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Regulatory Focus™ > News Articles > 2020 > 2 > Recon: Coronavirus Cases Surge After Change in Diagnostic Criteria; Teva Reports Higher Margins Afte

Recon: Coronavirus Cases Surge After Change in Diagnostic Criteria; Teva Reports Higher Margins After Restructuring

Posted 13 February 2020 | By Michael Mezher 

Recon: Coronavirus Cases Surge After Change in Diagnostic Criteria; Teva Reports Higher Margins After Restructuring

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Coronavirus Test Kits Sent to States Are Flawed, CDC Says (NYTimes) (Reuters)
  • Amgen Sues Pfizer Over Proposed Neulasta Biosimilar (Big Molecule Watch) (Law360-$)
  • The RAS rush: Revolution Medicines bags remarkable $238M IPO raise, more than doubling original goal (Endpoints)
  • LabCorp weathers rising personnel costs to beat expectations in Q4 (MedtechDive) (Press)
  • LabCorp begins work on developing coronavirus test (Reuters)
  • Explosions reported at Newburyport pharmaceutical manufacturing company (MassLive) (NBC)
  • Tax Games: Big Pharma versus Big Tech (Council on Foreign Relations)
  • The White House review of drug prices: Don't hate the player — hate the game (Endpoints) (White House)
In Focus: International
  • Experts fear China reluctant to accept WHO ground mission (Reuters)
  • Coronavirus Cases Seemed to Be Leveling Off. Not Anymore. (NYTimes) (WSJ) (Reuters)
  • The Road to a Coronavirus Vaccine Runs Through Oslo (Bloomberg)
  • China Stages Clinical Trial Blitz in Search of Coronavirus Cure (Bloomberg)
  • Results from Chinese drug trials for coronavirus due in weeks: expert (Reuters)
  • Coronavirus outbreak begins to disrupt booming China drug trials (Reuters)
  • Teva sees higher margins, lower debt from restructuring (Financial Times) (Endpoints) (Barrons)
  • Revenue growth at Ipsen numbs pain of palovarotene calamity (PMLive) (Fierce) (Endpoints)
  • Roche scores its first PD-L1 win in China, going straight for SCLC niche (Endpoints)
  • Novartis ‘Urgently’ Working To Improve Zolgensma Access Program (Pink Sheet-$)
  • EU Parliament Urges Post-Brexit Cooperation On Medicines (Pink Sheet-$)
Pharmaceuticals & Biotechnology
  • Oncology Center of Excellence Grows Leadership Structure, With A Vacancy Remaining (Pink Sheet-$)
  • The top biopharma companies targeting NASH (MedCity)
  • The Cancer Industry: Hype vs. Reality (Scientific American)
  • From bench to bedside, biologics require excellence at every stage (STAT)
  • Under-the-gun Acorda slashes Inbrija sales forecast amid lackluster launch (Fierce)
  • Purdue Wants To Make New Opioid Overdose Drug (Law360-$)
  • Elanco grabs $140M in deal with French pharma company; Another company announces a coronavirus vaccine hunt (Endpoints)
  • Pharmacy DIR Fees Hit a Record $9 Billion in 2019—That’s 18% of Total Medicare Part D Rebates (Drug Channels)
  • Biopharma Needs A Deal On Drug Pricing As Shield Against Possible Democrat Wins – BIO’s Greenwood (Pink Sheet-$)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Bristol-Myers' CAR-T gets priority review, mid-August PDUFA date (Fierce) (Press)
  • Deciphera nabs speedy review for GIST cancer hopeful (Fierce) (Endpoints)
  • FDA sets Q3 decision date for NS Pharma’s DMD drug (PMLive)
  • Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer (Press)
  • Longeveron LLC Announces Completion of Enrollment in Phase 2b Clinical Trial of Longeveron Allogeneic Mesenchymal Stem Cells (LMSCs) in Aging Frailty. (Press)
  • AVEO Oncology Announces Publication of Phase 1b/2 Study of Tivozanib in Advanced, Inoperable Liver Cancer in the British Journal of Cancer (Press)
