Recon: Novavax gets first emergency authorization in Indonesia; J&J pays $800M to settle most Risperdal suits

• Moderna says FDA needs more time to complete review of its COVID-19 shot for adolescents (Reuters) (NYTimes)
• Orphan drug tax credit on the chopping block again under Dem spending bill (Endpoints)
• Pelosi working to gather support for last-minute, last-ditch drug pricing policy (STAT)
• In key win, AbbVie lands FDA approval for Allergan's blurred-vision eye drop (Endpoints)
• Eli Lilly serves up a win over Biden's HHS in drug discount court case (Endpoints) (STAT)
• Merck delays $11.5B Acceleron buyout to give antitrust watchdog 'additional time for review' (Endpoints)
• J&J settles most Risperdal lawsuits, with $800 million in expenses (Reuters)
• Biden administration to publish details on Covid vaccine mandate for businesses in coming days (CNBC)

• GSK denies Mail on Sunday report of interest in Aurinia (Reuters)
• EU tells Grail to ‘actively work on’ alternatives to Illumina takeover (Politico) (Law360)
• AstraZeneca to transfer some drug rights to Covis Pharma in $270 mln deal (Reuters)
• Indonesia authorises Sinovac COVID-19 vaccine for children aged 6-11 (Reuters)
• Novavax COVID-19 vaccine receives first emergency use authorization (Reuters) (FT)
• WHO says seeks more data from Merck on COVID anti-viral, from Bharat on vaccine (Reuters)
• EMA encourages companies to submit type I variations for 2021 in November 2021 (EMA)

• Covid-19's global death toll tops 5M (NYTimes)
• Pregnant people were shut out of Covid vaccine trials — with disastrous results (Politico)
• Origin of Virus May Remain Murky, U.S. Intelligence Agencies Say (NYTimes)
• China says U.S. COVID origins report is without credibility (Reuters)
• Companies mull ending government contracts over vaccine mandate (Politico)
• Supreme Court Won’t Block Maine’s Vaccine Mandate for Health Care Workers (NYTimes)
• Detect nets FDA green light to bring routine molecular COVID testing to the home (Fierce)

• The loudest physician proponents of Aduhelm have all taken money from Biogen (STAT)
• Gene therapy startup Jaguar set to join NC manufacturing boom with $125M facility (Endpoints)
• Riding Covid-19 high, Aspen plans new additions at South African production site (Endpoints)
• A month after Biocon was handed a Form 483, documents reveal lackluster conditions (Endpoints)
• The Purdue bankruptcy plan was approved to distribute billions. Where is the money? (STAT)
• Gilead taps brakes on $4.9B bet after rival's failure, pushing blood cancer data out to 2022 (Fierce)
• Merck dives even further into cytokine research as deal spree continues (Endpoints)
• Gilead sales rise by 13%, buoyed by anti-COVID-19 drug Veklury (PMLive)
• Novartis UK awarded Innovation Passport for investigational therapy (PharmaTimes)
• Is that drug ad for me? People pay more attention to pharma DTC for familiar conditions, study finds (Endpoints)
• Gilead and MSD collab on Trodelvy/Keytruda breast cancer trial (PharmaTimes)
• EU Bodies Agree On New Drug Shortage Monitoring Platform (Pink Sheet)
• Daiichi jettisons ADC after flunking early solid tumor test (Fierce)
• Novo Nordisk bets big on obesity: Can marketing help it succeed in the notoriously tough therapy area? (Endpoints)
• Centessa provides peek at rare disease drug from extremely tiny study, leaving several questions unanswered (Endpoints) (STAT)
• Daiichi Sankyo scraps early-stage ADC program in gastrointestinal tumors after first phase fail (Endpoints)
• With the help of the NY governor's office, Strides Pharma acquires new manufacturing site (Endpoints)
• An Allergan psychiatric drug failed late-stage depression studies — but AbbVie is going for approval anyway (Endpoints)
• Two decades after Gleevec approval, Novartis scores new CML OK for 'wild card' STAMP inhibitor (Endpoints) (FDA)

• A smart knee implant promises to ‘help write the future of orthopedic technology.’ Surgeons aren’t so sure (STAT)
• Zimmer Biomet software error prompts Class I recall of Rosa One robotic neurosurgery platform (Fierce)
• Siemens' Varian leads latest FDA breakthrough device designations (MedtechDive)
• House Budget Reconciliation Bill Includes $150M For FDA IT Upgrades (MedtechInsight)
• A ‘STeP’ Backward? Expert Predicts ‘Slow, Quiet Death’ For FDA’s STeP Novel Devices Program (MedtechInsight)

• J&J Unit Escapes Antitrust Suit Over Prostate Cancer Drug (Law360)