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

• 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)

• 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-$)
• EU Parliament Urges Post-Brexit Cooperation On Medicines (Pink Sheet-$)

• 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 $9 Billion in 2019—That’s 18% of Total Medicare Part D Rebates (Drug Channels)
• Biopharma Needs A Deal On Drug Pricing As Shield Against Possible Democrat Wins – BIO’s Greenwood (Pink Sheet-$)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar
• 23rd US-Japan Cellular and Gene Therapy Conference – 12 March 2020

• 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)

• ‘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)