Recon: Philippines Considers Reviving Use of Sanofi Dengue Vaccine
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
PhRMA’s top lobbyist will leave at the end of August (STAT )
A Blood Test for Alzheimer’s? It’s Coming, Scientists Report (NYTimes )
Federal judge allows pharma to proceed with lawsuit against California transparency law (STAT )
BioMarin drops lower dose of its hemophilia gene therapy as it eyes submissions by year-end (Fierce ) (Endpoints )
Clovis dives as investor pessimism reaches 'unprecedented levels' (BioPharmaDive )
Congress is going after drug prices. Pharma CEOs aren't panicking, yet (BioPharmaDive )
A few questions on importation (Politico )
In Focus: International
Salk scientists create the world’s first human/monkey chimeras in China — cue the controversy (Endpoints )
Philippines weighs re-use of controversial dengue vaccine (Reuters )
Phase 3 trial of Transgene's oncolytic virus halted for futility (Fierce ) (Press )
Nucala receives self-administration EU approval (PharmaTimes )
Rakuten Medical reels in another megaround to fund cancer R&D (Fierce ) (Endpoints )
Fujifilm pays Biogen nearly $1B for Denmark biologics site (Fierce )
Boehringer posts solid first half as business revamp beds in (PMLive )
Still no ferry contracts for no-deal Brexit medicines supplies (PMLive )
How Will You Spend Extra £434m On No-Deal Brexit Planning? Industry Asks UK Gov’t (Pink Sheet -$)
Saudi Arabia backs $550 million investment in health start-up Babylon, valuing it at $2 billion (CNBC )
Congo’s Ebola Outbreak Isn’t Just Congo’s Problem (Bloomberg )
Pandemic bonds face scrutiny after Ebola outbreak yet to trigger payout (Reuters )
Fourth Ebola case found in Congo city, raising fears of faster spread (Reuters )
Rwanda says its border with Congo remains open (Reuters )
Fear, violence and distrust hamper U.S. involvement in Ebola outbreak (NBC )
Pharmaceuticals & Biotechnology
Will The Pfizer-Mylan Deal Face Antitrust Hurdles? (Pink Sheet -$)
FDA FY2020 User Fee Table (Focus )
Takeda staffers accuse drugmaker of favoring Shire employees during merger: report (Fierce ) (Korea Biomed )
Biosimilars: Rise In US FDA Approvals Means Lower Or Flat User Fees In FY 2020 (Pink Sheet -$)
PDUFA Application Fee Nears $3m Threshold In FY 2020 (Pink Sheet -$)
Radiopharmaceuticals: FDA Finalizes Guidance on Nonclinical Studies, Labeling (Focus )
Regenxbio inks viral vector rights deal with Pfizer (BioPharmaDive )
Enhancing CAR-T cell activity (Nature )
Everything Old is New Again: FDA Revises its 2014 Rare Pediatric Disease Priority Review Voucher Guidance for Industry (FDA Law Blog )
Janssen returns rights for experimental cancer immunotherapy to Alligator Bioscience, sending shares spiraling by 40% (Pharmafile )
A watchdog group sets aside emotions to assess drugs’ value. Patients say their lives are more than a number (STAT )
Backed by Novo and Orbimed, Thierry Abribat hauls in $75M for biotech #3 — a transatlantic upstart focused on rare diseases (Endpoints )
Using a more diverse microbiome, scientists look to create a better lab mouse (STAT )
Could stem cell transplants make BMS' checkpoint inhibitors work in resistant lymphoma? (Fierce )
Pharmacy groups seek to break an impasse over FDA framework for monitoring compounders (STAT )
Experimental treatment slows prion disease, extends life of mice (NIH )
Regenerative medicine companies raised $4.8B in first half of 2019 (Medcity )
Indivior Submits Products For Approval Outside The US, Where Pressures Mount (Scrip -$)
Medical Devices
FDA Updates Guidance on Devices in the Magnetic Resonance Environment (Focus )
B. Braun wins breakthrough nod for drug-coated balloon catheter (MassDevice )
Bio-Rad beats expectations on Q2 results (MassDevice )
Teleflex stock up on Street-beating Q2 earnings (MassDevice )
Hillrom to pay $130m for Breathe Technologies as fiscal Q3 numbers top forecast (MassDevice )
Fulgent Gets NY State Clinical Lab Permit, Approval to Offer Genetic Tests (GenomeWeb )
Class 1 Device Recall FilterTips (1500 ul) used with QIAsymphony SP/AS Instruments (FDA )
US: Assorted & Government
From Budget Deal to FY 20 Appropriations: Reasons for Optimism? (Alliance for a Stronger FDA )
CBD Piques the Interest of Consumer Health Giants (Bloomberg )
Canadian pot company Cronos gets foothold in US by buying popular CBD beauty brand Lord Jones (CNBC )
Inside Stephen Miller's push to change 'public charge' rule (Politico )
Fed. Circ. Design Patent Case Can Guide Medical Device Cos. (Law360 -$)
AVX Can't Shake Greatbatch's $22M Pacemaker Patent Win (Law360 -$)
CRISPR Interference Parties Propose Motions (Patent Docs )
Excellent Infuse Preemption Decision out of Eastern District of Michigan (Drug & Device Law )
Upcoming Meetings & Events
Europe
EU Regulatory Roundup: Regulatory Action Against Fresenius Kabi's Calea Affects UK Product Supply (Focus )
NICE backs Bayer’s Xarelto (PharmaTimes )
Top UK doctors warn Boris Johnson that no-deal Brexit would cause key cancer therapy supply shortages (Pharmafile )
Superbugs found lurking in London underground and hospitals (Reuters )
NICE recommends aspirin for cancer prevention for the first time (Pharmaceutical Journal )
Consultation on guidance on the safe use of bed rails (MHRA )
Toward a Just and Learning Culture in the NHS (Harvard Bill of Health )
Asia
Move over, Hong Kong: Shanghai’s new tech board sees fervent demand for maiden biotech IPO (Endpoints )
Australia
Allergan macro-textured breast implants and tissue expanders (TGA )
General Health & Other Interesting Articles
Poll Finds Trust In Science Is Rising (NPR )
If you smoke pot, your anesthesiologist needs to know (NBC )
Population and the Environment — Time for Another Contraception Revolution (NEJM )
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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