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Regulatory Focus™ > News Articles > 2020 > 4 > Recon: Blackstone invests $2B in Alnylam; Promising data prompts AstraZeneca to unblind Tagrisso stu

Recon: Blackstone invests $2B in Alnylam; Promising data prompts AstraZeneca to unblind Tagrisso study early

Posted 13 April 2020 | By Michael Mezher 

Recon: Blackstone invests $2B in Alnylam; Promising data prompts AstraZeneca to unblind Tagrisso study early

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Blackstone Invests $2 Billion in Alnylam Pharmaceuticals (WSJ) (Reuters) (Endpoints) (Press)
  • Early Experience With Remdesivir To Treat Severe COVID-19 Published (NPR) (Bloomberg) (WSJ) (Financial Times) (Reuters) (NEJM)
  • US coronavirus outbreak could peak this week, CDC director says (Reuters)
  • US still falling short on accurate testing, FDA chief says (Politico)
  • US close to coronavirus peak, but we have to take it 'day by day': FDA commissioner (ABC)
  • Fears of ‘Wild West’ as COVID-19 blood tests hit the market (AP)
  • Coronavirus Tests Are Being Fast-Tracked by the FDA, but It’s Unclear How Accurate They Are. (ProPublica 1, 2)
  • Large-scale COVID-19 antibody testing study launched in California (NBC)
  • South Korea set to ship coronavirus testing kits to US (Reuters)
  • Drugmaker Eli Lilly starts clinical testing of therapies for COVID-19 (Reuters)
  • He Could Have Seen What Was Coming: Behind Trump’s Failure on the Virus (NYTimes)
  • Trump inches toward open war with his health department (Politico)
  • A key ingredient that compound pharmacies need for hydroxychloroquine skyrockets in price (STAT)
  • AstraZeneca Wins First FDA Drug Nod for NF1 (Xconomy) (Endpoints) (FDA) (Press)
  • J&J Drops $400M Deal For Takeda's Surgical Patch (Law360-$) (MedtechDive)
  • Damage From OxyContin Continues to Be Revealed (NYTimes)
In Focus: International
  • France Reports Heart Incidents Linked to Drug Promoted by Trump (Bloomberg)
  • Small Chloroquine Study Halted Over Risk of Fatal Heart Complications (NYTimes)
  • Amneal running out of hydroxychloroquine raw material due to Finnish restrictions (Reuters)
  • UK cancels order for simple ventilators, needs more complex ones: source (Reuters)
  • AstraZeneca's top-selling cancer drug sees early unblinding in key trial (Reuters) (STAT)
  • WHO: 70 coronavirus vaccines are in development globally (The Hill)
  • Israeli defence firm Elbit Systems to produce ventilators (Reuters)
  • WHO is investigating reports of recovered COVID patients testing positive again (Reuters)
  • To Belgrade and beyond: Beijing exports China model of virus management (Reuters)
  • Ebola patient dies in Congo, first case in 50 days (Reuters)
  • Congo records second Ebola death in days: WHO (Reuters)
Coronavirus Outbreak
  • Developing Covid-19 Vaccines at Pandemic Speed (NEJM)
  • The Employer Will Test You Now (WSJ)
  • From Clinton to Trump, 20 years of boom and mostly bust in prepping for pandemics (NBC)
  • Apple and Google Team Up to ‘Contact Trace’ the Coronavirus (NYTimes)
  • New FDA coronavirus guidelines focus on protecting food service workers (Axios)
  • ‘We need an army’: Hiring of coronavirus trackers seen as key to curbing disease spread (STAT)
  • Startups spar with FDA over what constitutes a home coronavirus test (STAT)
  • Sewage analysis suggests a New England metro area with fewer than 500 COVID-19 cases may have exponentially more (ABC)
  • New FDA Policy Significantly Limits Serological Testing (FDA Law Blog)
  • Evaluation of nine commercial SARS-CoV-2 immunoassays (medRxiv)
  • Omeprazole As An Additive For Coronavirus Therapy (In the Pipeline)
  • Scientist Kizzmekia Corbett leads the way on COVID-19 vaccine trials with dedication and humor (NBC)
  • The White House Pushed FEMA To Give its Biggest Coronavirus Contract to a Company That Never Had to Bid (ProPublica)
  • 'Elbow to elbow:' North America meat plant workers fall ill, walk off jobs (Reuters)
  • How a Premier US Drug Company Became a Virus ‘Super Spreader’ (NYTimes)
  • Why Are Some People So Much More Infectious Than Others? (NYTimes)
  • Man Charged in Scheme to Sell 125 Million Nonexistent Masks (NYTimes)
  • How false hope spread about hydroxychloroquine to treat covid-19 — and the consequences that followed (Washington Post)
  • COVID-19 Patients Given Unproven Drug In Texas Nursing Home In 'Disconcerting' Move (NPR)
  • Inside first clinical trial testing malaria drug as coronavirus treatment (NBC)
  • China's new coronavirus cases rise to near six-week high (Reuters)
  • Iran records 4,585 coronavirus deaths as restrictions eased (Reuters)
  • UK coronavirus death toll nears 10,000 as minister says PM Johnson must rest (Reuters)
  • Some Spaniards head back to work in face masks as country loosens lockdown (Reuters)
  • Master protocols emerge as a critical clinical tool against COVID-19 (BioCentury)
  • Hope Biosciences Receives Second FDA Clearance for a Phase II Clinical Trial for Protection Against COVID-19 (Press)
  • FDA Authorizes Athersys to Initiate a Pivotal Clinical Trial Evaluating MultiStem® Cell Therapy in Patients With COVID-19 Induced Acute Respiratory Distress Syndrome (Press)
  • Celltrion plans July COVID-19 trial, advances 'super antibody' (Fierce)
Pharmaceuticals & Biotechnology
  • Coronavirus Pandemic Brings Hundreds Of US Clinical Trials To A Halt (NPR)
  • Biotech in the time of coronavirus: The return of mergers, acquisitions, and deals (STAT)
  • Lost opportunities from FDA, NIH inaction when sponsors fail to report clinical trial results (STAT)
  • Insurers, drug makers, and patient advocates blast two Trump proposals to drive down drug prices (STAT)
  • Q&A: Analyst-turned biotech exec-turned analyst reads the biotech Q1 tea leaves (Endpoints)
  • Aslan's Dupixent rival test put on hold amid COVID-19, but delays shouldn't hit readout (Fierce)
  • Notice of Change to the Application Due Date and correct Section II Award Information - Award Budget for RFA-FD-20-030 "Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (FDA)
Medical Devices
  • Abbott lands CE mark for tricuspid sibling of MitraClip (MedtechDive)
US: Assorted & Government
  • 3M claims distributor tried to sell masks to NYC officials for six times the price (The Hill)
  • Battle over drugs for Nevada execution ends with no decision (News Las Vegas)
  • Federal Government’s Battle To Reassert Control of FCA Filings Ostensibly in its Name (Drug & Device Law)
  • Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – April 12 UPDATE (Patent Docs)
  • CVC Reply No. 1 to Broad's Opposition No. 1 to CVC's Motion No. 1 to Be Accorded Benefit of Priority (Patent Docs)
  • Request for Information on Vaping Products Associated With Lung Injuries; Extension of Comment Period (FDA)
  • Expedited recall system for faulty or unauthorised COVID-19 devices (TGA)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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