Recon: US to order 100M more J&J vaccine doses; Lilly antibody combo cut COVID hospitalizations, deaths in second Phase III study

• 6 former FDA commissioners push Biden to nominate a permanent chief (STAT)
• Biden to order 100 million more doses of Johnson & Johnson vaccine (Politico) (Reuters)
• Biden Got the Vaccine Rollout Humming, With Trump’s Help (NYTimes)
• Lilly's combo therapy for COVID-19 cuts serious illness and death in large study (Reuters) (Endpoints) (Press)
• Lawsuit Argues 'Ticking Time Bomb' Could Invalidate Thousands Of Health Rules (NPR) (Law360)
• Pfizer’s Newest Vaccine Plant Has Persistent Mold Issues, History of Recalls (KHN)
• BioNTech Sees Potential to Supply 3 Billion Doses in 2022 (Bloomberg) (Reuters)
• Bluebird says its gene therapy was ‘very unlikely’ to be cause of patient’s cancer (STAT) (Fierce)
• Covid-19 Vaccines Targeting Multiple Variants Are in the Works at Moderna, Novavax (WSJ)

• Quad nations meeting to announce financing to boost India vaccine output (Reuters)
• WTO boss seeks boost for COVID-19 vaccine production, gets backing (Reuters 1, 2)
• Patent protection barriers not holding back vaccine production: drug groups say (Reuters)
• Pfizer wants to make vaccine in India if faster clearance, export freedom assured (Reuters)
• EU, UK in new skirmish over vaccines as post-Brexit ties sour (Reuters)
• Coalition eyes 100-day target for new vaccines against disease epidemics (Reuters)
• GlaxoSmithKline doubles cash paid to doctors for promoting its drugs (The Times)
• Sinopharm faces battle to turn Covid vaccine into a global success (FT)
• Bayer brushes off looming patent expiries (FT)
• EU's Breton expects J&J vaccine OK soon, not worried about overall second-quarter doses (Reuters)
• J&J has told Canada many times about challenges with COVID-19 vaccine: Trudeau (Reuters)

• Antibiotics may have been overused in COVID-19 patients: US study (Reuters)
• Convalescent Plasma Strikes Out As COVID-19 Treatment (NPR)
• Britain says it has set the record straight on EU vaccine ban suggestion (Reuters)
• CDC under scrutiny after struggling to report Covid race, ethnicity data (Politico)
• Europe to get 4 million more Pfizer/BioNTech COVID-19 shots this month (Reuters)
• Portugal approves AstraZeneca COVID-19 vaccine for over-65s (Reuters)
• Big Indian state scales down vaccinations, citing shortage (Reuters)
• DGCI's Subject Expert Committee recommends waiving off 'clinical trial mode' from Covaxin (Economic Times)
• BD, Abbott using apps to ease COVID-19 antigen test data bottlenecks (MedtechDive)
• No contract signed to produce Russian COVID-19 shot, France says (Reuters)
• Zimbabwe authorises Sputnik V, Sinovac coronavirus vaccines for emergency use (Reuters)

• The top 10 drugs losing U.S. exclusivity in 2021 (Fierce)
• Drug Approvals Over the Last Ten Years (In The Pipeline)
• Achilles' heel spotted for promising HIV prevention drug (Nature)
• Idorsia/insomnia: pharma pair’s second act opens well (FT)
• Carlyle-Backed China Biotech Firm Plans Hong Kong IPO (Bloomberg)
• Thermo Fisher will drop a whopping $600M into its manufacturing supply chain as Covid-19 work ramps up (Endpoints)
• Soleno Shaken By FDA Demand For Second DCCR Phase III Trial In PWS (Scrip)
• Lilly's cancer drug Retsevmo gets UK approval for multiple indications (Pharmafile)
• UK Set To Launch Drug Repurposing Project (Pink Sheet)
• GSK CEO Walmsley's pay falls to $9.7M as pandemic drags on profits (Fierce) (Endpoints)
• COVID-19 Drugmaker Eli Lilly Appoints New Compliance Chief (Law360)
• UK Funding Nod For Novartis Migraine Drug Finally Published After Bumpy Ride (Pink Sheet)
• CFO departs Intercept as trickle becomes mass exodus from NASH biotech (Endpoints)
• Dr Reddy's gets 3 observations from USFDA for US-based API plant (Economic Times)
• MHRA green light for DemeRx’s opioid use disorder trial (PharmaTimes)
• 70% of Major Products Fall Victim to Off-Year Drug Re-Pricing: Jiho Tally (PharmaJapan)
• Eli Lilly promotes Edgardo Hernandez to head its manufacturing operations as 19-year vet O'Neill hits the exit (Endpoints)
• Grifols snags the rest of GigaGen in $80M acquisition; Vertex moves cutting-edge diabetes treatment into the clinic (Endpoints)
• Arctic Vision collects $100M to bring US eye disease candidates overseas (Endpoints)
• Merck inks Keytruda deal with Surface Oncology; Rocket Pharmaceuticals gets expedited review of gene therapy for rare pediatric disease (Endpoints)
• AgomAb Therapeutics looks to take its 'true MET agonist' for broad use into the clinic with $74M round (Endpoints)
• Koch's 'disruptive' VC bets $110M on one of Flagship's new, big computational startups (Endpoints)

• EU remote audits under MDR in doubt as divergent national positions persist (MedtechDive) (MedtechInsight)
• Deerfield, Coridea launch NYC medtech incubator (Fierce)
• EU MDR Notified Body Designations Could Soar By A Third By End Of 2021 (MedtechInsight)
• Agilent names first chief medical officer as it expands diagnostics, genomics businesses (Fierce)
• Guidelines released for transition in Philippines to ASEAN harmonized requirements (Emergo)

• Fed. Circ. Backs Becton PTAB Wins On 2 Drug Dosing Patents (Law360)
• Opioid Distributor, Execs Can't Escape DOJ Indictments (Law360)