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Regulatory Focus™ > News Articles > 2020 > 6 > Recon: Gilead sets US remdesivir price; FDA rejects Intercept NASH drug

Recon: Gilead sets US remdesivir price; FDA rejects Intercept NASH drug

Posted 29 June 2020 | By Michael Mezher 

Recon: Gilead sets US remdesivir price; FDA rejects Intercept NASH drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Gilead sets price for Covid-19 treatment as HHS secures doses (Politico) (AP) (STAT) (Endpoints)
  • As the Coronavirus Spreads, Drug Pricing Legislation Remains Stalled (NYTimes) (WSJ)
  • FDA rejects Intercept Pharma’s drug for NASH (STAT)
  • US 'likely' to see shortage of pharmaceutical drugs if coronavirus outbreak continues, intelligence report finds (ABC)
  • Two patients die in Audentes gene therapy study, heightening concerns over high-dose treatments (STAT) (Endpoints)
  • Pfizer Says HHS Is Blocking Patient Access To Heart Drugs (Law360) (STAT)
  • US withdrawal from WHO threatens to leave it ‘flying blind’ on flu vaccines (STAT)
  • The biotech IPO boom is becoming ‘historic’ as four more throw their hats in (Endpoints)
In Focus: International
  • Astrazeneca, Moderna most advanced in COVID-19 vaccine race – WHO (Reuters)
  • CanSino's COVID-19 vaccine candidate approved for military use in China (Reuters)
  • Pharma giants to unveil major $1 billion venture to push novel antibiotics (STAT)
  • Brazil signs deal to produce experimental virus vaccine (AP)
  • Sinopharm Says Second Covid Vaccine Found to Be Safe (Bloomberg)
  • Pharmaceutical giants have added $51 billion to their market value in 2020 as they scramble to develop a coronavirus vaccine (BI)
Coronavirus Pandemic
  • Coronavirus produces ‘sinister’ tentacles in infected cells (Financial Times)
  • Ensuring Uptake of Vaccines against SARS-CoV-2 (NEJM)
  • How the Coronavirus Short-Circuits the Immune System (NYTimes)
  • Some COVID-19 patients aren't getting better. Major medical centers are trying to figure out how to help. (NBC)
  • ‘We have to act’ — HHS Secretary Azar warns ‘window closing’ to halt coronavirus spike (CNBC)
  • Hebei: China locks down 400,000 people after virus spike near Beijing (BBC)
  • FEMA Ordered $10.2 Million in COVID-19 Testing Kits It’s Now Warning States Not to Use (ProPublica)
  • Coronavirus (COVID-19) Update: Daily Roundup June 26, 2020 (FDA)
Pharma & Biotech
  • US FDA’s Data Strategy Under Increasing Pressure From Coronavirus Pandemic (Pink Sheet)
  • In its first tough test, CRISPR base editing slashes cholesterol levels in monkeys (STAT) (NYTimes)
  • J&J scraps late-stage study testing Stelara for lupus (Reuters)
  • Chiasma secures FDA approval for acromegaly pill Mycapssa years after near-catastrophic rejection (Fierce)
  • Takeda takes a $200M hit after Novartis is forced to yank its marketing application for Xiidra (Endpoints)
  • Kiniksa preps BLA as Regeneron drug cruises to a PhIII win — shares soar (Endpoints)
  • Market for Compounded Drugs Needs Greater Transparency and Regulatory Certainty (Pew)
  • EMA removes negative note on label of PTC's Duchenne drug; GSK, Akebia win Japan OK for oral anemia drugs (Endpoints)
  • Heron earns a second slapdown from the FDA on pain med — shares wither (Endpoints)
  • Novartis announces MET inhibitor Tabrecta™ approved in Japan for advanced non-small cell lung cancer with METex14 (Press)
  • GSK receives first regulatory approval for Duvroq (daprodustat) in Japan for patients with anaemia due to chronic kidney disease (Press)
  • Roche’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder (Press)
  • New China Indications For Merck, Novo, Boehringer Drugs (Pink Sheet)
  • Cost savings with biosimilar pegfilgrastim-cbqv in prophylaxis of chemo-induced febrile neutropenia (Big Molecule Watch)
  • FDA nod to Boston Scientific cardiac monitor clears challenge to Abbott, Medtronic (MedtechDive)
  • Labs warn COVID-19 testing demand will soon top capacity as new hotspots emerge (MedtechDive)
  • FDA clears Orthofix Firebird SI fusion system (MassDevice)
  • UK's NICE Recommends Boston Scientific’s Rezum Steam Treatment For BPH (MedtechInsight)
  • Medtronic renal denervation registry shows blood pressure improvements persist at 3 years (MedtechDive)
  • With FDA nod, Beckman Coulter plans to ship 30M antibody tests per month (Fierce)
  • Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation (MDA/2020/017) (MHRA)
  • India - Regulate medical devices in phased manner: Companies (Economic Times)
Government & Regulatory
  • Obamacare Faces Unprecedented Test as Economy Sinks (NYTimes)
  • Is it Lawful to Advertise a Device with an Emergency Use Authorization (EUA) Pending (Prior to Issuance of the EUA)? (FDA Law Blog)
  • A New Antitrust Approach After Humira 'Patent Thicket' Ruling (Law360)
  • Surescripts Says Pharmacies' Antitrust Claims Too Indirect (Law360)
  • Inovio Can't Force Supplier To Share COVID-19 Vaccine Tech (Law360)
  • Fresenius Takes Fiery Aim At Akorn's Ch. 11 Plan Disclosures (Law360)
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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