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Regulatory Focus™ > News Articles > 2021 > 6 > Recon: Novavax COVID-19 vax 90%-plus effective; GSK pays big for Iteos' TIGIT-targeted immunotherapy

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

Posted 14 June 2021 | By Kari Oakes 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government & Regulatory
  • 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)
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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