Recon: Bayer to buy US biotech Vividion for up to $2B; South Korea pledges $1.9B for COVID-19 vaccine production

• Moderna says its COVID-19 shot 93% effective six months after second dose (Reuters) (WSJ)
• Moderna's Covid-19 vaccine sales to trail Pfizer's total significantly in 2021 and 2022 (Endpoints)
• White House says US can provide COVID-19 boosters if needed (Reuters)
• Bayer to buy US start-up Vividion for up to $2bn (FT) (STAT) (BioPharmaDive)
• CVS stops giving J&J Covid vaccines in pharmacies, still offers shots at some MinuteClinics (CNBC)
• Athira cited altered studies in $15 million NIH grant application, creating legal risk (STAT)
• How Citizen Petitions Influence FDA Drug Approvals (Law360)
• Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous (ProPublica)

• S.Korea pledges nearly $2 bln to become major COVID-19 vaccine producer (Reuters)
• Ignoring WHO call, major nations stick to vaccine booster plans (Reuters)
• Merck KGaA raises outlook after forecast-beating Q2 profit (Reuters)
• Pfizer epilepsy drug prices were 'unfairly high,' UK review finds (Reuters) (Endpoints) (FT)
• Analysis: Sanofi's COVID-19 vaccine setback, drug pipeline cast long shadow (Reuters)
• Canadian agency loses a battle in effort to force a drug maker to lower ‘excessive’ pricing (STAT)

• Heart problems following vaccination in the U.S. are uncommon and short-lived, researchers reported. (NYTimes)
• Africa's COVID vaccine project takes a step forward with bottling agreement -document (Reuters)
• African Union says J&J vaccine shipments begin, warns of slow pace of deliveries (Reuters)
• Delays in deliveries of Russia's Sputnik V shot to be resolved this month -RDIF (Reuters)
• Pfizer to require U.S. workers receive COVID-19 vaccine or regular tests (Reuters)
• Covaxin receives GMP certificate from Hungary: Bharat Biotech (Economic Times)
• Both vaccine doses reduce risk of delta variant infection by up to 60 percent: study (The Hill)

• Novo Nordisk's new weight-loss drug getting a boost from pandemic -CEO (Reuters)
• FDA Approval Demonstrates the Role of Real-World Evidence in Regulatory Decision-Making on Drug Effectiveness (FDA)
• Gilead’s Kite jumps back to the bargaining table to forge $875M pact with a newly-emerged upstart on next-gen cell therapies (Endpoints)
• ICER offers final verdict against Biogen's aducanumab: No proof it works, clear prospect of harm, wildly overpriced (Endpoints)
• PepGen raises $113M to challenge Sarepta in DMD, build neuromuscular and neurologic pipeline (Fierce)
• The US FDA’s Advisory Committee Drought (Pink Sheet)
• Merck's Keytruda takes home adjuvant win in melanoma, escalating early-line fight with Bristol Myers (Endpoints)
• Billions in new research funding sparks a lobbying frenzy among patient advocates (STAT)
• Shares of BeyondSpring skyrocket on new, positive cancer drug trial results (Endpoints)
• Emerging from stealth mode, Aardvark rounds up enough cash to put its lead drug through Prader-Willi PhII (Endpoints)
• Feds throw lifeline to shuttered Viatris plant in West Virginia, but its fate remains uncertain (Fierce)
• Science pioneer, pharma research chief, global health advocate and biotech entrepreneur Tadataka ‘Tachi’ Yamada has died (Endpoints)
• A small vaccine developer favored by the UK government in Covid-19 touts a PhIII first in chikungunya (Endpoints)
• Mitsubishi Tanabe’s Spinal Cord Injury Drug Gets Fast-Track Tag in US (PharmaJapan)

• Siemens raises profit guidance again as industrial demand ramps up (Reuters)
• Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period (FDA)
• FDA Participates in New ‘Collaborative Communities’ to Address Emerging Challenges in Medical Devices (FDA)
• Nevro shares plunge 25% after sluggish Q2, execs brace for worse to come (MedtechDive)
• Intuitive Surgical maps out $500M expansion of Georgia facilities, workforce (Fierce)
• Radiology software company Sirona Medical emerges from stealth mode (STAT)
• Boston Scientific Lands NTAP Status For Single-Use Scope (MedtechInsight)
• South Korea MFDS plans several medical device regulatory updates for 2022 (Emergo)

• WilmerHale Attys Helped Lose Theranos Data, Judge Says (Law360)
• Judge denies Elizabeth Holmes’ request to suppress patient complaints about Theranos (CNBC)
• C.R. Bard Implant Called 'Ticking Time Bomb' At Trial Open (Law360)
• Endo Exec Ripped FDA 'Window Dressing,' Jury Hears (Law360)
• 2 Firms Seek To Lead GW Pharma Suit Over $7.2B Deal (Law360)
• Trade Groups Urge Justices To Hear NY Opioid Tax Challenge (Law360)
• Zetia Judge Must Rethink 'Faulty' Class Cert., 4th Circ. Says (Law360)