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Regulatory Focus™ > News Articles > 2020 > 4 > Recon: GSK, Sanofi team up for coronavirus vaccine; India to boost domestic API production

Recon: GSK, Sanofi team up for coronavirus vaccine; India to boost domestic API production

Posted 14 April 2020 | By Michael Mezher 

Recon: GSK, Sanofi team up for coronavirus vaccine; India to boost domestic API production

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In Focus: US
  • Trump: It's my decision when to reopen US economy (Reuters) (NPR)
  • NY, CA and other states plan for reopening as coronavirus crisis eases (Reuters) (NPR) (The Hill)
  • White House says Trump 'is not firing Dr. Fauci' (NPR) (Reuters)
  • J&J buoyed by Tylenol, branded drugs while devices struggle (Bloomberg) (CNBC) (Financial Times)
  • Despite qualms, arthritis drug to be tested in coronavirus study (NYTimes)
  • Retail scripts of vaccines, acute drugs decline sharply amid COVID-19 pandemic (Fierce)
  • Former FDA chief grabs spotlight with coronavirus plans to ‘turn the lights back on’ (Washington Post)
In Focus: International
  • GlaxoSmithKline, Sanofi team up for coronavirus vaccine (WSJ) (Financial Times) (STAT) (Press)
  • 'Mixed picture' in Europe, COVID-19 vaccine at least 12 months off: WHO (Reuters)
  • AstraZeneca to test impact of cancer drug Calquence on coronavirus patients (Reuters)
  • India to boost drug ingredient output to pare China reliance (STAT) (Economic Times)
  • Swiss ICUs face drug bottlenecks as world scrambles for coronavirus meds (Reuters)
  • Congo records third new Ebola case from same infection chain: WHO (Reuters)
  • UN agencies: 117 million children may miss measles shots due to COVID-19 (Reuters) (NYTimes)
  • China approves two experimental coronavirus vaccines to enter clinical trials (Reuters)
  • Getting a coronavirus test in Wuhan: Fast, cheap and easy (Reuters)
  • WHO chief says confident US funding will continue in COVID fight (Reuters)
  • Brazilian lawmakers propose compulsory licensing for Covid-19 products (STAT)
Coronavirus Pandemic
  • WHO says covid-19 immunity is an unknown; disease '10 times deadlier' than 2009 flu (NPR) (CNBC)
  • Reasons for hope: the drugs, tests and tactics that may conquer coronavirus (Reuters) (GEN)
  • Doctors ask for death penalty drugs to treat coronavirus patients (The Hill)
  • IMF says the world will ‘very likely’ experience worst recession since the 1930s (CNBC)
  • The next coronavirus testing debacle (Politico)
  • G20 health ministers to speak next week about coronavirus: statement (Reuters)
  • Moderna's coronavirus vaccine plan may be possible, but a lot has to go in its favor (BioPharmaDive) (Endpoints) (Fierce)
  • Johns Hopkins researchers publish a how-to guidebook on Covid-19 plasma transfusions (Endpoints)
  • Why a decades-old TB vaccine is getting attention in the fight against Covid-19 (STAT)
  • Ford making masks to protect workers against COVID-19 (Reuters)
  • Decontaminated N95 masks boost spirits of front-line hospital workers (Boston Globe)
  • Pentagon awards contract for N-95 mask sterilization at 60 sites (Reuters)
  • Anti-malarial drug touted by Trump was subject of CIA warning to employees (Washington Post)
  • Health Minister Vows to Shorten Review Time for Avigan (Pharma Japan)
  • ICMR may use remdesivir if local companies can manufacture it (Economic Times)
  • South Dakota launches clinical trial of hydroxychloroquine (The Hill)
  • Healios to enroll COVID-19 patients in phase II off-the-shelf cell therapy program for ARDS (Pharma Japan)
