Recon: FDA accepts Alvotech’s BLA for Humira biosimilar; Commission claims EU pharma revision will boost competitiveness

• Third Time Might Be a Charm for Alvotech as FDA Accepts BLA for Humira Biosimilar (BioSpace)
• FDA found lapses at Novo Nordisk's main US factory in May 2022, report says (Reuters)
• What to know about the polarizing ALS drug headed for FDA scrutiny next week (STAT)
• Civica Rx’s Unique Business Model Improves Drug Supply Security, Cuts Costs: Study (BioSpace)
• Neuralink, Elon Musk’s brain implant startup, set to begin human trials (CNN)
• Pharma's reputation hits record low in US as Republicans shun industry: Gallup (Fierce Pharma)
• New Training Models Address Workforce Gap in Biopharma Manufacturing (BioSpace)
• Hearing on Medicare drug price negotiation gets unusually heated (STAT)

• Dissent In Parliament As Commission Claims EU Pharma Revision Will Improve Competitiveness and Access (Pink Sheet)
• EU Group Facilitates Switching Multinational Trials To CTR (Pink Sheet)
• Novartis is scolded by U.K. trade group for the fourth time this year over Entresto promotions (STAT)
• Europe to decide on Novavax's COVID vaccine in October (Reuters)
• Spain's Catalonia region to provide period products for free at pharmacies (Reuters)
• Australia to hold independent inquiry into handling of COVID pandemic (Reuters)
• EU antitrust officials make surprise inspections at cardiovascular device company (MedTech Dive)
• Optimizing EU Medtech Regulatory Governance And Innovation: First Workshop Shapes Future Study (MedTech Insight)

• Mesoblast Sees Path Forward for Twice-Rejected Cell Therapy After FDA Meeting (BioSpace)
• AstraZeneca signs off on a ‘carbon negative’ new biotech building for one of its latest buyouts (Endpoints)
• Travere kidney drug narrowly fails confirmatory trial following FDA approval (STAT)
• ADHD medication errors jumped 300% since 2000 (Medical Marketing & Media)
• Different roads, same destination: Study shows COVID variants evolve to suppress immunity (Fierce)
• They carry a gene for ALS but aren’t sick. What does medical research owe them? (STAT)
• Valneva's half-year loss narrows on strong travel vaccine demand (Reuters)
• Aurinia appoints founder to board in handshake with MKT Capital (Endpoints)
• GSK's ViiV Healthcare takes Shutterstock-partnered campaign in new direction (Endpoints)
• After Versanis success, Aditum launches Celexor Bio with autoimmune drug from Acelyrin partner Inmagene (Endpoints)
• Hepalys to develop Inventiva’s NASH treatment; Everest licenses Kezar’s autoimmune drug (Endpoints)
• Samsung Biologics locks $242M BMS deal; Future Fields launches CDMO arm; SK pharmteco takes control of CBM (Endpoints)
• Aurinia quells investor unrest, names founder and ex-CEO Foster to its board (Fierce Pharma)

• FDA makes device conformity testing scheme permanent to streamline assessments (MedTech Dive)
• A new George Church startup raises $16M. The first-time founders have a ‘crazy vision’ to bring ML to cell therapy (Endpoints)
• Limited resources constrain federal oversight of medical device ads, GAO finds (MedTech Dive)
• CMR Surgical secures $165M for its robot expansion (MedTech Dive)
• Stryker adds minimally invasive bunion device to fast-growing extremities portfolio (MedTech Dive)
• CMS leader defends breakthrough device reimbursement proposal at House hearing (MedTech Dive)
• Boston Scientific Puts Charge In Neuromodulation Business By Acquiring Relievant (MedTech Insight)

• AstraZeneca refused to pay full bonus to US remote worker, lawsuit claims (Reuters)
• Free Covid tests will be offered again to all U.S. households (STAT)
• U.S. government awards $45 million for long COVID clinics (Reuters)
• Takeda settles antitrust lawsuit over gout drug Colcrys after trial kicked off (Fierce Pharma)
• Roche scores—again—in hemophilia drug patent case against Takeda (Fierce Pharma)