit accusing them of racketeering (STAT)
• Spinal Device Co. Wins Ban Against Rival, But Must Pay Bond (Law360)