Recon: Pfizer lowers revenue forecast on COVID vaccine sales; Illumina reveals timeline for Grail divestment
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
In Focus: International
- 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)
Pharma & Biotech
- 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)
Medtech
- 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)
Government, Regulatory & Legal
- 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
