Recon: FDA approves Takeda's lung cancer therapy; Moderna makes its case for boosters

• 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)