Recon: VA declines to cover Biogen's Aduhelm; FDA rejects Fibrogen anemia drug

• Biden struggles to find a permanent FDA chief as agency nears approval of Covid-19 vaccine (CNN)
• Veterans Affairs declines to cover Biogen’s Alzheimer’s drug over effectiveness, safety concerns (STAT) (Endpoints)
• RNA firm GreenLight Biosciences to go public in $1.2 billion deal (STAT)
• FDA declines to approve FibroGen's anemia drug (Reuters) (Endpoints)
• ‘We don’t unlearn’: What the pandemic has taught regulators about real-world data (STAT)
• CDC says pregnant people need Covid vaccine as delta surges (NBC)
• As AbbVie and Soliton shake hands on a $550M merger, the FTC says 'not so fast' (Endpoints)
• FDA Objects to CBD as Diet Supplement, Extending Uncertainty (Bloomberg)

• EU regulator looking at new possible side-effects of mRNA COVID-19 shots (Reuters)
• WHO-led trial to study three anti-inflammatory drugs for COVID-19 patients (Reuters)
• India in talks to buy 50 million doses of Pfizer vaccine (WSJ) (Reuters)
• UK orders extra Covid vaccines for autumn 2022 booster campaign (The Guardian)
• WHO says it urgently needs $7.7 billion to help poorer nations survive delta Covid variant (CNBC)
• The Carlyle Group axes auction by calling its $1.3B bid for Vectura 'final' — now the ball is in Philip Morris' court (Endpoints)

• GOP, industry signal fight over potential Biden vaccine ‘threat’ (Politico)
• Vaccine side effects remain rare and are outweighed by benefits of vaccination, the C.D.C. reported (NYTimes)
• Russia's Sputnik V shot around 83% effective against Delta variant, health minister says (Reuters)
• A WHO official on why we need a global tech strategy to fight vaccine misinformation (STAT)
• India's drug regulator approves study on mixing of Covaxin and Covishield doses (Economic Times)
• Spain gets green light to test homegrown COVID vaccine on humans, PM says (Reuters)
• Denmark to buy Novavax vaccines as part of EU deal (Reuters)

• Opinion: Plenty of qualified people are ready to run the FDA. Time for Biden to choose one (Endpoints)
• Priority review voucher updates: Who's won PRVs, who's bought them, and how much they're selling for (Endpoints)
• ‘Things are so messed up’: Patient access to antibiotics is lacking even in the wealthiest countries (STAT)
• Why the FDA Is Looking at the Chemicals in Sunscreens (Bloomberg)
• Life Sci Cos. Should Prep For Enforcement After COVID Pause (Law360)
• Philips Morris buys developer of inhaled heart attack drug, ramping up push into healthcare (BioPharmaDive)
• Did Lilly’s Olympic Ads Test The Boundaries On Celebrity Endorsement? (Pink Sheet)
• At an 'inflection point': GentiBio reels in $157M ahead of what CEO Adel Nada sees as a Treg boom (Endpoints)
• MHRA nod for Janssen’s relapsing multiple sclerosis drug Ponvory (PharmaTimes)
• Cannabidiol gains MHRA approval as adjunctive treatment of seizures (Pharmafile)
• Keytruda keeps expanding with another priority review; Medicxi-backed eye drop maker wins new funding, regional deal (Endpoints)
• Aiming to brush last year's flop aside, Fulcrum sees shares skyrocket on early look at sickle cell program (Endpoints)
• BioCryst scraps $200M offering after seeing share price slide (Fierce)
• Heat Biologics goes back to San Antonio to build a research and manufacturing facility (Endpoints)
• Emergency Use Authorization Requirements May Offer FDA Better Window Into Medication Errors (Pink Sheet)
• Using AI for a green thumb, Lumen teams with Google to help grow drug-producing algae (Fierce)
• SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to Microbial Contamination (FDA)

• QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo (MedtechInsight)
• FDA clears two single-use endoscopes for airway, sinus procedures (Fierce)
• Boston Scientific gets FDA nod for single-use bronchoscope, sees $2B opportunity (MedtechDive)
• FDA Patient Panel To Grapple With Recall Communications (MedtechInsight)
• Mahana Therapeutics gears up to launch IBS treatment app with $61M series B (Fierce)
• Q2 Dealmaking Statistics: Medtech And Diagnostics M&A And Alliance Activity, April-June 2021 (MedtechInsight)
• BD finds new global finance chief in 20-year Johnson & Johnson vet (Fierce)

• 20 Democrats urge leaders to fully fund pandemic preparedness in new package (The Hill)
• No MDL For Weight Loss Carcinogen Cases, JPML Says (Law360)
• 'This Cannot Go On': Opioid Trial Turmoil Intensifies In NY (Law360)
• Ex-Theranos CEO Must Unseal Mental Health Docs (Law360)
• Novartis Blood Cancer Drug Suits Centralized In Florida (Law360)
• Shire Pays $1.9M, Boosting ADHD Med Antitrust Deal To $3M (Law360)