Recon: FDA authorizes updated Pfizer and Moderna COVID vaccines; Moderna forges $1.8B cancer research pact with Immatics
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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