  • Can-Fite Submits Liver Cancer Phase III Protocol and Registration Plan to EMA for Namodenoson (Press)
  • Acucela Provides Update on Emixustat Phase 3 Clinical Trial in Patients with Stargardt Disease (Press)
Medical Devices
  • Why medtech is a different beast than biotech in the life sciences pack (STAT)
  • App that detects signs of eye diseases credited for preventing further vision loss for young boy (CBS)
  • FDA, MITRE offer tips for med device cybersecurity (HealthcareITNews)
  • FDA OKs 'Inside-Out' device for enabling hemodialysis in hard-to-treat patients (MedtechDive)
  • TransEnterix wins CE Mark for Sehance pediatric indication (MassDevice)
  • Wearable insulin delivery device maker Valeritas files for Chapter 11, selling company (MassDevice)
  • Class 1 Device Recall PneumoDart (FDA)
  • Orthofix Announces FDA Approval of STIM onTrack 2.1 Mobile App for Bone Growth Stimulators (Press)
US: Assorted & Government
  • Yesterday’s FTC Announcement: Reminder of Broad Commission Authority; Portent of Things to Come for FDA Regulated Companies? (FDA Law Blog)
  • States Lead The Way On Drug Pricing Reform (Law360-$)
  • 9th Circ. Halts Teen Suicide Suit Against Allergan (Law360-$)
  • Ex-Theranos CEO Escapes Charges She Defrauded Doctors (Law360-$)
  • PTAB Upholds Corcept Patent For Cushing's Syndrome Drug (Law360-$)
  • Juul Tried To Recruit Miley Cyrus To Woo Kids, Mass. AG Says (Law360-$)
  • CareDX, Inc. v. Natera, Inc. (D. Del. 2020) (Patent Docs)
  • Juul Bought Ads Appearing on Cartoon Network and Other Youth Sites, Suit Claims (NYTimes)
  • Injected heroin use still near all-time highs in U.S., may explain hepatitis-C rise (Reuters)
Upcoming Meetings & Events Europe
  • Pharma firm exploited patient group to lobby NHS for drug approval (PRWeek)
  • Support Yellow Card: report suspected reactions in patients taking multiple medicines (MHRA)
  • Self-expanding stents (S.M.A.R.T. and PRECISE) under MRI – various risks if MRI is operated outside the required conditions for these stents (MDA/2020/006) (MHRA)
  • Class 2 Medicines recall: Accord-UK Ltd, Gliclazide 40 mg Tablets (Northstar Livery), PL 20075/0687, (EL (20)A/08) (MHRA)
  • Ingenol mebutate gel (Picato▼): suspension of the licence due to risk of skin malignancy (MHRA)
  • Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions (MHRA)
  • Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materials (MHRA)
  • Nexplanon (etonogestrel) contraceptive implants: new insertion site to reduce rare risk of neurovascular injury and implant migration (MHRA)
  • Coronavirus crisis’ latest victim could be India’s pharmaceutical industry (SCMP)
  • CDSCO declares 34 samples as NSQ and 1,143 as SQ in random sampling for January 2020 (Pharmabiz)
  • TGA presentation: ISO TC 198 Sterilization of health care products, 11-12 February 2020 (TGA)
  • AZ invests in trees and production in Australia (InPharmaTechnologist)
Coronavirus Outbreak
  • ‘A bit chaotic.’ Christening of new coronavirus and its disease name create confusion (Science Mag)
  • Stress Test: Coronavirus Challenges China Emergency Approval Mechanism (Pink Sheet-$)
  • CDC confirms 15th US case of coronavirus among Wuhan evacuees under quarantine at Texas military base (CNBC)
  • Vietnam quarantines rural community of 10,000 because of coronavirus (Reuters)
  • Japan to spend 10.3 billion yen from budget reserve to fight coronavirus: Abe (Reuters)
  • Coronavirus deaths in China spike, Japan has first fatality (Reuters)
  • CROs, clinical researchers brace for impact of coronavirus shutdown across China (Fierce)
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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