Recon: ASCO 21 updates; Moderna goes for teen EUA

• Moderna says that its vaccine is effective for 12- to 17-year-olds and that it will seek F.D.A. authorization (NYT) (NPR)
• President Biden still hasn’t appointed a permanent FDA commissioner. That has big implications for upcoming drug approvals (Fortune)
• Bipartisan Legislation Introduced to Advance Biomedical Research Stalled by Pandemic (Global Genes)
• FBI warns of Conti ransomware attacks targeting U.S. healthcare networks (Healthcare IT News)
• We aren’t getting a national vaccine ‘passport.’ So let’s use the next best thing: CDC vaccination cards (KFF)
• Corporations Encourage Employee Vaccination but Stop Short of Mandates (KHN)
• Better Late Than Never? US FDA’s Oddly Timed COVID Master Protocol Guidance (Pink Sheet)
• C.D.C. Will Not Investigate Mild Infections in Vaccinated Americans (NYT)
• CDC identifies only 10,000 COVID-19 infections in fully vaccinated, but likely an undercount (The Hill)
• New York Covid vaccine rates plummet as states roll out more freebies for shots (CNBC)
• The lingering threat of fall Covid-19 outbreaks (Vox)

• 5 questions ahead of MDR's May 26 go-live date (MedTech Dive)
• EU infrastructure for COVID certificate ready from June, von der Leyen says (Reuters)
• EU Commission working on forced vaccine license transfers - Italy's Draghi (Reuters)
• UK government ‘concerned’ over Elliott Management’s plans for GSK (PMLive)
• WHO director-general calls for countries to vaccinate at least 10 percent of their populations by September (The Hill)
• WHO risks paralysis due to funding shortage – Ryan (Reuters)
• Mexico ramping up COVID-19 trial work tapping Sanofi, China's shots in late-stage tests (Fierce)
• State Department, CDC warn against travel to Japan ahead of Summer Olympics (NBC)
• India isn’t the only one. Covid cases are rising at record levels in these places too (CNBC)
• Poland dangles lottery jackpot to boost COVID vaccination drive (Reuters)
• Bharat Biotech expects EUA from WHO for Covaxin in July- September (Economic Times)

• Timeline: How the Wuhan lab-leak theory suddenly became credible (WaPo)
• U.K. Study Shows Power of Digital Contact Tracing for COVID-19 (NIH Director’s Blog)
• Op-Ed: The Jury Is Out on COVID Boosters (MPT)
• Children's Risk Of Serious Illness From COVID-19 Is As Low As It Is For The Flu (NPR)
• Tocilizumab May Benefit Certain Severe COVID-19 Patients (MPT)
• Explainer: What is 'black fungus' that is hitting India's COVID-19 patients? (Reuters)
• How COVID Changed Science (SciAm)
• Op-Ed: Protect the Patents (MPT)

• Biogen's $1B Swiss plant scores regulatory nod as drugmaker awaits pivotal FDA decision on aducanumab (Fierce)
• Novo Nordisk's Keenly Awaited Semaglutide Trial To ‘Redefine’ Alzheimer’s? (Scrip)
• 'Rejuvenating' the Alzheimer's brain (Eurekalert)
• Breakthrough designation for Boehringer’s drug for cognitive impairment associated with schizophrenia (Pharmaletter)
• Medicare: Cover amyloid PET scans and stop keeping people with dementia in the dark (STAT)
• Xeris to Acquire Strongbridge (Global Genes)
• Most Oncology Trials Fail to Report Timely Results (MPT)
• Pushing the envelope with PCSK9 (Nature)
• New JV from upstart biotechs Pyxis, Alloy aims for rapid drug development in cancer, autoimmune diseases (Fierce)
• ADC Therapeutics taps Avid for production of its new blood cancer med Zynlonta (Fierce)
• Keytruda challenger takes center stage at ASCO 2021 (Pharmaletter)
• LAG3 beyond BMS at ASCO21: Data Byte (Biocentury)
• Viral vector crunch as gene therapies, vaccines take off (Pharmaletter)
• Spurred on by Moderna and Pfizer's success, a Belgian biotech has big ambitions for its self amplifying RNA vaccine play (Endpoints)
• ‘It’s not a cure’: A gene therapy is opening a new chapter for children, but challenges endure (STAT)
• Nanoparticle based shot could boost efficacy, accelerate production of seasonal flu vaccines (Biopharma)
• Will the puzzle pieces ever snap together for CAR-T for solid tumors? (Endpoints)
• Days after FDA clears C3 drug, Apellis spotlights ex-US PhIII win among patients who haven't taken Soliris (Endpoints)
• Blackstone draws on four senior advisers’ diverse experiences as deal range continues to expand (Biocentury)
• Pieris inks respiratory partnership with Genentech, adding another to slate of milestone-heavy deals (Endpoints)
• Xilio inks Merck deal to run checkpoint inhibitor combo tri (Fierce)
• EC approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukemia (Roche)
• Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals (PubMed)
• New research begins on producing HIV treatments in plants (Pharmafile)
• Racemases: The hunt for drugs to neutralise these critical enzymes (Eurekalert)
• Hemp Seed Breeders Need Academic Research to Solve Total THC Problem (PR Newswire)

• FDA clears 2 endoscopes that avoid reprocessing (MedTech Dive)
• Boston Scientific Recalls Over 30,000 Stent Systems Due to Migration Risk (MD+DI)
• Medicare created a $30 billion market overnight – now we must get it right (MedCity News)
• Guardant’s Partnership with Janssen Bears Fruit (MD+DI)
• Ransomware, other cyber threats mount as medtech industry tries to adapt (MedTech Dive)
• New Microporous 3D Printing Material Offers A New Kind of Design Freedom (PR Newswire)
• Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home (Harvard Law Blog)
• Why DarioHealth plans to acquire a behavioral health company (MedCity News)
• ‘Underfunded and undervalued’: Ro’s acquisition of Modern Fertility puts a spotlight on health tech’s gender gap (STAT)

• DEA Can't Ban Psilocybin Therapy, States Tell 9th Circ. (Law360)
• Thorny Questions Raised by Lanham Act Claim Better Left to FDA (Drug & Device Law)
• Hagens Berman Loses Privilege In Thalidomide Sanction Fight (Law360)
• Eli Lilly Says HHS Trying To Foil Case Over Drug Discounts (Law360)
• Ariosa, Illumina Resolve DNA Patent Dispute At High Court (Law360)