Recon: J&J Partners with HHS on Coronavirus Vaccine; Dr. Reddy’s to Acquire Part of Wockhardt’s India Business for $260M

• Johnson & Johnson partners with US agency to develop coronavirus vaccine (Reuters) (Press)
• Coronavirus-Drug Development Becomes a Top Focus at Gilead (WSJ)
• Coronavirus sparks US concern over medical supplies (Financial Times)
• Seattle Genetics makes case for Padcev plus Keytruda in first-line bladder cancer (PMLive) (Press)
• Easing concerns, FibroGen, AstraZeneca secure FDA date for their anemia drug in broad chronic kidney disease population (Endpoints) (Press)
• Merck's Keytruda rides breast cancer hot streak to frontline chemo-combo win (Fierce) (Endpoints) (Press)
• Major drug makers haven’t stepped up to manufacture NIH coronavirus vaccine, Fauci says (STAT)
• Trump's national security adviser says coronavirus could impact US-China trade deal: CNN (Reuters)

• Wockhardt selling plant and piece of its business to Dr. Reddy’s for $260M (Fierce) (Economic Times) (Press)
• Drugmakers braced for coronavirus disruption to China supplies (Financial Times)
• European Medicines Agency Counts The Cost Of Brexit (Pink Sheet-$)
• Pharma industry calls for GMP agreement between EU and UK (EPR)
• Novartis christens new UK HQ in West London, kicking off its big inclisiran CV trial (Endpoints)
• NICE turns down Keytruda/Inlyta combo for kidney cancer (PMLive) (PharmaTimes)
• Novel Ticagrelor Reversal Agent Wins Place On EMA’s PRIME (Pink Sheet-$) (Press)
• AlloVir gains PRIME designation for Viralym-M in Europe (PharmaLetter-$) (Press)
• WHO adviser says an antimicrobial fund can help a market that ‘needs to be fixed’ (STAT)

• Biopharma’s big bet on cancer is laid bare (Vantage)
• After a new version of a decades-old drug gets orphan status, the price suddenly skyrockets (STAT)
• API manufacturers address critical medicines shortages leaving Europeans and Americans vulnerable and dependent on Asian supplies (EFCG)
• New Sanofi chief Paul Hudson takes the ax to his executive committee, chopping 4 key players (Endpoints)
• NCATS, FDA meeting shines light on AAV manufacturing innovation (BioCentury)
• Approvals in 2019: international review and a new agnostic molecular entity (Nature)
• US FDA’s Human Drugs Program Suffers In Adjustment Of Agency Priorities (Pink Sheet-$)
• Expanded Access Advocates Seek Reimbursement Mandate, Manufacturer Incentives From Congress (Pink Sheet-$)
• Corey Goodman marshals $105M mega-round for his CD47 upstart, looking to break new ground in PhII (Endpoints)
• Ligand snags Roche-partnered drug in Icagen buyout (Fierce) (Endpoints)
• ALX raises $105M for midphase trials of CD47 cancer drug (Fierce)
• Knives Out: Carving Up an aBLA (FDA Law Blog)
• FDA approves an inhibitor of a novel ‘epigenetic writer’ (Nature)
• Industry Applauds US FDA Plans For Novel Excipients Review Pathway, But Urges Refinement (Pink Sheet-$)
• New report: Biopharmaceutical industry supports over 4 million jobs and $1.1 trillion in U.S. economic output (PhRMA)

• Astex Pharmaceuticals Announces U.S. Food and Drug Administration (FDA) Acceptance for Review of an NDA for the Combination Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727 or oral C-DEC), for the Treatment of MDS and CMML (Press)
• XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC (Press)
• Prevail Therapeutics’ PR001 Receives Orphan Drug Designation and Rare Pediatric Disease Designation from FDA (Press)
• PRIVIGEN® (Immune Globulin Intravenous (Human), 10% Liquid) Granted Orphan-Drug Designation for the Investigational Treatment of Systemic Sclerosis (SSc) (Press)

