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Regulatory Focus™ > News Articles > 2020 > 7 > Recon: J&J begins its first COVID-19 vaccine clinical trial; AstraZeneca reports rise in first-half

Recon: J&J begins its first COVID-19 vaccine clinical trial; AstraZeneca reports rise in first-half profit

Posted 30 July 2020 | By Michael Mezher 

Recon: J&J begins its first COVID-19 vaccine clinical trial; AstraZeneca reports rise in first-half profit

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Drugmakers Race to Build Covid-19 Vaccine Supply Chains (WSJ)
  • FDA could issue emergency use authorization for coronavirus vaccine in a matter of weeks (CNN)
  • FDA Nears Decision Authorizing Covid-19 Treatment With Convalescent Plasma (WSJ)
  • J&J starts human study of COVID-19 vaccine after promising monkey data (Reuters) (FT) (NYTimes)
  • Inovio vaccine candidate shows promise in non-human study (Reuters)
  • Rare Pediatric Priority Review Voucher Program Seems Headed For Short-Term Renewal (Pink Sheet)
  • FDA chief: Hydroxychloroquine use a decision between doctor and patient (The Hill)
  • Eli Lilly starts mid-stage study of COVID-19 treatment (Reuters) (Press)
  • Drug maker settles charges of offering ‘bogus’ research grants to boost use of its medicine (STAT)
  • Coles-led Cerevel Therapeutics to raise $445 million to develop brain drugs with fewer side effects (STAT) (Endpoints)
In Focus: International
  • WHO urges countries to support 'COVAX' vaccine scheme (Reuters)
  • A big obstacle: Where can CanSino test its vaccine abroad? (Reuters) (Pink Sheet)
  • Russia Plans to Register First Covid-19 Vaccine by Aug. 12 (Bloomberg)
  • AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries (Reuters)
  • AstraZeneca CEO says ‘unpredictable’ coronavirus may require annual vaccinations (CNBC)
  • AstraZeneca bucks industry trend with rise in first-half profits (FT)
  • GlaxoSmithKline warns of hit to vaccines business (FT)
  • EU warns of risk of syringe shortages for possible COVID-19 vaccine (Reuters)
  • Novartis turns to Sangamo with a $795M-plus deal aimed at using zinc finger tech for the neuro pipeline (Endpoints)
  • NICE rejects NHS funding for Kyowa Kirin's Poteligeo (PharmaTimes)
  • South Korea's Celltrion gets UK approval for trials of COVID-19 antibody drug (Reuters)
  • China to add 56 drugs to price-slashing bulk-buy program (Reuters)
Coronavirus Pandemic
  • More Than 150,000 People Have Died From Coronavirus In The US (NPR)
  • McConnell opens door to smaller coronavirus relief deal (The Hill)
  • Quest says FDA cleared new ‘lab method’ that will cut coronavirus testing delays (CNBC)
  • Moderna, Pfizer Protocols May Make COVID Vaccine Candidates Hard to Compare (Pink Sheet)
  • Moderna, Pfizer begin to give glimpse of Covid-19 vaccine pricing — and profits (Endpoints)
  • Old Vaccines May Stop the Coronavirus, Study Hints. Scientists Are Skeptical. (NYTimes)
  • Irregularities in COVID Reporting Contract Award Process Raises New Questions (NPR) (Law360)
  • Coronavirus (COVID-19) Update: Daily Roundup July 29, 2020 (FDA)
Pharma & Biotech
  • Venture capitalists are still showering biotechs with cash, even as the coronavirus upends markets (STAT)
  • Teva, Takeda offload generics, manufacturing plant to Nichi-Iko in Japanese venture reshuffle (Fierce)
  • Clinical Trial Transparency To Move Up A Notch In UK (Pink Sheet)
  • Boehringer/Lilly's Jardiance hits the mark in pivotal heart failure trial (PMLive)
  • Bristol Myers Squibb and bluebird bio return to FDA; Takeda gets a breakthrough nod (Endpoints)
  • Amgen's psoriasis pill Otezla thrives amid pandemic against injectable rivals (Fierce)
  • Can Sanofi's top drug carry it through a pandemic? (BioPharmaDive)
  • Otsuka Files Japan NDA for Preventive Treatment of Migraines (PharmaJapan)
  • Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS) (Press)
  • AbbVie preps a challenge to a rival migraine drug from Biohaven, spelling out an upbeat set of PhIII data (Endpoints)
  • F-star's Eliot Forster maps a shortcut to Wall Street, bagging more cash to fuel oncology pipeline work (Endpoints)
  • The lead drug in Alexion’s $930M buyout deal last fall just flopped — adding injury to analysts’ M&A insults (Endpoints)
Medtech
  • Smith & Nephew falls short of expectations, citing COVID-19 headwinds (MedtechDive)
  • Boston Scientific sees sharp US recovery in Q2, CEO says 'procedures can't be deferred forever' (MedtechDive)
  • Baxter Reports Second-Quarter 2020 Results (Press)
  • FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy (Press)
Government & Regulatory
  • FDA Warns Companies Illegally Selling Hangover Remedies (FDA)
  • Gilead Can’t Fend Off Antitrust Suit Over HIV Drug Pricing (Bloomberg)
  • HIV Drug Suit Against Gilead, BMS And Janssen Trimmed (Law360)
  • Pelosi huddles with chairmen on surprise billing but deal elusive (The Hill)
  • Seeking to battle high drug prices and the opioid crisis, two states ponder banning gifts to doctors (STAT)
  • Full Fed. Circ. Won't Rehear Actelion Spinoff's Patent Term Bid (Law360)
  • DEA Publishes Proposed Rulemaking Addressing Reporting of Thefts and Significant Losses of Controlled Substances (FDA Law Blog)
  • New York Chantix Case: Great on Preemption, Not So Hot on “Failure to Test.” (Drug & Device Law)
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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