You are here:
Homepage
News & Insights Search
Recon: Vir, Alnylam plan clinical trials for COVID-19 RNAi drug; EU pledges €1B for coronavirus vaccine development
Recon: Vir, Alnylam plan clinical trials for COVID-19 RNAi drug; EU pledges €1B for coronavirus vaccine development
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Trump contradicts top health officials with vaccine timeline, malaria drug claims (Politico )
Trump now says he hopes US coronavirus deaths less than 100,000 (Reuters )
Vir, Alnylam plan human trials by year-end for potential COVID-19 therapy (Reuters ) (Endpoints )
US steers clear as global COVID-19 pledging conference begins (Reuters )
Health officials eyeing at least one of 14 potential coronavirus vaccines to fast-track (NBC )
Gilead Lobbying Rose As Interest In COVID-19 Treatment Climbed (NPR )
Roche wins US nod for COVID-19 antibody test, aims to boost output (Reuters ) (CNBC )
Former FDA commissioner warns of new fall epidemic amid 'persistent spread' (Politico )
DHS report accuses China of hiding coronavirus info so it could hoard supplies (Politico )
In Focus: International
Profits and Pride at Stake, the Race for a Vaccine Intensifies (NYTimes )
UN calls for COVID vaccine, treatment available for all (Reuters )
Cost of vaccinating billions against Covid-19 put at more than $20bn (Financial Times )
China’s Coronavirus Vaccine Drive Empowers a Troubled Industry (NYTimes ) (Financial Times )
EU warns against suspension of children vaccination amid coronavirus crisis (Reuters )
EU to provide one billion euros for global vaccine search: Von der Leyen (Reuters )
European Investment Bank joins WHO in pandemic help for Africa (Reuters )
The Coronavirus Still Is a Global Health Emergency, W.H.O. Warns (NYTimes ) (Reuters )
Turkey eases export rules for medical devices used for virus (AP )
Canada giving AbCellera Biologics C$176 million for coronavirus research (Reuters )
Japan aims to fast-track review of anti-viral drug remdesivir (Reuters ) (PharmaJapan )
Eli Lilly And Junshi Biosciences To Co-Develop Therapeutic Antibodies For Treatment Of Covid-19 (Reuters ) (Press )
Coronavirus Pandemic
Blood-Pressure Drugs Don’t Increase Coronavirus Risk (WSJ ) (NYTimes )
The Covid-19 Riddle: Why Does the Virus Wallop Some Places and Spare Others? (NYTimes )
Coronavirus gets a promising drug. MAGA world isn’t buying it. (Politico )
Amgen adds Otezla to the COVID-19 candidate list (PMLive )
Lawmakers ask HHS to ensure Gilead’s remdesivir is affordable if US taxpayers funded R&D (STAT )
With the pricing ball in Gilead’s court, ICER offers some parameters on how it can be played — analyst sees at least '$1B in theory' (Endpoints )
German study suggests infections are 10 times the number of confirmed cases (Reuters )
New Zealand reports no new coronavirus cases for first time since mid-March (Reuters )
Britain to trial new coronavirus tracing system (Reuters )
Coronavirus Sweeps Across Brazil, a Land Ill-Equipped to Fight It (WSJ )
Coronavirus (COVID-19) Update: Daily Roundup May 1, 2020 (FDA )
Pharma & Biotech
Why Are Clinical Trials So Complicated? (In The Pipeline )
With coronavirus pandemic, venture capitalists are taking extra precautions (STAT )
How Remdesivir, New Hope for Covid-19 Patients, Was Resurrected (NYTimes )
How an unproven drug became a bellwether for global stocks (Financial Times )
Belgian Body Welcomes Clawback Exemption For Generics/Biosimilars Amid Price Cuts (Pink Sheet )
BioMarin broadens its gene therapy horizons with a new R&D alliance in rare cardio cases (Endpoints )
Recent Study Examines the Influence of Institutional Incentives in Uptake of Biosimilars (Big Molecule Watch )
Precision Medicine Evidence Gaps Could Be Filled With Real-World Data, Central Repository (Pink Sheet )
Agios drops as COVID-19 takes a toll on drug studies (BioPharmaDive )
Newron's Merck KGaA-in licensed compound fails Rett Syndrome study, shares wilt (Endpoints )
DoP gives green signal to six manufacturers for export of 2,000 MT of paracetamol API (Pharmabiz )
Without showing any data, CytoDyn touts treatment for Covid-19 as winner — while its CEO sells stock (STAT )
New Darzalex formulation wins FDA approval; Israeli biotech plans $50M IPO (Endpoints ) (FDA )
Menarini bags Stemline and a rare disease drug in $677M buyout. But will a better offer follow? (Endpoints )
Medtech
Stryker sees 50% of revenue vulnerable to elective procedure pullback (MedtechDive )
Coronavirus surge in critical care sales helps Hillrom beat Q2 guidance (MedtechDive )
Cerus gains FDA approval for blood plasma kit (MassDevice )
BioMerieux COVID testing product gets U.S. emergency use authorization (Reuters )
Routine cancer screenings have plummeted during the pandemic, medical records data show (STAT )
Some consumer wearables might accurately track sleep (Reuters )
Takuo Aoyagi, an Inventor of the Pulse Oximeter, Dies at 84 (NYTimes )
Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide (FDA )
Government & Regulatory
‘It just had to do with luck’: Inside Biden’s struggle to contain the H1N1 virus (Politico )
CMS rolls back more Medicare, telehealth regs for providers working through pandemic (HealthcareDive )
Oklahoma AG Mike Hunter refiles lawsuits against 3 opioid distribution companies (The Oklahoman )
Doctor Who Promoted Malarial Drug Draws Scrutiny of Federal Prosectors (NYTimes )
Pharmacovigilance Inspection Program metrics report: Jan - Dec 2019 (TGA )
Update to Manufacturing Principles for medicines, APIs & sunscreens (TGA )
Former Naturopath Charged Criminally for Trafficking in Misbranded Drugs Claiming They Could Prevent COVID-19 (FDA )
Daiichi Told Cancer Drug Patent Fight Must Be Arbitrated (Law360 )
Purdue Creditors Get OK For Sackler Bank Subpoenas (Law360 )
Preemption and Second-Guessing FDA Classifications (Drug & Device Law )
Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp. (Fed. Cir. 2020) (Patent Docs )
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.