• Exact Sciences beefs up sales force as it seeks big Cologuard bump in 2020 (MedtechDive)
• Automated Virtual Reality Therapy Pioneer Oxford VR Secures Record $12.5 Million Investment (Forbes)
• Baxter, Cosmed win FDA clearance for portable metabolism monitor (MassDevice)
• FDA clears Varian’s AI-driven radiation therapy (MassDevice)
• Baxter and COSMED Announce U.S. FDA 510(k) Clearance of Q-NRG+ Indirect Calorimetry Device (Press)
• World’s First Bedside MRI System Receives FDA 510(k) Clearance (Press)
• TransEnterix Announces CE Mark Approval for Pediatric Indication for Senhance Surgical System (Press)
• Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee (FDA)

• Drug Pricing and Pharmaceutical Patenting Practices (CRS)
• Tenet Healthcare and Affiliated California Hospital to Pay $1.41 Million to Settle False Claims Act Allegations for Implanting Unnecessary Cardiac Monitors (DoJ) (Law360-$)
• Roundtable: Are We Prepared? Protecting the U.S. from Global Pandemics (Senate Homeland Security & Governmental Affairs)
• The Implications Of USMCA For Biologic Innovation (Law360-$)
• Federal “Buy American” Standard for Prescription Drugs Invalidated (Drug & Device Law)
• Genetic Counselors Medicare Payment Bill Gaining Support Despite 'Scope of Practice' Disagreement (GenomeWeb)
• Health care's central role in New Hampshire (Politico)
• A $4 Million NICU Bill: The Price of Prematurity (NYTimes)
• Surprise Surgery Bills Happen Even When Patients Plan Ahead (Reuters)

• FDA Advisory Committee Calendar
• Blood Products Advisory Committee; Notice of Meeting – 2 April 2020

• Infringement - Commission takes Italy to Court for its incomplete regime of access to genetic resources (EC)
• UK Supreme Court Weighs Patent Disclosure In Mice Row (Law360-$)
• Luxturna & Crysvita Pioneer Scotland’s New Orphan HTA System (Pink Sheet-$)
• UK Firms Asked To Check Coronavirus Supply Chain Impact (Pink Sheet-$)
• Medicines: marketing authorisation holders submission of Nitrosamine risk evaluation (MHRA)
• Integrated Yellow Card reporting now available in 93% of GP practices in the UK (MHRA)
• Class 3 FMD Medicines Recall, Beconase Aqueous Nasal Spray, (Beclometasone Dipropionate 50μg), PL 10949/0104, EL (20)A/07 (MHRA)

• PMDA to Set Up New Consultation Services for Continuous Manufacturing, Database Use (PharmaJapan)

• Union Health Ministry notifies medical equipment used on humans or animals as "drugs" (Economic Times)
• Biotech department set to work on vaccines for coronavirus (Economic Times)
• NPPA seeks explanation from drug manufacturers on 228 cases of DPCO violation (Pharmabiz)

• TGA presentation: Drug discovery - A regulatory toxicologist's perspective, 1 February 2020 (TGA)

• Coronavirus death toll surpasses 1,100 (CNN)
• Indonesia Has No Reported Coronavirus Cases. Is That the Whole Picture? (NYTimes)
• Chinese company starts mass producing Gilead coronavirus drug (Pharmafile) (Endpoints)
• European Commission COVID-19 Latest Developments (EC)
• Medtronic and its foundation providing $1.2m for coronavirus relief (MassDevice)
• Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records (The Lancet)
• US evacuees freed from coronavirus quarantine, officials fear discrimination (Reuters)
• Hospitals, governments need more data to prepare for the new coronavirus outbreak (STAT)
• Uzbekistan sends protective equipment to virus-hit China (Reuters)
• Cambodia to allow cruise ship shunned over virus fears to dock (Reuters)
• Taiwan says it didn't need China's permission for WHO meeting (Reuters)
• Huge Shelters for Coronavirus Patients Pose New Risks, Experts Fear (NYTimes)
• Japan cruise ship coronavirus cases climb to 175, including quarantine officer (Reuters)

• 18th Invitation to manufacturers and suppliers of medicinal products for HIV infections and related diseases to submit an Expression for Interest (EOI) for product evaluation to the WHO Prequalification Unit - Medicines Team (WHO)