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

• 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)

• 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 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)

• 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)

• 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)