Recon: NIH may own IP for Moderna COVID-19 vaccine; UniQure sells gene therapy rights to CSL for $450M
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Trump’s Drug Push Still Keeps Door Open for Banned Indian Firm (Bloomberg )
Bolton casts light on Trump’s deference to China on coronavirus (Politico )
Trump administration ending support for drive-thru testing sites (Politico )
Breakthrough Drug for Covid-19 May Be Risky for Mild Cases (NYTimes )
The NIH claims joint ownership of Moderna's coronavirus vaccine (Axios )
Moderna adds Catalent as vaccine manufacturing partner (BioPharmaDive )
Democrat raises questions about Trump administration's deliveries of ventilators abroad (NBC )
US group raises pricing recommendation for Gilead's remdesivir in COVID-19 (Reuters )
Hospitals see shortages of a cheap steroid that one study says helps Covid-19 patients (STAT )
Merck treads on Sanofi, Regeneron's turf with Keytruda's latest skin cancer OK (Fierce ) (Endpoints )
In Focus: International
Sosei, AbbVie sign drug discovery deal worth up to $1 bln (Reuters ) (Endpoints )
Vaccine alliance finds manufacturing capacity for 4 billion doses of coronavirus vaccines (Reuters )
In a surprise, UniQure sells its hemophilia gene therapy for $450M (BioPharmaDive ) (Endpoints ) (PMLive )
Australian drugmakers hit by critical shortages at height of pandemic, inquiry hears (The Guardian )
Germany flexes its muscles on foreign investment (Financial Times )
World's second-worst Ebola outbreak formally ends (The Hill ) (WHO )
Coronavirus: Vaccine volunteers begin to get immunized (BBC )
A pill to fight alcoholism causes an uproar in France over a regulator’s view of a clinical trial (STAT )
NICE knocks back Novartis’ oral MS drug Mayzent in draft guidance (PMLive )
NICE green light for Roche's Rozlytrek (PharmaTimes )
Sustained decline in sleeping sickness cases puts elimination within reach (WHO )
Coronavirus Pandemic
Decades-Old Soviet Studies Hint at Coronavirus Strategy (NYTimes )
Price for Gilead's COVID-19 drug should shrink if cheap steroid widely used, ICER says (BioPharmaDive )
Trump promised to pay for Covid care. But patients with long-term symptoms see huge bills. (Politico )
Where The Women Aren't: On Coronavirus Task Forces (NPR )
CDC Is Still Inaccurately Counting Coronavirus Tests, a Watchdog Agency Finds (NYTimes )
Study Raises Concerns for Pregnant Women With the Coronavirus (NYTimes )
How will the world's poorest people get a coronavirus vaccine? (The Guardian )
Arizona ‘Overwhelmed’ With Demand for Tests as U.S. System Shows Strain (NYTimes )
How Orphan Drug Policy Could Impede Access To COVID-19 Treatments (Health Affairs )
LabCorp launches COVID-19 test to track neutralizing antibodies (Fierce )
CVS launches return-to-work service, including in-house COVID-19 testing option (MedtechDive )
Partnering with the European Union and Global Regulators on COVID-19 (FDA )
Coronavirus (COVID-19) Update: Daily Roundup June 24, 2020 (FDA )
Coronavirus (COVID-19) Update: Joint Statement from USDA and FDA on Food Export Restrictions Pertaining to COVID-19 (FDA )
Pharma & Biotech
Why Aren’t FDA Drug Facility Inspections Resuming? (FDA Law Blog )
Virtual clinical trials now being used to fast-track drug development during coronavirus crisis (CNBC )
Approval of Denosumab biosimilar and launch of teriparatide biosimilar in China and South Korea (Big Molecule Watch )
Yale spinout re-engineers an immunotherapy GSK, others once abandoned (Endpoints )
AstraZeneca touts triplet inhaler Breztri's COPD win ahead of key FDA decision (Fierce )
New research highlights how biases play a role in FDA drug approvals (Pharmafile )
Decentralized Trials Guidance May Reflect US FDA’s Lessons Learned During COVID-19 (Pink Sheet )
Alzheimer's Researchers Go Back To Basics To Find The Best Way Forward (NPR )
Over a decade ago, a disastrous trial killed research on a potential immunotherapy. Can a Regeneron bispecific revive it? (Endpoints )
CRISPR Therapeutics blueprints cell therapy manufacturing site; Regeneron fights back against kickback claims (Endpoints )
Relay and iTeos join IPO deluge while Akouos and Fusion decide they can earn more (Endpoints )
Takeda joins microbiome-focused biotech partner's $52.6M raise as it pursues more in-house cancer work (Endpoints )
Acceleron promised they had great data on sotatercept in late January. But was it good enough to justify a doubling of the stock price? (Endpoints )
Indian pharma consignments from China held by customs, importers worried (PharmaBiz )
Medtech
FDA approves Medtronic’s latest DBS (MassDevice )
PBM RemedyOne will offer Pear Therapeutics reSET, reSET-O (MobiHealthNews )
Philips wins FDA approval for new automated external defibrillators (MassDevice )
FDA clears Preceptis Medical’s in-office ear tube placement for kids (MassDevice )
Government & Regulatory
Mylan, seeking to market Victoza generic, convinces panel to start up patent review (Fierce )
J&J Surgical Rip-Offs Lead To Seizure, FDA Criminal Probe (Law360 )
Full Fed. Circ. Skips Biogen Fight Over MS Drug Patent (Law360 )
An Inside Look At DOJ Fight Against COVID-19 Price-Gouging (Law360 )
Prevagen Maker Inks Deal To Settle Half-Dozen False Ad Suits (Law360 )
Roundup Maker to Pay $10 Billion to Settle Cancer Suits (NYTimes )
He Removed Labels That Said “Medical Use Prohibited,” Then Tried to Sell Thousands of Masks to Officials Who Distribute to Hospitals (ProPublica )
Senate Bills Would Require More COVID-19 PPE, US Manufacturing Capacity, Use Of Analytical Imaging (MedtechInsight )
Country of origin and medicine quality (TGA )
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.
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