Recon: FDA approves Takeda's lung cancer therapy; Moderna makes its case for boosters
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Moderna says COVID-19 vaccine protection wanes, makes case for booster (Reuters)
- U.S. Booster Policy Is in Flux as Studies Add to Dissent (NYTimes)
- U.S. FDA approves Takeda's lung cancer therapy (Reuters) (FDA)
- Drug Plan Fails, Signaling Thorny Path for Democrats’ $3.5 Trillion Bill (NYTimes)
- PhRMA launches 7-figure ad campaign against Democrats' drug pricing measures (The Hill)
- Drug makers failed to block House provision cracking down on orphan drug tax credits (STAT)
- A ‘wonky’ congressional report will be a pharma talking point in the drug pricing debate (STAT)
- How Fauci and the NIH Got Ahead of the FDA and CDC in Backing Boosters (KHN)
- FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation (FDA)
- Prenetics, a Covid-19 Testing Startup, to Go Public in SPAC Merger (WSJ)
- Iran approves U.S. firm J&J's shot as it fights fifth COVID wave (Reuters)
- Indonesia in talks with WHO to become global vaccine hub: minister (Reuters)
- Swedish PM says children aged 12-15 will be offered COVID vaccine (Reuters)
- Leaders Make Urgent Call To Accelerate Vaccination Globally And In Africa (WHO)
- Transforming the regulation of software and artificial intelligence as a medical device (MHRA)
- Access Consortium: Alignment with ICMRA consensus on immunobridging for authorising new COVID-19 vaccines (MHRA)
- China should consider vaccinating children aged under 12 against COVID - China CDC expert (Reuters)
- Amgen combination treatment with KRAS-blocking drug shows improved response in colon cancer patients (STAT) (Endpoints)
- FDA clears first-of-its-kind trial to see if CRISPR gene editing can cure HIV (Endpoints) (Fierce)
- BioCryst’s HAE med Orladeyo wins NICE nod (PharmaTimes)
- Not so fast: FDA tacks 3 more months onto decision date for Calliditas' rare kidney disorder drug (Endpoints)
- Novo Nordisk Foundation tees up $47.5M to explore the drivers of genetic disease with the Broad Institute (Endpoints)
- Pfizer backs a small Swiss upstart's attempt to discover a non-viral gene therapy (Endpoints)
- Who needs primary endpoints anyway? Aerie touts silver linings from failed PhIIb, plots PhIII in dry eye disease (Endpoints)
- Endocrine-focused biotech gets new cash for its peptides, with dreams of launching a franchise (Endpoints)
- Acepodia uncorks a very early win for its antibody-natural killer cell conjugates in HER2 tumors (Endpoints)
- Chinese CAR-T player books a megaround to drive bustling cell therapy portfolio through the clinic (Endpoints)
- Former Shkreli company Travere lands licensing deal with Vifor on kidney drug (Endpoints)
- Gilead keeps pushing trove of Trodelvy data as it seeks to become new standard of care in TNBC (Endpoints)
- Zymeworks squares up with Herceptin after HER2 bispecific aces mid-stage test in esophageal cancer (Endpoints)
- New FDA Office Aims To Improve IT Interactions With Sponsors (MedtechInsight)
- Zimmer Biomet dubs spine, dental spinout ZimVie and names C-suite appointments (Fierce)
- Smiths Medical recalls nearly 30 years' worth of fluid warmers due to risk of aluminum exposure (Fierce)
- Oxford Nanopore scores £150M investment, genomic sequencing cloud support from Oracle (Fierce)
- Theranos whistleblower testifies blood-test machines were about as accurate as a coin toss (CNBC)
- Allergan Cuts Deal With Generic Cos. Over Depression Drug (Law360)
- After a court let them off the hook, generic Zantac makers plan to seek legal expenses from consumers (STAT)
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