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.