Recon: FDA approves Oyster Point's dry eye nasal spray; EMA reviewing Pfizer vaccine in young children

• FDA considering lowering recommended age for Pfizer/BioNTech COVID-19 boosters (Reuters)
• FDA delays decision on Moderna's COVID-19 vaccine for adolescents (WSJ) (Reuters)
• FDA declines to approve Revance's frown-line treatment (Reuters) (Endpoints)
• Oyster Point's drug becomes first FDA-approved nasal spray to treat dry eyes (Reuters) (Endpoints)
• Biogen trial of ALS drug fails main goal, but company says data are encouraging (Reuters) (STAT)
• Roche's Tecentriq crosses the finish line first in adjuvant lung cancer, potentially kicking off gold rush (Endpoints) (FDA)
• FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira (FDA)
• U.S. FDA declines to approve United-MannKind's lung disease therapy (Reuters)
• Ex-Theranos project manager testifies that Holmes told him to conceal parts of testing lab (CNBC)

• Merck COVID-19 pill sparks calls for access for lower income countries (Reuters)
• EU evaluating use of Pfizer's COVID-19 vaccine in young children (Reuters)
• EU has exported over 1 bln COVID-19 vaccines, von der Leyen says (Reuters)
• EU approves two sites for making Pfizer's COVID-19 vaccine (Reuters)
• India's vaccine effort slows as dose gap trumps output jump (Reuters)
• Valneva jumps on positive results for COVID-19 vaccine candidate (Reuters)
• WHO says it 'cannot cut corners' in approving India's Covaxin shot (Reuters)

• Lawsuits demand unproven ivermectin for COVID patients (AP)
• TGA Provisional Approval of Roche Products Pty Ltd COVID-19 treatment, casirivimab + imdevimab (RONAPREVE) (TGA)
• TGA grants provisional determination to Roche Products Pty Ltd COVID-19 treatment tocilizumab (ACTEMRA) (TGA)

• Third time's the charm: Adamis nabs approval of high-dose naloxone injection after two CRLs (Endpoints)
• Two drugmakers hit with PDUFA date delays from FDA amid backlog of inspections (Endpoints)
• Phathom's old Takeda drug bests Prevacid in a PhIII GI trial. Next stop? The FDA (Endpoints)
• Omeros plunges deeper after FDA rejects rare disease drug, asking for more information (Endpoints)
• Vertex gets much-needed win with ‘extraordinary’ first patient results on potential diabetes cure (Endpoints)
• UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug (Scrip)
• Esperion gets out the budget ax, chopping 170 staffers as its big drug launch sputters (Endpoints)
• Langer, Ciechanover godfather the latest AI upstart; Ipsen forges $446M AML development pact (Endpoints)

• Illuminating the black box: Five ways the FDA could build transparency into AI devices (Endpoints)
• Philips CPAP recall still chips away at earnings, with nearly 40% drop in Q3 connected care sales (Fierce)
• Medtronic misses bid for early FDA OK in renal denervation, stock slides (MedtechDive)
• ReCor Medical's renal denervation device misses blood pressure endpoint after European launch (Fierce)
• Natera launches lung DNA test for catching transplant rejections (Endpoints)
• Medtronic to leap ahead in diabetes race with $300M Triple Jump purchase: report (Fierce)
• Philips recalls, supply chain challenges dim 2021 outlook (MedtechDive)

• Most Cancer Claims Survive In Suit Over Weight Loss Drug (Law360)
• Zydus Infringed AstraZeneca's Diabetes Drug IP, Judge Rules (Law360)
• Nimbus, Bristol-Myers Can't Sell Psoriasis Drug Amid Dispute (Law360)
• UK Watchdog Probing Thermo Fisher's $21B PPD Deal (Law360)