Recon: Embattled Theranos to Finally Shut Down; NICE Okays Novartis' Kymriah After Price Drop
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Blood-Testing Firm Theranos to Dissolve (WSJ ) (CNBC ) (Financial Times )
Report: Hospitals mark up drugs by 500% (Axios )
Insurance tactic drags down U.S. drug prices in second quarter: analyst (Reuters )
Agios names former Celgene executive Jacqualyn Fouse as next CEO (Reuters ) (Forbes )
Scientists Are Retooling Bacteria to Cure Disease (NYTimes )
Government Pharma Investigations Target Pricing, Opioids, Trade Practices (Pink Sheet -$)
IPO: A Go-Go Or A No-No? (LifeSciVC )
The Amazon-Berkshire-JPM health venture led by Atul Gawande has a COO: Jack Stoddard (CNBC ) (BioCentury )
Is mistrust of ‘big pharma’ enough to help unseat a Democratic stalwart in Congress? (STAT )
Inappropriate ‘interchangeability’ requirement for biosimilars will cost the US billions (STAT )
The Senate can change the course of the opioid crisis. Here are 50 ways it can do that (STAT )
Rudy Giuliani’s Consulting Firm Had Hand In Halting Florida’s Opioid Investigation (KHN )
CDER Exclusivity Board: Barium is Not an NCE Eligible for 5-Year Exclusivity (FDA Law Blog )
In Focus: International
Gene therapy breakthrough wins world's largest vision award (Reuters )
Pfizer says Brexit will cost the company $100 million (Pharmafile )
New report re-ignites fresh buzz that Bayer is prepping an R&D overhaul and job cuts (Endpoints )
Boost for 'made in China' medicine as Chi-Med wins key approval (Reuters ) (STAT )
After dropping the price, Novartis wins U.K. coverage for its CAR-T drug to treat childhood leukemia (STAT ) (BioCentury )
Merck gets partial thumbs-down on Keytruda in lymphoma from NICE cost-effectiveness watchdogs (Fierce )
Sanofi reaps first fruit of Ablynx buyout with a European OK for its lead rare disease drug (Endpoints )
Europe wide policy could boost generics market, study suggests (Pharmafile )
Bayer forecasts lower earnings on Monsanto delays (Financial Times )
Vertex Finalizes Orkambi Deal With Australia (BioCentury )
ProQR drug for rare childhood blindness succeeds in early trial (Reuters )
EC Approves Puma's Nerlynx As Adjuvant For Breast Cancer (Biocentury )
Novo, Oxford Uni set to launch diabetes alliance and research labs (PharmaTimes )
BioMarin investing $43M in fill-finish line at plant in Ireland (Fierce )
Pharmaceuticals & Biotechnology
Make The ‘Purple Book’ More Orange, US FDA Told At Biosimilars Hearing (Pink Sheet -$)
Novo Nordisk Grabs Shark Antibody-Based CNS Delivery Technology From Ossianix (SCRIP -$)
Pediatrics group encourages parents to steer clear of popular FluMist in favor of shots (STAT )
Struggling MannKind sees shares rocket up on $105M-plus alliance with United on inhaled treprostinil (Endpoints )
Radius Health hires oncology-focused CMO as it moves into breast cancer trials (Fierce )
Sanofi diabetes VP jumps to NYC metabolic disease startup Applied Therapeutics (Fierce )
Immunotherapy Offers Hope For Some Men With Aggressive Prostate Cancer (Forbes )
Industry Groups Seek Clarity On FDA's Draft Waiver Guidance Under DSCSA (Pink Sheet -$)
A 'More Radical Idea': Set Expiration Dates For Priority Review Vouchers (Pink Sheet -$)
Redmile, GV power exosome specialist Evox to £36M round (Fierce )
Why Big Pharma Cheers Rahm Emanuel's Exit As Chicago's Mayor (Forbes )
The high-roller club in biopharma: Who’s paying top-dollar for upfronts? And who are the busiest players at the deal table? (Endpoints )
FDA Hits Malaysian OTC Manufacturer for Multiple Deficiencies (FDANews -$)
All study participants have a right to know their own results. My lab has been doing that for years (STAT )
US FDA marks Lupin’s ‘sartans’ safe, but still issues one observation (InPharmaTechnologist )
