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Recon: Moderna plans to start Phase 3 coronavirus vaccine study on 27 July; Roche, Blueprint partner on targeted cancer drug
Recon: Moderna plans to start Phase 3 coronavirus vaccine study on 27 July; Roche, Blueprint partner on targeted cancer drug
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Vaccine-makers’ ‘no profit’ pledge stirs doubts in Congress (Politico )
Moderna will begin late-stage coronavirus vaccine trial on July 27 (CNBC ) (Reuters )
US COVID-19 vaccine program to start manufacturing by late summer, says official (Reuters ) (Endpoints ) (CNBC )
Hospitals Stock Up on Covid-19 Drugs to Prepare for Second Wave in Fall (WSJ )
Blueprint Medicines partners with Roche to develop and sell genetically targeted cancer drug (STAT )
FDA rejects Verrica’s skin warts pitch, a month after flagging application ‘deficiencies’ (Endpoints )
Ohio sues Express Scripts for ‘egregiously’ overcharging for medicines (STAT )
In Focus: International
Global vaccine plan may allow rich countries to buy more (AP )
Covid Shot Derived From Tobacco-Like Plant Tested in Humans (Bloomberg )
Pharmas restart drug trials after pandemic-related declines, Medidata finds (Reuters )
Lupin shuts manufacturing drug plant after 17 employees test positive for Covid-19 (Economic Times )
Merck KGaA's manufacturing group could see billions from COVID-19 work: analyst (Fierce )
Pharma trade group scolds Gilead again for misleading information about a rival HIV drug (STAT )
Cytokinetics nabs Chinese partner, up to $450M as CV becomes company focus (Endpoints )
European Parliament backs WHO effort to create a Covid-19 technology access pool (STAT )
NICE links with Colombia’s Institute of Health Technology Assessment (PharmaTimes )
Coronavirus Pandemic
Immunity to the coronavirus may last only a few months, UK study finds (CNBC )
Mulvaney calls U.S. coronavirus testing abilities 'inexcusable,' breaking from Trump (Politico )
TimesFauci says US local public healthcare is ‘in tatters’ (Financial Times )
Coronavirus Sparks New Interest In Using Ultraviolet Light To Disinfect Indoor Air (NPR )
3M partners with MIT researchers to develop U.S.-backed rapid coronavirus antigen test (CNBC )
Joined-Up EU Approach Is Key To Continuing COVID-19 Fight (Pink Sheet )
AstraZeneca taps IQVIA to 'warp speed' its US pandemic vaccine research (Fierce )
Coronavirus (COVID-19) Update: Daily Roundup July 13, 2020 (FDA )
Pharma & Biotech
Biotech Properties Draw Billions of Dollars as Other Real Estate Languishes (WSJ )
Sanofi and MD Anderson team up to accelerate cancer drug testing (STAT ) (Endpoints )
Biogen, Eisai take Alzheimer’s candidate BAN2401 into phase 3 (PMLive )
Generic Drug User Fee Program Sees First-Ever Fee Spending Decrease, FTE Decline (Pink Sheet )
Massachusetts biotech Revitope scores first collaboration thanks to dual-engaging T cell platform (Endpoints )
Billions of dollars worth of SPACs are riding on the biotech IPO boom (Endpoints )
Junshi taps Revitope for next-gen anticancer bispecifics (Fierce )
Digital cancer pathology player Paige adds investments from Goldman Sachs, others (Fierce )
US FDA Advisory Cmte. To Evaluate Terlipressin's Clinical Outcomes, Risk Of Respiratory Failure (Pink Sheet )
Why pay $4B for a steady diet of disappointment? Porges turns thumbs down on Alexion’s M&A strategy, offers some pointers (Endpoints )
A neoantigen pioneer says its tech is working great. So what wrecked the share price? (Endpoints )
J&J nabs new OK for IL-23 drug Tremfya; Merck KGaA spinout ups Series A tally to €20.1M (Endpoints )
Medtech
Edwards to pay Abbott $468M to settle mitral, tricuspid repair device patent disputes (MedtechDive )
Quest Q2 better than feared, as demand surges for COVID-19 diagnostics (MedtechDive )
Shareholder challenges Thermo Fisher's $11.5B deal to buy Qiagen (MedtechDive ) (Fierce )
Abbott lays out plan for US study of FreeStyle Libre 3 (MedtechDive )
An insider's look at how GM, Ventec ramped up ventilator production amid COVID-19 (MedtechDive )
QSR Author Kim Trautman: FDA Should Change Name Of New Quality System Reg (And Other Thoughts) (MedtechInsight )
Industry Fears Disruption For EU Medtech Market Surveillance System (MedtechInsight )
US House Panel Votes For 5.8% Cut In FDA Device Center’s 2021 Budget Authority, Seeks COVID-19 Review (MedtechInsight )
Government & Regulatory
Electronic Submissions; Data Standards; Support for Standard for the Exchange of Nonclinical Data (Federal Register )
New York Woman Sentenced for Selling Abortion-Inducing Pills Illegally Smuggled Into US (FDA )
3rd Circ. Mulling FTC-AbbVie Pause Till High Court Acts (Law360 )
5 Compliance Lessons From Novartis' FCPA Settlement (Law360 )
Lilly Bars Contract Pharmacies From 340B Discounts Despite HRSA Guidance (Pink Sheet )
Judge waives requirement for in-person visit to get abortion pill during pandemic (The Hill )
Mallinckrodt Aims To Nix Medicaid FCA Suit Over Acthar Gel (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.