Recon: Pfizer lowers revenue forecast on COVID vaccine sales; Illumina reveals timeline for Grail divestment

• AstraZeneca's Tagrisso-chemo combo given priority review in US (Reuters)
• New RSV protections for infants hit cost, insurance hurdles in U.S. rollout (CNBC)
• Rite Aid Files for Bankruptcy, Undone by Years of Losses (The Wall Street Journal)
• Pfizer slashes revenue forecast on lower COVID sales, will cut costs (Reuters)
• Moderna reaffirms annual COVID vaccine sales forecast (Reuters)
• Medicare to cover more brain scans related to Alzheimer’s drugs (STAT)
• HHS dispatches millions to next-generation Covid targets, including intranasal vaccine (STAT)
• AbbVie Drug Price Connection Touted by Chamber in Updated Suit (Bloomberg Law)
• CMS wants Part D plans to be on their best behavior (Politico)
• Aldeyra braces for potential dry eye disease rejection after FDA says more data are necessary (Endpoints)

• Commission Predicts 43 Notified Bodies Under MDR And 12 Under IVDR By End November (MedTech Insight)
• EMA ‘Extremely Collaborative And Well Prepared’ During Review Of Santhera’s DMD Drug Agamree (Pink Sheet)
• Treatment For Maple Syrup Urine Disease Among Ten New EU Filings (Pink Sheet)
• Synaffix joins forces with Sotio on $740M ADC licensing deal, plans expansion after Lonza acquisition (Endpoints)
• Illumina details EC timeline, funding requirements for Grail divestment (MedTech Dive)
• Israeli Medtech Leaders Say War Is Impacting Companies, Driving Industry Humanitarian Effort (MedTech Insight)
• Undertaking Decentralized Clinical Trials In The UK ‘Should Not Be A Luxury’ (Pink Sheet)
• French Industry Faces €850m In Price Cuts & Curbs On Prescribing (Pink Sheet)
• EMA Considers Accelerated Review Of Madrigal’s NASH Drug Filing, Discloses Other Fast-Track Decisions (Pink Sheet)

• Novo Nordisk in $1.3 bln deal to buy hypertension drug (Reuters)
• AstraZeneca chair tasked with finding replacement for boss Pascal Soriot (This Is Money)
• Omeros terminates development of kidney disease therapy after study failure (Reuters)
• Nuvalent’s $300M offering; Spark ends epilepsy deal; A small IPO (Endpoints)
• Tang Capital continues biotech buying spree with acquisition bid for Rain Oncology (Endpoints)
• Bellerophon's board approves liquidation plan, leaves Nasdaq after layoffs and trial failures (Endpoints)
• BMS buys Mirati for $4.8B; Pfizer to slash cost; Q&A with Vertex CSO; Alnylam's Onpattro setback; and more (Endpoints)

• Masimo wins de novo authorization for measure of high blood oxygen levels (MedTech Dive)
• J&J receives 510(k) clearance for foot fixation device, targets growing bunion market (MedTech Dive)
• FDA: ‘We have had a very loud voice’ on EtO (MedTech Dive)
• CDRH On Track To Meet All MDUFA V Goals (MedTech Insight)
• Abiomed Letter Underscores Questions On FDA’s Clinical Decision Support Guidance (MedTech Insight)

• Eye docs urge Medicare to lower insurance hurdles amid shortage of repackaged Avastin (STAT)
• AbbVie Drug Price Connection Touted by Chamber in Updated Suit (Bloomberg)
• Supreme Court Rebuffs Surgeon’s Challenge to Reporting Scheme (Bloomberg)