Regulatory Focus™ > News Articles > 2021 > 9 > Recon: FDA approves Takeda's lung cancer therapy; Moderna makes its case for boosters

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

Posted 16 September 2021 | By Michael Mezher 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech                                                                                                     
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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