Recon: Novavax COVID-19 vax 90%-plus effective; GSK pays big for Iteos' TIGIT-targeted immunotherapy

• Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine (NYT) (NPR) (Reuters)
• Another Sad Coronavirus Pandemic Milestone Is Approaching (NPR)
• U.S. Not On Pace To Meet Biden's Vaccination Goal (NPR)
• Eight states see rise in new COVID-19 infections (The Hill)
• U.S. has administered over 309 million doses of Covid-19 vaccines, CDC says (CNBC)
• How did 75 million J&J vaccines get ruined? FDA details the manufacturing woes at Emergent's beleaguered site (Fierce)
• America’s broken PPE supply chain must be fixed now (STAT)
• Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl ER Tablets for NDMA Impurity (FDA)

• UK’s Johnson set to delay end of COVID curbs as Delta cases rise (Reuters)
• Delta plus: New Covid variant identified in India, experts say no cause of concern for now (Economic Times)
• Africa May Be On The Verge Of A Third Wave Of COVID-19 Infections (NPR)
• India's COVID-19 Outbreak Is Slowing Down (NPR)
• Mexico to receive first J&J COVID-19 vaccines on Tuesday (Reuters)
• Germany demands that J&J make up COVID-19 vaccine gap in July (Reuters)
• Theramex announces license agreement for Prolia biosimilar in Europe and Australia (Big Molecule Watch)

• China’s ‘Bat Woman,’ at the Center of a Pandemic Storm, Speaks Out (NYT)
• Blinken calls on China to be transparent, share information for probe into COVID-19 origins (The Hill)
• COVID-19 Vaccines: Myocarditis Reports Could Slow Expansion Into Pediatric Age Groups (Pink Sheet)
• Moderna says it hasn’t found a link between its Covid vaccine and heart inflammation (CNBC)
• WTO head says pandemic-related trade barriers are rising (Reuters)
• Celltrion says trial shows antibody COVID-19 treatment to be safe and effective (Reuters)

• GSK pays up big for rights to TIGIT-targeted cancer immunotherapy from Iteos (STAT)
• Why “Radiopharmaceutical” Should be Part of your Healthcare Vocabulary (The Health Care Blog)
• Moderna founder raises another $2B to fuel new startups (BioPharma Dive)
• Looking beyond the pandemic, Moderna appoints J&J veteran Paul Burton as new CMO (Endpoints)
• U.S. FDA declines to approve Avenue's tramadol painkiller again, shares drop (Reuters)
• FDA extends review period for another Incyte NDA (Pharmaletter)
• FDA pushes back Ascendis' PDUFA for long-acting hormone therapy (Endpoints)
• bluebird bio presents new data for beti-cel in beta thalassemia at EHA2021 (PMLive)
• New data raise profile of Truxima at EHA 2021 (Pharmaletter)
• ASCO 2021 recap: Lynparza’s lift, Grail goes on, LAG validation & more (MedCity News)
• In next-gen BTK battle, AbbVie and J&J tout pivotal data backing Imbruvica as a combo treatment (Endpoints)
• Yescarta provides sustained survival benefit vs current therapies in FL (Pharmaletter)
• New Evrysdi data show improved motor function in pre-symptomatic babies with SMA (Roche)
• Terns Pharmaceuticals touts safety data from an ex-Eli Lilly candidate in the hunt for NASH treatment (Endpoints)
• Sanofi's treatment for rare anemia hits goal in 2nd phase 3 (Fierce)
• Biogen's $56K price on Aduhelm 'simply unacceptable,' Alzheimer's Association says after vouching for FDA approval (Fierce)
• Would I Give Aducanumab to My Mother? (Hastings Center)
• A pricey new drug that may not work? Why drug pricing critics are staying quiet. (Politico)
• PhRMA hosts first stakeholder workshop on clinical trial diversity (PhRMA)
• Opdivo plus Yervoy scores NICE backing for certain bowel cancer patients (PharmaTimes)
• AstraZeneca, Daiichi Sankyo launch Enhertu head-to-head trial with eyes on a new breast cancer standard (Fierce)
• ‘You have to get up on the podium’: Incoming BIO chair Paul Hastings on diversity, drug pricing and working with the FDA (Endpoints)
• New hope for anti-obesity drugs (Nature Reviews Drug Discovery)
• Lyophilized products are on the rise: Here's what you need to know (BioPharma Dive)
• Hot-melt extrusion can improve bioavailability: Avomeen (Outsourcing Pharma)

• Philips recalls ventilators, sleep apnea machines due to health risks (Reuters)
• Medtronic's FDA approval sets up fight for recharge-free pain market (MedTech Dive)
• FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device (MedTech Dive)
• Can DIY Endothelial Measurements Find Preclinical Cardiovascular Disease? (MD+DI)
• Who won the startup pitch contest at INVEST Precision Medicine? (MedCity News)

• Modernizing The Regulation of Laboratory Developed Tests (LDTs): Senator Rand Paul Identifies A Better Way Forward (FDA Law Blog)
• We Report on FDA-Based Failure-To-Report Claims – A 50-State Survey (Drug & Device Law)
• When Assessing A Health Technology’s Value, Don’t Ignore The Supply Chain (Health Affairs)