Recon: FDA authorizes updated Pfizer and Moderna COVID vaccines; Moderna forges $1.8B cancer research pact with Immatics

• US FDA authorizes Pfizer-BioNTech and Moderna's updated COVID shots (Reuters) (FDA)
• NIH nominee Bertagnolli will get a confirmation hearing next month, Sanders says (STAT) (Endpoints)
• Moderna strikes $1.8B cancer research deal with Immatics (Endpoints)
• House transparency, PBM reform bill gains bipartisan support (STAT)
• DOJ and Mifepristone maker ask Supreme Court to make ultimate decision on abortion drug in 2024 (CNN)
• Novartis' Sandoz targets biosimilar version of J&J drug in Samsung deal (Reuters)
• Walgreens to pay $44M to settle claims over fraudulent Theranos tests (MedTech Dive)
• Kroger inks $1.4B settlement deal for opioid lawsuits (Endpoints)
• Novo, Lilly set to dominate $71B GLP-1 drug market by 2032: J.P. Morgan (Fierce Pharma)

• UK's Syncona writes off 54.5 mln stg after Novartis ends Gyroscope's therapy (Reuters)
• Wegovy launch in UK may underline Novo's need to get ahead of Lilly (Reuters)
• Roche open to big acquisitions 'if it makes scientific and financial sense', CEO tells NZZ am Sonntag (Reuters)
• AstraZeneca's Tagrisso-chemo combo results raise bar for J&J cancer drug-analysts (Reuters)
• AstraZeneca seeks to calm CEO speculation after shares drop (Reuters)
• Bayer faces Essure lawsuit after UK court clears 200 women to claim for damages (MedTech Dive)

• Biogen names Jane Grogan as head of research (The Pharma Letter)
• Crinetics acromegaly drug succeeds in late-stage trial but would face stiff competition if approved (STAT)
• Former Stanford President Steps Down From Regeneron Board (Bloomberg)
• Crinetics soars on 'picture perfect' data for hormonal disorder drug (Reuters)
• Novartis stops work on geographic atrophy gene therapy GT005 (FirstWord Pharma)
• WCLC23: Daiichi says HER3-DXd yields nearly 30% ORR in mid-stage lung cancer trial (FirstWord Pharma)
• WCLC23: AstraZeneca, Daiichi tout early data for dato-DXd plus Imfinzi in NSCLC (FirstWord Pharma) (Endpoints)
• NASH company Madrigal names former Sanofi exec Bill Sibold as new CEO (Endpoints)
• GSK spends big on new RSV vax commercials, but it's an AbbVie clean sweep as August's top pharma drug ad spender (Fierce Pharma)
• Pfizer CEO throws weight behind migraine awareness campaign, pushing supportive employer message (Fierce Pharma)
• Orano Med and Orbit Discovery collaborate on radioligand therapies for cancer (Pharma Times)
• Brainomix’s e-Lung enters TIPAL trial (Pharma Times)
• AMO Pharma reveals data from myotonic dystrophy study (Pharma Times)

• Intuitive’s Tony Jarc on how AI is improving robotic surgery (MedTech Dive)
• Microsoft teams with Paige to use supercomputers to train cancer pathology AI models (MedTech Dive)
• Microplate Dx secures £2.5m for rapid diagnostic technology development (Pharma Times)

• Lawsuit raises antitrust and kickback allegations around cancer patient referrals (STAT)
• Amid another rise in cases, Covid’s new normal has set in (STAT)
• FDA’s New RWE Guidance Provides Recommendations for Sponsors Conducting Non-Interventional Real-World Studies and Describes the Potential to Use RWE for Initial Approvals in One Limited Circumstance (FDA Law Blog)
• Real-World Data Can Include EUA Observations, US FDA Final Guidance Says (Pink Sheet)
• Medicare Copay ‘Smoothing’ Plan Shows Nothing Is Simple In Part D (Pink Sheet)
• Q&A Guidance Clarifies Human Factors Testing For Combination Products (MedTech Insight)
• FDA Data: Breakthrough Program Accepted 45% Of Applicants Since 2015 (MedTech Insight)
• Market Fast Track Or Regulatory Trap? Consultant Ken Block On US FDA’s Breakthrough Devices Program (MedTech Insight)