Recon: Amgen joins hunt for coronavirus drug; Novartis cancels $1B sale of Sandoz to Aurobindo

• Questions About Accuracy of Coronavirus Tests Sow Worry (WSJ)
• A Ventilator Stockpile, With One Hitch: Thousands Do Not Work (NYTimes)
• Trump says US will soon have more ventilators than it needs for virus victims (Reuters)
• FEMA Hadn't Ordered Ventilators. Manufacturers Forged Ahead Anyway (NPR)
• Pelosi forms House committee to oversee coronavirus response (The Hill)
• US weekly jobless claims double to 6.6 million (CNBC)
• Biotech Pioneer Amgen Joins Hunt for Coronavirus Drug (WSJ) (Press)
• The latest failure in Alzheimer’s casts doubt on Biogen’s ostensible success (STAT)
• Big biotech venture funds raise billions despite coronavirus fears (STAT)
• First US coronavirus patients being treated with plasma therapy (The Hill)
• Doctors can't use COVID-19 antibodies from gay men or anyone taking PrEP (NBC)
• Merck scores new advance on tumor-agnostic front as Keytruda beat chemo-based regimens in a type of colorectal cancer (Endpoints)
• Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients (NYTimes) (Endpoints) (The Niche)
• OrthoPediatrics buys FDA-approved scoliosis tech, challenging Zimmer for market (MedtechDive)

• COVID-19 cases and deaths rising, debt relief needed for poorest nations: WHO (Reuters)
• EU will avoid medicine shortage, industry chief says (Reuters)
• Shortage of drugs and equipment: Brussels hospitals sound the alarm (Reuters)
• European labs to receive control material to spot false negative coronavirus tests (Reuters)
• Novartis cancels $1B sale of generics after antitrust concerns forced delays (Endpoints) (Economic Times) (Press)
• EU To Suspend VAT On Medical Supplies Amid Pandemic (Law360)
• Clinical trial of Gilead’s coronavirus hopeful remdesivir begins in UK (PMLive)
• Britain's Hancock will set out new testing measures for coronavirus (Reuters)
• UK government reveals only 2,000 key NHS staff have been tested for coronavirus (PMLive)
• Mexico scrambles to meet desperate U.S., European ventilator demand (Reuters)
• G-20 prepares coronavirus rescue package for Africa (Politico)
• Chinese smartphone health code rules post-virus life (AP)

• White House advisor Fauci says coronavirus vaccine trial is on target and will be ‘ultimate game changer’ (CNBC)
• Ex-FDA chief warns ‘parts of our lives’ will stay shut down without a coronavirus drug by fall (CNBC)
• Ventilators Can Save Lives Of Some COVID-19 Patients, But They're No Panacea (NPR)
• FDA commissioner on whether serology testing will allow US to reopen society (Fox)
• Bill Gates: Here’s how to make up for lost time on covid-19 (Washington Post)
• What We Need to Understand About Asymptomatic Carriers if We’re Going to Beat Coronavirus (ProPublica)
• Coronavirus disease (COVID-19) advice for the public: When and how to use masks (WHO)
• Covid-19 Changed How the World Does Science, Together (NYTimes)
• Malaria Drug Helps Virus Patients Improve, in Small Study (NYTimes)
• Chloroquine ‘Approval’ For COVID-19 And The US FDA’s New Reality (Pink Sheet-$)
• Bringing Needed Structure to COVID-19 Drug Development (NIH)
• Some Coronavirus Patients Show Signs of Brain Ailments (NYTimes)
• A Coronavirus Fix That Passes the Smell Test (Bloomberg)
• The Coronavirus Patients Betrayed by Their Own Immune Systems (NYTimes)
• Coronavirus can spread one to three days before symptoms appear: CDC study (Reuters)
• A Million N95 Masks Are Coming From China—on Board the New England Patriots’ Plane (WSJ)
• Biopharma, Payers Seek National Guidelines For Prescribing Potential COVID-19 Drugs (Pink Sheet-$)
• Brii, Chinese partners eye Q3 start for COVID-19 antibody trial (Fierce)
• These Coronavirus Exposures Might Be the Most Dangerous (NYTimes)
• HHS expands partnership with Janssen to develop coronavirus therapeutics (HHS)
• Australia begins pre-clinical testing for coronavirus vaccine (Reuters)
• California Hospitals Face Surge With Proven Fixes And Some Hail Marys (KHN)
• Why is New Orleans' coronavirus death rate seven times New York's? Obesity is a factor (Reuters)
• California Company Under Scrutiny For 'At-Home' Coronavirus Test Claims (NPR)
• Pentagon looking to provide up to 100,000 body bags for civilians in virus outbreak (Reuters)
• U.N. nuclear agency sending coronavirus testing gear to 40 countries (Reuters)
• Home Depot Halts Sales of N95 Masks Amid Shortage, Company Says (NYTimes)
• Israelis told to wear face masks in public, mark religious holidays with close family only (Reuters)
• Coast Guard Tells Cruise Ships With COVID-19 Cases To Stay Away From U.S. Ports (NPR)
• Medical Professionals Across Merck & Co., Inc., Pfizer Inc., and Eli Lilly and Company Activate to Support Health Systems, First Responders and Patients Amid COVID-19 Pandemic (Press)
• France passes 4,000 coronavirus deaths, no end of lockdown in sight (Reuters)
• Spain's coronavirus death toll tops 10,000 after another record daily toll (Reuters)
• Italy coronavirus death rate slows but studies suggest true tally higher (Reuters)
• Coronavirus (COVID-19) Update: Daily Roundup April 1, 2020 (FDA)
• FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data (FDA)
• Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the Coronavirus Disease 2019 Pandemic (FDA)
• Paratek Pharmaceuticals Announces Initiation of Funding from BARDA for All FDA Required Post-marketing Studies for NUZYRA (omadacycline) (Press)