Esketamine closer to shaking up depression market (PharmaLetter -$)
Bach to Chair MEDCAC (Biocentury )
Eiger to Seek FDA Approval Of Progeria Therapy (Biocentury )
Another C-Suite Departure at Immunocore (Biocentury )
Pfizer Prices $5,000,000,000 Debt Offering (Press )
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
Merck's Keytruda threatens Pfizer, Merck KGaA's Bavencio with Merkel cell 'priority' tag (Fierce ) (Press )
BioCryst says oral drug works for HAE attacks (Fierce )
EyeGate’s anti-inflammatory eye drug and electric delivery device fail phase 3 trial (Fierce )
Abivax posts ulcerative colitis data, commits to phase 2b (Fierce )
Lysogene Announces FDA approval of IND Application to Initiate Phase 2-3 Clinical Trial in MPS IIIA (Press )
Horizon Pharma plc Completes Enrollment of Confirmatory Phase 3 Trial of Teprotumumab Ahead of Schedule (Press )
Mati Therapeutics Interim Phase II Nepafenac Clinical Trial Results Signal Significant Post-op Pain Reduction in Cataract Surgery Patients (Press )
Medical Devices
Should Medtronic’s return to the standalone continuous glucose monitoring market worry competitors? (MedCity )
Vyaire Medical, Inc. Recalls Tri-Flo Subglottic Suction System Due to Risk of Device Breakage (FDA )
Philips inks agreement with Air Force for patient monitoring tech (MedCity )
TAVR Maturity Not Over the Hump in U.S. (Medpage )
A Rival to the Renal Denervation Therapy Procedure? (MDDI )
Biodesix Makes the Case for VeriStrat Through New Study (MDDI )
MicroPort’s drug-eluting stent performs well in European study (Drug Delivery )
Nonradioactive Breast Cancer Marking Platform Gains Second Nod from FDA (MDDI )
US: Assorted & Government
A New Lawsuit Threatens Obamacare. Here’s What’s at Stake and What to Expect in Oral Arguments (NYTimes )
Medicaid To Introduce Value-Based Drug Pricing (Forbes ) (Pink Sheet -$)
Court Can't Block Nonfinal Compounding Policy, FDA Says (Law360 -$)
Sanctions For An MDL Bellwether Plaintiff’s Discovery Conduct (Drug & Device Law )
Generics Cos. Urge Fed. Circ. To Upend Depomed Patent Win (Law360 -$)
Teva Worker's Discrimination Suit Stays Alive In Pa. (Law360 -$)
Tribe Can't Fault Generics Cos. For Opioid Crisis, Court Told (Law360 -$)
Upcoming Meetings & Events
Europe
EMA Clarifies Role Of And Need For Data Monitoring Committees (Pink Sheet -$)
Medicines: licensing time-based performance measures (MHRA )
MHRA phase I accreditation scheme (MHRA )
Number of UK trial contracts collapses ahead of Brexit (PharmaLetter -$)
Russia approves new state strategy for pharmaceutical industry (PharmaLetter -$)
Russian drugmakers see delays in investment projects due to geopolitical tensions and sanctions (PharmaLetter -$)
NHS could save £480m a year by cutting agency staff (PharmaTimes )
UK research charity LifeArc appoints experienced leader Melanie Lee as new CEO (Pharmafile )
Asia
Korean medtech companies to get a boost from Medtronic (Medical Design & Outsourcing )
Gazyva, Imfinzi Launched Following Japan Listing, Entyvio In The Wings (SCRIP -$)
India
J&J hip implants: Govt sets up new panel to decide final compensation for patients (Economic Times )
Interim relief: J&J told to pay Rs 20 lakh to each recipient of faulty hip implant (Economic Times )
I won't be silent anymore: Shivinder's charge against his brother in 6 points (Economic Times )
Australia
ResApp announces strong results from Australian pediatric trial of respiratory diagnostic tool (mobihealthnews )
Australia lists new ADHD and RA drugs on PBS (PharmaLetter -$)
Other International
Improving drug safety in East Africa is aim of new project (EPR )
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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