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)
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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