Recon: EMA recommends Valneva COVID vaccine; Novartis wins FDA approval for Tafinlar + Mekinist combo

• Biogen, citing insurance challenges, shutters one of its Aduhelm studies (BioPharmaDive)
• U.S. FDA labels Baxter's respiratory device recall as most serious (Reuters)
• Novartis wins U.S. approval for targeted cancer drug combination (Reuters)
• Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one (STAT)
• U.S. FDA halts sales of Juul e-cigarettes in nicotine crackdown (Reuters)
• New Senate proposal to lower insulin prices would let drugmakers lock in their current profits (STAT)
• FDA probes one more infant death potentially related to Abbott baby formula (Reuters)

• EU watchdog backs Valneva's COVID shot as contract talks go on (Reuters) (EMA)
• EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17 (EMA)
• WHO eyes decision on monkeypox 'emergency', Africa says it's long overdue (Reuters)
• Smallpox drugmakers get new orders as monkeypox spreads (Reuters)
• GSK, Novartis pledge funds for diseases that mostly affect the poor (Reuters) (Fierce)
• Uniqure’s Huntington’s gene therapy lowers key protein in small trial (STAT) (Fierce)
• Africa must end food, pharma import dependence, AfDB president says (Reuters)
• BioNTech breaks ground on first mRNA vaccine manufacturing facility in Africa (Endpoints)
• AstraZeneca continues to build out its presence in China with new COPD drug manufacturing site (Endpoints)
• Clinical management of COVID-19: Living guideline, 23 June 2022 (WHO)

• The Quality Lowdown: US FDA Renews Attention To Contamination Challenges (Pink Sheet)
• Indonesia to buy 29 mln foot and mouth disease vaccine doses as outbreak worsens (Reuters)
• FDA warns Mexican glycerin manufacturer for refusing an inspection (Endpoints)
• Pfizer donates first $5M in Russian profits since the war started to help Ukrainians (Endpoints)
• AstraZeneca debuts first consumer campaign for its Covid-19 prophylactic Evusheld — and a first for EUA drugs (Endpoints)
• F-star bought out in $161M all-cash deal as Hong Kong's Sino Biopharm looks toward international expansion (Endpoints)
• Xenon jumps on positive data-to-immediate public offering train to bankroll PhIII epilepsy study (Endpoints)
• MilliporeSigma looks to keep up with the competition in new Wisconsin expansion (Endpoints)

• Patient death prompts another recall of Medtronic’s HVAD System (MedtechDive)
• Wearables are collecting a flood of data. An ambitious new study of pregnancy aims to prove that’s valuable for health (STAT)
• BD recalls two years’ worth of bone marrow needle kits after 37 complaints (Fierce)
• Bioventus agrees to staggered payment plan to close stalled $315M CartiHeal takeover (MedtechDive)
• FDA Plans Meeting On Pulse Oximeter Accuracy (MedtechInsight)
• French Company Gets FDA Breakthrough Status For Brain Device (MedtechInsight)

• Fight over where to house ARPA-H still brews with House bill's passage (Endpoints)
• Congress lays out its demands for FDA in 2023 — on everything from machine learning to immunotherapies (Endpoints)