Recon: FDA Approves Esperion Cholesterol Treatment, Lundbeck Migraine Drug; ICER Partners With Aetion for Patient Data

• Coronavirus threatens shortages of about 150 drugs (Axios)
• White House to ask Congress for emergency coronavirus funding (Politico 1, 2)
• Local Officials in AL, CA Resist Plans to House Coronavirus Patients (NYTimes) (Reuters) (NBC)
• Companies in pharmaceutical supply chain develop system to track counterfeit drugs (Reuters)
• Gilead Surges After WHO Comments on Coronavirus Drug Testing (Bloomberg)
• Esperion says cholesterol drug gets FDA approval; eyes $10 per pill pricing (Reuters) (AP) (WSJ) (STAT) (Endpoints)
• Lilly’s Trulicity scores CV reduction indication in the US (PMLive) (Reuters) (Press)
• FDA approves Lundbeck's migraine prevention therapy (Reuters) (Endpoints) (Press)
• ICER signs deal with Aetion for patient data (Reuters) (Pink Sheet-$) (STAT) (ICER)
• Battle of the 'bots: 4 robotic surgery rivalries to watch in the year ahead (MedtechDive)
• Deadline Approaching for Agencies to Post Regulatory Guidance (Bloomberg Law)
• At Walgreens, Complaints of Medication Errors Go Missing (NYTimes)

• Coronavirus cases spread outside China, fall inside, winning WHO's praises (Reuters)
• WHO says it no longer uses 'pandemic' category, but virus still emergency (Reuters) (NYTimes)
• China Pushes Factories to Reopen, Risking Renewed Virus Spread (Bloomberg)
• US FDA Revokes ‘Voluntary Action Initiated’ Status For Aurobindo Pharma’s Hyderabad Unit (Bloomberg) (Economic Times)
• A Chinese biotech partners with GSK to boost its coronavirus vaccine development (STAT) (BioPharmaDive) (Endpoints)
• France should make more of the goods it needs as epidemic shows risk: finance minister (Reuters)
• Sanofi outlines big API plans as coronavirus outbreak reportedly threatens shortage of 150 drugs (Endpoints) (Press)
• World Pharmacopoeias move towards increased global co-operation (Council of Europe)

• With supply tight, Novartis readies gene therapy plant for production (BioPharmaDive) (BioProcessInternational)
• The man in charge of discovering new drugs at the world's biggest biotech told us how Amgen's 'triple threat' genetics approach can overcome the industry's high failure rates (Business Insider)
• TMAP: Planning for Efficient, Effective Data Management at FDA (Alliance for a Stronger FDA)
• Coronavirus crisis shows pharmaceuticals have offshored supply chain, Navarro says (Fox Business)
• After 40 years, the Alzheimer’s Association sees signs of progress against a devastating disease. Is it real? (STAT)
• New York Governor Plans Consortium for Alzheimer's Disease Genetic Research (GenomeWeb)
• Combating substandard and falsified medical products (WHO)
• ICER’s Biopharma Members: Why They Joined And What They Get (Pink Sheet-$)
• Animal health vet Juergen Horn makes new antibody play for pets, raking $15M in Series A haul (Endpoints)
• Biocon confident of approval for Lantus copy after Malaysia plant inspected by FDA a third time (Fierce)
• NGM Bio takes leap forward in crowded NASH field (Endpoints)
• Empty AstraZeneca plant sized up by CDMO which may or may not be AGC Biologics (Fierce)
• Puma Biotech's Nerlynx remains a dud. Will a breast cancer expansion turn things around? (Fierce)
• With strong data on lead drug, Kadmon and CEO Harlan Waksal plot their redemption (STAT) (Fierce)
• Opportunities and challenges with microphysiological systems: a pharma end-user perspective (Nature)
• Antigen-based metric could better predict which patients benefit from immunotherapy, study says (STAT)
• Taro Pharmaceuticals USA Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing (FDA)

• FDA grants ‘breakthrough’ status to antibiotic alternative as ContraFect rushes to join fight against superbug (Endpoints)
• Novartis gets a boost in blockbuster multiple sclerosis race with Roche (Endpoints) (Scrip-$)
• Hormone Blocker Sticker Shock: Kids Drug Costs 8 Times More Than One For Adults (NPR)
• FDA approves first adjuvanted quadrivalent flu vaccine in over-65s (Pharmafile) (Press)
• Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer (Press)
• Teva Announces FDA Approval of ArmonAir® Digihaler™ (fluticasone propionate) Inhalation Powder (Press)
• Aura Biosciences Presents Updated Phase 1b/2 Clinical Data for AU-011 at the 43rd Annual Macula Society Meeting (Press)
• Magenta Therapeutics Completes Dosing in Phase 1 MGTA-145 Trial, Demonstrating Rapid, Single-Day First Line Stem Cell Mobilization and Collection (Press)
• Sojournix Announces Initiation of Phase 2 Clinical Trial of SJX-653, a Novel Selective NK3 Antagonist for Menopausal Hot Flashes (Press)
• Concert Pharmaceuticals Selected for Late-Breaking Oral Presentation of CTP-543 Phase 2 Data in Alopecia Areata at the 2020 American Academy of Dermatology Annual Meeting (Press)
• Pandion Announces First Subject Dosed in a Phase 1 Clinical Trial of PT101, an IL-2 Mutein Fc Fusion Therapy for Autoimmune Disease (Press)
• Tetra Bio-Pharma Provides Additional Information on QIXLEEF Following Letter of Advice & Type B Meeting with USA FDA (Press)

