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

• 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)

• 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)

• 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)

• 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)

• JPML Weighs New Opioid MDL As McKinsey Suits Surge (Law360)
• Elizabeth Holmes’ lawyers cite widespread negative coverage in request to expand jury selection (CNBC)