The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 7 > Recon: EU reportedly strikes deals for Roche, Merck KGaA COVID drugs; Biogen submits aducanumab BLA

Recon: EU reportedly strikes deals for Roche, Merck KGaA COVID drugs; Biogen submits aducanumab BLA

Posted 08 July 2020 | By Michael Mezher 

Recon: EU reportedly strikes deals for Roche, Merck KGaA COVID drugs; Biogen submits aducanumab BLA

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Trump administration submits formal notice of withdrawal from WHO (STAT) (WSJ)
  • Pence, Azar reassure governors Trump won't end virus emergency declaration (Politico)
  • Drug prices steadily rise amid pandemic, data shows (Politico)
  • In a test for Hahn's FDA, Biogen submits controversial Alzheimer's drug aducanumab (Fierce) (Endpoints) (BioPharmaDive)
  • Trump and Navarro press again for hydroxychloroquine. Can the FDA stay independent? (Endpoints)
  • Novartis teams with Civica Rx to ease hospital shortages for high-demand injectables (Fierce)
  • Merck hits rare FDA setback for cancer drug Keytruda (BioPharmaDive) (Endpoints)
  • Merck dangles up to $425 million to team with Flagship’s Foghorn Therapeutics (Endpoints)
  • Gilead axes $445M Precision Biosciences gene therapy hep B pact (Fierce)
  • Genentech, Amgen Settle Herceptin, Avastin Biosimilar Disputes (Big Molecule Watch) (Patent Docs)
In Focus: International
  • ‘Desperation science’ slows the hunt for coronavirus drugs (AP)
  • The Dangerous Race for the Covid Vaccine (Politico)
  • EU secures potential COVID-19 drugs from Roche, Germany's Merck – source (Reuters)
  • EU scrambles to buy intensive care drugs to tackle COVID shortages (Reuters)
  • Gilead Sciences to create 140 jobs at Irish operations (RTE)
  • EU gives AZ’s Lynparza green light for BRCA-mutated pancreatic cancer (PMLive)
  • Did a pharma trade group try to sabotage a Dutch government report on compulsory licensing? (STAT)
Coronavirus Pandemic
  • W.H.O. to Review Evidence of Airborne Transmission of Coronavirus (NYTimes)
  • SCIENCE & TECH SPOTLIGHT: Herd Immunity For COVID-19 (GAO)
  • Analysis: How A COVID-19 Vaccine Could Cost Americans Dearly (KHN)
  • Scientists warn of potential wave of COVID-linked brain damage (NBC)
  • Trump to launch short-term 'surge' COVID-19 testing in hot spot cities (The Hill)
  • Drug controller asks states to enforce maximum retail price for Remdesivir (Economic Times)
  • New clinical trial platform launched to accelerate COVID-19 treatments (PharmaTimes)
  • Could Amgen test Enbrel or other anti-TNF drugs against COVID-19? CEO Bradway drops a hint (Fierce)
  • Coronavirus (COVID-19) Update: Daily Roundup July 7, 2020 (FDA)
Pharma & Biotech
  • 5 FDA approval decisions to watch in the 3rd quarter (BioPharmaDive)
  • Update from WHO and Pew Charitable Trusts: urgent action needed to accelerate antibiotic development (WHO)
  • A swift big pharma endorsement for Kiadis (Vantage) (Endpoints)
  • Gene-editing discovery could point the way toward a ‘holy grail’: cures for mitochondrial diseases (STAT)
  • WHO Drafting Regulatory Convergence White Paper On Cell And Gene Therapies, US FDA's Marks Says (Pink Sheet)
  • Mallinckrodt’s Hepatorenal Syndrome Drug Terlipressin Gets A Virtual AdComm (Pink Sheet)
  • A moment of truth arrives for CytoDyn’s Covid-19 drug. Don’t let spin obscure it (STAT)
  • Purdue Pharma Made Political Contributions After Going Bankrupt (The Intercept)
  • Expectations Are High For New EMA Boss (Pink Sheet)
  • EMA Scientific Advice Demand Up But Not For Orphan Drugs (Pink Sheet)
  • ‘Open & Constructive’: Early Feedback Supports Simultaneous Scientific Advice In Europe (Pink Sheet)
  • Indian drug companies complain of hefty charges on stuck consignments from China (Economic Times)
  • GSK sets the stage for a toe-to-toe market showdown with Gilead's HIV champion Truvada (Endpoints)
  • Zai Lab inks China deal with Turning Point with $25M upfront; Xencor, Atreca team up on bispecifics (Endpoints)
  • 'Fundamentally different' from Portola, Dutch biotech lands €32M to steer anti-anticoagulant through the clinic (Endpoints)
  • Singular focus on ROR1 earns VelosBio $137M to fund PhI ADC and other programs (Endpoints)
  • Concert gets BTD for alopecia drug, setting up a late-stage showdown with giant rival Pfizer (Endpoints)
  • European Commission Unlikely To Allow Virtual Audits Under MDR/IVDR In The Short Term (MedtechInsight)
  • CMS not yet sold on Baxter, Outset tech in kidney care payment proposal (MedtechDive)
  • Illumina launches whole-genome analysis software to help identify rare diseases (Fierce)
  • Cochlear receives FDA clearance for three new hearing devices (mobihealthnews)
  • RapidAI snags FDA clearance for neuroimaging analysis device (mobihealthnews)
Government & Regulatory
  • AbbVie draws first blood in trade secrets war between Allergan's Botox and Evolus (Fierce) (Law360)
  • More Preemption of Breast Implant Claims (Drug & Device Law)
  • Amerisource Tries To Save CEO From Opioid Bellwether Depo (Law360)
  • Bias Charge Is 'Dangerous Fiction,' Opioid MDL Judge Says (Law360)
  • Pharma Co. Files Ch. 11 Plan Proposing Icahn Acquisition (Law360)
  • High Court Allows Employers To Opt Out Of ACA’s Mandate On Birth Control Coverage (KHN)
  • TGA issues fines of nearly $1.8 million for alleged illegal activity in 2019-20 (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.

Tags: US, worldwide

Regulatory Focus newsletters

All the biggest regulatory news and happenings.