• On FDA's agenda: ortho reclassifications, cancer tests, AI in imaging (MedtechDive)
• New Genomic Tests Aim to Diagnose Deadly Infections Faster (NYTimes)
• Abbott touts real-world data around FreeStyle Libre system (MassDevice)
• FDA Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome (FDA) (GenomeWeb)
• FDA Grants Premarket Clearance of Asuragen’s AmplideX® Fragile X Dx and Carrier Screen Kit (Press)
• Dexcom lands CE Mark for continuous glucose monitor use by pregnant women (MassDevice)
• Fist Assist announces CE Mark and European launch (MassDevice)
• Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters (FDA)

• Alkermes sued over death of man who overdosed after taking addiction treatment Vivitrol (STAT)
• Attorney general dismisses lawsuit against three opioid distributors, but plans to refile later (The Oklahoman)
• Pharma Ruling Broadens Gov't Drug Procurement Options (Law360-$)
• Opioid Cos. Must Face Benefit Plans' Suit In MDL (Law360-$)
• Feds Want 1st Circ. To Back Convictions Of Ex-NECC Execs (Law360-$)
• Teva Floated As Bellwether In Generic Drug Price-Fixing MDL (Law360-$)
• Vape Group To Send FDA Deadline Challenge Row To 6th Circ. (Law360-$)
• Ad Watchdog Asks FTC To Review Co.'s CBD Health Claims (Law360-$)
• AstraZeneca Stuck With FCA Case Over Crestor Marketing (Law360-$)
• Ohio Doctor Pleads Guilty to Unlawful Distribution of Opioids (DOJ)
• Adequate Warnings Should Be Enough (Drug & Device Law)
• PTAB Life Sciences Report (Patent Docs)
• SEC reportedly probing Altria’s Juul investment (CNBC)

• FDA Advisory Committee Calendar
• EMA: From data to evidence in medicines regulation – 22 April 2020
• Team-NB: 62nd NB-Med meeting in Brussels – 1-2 April 2020
• Allergenic Products Advisory Committee; Notice of Meeting – 15 May 2020
• Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting – 23 April 2020

• Swiss approval for orphan drug Crysvita (PharmaLetter-$)
• Indian Drugmaker Cited in EU for Serious GMP Violations (FDA News-$)
• Relationship between the revised risk management standard and European regulatory requirements (BSI)
• Start of survey about the use of benzodiazepines and related substances for sleep disorders in Belgium (FAMHP)

• Fosun, A China Investment Heavyweight, Elevates Drug Exec In Shake-Up As Coronavirus Hits (Forbes)
• ‘Highly Questionable’ GMP Compliance In Pakistan Prompts New Licensing System (Pink Sheet-$)
• Biocon gets 3 USFDA observations for insulin facility in Malaysia (Economic Times)

• 8,700 pharma firms in India claimed tax deductions for ‘gifts’ (Economic Times)
• Bringing medical devices under Drugs Act to help medical device regulation effective: ICRA (Pharmabiz)
• Coronavirus outbreak causes supply problem for India’s drugmakers (Financial Times)
• Abbott launches quadrivalent vaccine for influenza in India (Economic Times)
• Daiichi-Ranbaxy arbitration case: Singh brothers hearing in Singapore Supreme Court starts today (Economic Times)

• What We Know About the Coronavirus, From Symptoms to Who Is at Risk (WSJ)
• COVID-19: EU working on all fronts, €232 million for global efforts to tackle outbreak (European Commission) (Statement)
• China says new coronavirus cases drop to 409 on February 23 but deaths jump to 150 (Reuters)
• China braces for inevitable big hit to economy from virus, says Xi (Reuters)
• Large parts of China ease coronavirus curbs, many report no new cases (Reuters)
• Virus epicenter Wuhan revokes announcement easing lockdown (Reuters)
• DuPont ramps up safety suit production as coronavirus causes shortages in China (CNBC)
• Harvard joins coronavirus fight with $115 million and a high-profile Chinese partner (Endpoints)
• MHRA update on novel coronavirus (COVID-19) (MHRA)
• South Korea coronavirus cases surge, two more die (Reuters)
• Sixth Italian dies from coronavirus in Europe's worst flare-up (Reuters)
• Coronavirus kills 12, up to 61 infected in Iran: minister (Reuters)
• Three Gulf states, Iraq report first coronavirus cases, linked to Iran (Reuters)
• Afghanistan confirms first coronavirus case in province bordering Iran (Reuters)
• Israel may quarantine 200 South Korean visitors in army base: report (Reuters)
• Samsung Electronics confirms coronavirus case at phone factory complex in South Korea (Reuters)
• Third death from Japan cruise ship as health minister vows to set virus strategy (Reuters)

• France pledges US$100 million (€90 million) for WHO Academy (WHO)

• Physicians, Hospitals Meet Their New Competitor: Insurer-Owned Clinics (WSJ)
• Drop in cancer deaths reflect failures of our society. Really (Boston Globe)