Regulatory Recon: Zika Case in Florida Could be First Locally Acquired Case (20 July 2016)
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In Focus: US
- Zika case in Florida could have come from local mosquito, a first in continental US (STAT) (AP) (NPR) (Miami Herald)
- Theranos: looking ahead (The Hill)
- America’s health care prices are out of control. These 11 charts prove it. (Vox)
- FDA warns Oscor on process control records (Mass Device)
- GMO Labeling Bill Is A Pen Stroke Away From Becoming Law: What Comes Next? (FDA Law Blog)
- Valeant wins first round in $445M gamble on brodalumab approval (Endpoints) (PharmaTimes)
- Once-promising obesity drug is scrapped after patient deaths (STAT) (Reuters)
- FDA approves Progenics and Valeant’s oral Relistor for OIC (PharmaLetter-$)
- The trouble with the Cancer Moonshot (Modern Healthcare)
- Medtronic wins 1st FDA nod for cement-augmented spine screws (Mass Device)
- Ex-Acclarent Execs Beat Felony Off-Label Fraud Charges (Law360-$)
In Focus: International
- EU clears AZ's FDA-rejected diabetes combination (PMLive)
- EU clears Gilead’s pan-genotypic hepatitis C therapy (PharmaTimes)
- New Irish pharma deal to save €750 million, says minister (Pharmafile)
- Pricing dispute hits supply of TB drugs in Pakistan (Reuters)
- Biocon partner Fujifilm launches its insulin glargine in Japan (PharmaLetter-$)
- African study exceeds U.N. 'test and treat' goal for ending HIV pandemic (Reuters)
- Pfizer's multidose Prevenar 13 wins WHO backing; early 2017 launch planned (Fierce)
- UK Human Medicines Regulations 2012; Advisory Bodies annual report 2015 (MHRA)
- WHO encourages countries to act now to reduce deaths from viral hepatitis (WHO)
US: Pharmaceuticals and Biotechnology
- Gene Therapy Trial Wrenches Families as One Child’s Death Saves Another (MIT Tech Review)
- BioRegnum: Another great reason emerges for AstraZeneca to target new biotech deals (Endpoints)
- Synthorx lines up some big synthetic biology R&D goals after grabbing a $10M round (Endpoints)
- Merck KGaA blueprints a $115M ‘collaboration campus’ for Massachusetts (Endpoints)
- Biotech vet Gould lands $55M startup round for a new Third Rock platform biotech (Endpoints)
- Lonza: Biologic APIs boosted H1 revs and CAR-T deal will help sustain growth in H2 (InPharma-Technologist)
- Merck, Amgen Invest in Akili as Therapeutic Video Game Moves Ahead (Xconomy)
US: Pharmaceuticals and Biotechnology: Study Results, Filings and Designations
- Johnson & Johnson Raises Guidance, Buoyed by Pharma Growth (WSJ-$)
- Teva Settles Drug Patent Row With Celgene, Astellas (Law360-$)
- Jounce bags $225m upfront in Celgene immuno-oncology deal (PMLive)
Medical Devices
- Abbott sales beat on higher demand for medical devices (Reuters)
- Eurofins Zika Test Receives FDA Emergency Use Authorization (GenomeWeb)
- Boston Scientific to settle IRS beef for $275m (Mass Device)
- FDA readies panel on diabetes dosing label for Dexcom’s G5 CGM (Mass Device)
- Your inhaler’s watching you: drugmakers race for smart devices (Mass Device)
- US medical device market path defined in 10 key terms (Mass Device)
US: Assorted and Government
- FDA Information Collection Activities; Proposals, Submissions, and Approvals: Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications, etc., in Prescription Drug User Fee Acts (Federal Register)
- In convention speech, McConnell blames Democrats for Zika standoff (STAT)
- White House Summit on Global Development: Reflecting on Real Progress (White House)
Upcoming Meetings and Events
China
- CFDA Vice Minister Jiao Hong meets Inspector General of the Netherlands Health Care Inspectorate (CFDA)
General Health and Other Interesting Articles
- Suboxone Underused, Opioids Overused in Medicare (MedPage Today)
- High rates of injection drug use increases gay teens’ HIV risk (STAT)
- Genetically Attenuated Parasite Boosts Malaria Immunity (GEN)
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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