Recon: Moderna, Lonza strike deal on COVID-19 vaccine; AbbVie, Amgen post Q1 results

• Moderna, Switzerland's Lonza strike deal on potential COVID-19 vaccine (Reuters) (CNBC)
• Why one breakthrough drug won't end the pandemic (Politico)
• Gilead to work with partners to ramp up production of potential coronavirus treatment (Reuters) (CNBC) (Financial Times)
• About Remdesivir and About “Game-Changers” (In The Pipeline)
• The latest obstacle in the search for a coronavirus treatment: Too many drug trials (Politico)
• AbbVie sees substantial hit to Botox from pandemic, lowers Humira forecast (Reuters) (Press)
• Amgen studying Otezla for coronavirus, Q1 results beat estimates (Reuters) (Press)
• FDA's lax rules on coronavirus blood tests open US market to dubious vendors (Reuters)
• Labs Across U.S. Join Federal Initiative to Study Coronavirus Genome (NYTimes)

• Potential UK COVID-19 vaccine producer eyes making a million doses a month (Reuters)
• EU actions to support availability of medicines during COVID-19 pandemic (EMA)
• WHO and European Investment Bank strengthen efforts to combat COVID-19 and build resilient health systems to face future pandemics (WHO)
• WHO official says agency not invited to take part in China's coronavirus investigation (NBC)
• NICE joins international COVID-19 pandemic response (PharmaTimes)
• Promising drug against Covid-19 unlikely to be available in UK soon (The Guardian)
• Remdesivir: five Australian hospitals to receive experimental coronavirus drug (The Guardian)
• Billions worldwide living with herpes (WHO)
• Canada's coronavirus curve flattens but worrying trends emerge: top medical officer (Reuters)

• Nearly a dozen approved drugs could be effective against COVID-19: study (Reuters)
• Statement on the third meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of coronavirus disease (COVID-19) (WHO)
• Coronavirus Is Likely to Generate Telltale Signs, Fauci Says (Bloomberg)
• How A.I. Steered Doctors Toward a Possible Coronavirus Treatment (NYTimes)
• Find a Vaccine. Next: Produce 300 Million Vials of It. (NYTimes)
• Los Angeles coronavirus testing website strains as free appointments fill up (Reuters)
• Do-It-Yourself Cheek Swab Tested As Next Best Thing To Detect Coronavirus (KHN)
• Doctors anticipate patient requests for experimental remdesivir before all the evidence comes in (STAT)
• U.S. calls ingredients in some ethanol-based hand sanitizers unsafe (Reuters)
• 10X: Moderna creates a billion-dose vaccine pact in a frenzied race to beat Covid-19 — globally (Endpoints)
• China's Hubei, where coronavirus began, eases lockdown (Reuters)
• Fax-loving Japan to introduce online system for reporting coronavirus (Reuters)
• Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization (FDA)

• 10 years of biosimilars: lessons and trends (Nature)
• What value? High prices for dozens of cancer drugs aren’t tied to better clinical benefits (STAT) (The Lancet)
• Generic Firms Want Congress To Build On CARES Act To Prevent Critical Drug Shortages (Pink Sheet)
• AAM Offers Drug Manufacturing Repatriation Plan … For A Price (Pink Sheet)
• Antibiotic Development: HHS Not Yet Sold On ‘Pull’ Incentives (Pink Sheet)
• Indian pharmas call on FDA to perform 'virtual' facility checks during COVID-19 inspection lockdown (Fierce)
• Tick saliva-derived drug shows promise in mid-stage rare skin disease study (Endpoints)
• One More On QIDP List – Does It Help Wockhardt? (Scrip)
• Bristol Myers Squibb gets priority review for AML drug as list of potential Celgene hits lengthens (Endpoints) (Press)
• High-profile R&D specialist David Lebwohl jumps to new job as CMO of a pioneering CRISPR player; Troubled AMAG Pharmaceuticals taps Scott Myers as CEO (Endpoints)
• Bob Langer-founded Lyra Therapeutics raises $56M in latest high-end biotech IPO (Endpoints)
• Fiscal Year 2020 Generic Drug Regulatory Science Initiatives; Public Workshop; Remote Only (FDA)

• For FDA, The Third Time Wasn’t The Charm For Releasing A Draft Of Its Harmonized Quality System Reg (MedtechInsight)
• Medtronic's blood filtering machine cleared for the smallest children (Fierce)
• FDA clears Synaptive's smaller, point-of-care MRI scanner (Fierce)
• Abiomed buys artificial lung device for use with Impella, potential COVID-19 patients (MedtechDive)
• Hologic to launch 2nd coronavirus test amid broader sales slide (MedtechDive)
• Teleflex yanks guidance as coronavirus craters key product (MedtechDive)
• Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use (FDA)
• The U.S. needs to make more CPAP machines. Our supply chain is blocking that (STAT)
• Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use (FDA)
• Ophthalmic Devices Panel of the Medical Devices Advisory Committee: Notice of Meeting; Postponement (FDA)

• 2020: USTR publishes a tone-deaf Special 301 Report, repeats old complaints (KEI) (Report)
• Post-market review of face masks (TGA)
• Engaging with international partners on COVID-19 (Health Canada)
• Leading Cancer Treatment Center Admits to Antitrust Crime and Agrees to Pay $100 Million Criminal Penalty (Department of Justice)
• Court Says FibroGen’s UK Roxadustat Patents Are Invalid (Pink Sheet)
• PTAB Sets Date for Oral Argument in CRISPR Interference (Patent Docs)
• Swift Enforcement Against COVID Fraudsters (FDA Law Blog)
• New Pharmacy Bellwether Trial Set For 2021 In Opioid MDL (Law360)
• Becton Wins 2 Of 3 At PTAB In Medication Dosing IP Row (Law360)