  • When should coronavirus lockdowns be lifted? WHO offers advice on adapting to a ‘new normal’ (CNBC) (Reuters)
  • First UN solidarity flight departs Addis Ababa carrying vital COVID-19 medical supplies to all African nations (WHO)
  • US coronavirus death toll tops 23,000 - Reuters tally (Reuters)
  • India extends coronavirus lockdown until May 3 (CNBC)
  • Brazil likely has 12 times more coronavirus cases than official count, study finds (Reuters)
  • French new coronavirus death toll rises by 574 to 14,967 (Reuters)
  • UK coronavirus death toll could be far higher than previously shown (Reuters)
  • UK chief adviser expects COVID deaths curve to plateau for two or three weeks (Reuters)
  • Coronavirus not contained in Germany, warns institute as government weighs easing (Reuters)
  • Italy's daily coronavirus cases decline, deaths rise (Reuters)
Pharma & Biotech
  • Zai Lab targets blood cancers in deal with Regeneron (STAT)
  • Biogen Alzheimer's filing likely hit by pandemic, as drugs against the disease set for delay (Fierce)
  • Alnylam's vutrisiran gets fast-track treatment at the FDA (Fierce)
  • FDA clears wave of foreign manufacturing plants as COVID-19 concerns continue to grow (Fierce) (Economic Times)
  • Merck Bid for Second Pan-Cancer Keytruda Indication Would Raise Tumor Mutation Burden to cdx Status (Precision Oncology News)
  • Was Coronavirus A Factor In US FDA Approval Of Proventil HFA First Generic? (Pink Sheet)
  • Ploughing through a crowded PD-(L)1 market, Beigene loads up on promising lung cancer data (Endpoints)
  • Micro-cap Mei Pharma lands $100M upfront on beleaguered PI3K pathway (Endpoints)
  • Touting new way of mining neuro targets, Takeda spinout draws $45M from GV, Bill Gates, Foresite (Endpoints)
  • Alnylam's new pipeline star gets on FDA fast track; ARCH-backed biotech nabs orphan drug status (Endpoints)
  • SMC accepts four medicines for NHS use (PharmaTimes)
  • Coronavirus impact on India's pharma sector (Economic Times)
  • Drug, medical device manufacturing companies operate at 50% capacity (Economic Times)
  • Pharma sector flags shortage of packaging materials, transport (Economic Times)
Medtech
  • Takeaways From FDA's Relaxed Rules For Making Face Masks (Law360)
  • South Korea set to double supply of coronavirus tests to US (Reuters)
  • Coronavirus saliva test gets FDA emergency use approval, Rutgers University says (CNBC)
  • GE, Medtronic, Resmed among 7 medtechs part of $1.4B in finalized HHS ventilator contracts (MedtechDive)
  • FDA quickly authorizes its 2nd blood filtering device for COVID-19 (Fierce)
  • FDA EUAs go to 1st blood purifiers for COVID-19 patients, new N95 sterilizers (MedtechDive)
  • The latest coronavirus shortage: hospital infusion pumps (MedtechDive)
  • J&J blames pandemic for medical device sales slump (MedtechDive)
Government & Regulatory
  • Qualification opinion of clinically interpretable treatment effect measures based on recurrent event endpoints that allow for efficient statistical analyses (EMA)
  • Coronavirus (COVID-19) Update: Daily Roundup April 13, 2020 (FDA)
  • Trump’s disdain for ‘Obamacare’ could hamper virus response (AP)
  • Teva Unit in Puerto Rico Settles With EPA Over Pharma Pollution (Bloomberg Law) (Law360)
  • Complete Summary Judgment in Remanded Pelvic Mesh Case (Drug & Device Law)
  • Where's Medicare disparity data on coronavirus? (Politico Pulse)
  • US FDA Is Pulled Into Zofran Product Liability Litigation (Pink Sheet)
  • Walmart Hid That It Was Under Criminal Investigation for Its Opioid Sales, Lawyers Say (ProPublica)
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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