Recon: Gilead says NIH remdesivir study met primary endpoint; Novartis’ Cosentyx gets expanded EU indication

• Gilead says critical study of Covid-19 drug shows patients are responding to treatment (NYTimes) (STAT) (Endpoints) (Politico) (Financial Times) (Reuters)
• Congress sounds alarm over inaccurate antibody tests (NBC)
• Race for Coronavirus Vaccine Accelerates as Pfizer Says US Testing to Begin Next Week (WSJ)
• Miscalculation at Every Level Left US Unequipped to Fight Coronavirus (WSJ)
• Coronavirus testing chief says ‘no way on Earth’ US can test 5M a day (CNBC)
• Pfizer resumes trial recruitment suspended by coronavirus (BioPharmaDive)
• J&J inks 2nd manufacturing deal to boost capacity for COVID-19 vaccine (Fierce)
• IQVIA: 80% of our trial sites are 'inaccessible' due to pandemic, eyes Q4 for turnaround (Fierce)
• LabCorp swings to a loss, withdraws 2020 guidance as coronavirus outbreak drives up costs (CNBC)
• Merck, with a heavy presence in physician-administered drugs, predicts a $2.1B sales hit from COVID-19 (Fierce)
• ‘HHS has been kicked in the teeth’ (Politico)

• UK cuts number of ventilator designs it supports in coronavirus battle (Reuters)
• India's Serum Institute to make millions of potential coronavirus vaccine doses (Reuters)
• India Drugmaker Set for Best Day Since 2004 After Developing Anti-Viral Tablets (Bloomberg)
• GSK boss does not see mass-produced coronavirus vaccine before mid-2021 (Reuters)
• Novartis wins expanded European OK for Cosentyx amid pursuit of $5 billion sales (Reuters)
• AstraZeneca sees sales boost from COVID-19 stockpiling (PMLive)
• Germany buys extra flu jabs to avoid double hit to healthcare (Reuters)
• BerGenBio shares soar on COVID-19 drug trial news (Reuters)
• The biopharma funding engine motors on, as Chinese biotech raises nearly $280M in monster round (Endpoints)

• The Hunt for Covid-19 Drugs and Vaccines Becomes Even More Complex (WSJ)
• Hospital demand for hydroxycholoroquine to treat Covid-19 patients is waning (STAT)
• Three US children with COVID-19 have rare inflammatory syndrome (Reuters)
• A.I. can’t solve this: The coronavirus could be highlighting just how overhyped the industry is (CNBC)
• Guidelines call for 14-day drop in cases to reopen. No state has met them. (NBC)
• What Antibody Studies Can Tell You — and More Importantly, What They Can’t (ProPublica)
• Cyber-intel firms pitch governments on spy tools to trace coronavirus (Reuters)
• Medics Question A Practice That Might Speed Up Testing Of A Coronavirus Vaccine (NPR)
• Airborne Coronavirus Detected in Wuhan Hospitals (NYTimes)
• Heartburn drug trial shows ‘reasonable confidence’ famotidine could help treat coronavirus, hospital CEO says (CNBC)
• WHO May Host Virtual World Health Assembly May 18 – COVID-19 To Be Main Agenda Item (Health Policy Watch)
• Putin extends Russia's lockdown for two weeks, prepares to ease in mid-May (Reuters)
• Italy's tops 200,000 coronavirus cases, daily death toll rises (Reuters)
• UK widens virus testing scheme to all care home residents (Reuters)
• Coronavirus (COVID-19) Update: Daily Roundup April 28, 2020 (FDA)
• ANVISA introduces temporary measures to combat COVID-19 in Brazil (Emergo)

• Full steam ahead, Pfizer goes bargain hunting in an age of coronavirus — with a special focus on cancer and rare diseases (Endpoints)
• GSK partners with Arthritis Foundation as it preps Voltaren for OTC switch (Fierce)
• What makes a drug discovery consortium successful? (Nature)
• Off-the-shelf CAR-T therapy helps leukemia patients in a small, first-in-human trial (STAT)
• One IPO attempt pulled, a drug on partial hold and a pandemic, but ADC tries again (Fierce)
• Patients, drug makers grapple with how to continue cancer trials during the coronavirus (STAT)
• Merck grabs FDA green light for less-frequent Keytruda dosing regimen (Fierce) (FDA)
• Blueprint’s voyage ends in disaster (Evaluate) (Endpoints)
• Novartis spinout resTORbio reverse merges with T cell biotech after big PhIII failure (Endpoints)
• AstraZeneca, GSK reiterate 2020 outlook; Shanghai biotech I-Mab is looking for a US partner — report (Endpoints)
• Sue Desmond-Hellmann joins the marquee crowd of biopharma experts at GV booting up a new generation of drug hunters (Endpoints)
• Having sold its corporate self, Tocagen auctions off scientific platform to San Diego biotech (Endpoints)
• In the heart of Texas, the AveXis crew gathers for another go at gene therapy with $30M and a powerhouse academic pact to start (Endpoints)

• Thrive, chasing Grail with a cancer blood test, finds tumors in seemingly healthy women (MedtechDive)
• Boston Scientific rises despite Q1 bottom-line slide (MassDevice)
• Novocure shares data from post-approval brain cancer device trial (MedtechDive)
• Implications of the new ISO 14971 edition for usability engineering (Emergo)

• Federal Circuit Finds Pfizer’s RUXIENCE Plans Insufficient to Establish Standing to Appeal IPR (Big Molecule Watch)
• Drug Price Increases Dwarf ACA Donut Hole Fix for High-Cost Meds (Pink Sheet)
• Antibiotic Resistance: Additional Federal Actions Needed to Better Determine Magnitude and Reduce Impact (GAO)
• SEC charges company & CEO in COVID-19 mask scam (MassDevice)
• Disinfectants for use against COVID-19 included in the ARTG for legal supply in Australia (TGA)