• Two companies bet on ‘chemogenetics’ to sidestep challenges with neurological drug development (STAT)
• Insulin Cost and Pricing Trends (American Action Forum)
• Drugmakers await reckoning as doctors, patients make tough choices during pandemic (BioPharmaDive)
• FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors (FDA)
• Ultragenyx's gene therapy technology finds another interested party (BioPharmaDive)
• Regulatory approaches to stimulate innovative renal replacement therapies (Nature)
• In conversation with Cytiva's Emmanuel Ligner on closing a $21.4B deal in a time of coronavirus (Fierce)
• Amgen Buys Out Joint Venture to Establish Japanese Subsidiary (SFV Business Journal)
• US FDA Exploring Virtual Advisory Cmtes.; Might Sponsors Want To Wait For In-Person Meetings? (Pink Sheet-$)
• Neurology At The Forefront Of US FDA Complex Innovative Trial Design Pilot (Pink Sheet-$)
• US FDA And Sponsors Resolve Disclosure Issues On Complex Trial Design Pilot Projects (Pink Sheet-$)
• UCB completes the acquisition of Ra Pharmaceuticals – to deliver differentiated therapies to patients (Press)
• As therapies for COVID-19 begin testing, the FDA prepares to face a “breakthrough” problem (AgencyIQ)
• Invoking Bayh-Dole may be needed to get affordable Covid-19 treatments (STAT)
• What If Gov't Allows Patent Infringement For COVID-19 Drugs? (Law360)
• Stepping out alongside ARCH's record raise, Flagship adds a $1.1B monster fund of its own (Endpoints) (Fierce)
• Sue Desmond-Hellmann joins Pfizer board; Kite Pharma taps ally in push to expand CAR-T (Endpoints) (Press)
• ARCH chief Bob Nelsen has $1.5B to prove 2 simple points: ‘We’re in the most innovative time ever’ and investors are staying (Endpoints) (Fierce)
• Dynacure secures $55M as their Ionis-developed drug moves into clinic (Endpoints)

• OSE lung cancer vaccine clears phase 3 hurdle, but COVID-19 stalls programme (PMLive)
• Dermavant Completes Patient Enrollment for Two Phase 3 Clinical Trials of Tapinarof for the Treatment of Psoriasis (Press)
• Biogen Announces First Patient Treated With Higher Dose of SPINRAZA® (nusinersen) in Phase 2/3 DEVOTE Study (Press)
• Seattle Genetics Announces Potential Accelerated Approval Pathway in the U.S. for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Urothelial Cancer (Press)
• Affimed Announces FDA Granted Orphan Drug Designation for Lead Innate Cell Engager AFM13 for the Treatment of T-cell Lymphoma (Press)
• NOXXON Announces Completion of Patient Recruitment for the First Dose Cohort in the Phase 1/2 Brain Cancer Study Of NOX-A12 Plus Radiotherapy (Press)
• Zymeworks Announces First Patient Dosed in Phase 1b/2 Trial of ZW25 in First-Line HER2-Positive Breast Cancer and Gastroesophageal Adenocarcinoma Conducted by BeiGene (Press)
• Axial Biotherapeutics Announces Positive Topline Results from Phase 1b/2a Clinical Trial of AB-2004 for the Treatment of Autism Spectrum Disorder (Press)

• Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices (JAMA)
• Rescheduled: Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 (FDA)
• Homeland Security warns on BD Pyxis Medstation and Pyxis Anesthesia (MassDevice)
• CrossBay Medical Receives FDA Clearance for CrossGlide Endometrial Tissue Sampler (Press)
• Class 1 Device Recall LeMaitre 5F Plus Over the Wire Embolectomy Catheter (FDA)

• Medicare Part D and Insulin Affordability — The Devil Is in the Details (NEJM)
• Loeffler reports more stock sales, denies wrongdoing (AJC)
• Special Master Appointed to Decide Requests to Seal and Redact in Genentech v. Amgen BPCIA Litigations (Big Molecule Watch)
• CDC credits a sharp decline in C. diff infections to checklists and better antibiotic stewardship (STAT)
• Theranos Judge Rips 'Tone' Of Attys' Pandemic-Related Filing (Law360) (CNBC)
• Pfizer Gets Rival's Epinephrine Injection Patent Killed (Law360-$)
• Update: State Controlled Substance Pharmacy Law Waivers and COVID-19 Response (FDA Law Blog)
• The Next Personal Jurisdiction Issue for the Supreme Court (Drug & Device Law)

• Development Considerations of Antifungal Drugs to Address Unmet Medical Need – 4 August 2020
• Developing Antifungal Drugs for the Treatment of Coccidiodomycosis (Valley Fever) Infection – 5 August 2020

• Russian Pharma Company Biocad Obtains European Certification for Biosimilars to Treat Cancer (Big Molecule Watch)
• NuVasive suspends UK sales of Magec rod amid safety concerns (MedtechDive)
• NICE publishes second set of rapid COVID-19 guidelines (PharmaTimes)
• UK MHRA Finds Labs Releasing Unreliable Data Due To Pressure From Pharma (Pink Sheet-$)

• Zydus Cadila gets final nod from USFDA to market generic seizures drug (Economic Times)

• TGA collaborating to help ensure the supply of ventilators (TGA)