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Regulatory Focus™ > News Articles > 2020 > 9 > Recon: Gilead to buy Immunomedics for $21B; Trump signs international reference pricing order

Recon: Gilead to buy Immunomedics for $21B; Trump signs international reference pricing order

Posted 14 September 2020 | By Michael Mezher 

Recon: Gilead to buy Immunomedics for $21B; Trump signs international reference pricing order

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Trump unveils plan to slash drug costs tied to what's paid abroad (Politico) (NYTimes) (WSJ) (STAT)
  • Trump Pressed for Plasma Therapy. Officials Worry, Is an Unvetted Vaccine Next? (NYTimes)
  • Gilead Reaches Deal to Buy Immunomedics for $21 Billion (WSJ) (FT) (Reuters) (STAT)
  • Merck to buy $1 bln stake in Seattle Genetics, co-develop cancer therapy (Reuters)
  • Trump officials interfered with CDC reports on Covid-19 (Politico)
  • US Employers Eye Cutting Wasteful Drugs Worth $6 Billion (Bloomberg)
  • Kodak Deal Draws Review From Watchdog at Agency Involved in Planned Loan (WSJ)
  • Pfizer and BioNTech announce plan to expand Covid-19 vaccine trial (STAT) (Reuters) (Press)
  • Eli Lilly Arthritis Drug Helped Hospitalized Covid-19 Patients Recover Faster (WSJ) (Press)
  • FDA rejects Mallinckrodt's kidney drug over risk-benefit doubts (Fierce) (Endpoints)
  • Vaccine maker got $1 billion from taxpayers. Now it’s boosting drug prices (LA Times)
In Focus: International
  • WHO head urges rich nations to join vaccine scheme by Friday deadline (Reuters)
  • Oxford and AstraZeneca resume coronavirus vaccine trial (FT) (Reuters)
  • Regeneron's antibody drug added to UK Recovery trial of COVID treatments (Reuters) (BBC)
  • Coronavirus: UK to test inhaled vaccines (BBC)
  • Russia completes volunteer recruitment for COVID-19 vaccine trial: fund (Reuters)
  • UAE announces emergency approval for use of COVID-19 vaccine (Reuters)
  • Roche says two-thirds of Evrysdi patients had got rival treatments (Reuters)
  • Novartis aims to expand Beovu use after safety fears hurt launch (Reuters)
  • Canada's Pascal Biosciences partners with SoRSE to test cannabis-based cancer therapy (Reuters)
Coronavirus Pandemic
  • Vaccine Makers Keep Safety Details Quiet, Alarming Scientists (NYTimes)
  • Not enough Covid vaccine for all until 2024, says biggest producer (FT)
  • Trump Loyalists Tried to Influence CDC Virus Reports (NYTimes)
  • Early research from 23andMe strengthens link between blood types and Covid-19 (STAT)
  • Gilead CEO: We’re studying new ways to treat coronavirus with remdesivir outside of the hospital (CNBC)
  • As COVID-19 Vaccine Trials Move At Warp Speed, Recruiting Black Volunteers Takes Time (NPR)
  • Valneva announces major COVID-19 vaccine partnership with UK government (PMLive)
  • Coronavirus (COVID-19) Update: Daily Roundup September 11, 2020 (FDA)
Pharma & Biotech
  • Neurocrine launches Parkinson's therapy as COVID-19 related disruptions ease (Reuters)
  • Cancer Projects to Diversify Genetic Research Receive New Grants (NYTimes)
  • PIC/S Interprets Checklist For Auditing Drug GMP Inspectorates (Pink Sheet)
  • How much is a startup worth? For biotech companies, the answer is rarely public (STAT)
  • US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal (Reuters)
  • ICER criticizes cost of 8 targeted immune modulators for UC, recommending some deep discounts (Endpoints)
  • Gilead’s CAR-T player Kite waves goodbye to research chief Peter Emtage as another top exec hits the exit (Endpoints)
  • Arie Belldegrun and David Chang godfather the $110M launch of a new cell therapy player. And this one is also thinking big (Endpoints)
  • Thanks to a $77.5M Series B, Escient moves into the clinic with the first of its sensory receptor candidates (Endpoints)
  • Escape Bio nabs $73M as race with well-heeled Biogen and Denali heats up (Endpoints)
  • Stronger Unapproved Stem-Cell Enforcement Accompanies FDA Center for Biologics’ Cell and Gene Therapy Advancement Efforts (IPQ)
  • FDA grants Dupixent® (dupilumab) Breakthrough Therapy designation for eosinophilic esophagitis (Press)
  • Novartis reports positive topline results from the first Phase III trial of Beovu® versus aflibercept in patients with diabetic macular edema (DME) (Press)
  • Novartis data show early treatment with Mayzent® (siponimod) delays disability progression and show benefits in cognitive performance in patients with secondary progressive multiple sclerosis (SPMS) (Press)
  • Abbott, Illumina, other medtechs shape guide conveying device risks to patients (MedtechDive)
  • Fitbit to launch first ECG app in U.S., Europe next month (Fierce)
  • MHRA’s Lee To Give UK Medtech Industry Greater Diagnostics Focus (MedtechInsight)
Government, Regulatory & Legal
  • Patent board delivers blow to University of California over its CRISPR invention claims (STAT) (Science)
  • A Pennsylvania lawmaker wants to tie prescription drug prices to what Canada pays (STAT)
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

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