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Recon: FDA approves Amgen’s KRAS-blocking lung cancer drug; EMA recommends Pfizer-BioNTech vaccine for children ages 12-15

Posted 28 May 2021 | By Michael Mezher 

Recon: FDA approves Amgen’s KRAS-blocking lung cancer drug; EMA recommends Pfizer-BioNTech vaccine for children ages 12-15

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • A $6 trillion budget lays out Biden's vision, but Republicans unlikely to be swayed (Reuters) (Politico)
  • Boxed in: How a single Pfizer decision complicated the Covid vaccine rollout while boosting profits (STAT)
  • Amgen wins FDA approval for first KRAS-blocking lung cancer drug (STAT) (FDA)
  • US FDA approves Bristol Myers' bowel disease treatment (Reuters)
  • With latest FDA nod, Biohaven's Nurtec becomes first migraine med to prevent—and treat—attacks (Fierce)
  • Illumina accuses FTC of running out the clock on its bid to acquire Grail (San Diego Union-Tribune) (Law360)
  • FDA adcomm votes in favor of approving Provention Bio’s drug to delay type 1 diabetes (Endpoints)
  • FDA, J&J Near Deal for Covid-19 Vaccine Production at Baltimore Plant (WSJ) (Reuters)
  • FDA official says heart issue possibly linked to Covid vaccines is rare, would inoculate own kids (CNBC)
In Focus: International
  • European Medicines Agency approves Pfizer jab for 12 to 15-year-olds (FT) (EMA)
  • J&J unsure of meeting June COVID-19 vaccine supply target for EU (Reuters)
  • Britain approves J&J COVID-19 vaccine, cuts order (Reuters) (MHRA)
  • Patents are needed to develop medicines for future pandemics – Merkel (Reuters)
  • AstraZeneca drug Tagrisso gets EU nod for early lung cancer treatment (Reuters)
  • Russian court rejects U.S firm's lawsuit over COVID-19 drug remdesivir (Reuters)
  • Mexico authorizes J&J's COVID-19 vaccine for emergency use (Reuters)
  • WHO, GAVI seek 190 mln COVID-19 vaccine doses by end-June to fill gap (Reuters)
Coronavirus Pandemic
  • U.S. Is Said to Have Unexamined Intelligence to Pore Over on Virus Origins (NYTimes)
  • WHO experts preparing proposal for next studies on virus origin – spokeswoman (Reuters)
  • Covid-19: Pfizer-BioNTech vaccine is “likely” responsible for deaths of some elderly patients, Norwegian review finds (BMJ)
  • Why Apple and Google’s Virus Alert Apps Had Limited Success (NYTimes)
  • Russia to supply UNICEF with Sputnik V doses for 110m people, says RDIF (Reuters)
  • Japan to consider sharing COVID-19 vaccines amid calls to help Taiwan (Reuters)
Pharma & Biotech
  • Real-World Data Of Cancer Drugs In Elderly Could Push Regulators Toward Broader Trial Eligibility (Pink Sheet)
  • EQRx readies a lower-cost alternative to pricey cancer immunotherapies (BioPharmaDive)
  • Eye injections causing blindness? FDA’s stem cell clinic crackdown readies for action (Endpoints)
  • ‘We shouldn’t leave anybody behind’: Inequities in cancer genomics undercut promise of precision medicine (STAT)
  • Generic Industry’s Future May Include A Role In The Gene Therapy Space (Pink Sheet)
  • NICE green lights Tremfya to treat active psoriatic arthritis (PharmaTimes)
  • Joint HMA/EMA Workshop on Artificial Intelligence in Medicines Regulation (EMA)
  • Biogen adds key manufacturing plant to its potentially quixotic aducanumab launch plan (Endpoints)
  • With two debuts and a SPAC, biopharma notches another busy week as IPO raise soars past $7B (Endpoints)
  • CDMO Tergus cuts the ribbon on Durham plant, latest in a line of companies packing into the emerging NC hub (Endpoints)
  • Recursion CSO heads west for mini-brain upstart; Novartis vet steps up to the plate as CFO for Andrew Hirsch at C4 Therapeutics (Endpoints)
  • China's patent law revisions set to take effect June 1; Verrica's second trip to the FDA is delayed (Endpoints)
  • Analysts tip Edwards' US TAVR growth at 90% in April (MedtechDive)
  • Medtronic scores European approvals for 2 diabetes management devices (Fierce)
  • Medtronic steps up robotics bet as its challenger to Intuitive starts clinical trial (MedtechDive)
  • FDA clears radar-powered, contactless patient monitor from Xandar Kardian (Fierce)
  • Olympus buys partner Medi-Tate and its minimally invasive prostate device (Fierce)
  • Scientia raises $50M to develop guidewires and microcatheters for stroke, cancer treatment (Fierce)
  • Swiss medtech sounds alarm as MDR erects barriers to EU market (MedtechDive)
Government, Regulatory & Legal
  • JPML Weighs New Opioid MDL As McKinsey Suits Surge (Law360)
  • Elizabeth Holmes’ lawyers cite widespread negative coverage in request to expand jury selection (CNBC)
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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