Posted 25 June 2020 | By Michael Mezher 

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  • NICE knocks back Novartis’ oral MS drug Mayzent in draft guidance (PMLive)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)


  • 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.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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