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June 10, 2020
by Michael Mezher

Recon: Fujifilm to spend $928M to expand Danish facility; AbbVie, Genmab partner on cancer therapy

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Coronavirus Vaccine Candidates’ Pivotal US Testing to Start This Summer (WSJ)
  • Johnson & Johnson to begin human trials for coronavirus vaccine in late July, earlier than expected (CNBC)
  • The coronavirus vaccine frontrunners have emerged. Here's where they stand (BioPharmaDive)
  • Pharma Dealmakers, Sidelined in Pandemic, Are Ready for Comeback (Bloomberg)
  • White House goes quiet on coronavirus as outbreak spikes again across the US (Politico)
  • Price Limits Will Scare Off Covid Vaccine Makers, Fauci Warns (Bloomberg)
  • Abbvie to partner with Genmab in $750 million cancer therapy deal (Reuters) (Press)
  • Merck's bladder cancer late-stage study fails to meet main goals (Reuters)
  • Retracted COVID-19 studies expose holes in vetting of data firms (Reuters)
In Focus: International
  • Europe to accelerate trials of gene-engineered COVID-19 vaccines – sources (Reuters)
  • Six EU leaders urge greater collaboration to tackle future pandemics (Reuters)
  • Singapore approves remdesivir drug for emergency COVID-19 treatment (Reuters)
  • In the WHO’s Coronavirus Stumbles, Some Scientists See a Pattern (NYTimes)
  • Japan's AnGes speeds towards 2021 rollout in coronavirus 'vaccine war' (Reuters)
  • Short-Sellers Set Their Sights on Surging Asia Biotech Stocks (Bloomberg)
  • Anti-inflammatory and cancer drugs tested in UK as possible COVID-19 therapy (Reuters)
  • Indian firm Panacea says aiming to make COVID-19 vaccine (Reuters)
  • Temasek-backed Tychan to start human trials next week for COVID-19 treatment (Reuters)
  • Japan's Fujifilm to spend $928 million to double capacity of Danish drug facility (Reuters) (Endpoints)
  • Sanofi sharpens focus on bispecifics, and China, with Alphamab deal (Endpoints)
  • Many Canadian medical societies fail to disclose industry funding in their clinical guidelines (STAT)
  • Russian factory recalls ventilator model linked to hospital fires (Reuters)
Coronavirus Pandemic
  • Fauci Warns That the Coronavirus Pandemic Is Far From Over (NYTimes)
  • Vaccine Makers Hedge Bets On Which One Will Emerge As Effective And Safe (NPR)
  • Widespread mask-wearing could prevent COVID-19 second waves: study (Reuters)
  • For virus-tamer Merkel, global alliances trumped nationalism (Reuters)
  • WHO Americas director concerned about pandemic surging in new Latin America regions (Reuters)
  • Brazil restores detailed COVID-19 data to national website (Reuters)
  • The novel coronavirus attacks the lungs. A biotech company sees a common enzyme as key to protecting them (STAT)
  • Illumina debuts next-generation sequencing test for COVID-19 (Fierce) (Reuters)
  • Serum Institute investing USD 100 million on potential COVID-19 vaccine (Economic Times)
  • Ex-FDA chief scientist slams 'chaos' caused by agency approach to antibody tests (MedtechDive)
  • Ghana's Incas Diagnostics expects approval for COVID-19 antibody test (Reuters)
  • Why Drug Companies May Resist Milking Covid-19 Treatments (WSJ)
  • Cepheid developing test to distinguish COVID-19 from flu, RSV (MedtechDive)
  • Coronavirus (COVID-19) Update: Daily Roundup June 9, 2020 (FDA)
Pharma & Biotech
  • Bone Drugs May Have Added Benefit: Lower Pneumonia Risk (NYTimes)
  • China says clinical trials show African swine fever vaccine safe so far (Reuters)
  • Lilly pens antisense neuro pact with Evox Therapeutics (Fierce)
  • Scientists create embryo-like research model from human stem cells (Reuters)
  • FDA’s Scandal In Waiting? (Pink Sheet)
  • Medical Care Costs Associated with Cancer Survivorship in the United States (AACR)
  • US Biosimilars Market Is On Solid Footing, 10 Years In (Scrip)
  • EU expands reach of Vertex' CF drug Kalydeco (PharmaTimes)
  • UK Early Access Win For New Opdivo Indication (Pink Sheet)
  • Pfizer offers 3rd round of JAK data, this time in kids. Can it compete? (Endpoints)
  • Denali scoots past a setback with barely a scratch, quickly calling up a backup Alzheimer’s player on the bench (Endpoints)
  • IPO bound? Five years in, Art Krieg and the Checkmate crew collect $85M to back up their 1-drug pipeline (Endpoints)
  • Rare disease startup NFlection scores $20M in Series A haul; Gilead partner Galapagos signs pact with Oxford biotech (Endpoints)
Medtech
  • Medical device startup raises almost $44M to advance a less-invasive treatment for fluid in the brain (STAT)
  • Siemens Healthineers, Geisinger ink 10-year digital health partnership (MedtechDive)
  • Polish scientists design remote-controlled ventilator to fight COVID-19 (Reuters)
  • MDR delay impact extends beyond European Union (Emergo)
  • The European MDR and human factors engineering: Designing user-friendly software user interfaces and informational resources (Emergo)
Government & Regulatory
  • EMA SME office annual report 2019 (EMA)
  • Harvard's Charles Lieber indicted for lying to the feds, bringing US researchers' China ties back to the spotlight (Endpoints)
  • U.S. charges firm president, trader in COVID-19 fraud schemes (Reuters)
  • FTC, Impax Spar At 5th Circ. Over Opana ER Deal (Law360)
  • Merck Can't Wipe Out Microspherix's PTAB Win (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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