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Regulatory Focus™ > News Articles > 2020 > 6 > Recon: GAVI raises $8.8B for immunization campaigns to 2025; AbbVie partners for COVID-19 antibody t

Recon: GAVI raises $8.8B for immunization campaigns to 2025; AbbVie partners for COVID-19 antibody therapy

Posted 05 June 2020 | By Michael Mezher 

Recon: GAVI raises $8.8B for immunization campaigns to 2025; AbbVie partners for COVID-19 antibody therapy

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Wholesale drug prices — and net prices — keep falling for most drugs (STAT)
  • Novavax gets US defense funding for its COVID-19 vaccine (Reuters)
  • Inovio sues a key contract manufacturer as it races to develop a Covid-19 vaccine (STAT) (Endpoints)
  • Melinta wins bidding war to land deal to acquire Tetraphase (Fierce) (Endpoints)
  • Merck wins a third FDA nod for antibiotic (Endpoints) (FDA)
  • Trump says US has 2 million coronavirus vaccine doses ‘ready to go’ (CNBC)
  • Abbvie strikes partnership to develop COVID-19 antibody therapy (Reuters)
  • Trump Administration Sets Demographic Requirements for Coronavirus Reports (NYTimes)
  • Doctors Heavily Overprescribed Antibiotics Early in the Pandemic (NYTimes)
In Focus: International
  • Hydroxychloroquine Studies Tied to Data Firm Surgisphere Retracted (WSJ) (STAT) (NYTimes)
  • WHO says it did not see Surgisphere data that halted virus drug trial (Financial Times)
  • AstraZeneca lays out plan for producing 2B doses of Covid-19 vaccine, if it works (STAT) (Reuters)
  • Italian medical firms seek investors to fund domestic COVID-19 vaccine trial (Reuters)
  • GAVI raises $567 million of $2 billion goal to buy COVID-19 vaccines for poor (Reuters)
  • Vaccines group raises $8.8 billion for immunisation plans for poor countries (Reuters)
  • UK Pharma Exec Barred After Admitting To Drug Supply Plot (Law360) (CMA)
  • EU High Court Told To Uphold €94M Pay-For-Delay Fine (Law360)
  • UCB buys epilepsy firm Engage Tx in $270m deal (PMLive)
  • Lonza picks Roche executive as CEO, ending year of turmoil at the top (Reuters) (Endpoints)
  • Hitachi, Toshiba, Miraca to set up factory for coronavirus antigen tests (Reuters)
  • Australia's CSL says to help fund, make vaccine candidate if it proves successful (Reuters)
Coronavirus Pandemic
  • 'It's not over': COVID-19 cases rise in some nations easing lockdowns: WHO (Reuters)
  • Coronavirus Rips Into Regions Previously Spared (NYTimes)
  • This Time, Hardly Anyone Followed Trump’s Lead on Virus Drugs (NYTimes)
  • UK halts trial of 'useless' hydroxychloroquine in COVID-19 patients (Reuters)
  • U.S. doctors group sues FDA for limiting access to drug touted by Trump for COVID-19 (Reuters)
  • Blood pressure drugs linked to lower COVID-19 mortality: study (Reuters)
  • BARDA taps Evidation Health to digitally monitor healthcare workers for early COVID-19 symptoms (Fierce)
  • Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with coronavirus (COVID-19) (MHRA)
  • FDA publishes validation data from 5 more COVID-19 antibody tests, both authorized and not (Fierce) (FDA)
  • Coronavirus (COVID-19) Update: Daily Roundup June 4, 2020 (FDA)
Pharma & Biotech
  • Kenneth Frazier, the Merck boss taking a stand against racial injustice (Financial Times)
  • Longtime executive Tony Coles on biotech, racism, and opportunities for change (STAT)
  • Specialty Drugs — A Distinctly American Phenomenon (NEJM)
  • Lower Prices and Greater Patient Access — Lessons from Germany’s Drug-Purchasing Structure (NEJM)
  • Bristol Myers is cleaning up the post-Celgene merger pipeline, and they’re sweeping out an experimental checkpoint in the process (Endpoints)
  • China Approves More Drugs For Cancer, Rare Diseases (Pink Sheet)
  • Opdivo Top-Selling Drug in May, Keytruda Falls to Second: Encise (PharmaJapan)
  • Biomanufacturers Cope with Challenges of Going Continuous (GEN)
  • US Drug Shortages In COVID-19 Era: A Domestic Problem With Domestic Solutions (Pink Sheet)
  • Legend fetches $424 million, emerges as biggest winner yet in pandemic IPO boom (Endpoints)
  • Atlas raises new $400M fund amid spree of VC raises. Here’s what they’ll spend it on (Endpoints)
  • Portion of Neil Woodford’s remaining investments, including Nanopore, sold off for $284 million (Endpoints)
  • RA Capital, Hillhouse join $310M rush to back Everest's climb to commercial heights in China (Endpoints)
  • David Chang steps up to CEO spot at WuXi's cell and gene therapy CDMO; David Meline is the new CFO at Moderna (Endpoints)
  • Could Vioxx Make a Comeback? Recalled Drug Receives Orphan Designation (Bill of Health)
Medtech
  • Pandemic causes expected wearable shipments to plummet by 27M this year (MedtechDive)
  • Medical devices: software applications (apps) (MHRA)
  • FDA approves Abiomed’s Impella ECP clinical trial (MassDevice)
  • Medtronic lands CE Mark for shorter therapy for high bleeding risk heart patients (MassDevice)
  • SMT’s TAVR wins CE Mark for aortic stenosis (MassDevice)
Government & Regulatory
  • Ill. High Court Boots Out-Of-Staters From Bayer Device Suit (Law360)
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.

Tags: US, worldwide

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