Regulatory Focus™ > News Articles > 2020 > 2 > Recon: 21 States Reject Drug Wholesalers’ $18B Opioid Settlement; China NMPA Approves Roche’s Tecent

Recon: 21 States Reject Drug Wholesalers’ $18B Opioid Settlement; China NMPA Approves Roche’s Tecentriq for Lung Cancer

Posted 14 February 2020 | By Michael Mezher 

Recon: 21 States Reject Drug Wholesalers’ $18B Opioid Settlement; China NMPA Approves Roche’s Tecentriq for Lung Cancer

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 21 States Reject $18 Billion Offer From Drug Wholesalers to Settle Opioid Litigation (WSJ) (Reuters)
  • Americans with employer coverage saw growth in drug spending outpace other medical costs (STAT)
  • As opioid crisis intensified, many family doctors found promotional pitches were very good (STAT)
  • The list of the 11 blockbusters-to-be in line for a 2020 launch highlight agony and ecstasy of drug R&D (Endpoints)
  • Grassley aims for 25 GOP co-sponsors on drug bill (Politico)
  • The cancer genes Wall Street is flooding with cash (BioPharmaDive)
  • Georgia bill seeks lower drug prices by focusing on middlemen (AJC)
  • US healthcare stocks have bigger forces at play than politics (Financial Times)
  • Democratic senators ask FDA to ban device used to shock disabled students (The Hill)
In Focus: International
  • Roche's Tecentriq wins first approval in China for lung cancer (Reuters) (Press)
  • Four countries in the African region license vaccine in milestone for Ebola prevention (WHO)
  • AstraZeneca braces for coronavirus hit, but no impact so far (Reuters) (Endpoints) (PMLive)
  • Indivior shares plunge as it warns of loss this year (Financial Times)
  • AstraZeneca's Chinese investment bank partner raises $229M for its own new fund — and it's all about the coronavirus (Endpoints) (Fierce)
  • 400 Novartis workers prepare for job losses at UK manufacturing site (Fierce)
  • Lenders cheered as Kenya binged on medical equipment. Did patients get help? (Reuters)
  • WHO says joint China mission to start coronavirus investigations this weekend (Reuters)
  • Biotech firm Novacyt to launch coronavirus test next week (Reuters)
  • Coronavirus Drug Shows Global Hurdles To Patent Protection (Law360-$)
Pharmaceuticals & Biotechnology
  • Carl June on CRISPR, CAR–T and how the Vietnam War dropped him into medicine (Endpoints)
  • The Americans forced into bankruptcy to pay for prescriptions (The Guardian)
  • Balancing Drug Prices and Innovation: An Interview with Stacie Dusetzina (The Incidental Economist)
  • New entries, price hikes spur changes among the 20 most expensive drugs — though not the kind politicians like to see (Endpoints) (Fierce)
  • If you were a cancer patient, where would you rather be — the United States or Europe? (Endpoints)
  • Novimmune unit nabs Takeda milestone payment for hemophilia work (Fierce)
  • Melinta seeks buyout bids to secure escape from bankruptcy (Fierce)
  • Major Strides in HER2 Blockade for Metastatic Breast Cancer (NEJM)
  • ‘Nobody talks about it because everyone is on it’: Adderall presents esports with an enigma (Washington Post)
  • Does Your Unapproved Device, Drug or Biologic Qualify for an Emergency Use Authorization (EUA)? (FDA Law Blog)
  • PhRMA report reveals nearly 600 drugs in US paediatric pipeline (EPR) (Report)
  • A longtime health care investor recalls the insulin bong, praises discipline in valuations, and looks to South America (STAT)
  • Palleon's first CSO explains how they (and she) got here; Enterprise taps Roche and Novartis vet David Morris as CMO (Endpoints)
  • AstraZeneca sweeps two cancer drugs to the scrap heap; Epizyme nabs priority review for second rare cancer NDA (Endpoints) (Press)
  • Wockhardt Limited, et al.; Withdrawal of Approval of 28 Abbreviated New Drug Applications (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Interim data shows Stelara promise in Crohn’s (PharmaTimes) (Press)
  • Verona unveils Phase II COPD results (PharmaTimes)
  • Polatuzumab vedotin meets endpoint in Japanese study (PharmaLetter-$) (Press)
  • Enrollment Begins for Latiglutenase (IMGX003) Phase 2b Trial for Treatment of Celiac Disease (Press)
Medical Devices
  • Medtronic buys British surgical AI company, adding to Hugo robot effort (MedtechDive)
  • Insulet warns of defect with Dash personal diabetes manager (MedtechDive)
  • Baxter probe finds $276 million in overstated income (MassDevice)
  • FDA approves Orthofix’s mobile app for bone growth stimulators (MassDevice)
  • Lucid Diagnostics EsoGuard DNA Test Gets FDA Breakthrough Device Status (GenomeWeb)
  • Pulse Biosciences Provides Update on FDA 510(k) Submission for the CellFX System in Dermatology (Press)
US: Assorted & Government
  • Pharma Enforcement Remains 'Priority Area' In FTC's 2021 Budget Request (Pink Sheet-$)
  • Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation (Big Molecule Watch)
  • Oklahoma Botched 2 Executions. It Says It’s Ready to Try Again. (NYTimes)
  • Bipartisan bill would cap insulin costs in Connecticut (AP)
  • J&J Unit Settles Noncompete Dispute With Texas-Based Rival (Law360-$)
  • 6th Circ. Halts Nationwide Discovery In Opioid MDL (Law360-$)
  • Chancery Drops Suit Over Biopharma Firm's Cholesterol Drug (Law360-$)
  • Acetris Case – Federal Circuit Rules that a Drug Tableted in the U.S. is Manufactured in the U.S. and Eligible for Government Procurement (FDA Law Blog)
  • D.Utah Rejects Personal Jurisdiction over Parent Company; Trims Claims Against Subsidiary (Drug & Device Law)
Upcoming Meetings & Events Europe
  • NICE recommends wireless device for overactive bladder (PharmaTimes)
  • Genetron Health Obtains Regulatory Approval in China for NGS Instrument, Lung Cancer Panel (GenomeWeb)
  • Drug marketers to be held responsible for quality (Economic Times)
  • As Belviq Goes Off India Market, Patent Case May Fizzle (Scrip-$)
  • Application to reduce the deferral period for some blood donors under consideration (TGA)
Coronavirus Outbreak
  • China Expands Chaotic Dragnet in Coronavirus Crackdown (NYTimes)
  • China’s capital Beijing imposes 14-day quarantine on arrivals (Reuters)
  • China reports 5,090 new coronavirus cases in mainland, 121 new deaths (Reuters)
  • China says 1,716 health workers infected by coronavirus, six dead (Reuters)
  • Biotech firms consider contingency plans as the coronavirus outbreak hits CROs (C&EN)
  • Coronavirus/vaccines: the jab tab (Financial Times)
  • Gilead drug prevents type of coronavirus in monkeys; raises hope for China trials (Reuters)
  • The lessons of West Africa’s Ebola’s crisis will save the continent from the worst of coronavirus (Quartz)
  • US Supports Aid to North Korea for Fighting the Coronavirus (NYTimes)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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