Recon: FDA delays decision on Spectrum drug due to COVID travel restrictions; Bayer to buy AskBio for up to $4B

• FDA delays decision on Spectrum Pharma's drug candidate due to travel curbs (Reuters) (Endpoints)
• Two Companies Restart Virus Trials in U.S. After Safety Pauses (NYTimes) (FT)
• South Korea pharma Celltrion's COVID test gets US emergency use authorisation (Reuters)
• U.S. disease expert Fauci says vaccine verdict due by early December (Reuters)
• Senate Health Committee chair asks Cuomo, Newsom to 'stop second guessing' FDA on vaccine efficacy (The Hill)
• Bayer to buy gene therapy company AskBio for as much as $4 billion (STAT) (Endpoints) (FT)
• Florida fails to attract bidders for Canada prescription drug importation program (Miami Herald)
• Kodak Loan Debacle Puts a New Agency in the Hot Seat (NYTimes)
• The Trump Administration Shut a Vaccine Safety Office Last Year. What’s the Plan Now? (NYTimes)
• 'A mass exodus': HHS staffers jumping ship amid pandemic, fears of Trump loss (Politico)
• 'Toxic': CDC staffers say morale inside the public health agency has plummeted during the pandemic (NBC)

• European Union Would Apply Lower Threshold in Assessing Covid-19 Vaccine (WSJ)
• Vaccine hopes rise as Oxford jab prompts immune response among old as well as young adults (Reuters)
• Vaccine deal allows AstraZeneca to take up to 20% on top of costs (FT) (Reuters)
• South Korea urges people to get flu shots, trust its steps on health (Reuters)
• Singapore temporarily halts use of two flu vaccines after South Korea deaths (Reuters)
• Canada to invest up to C$214M for research into domestic-made vaccines: PM (Reuters)
• UK says on vaccine: we're not there yet, eyes first half of 2021 (Reuters)
• Israel to start COVID-19 vaccine human trials on Nov. 1 (Reuters)
• Qatar signs deal to buy Moderna COVID-19 vaccine (Reuters)
• Steroids boost survival of preterm babies in low-resource settings, new study finds (WHO)

• U.S. Vice President Pence tests negative for coronavirus: office (Reuters)
• Will FDA Heed Its Outside Experts' Advice On COVID-19 Vaccine (NPR)
• ‘There’s only one chance to do this right’—FDA panel wrestles with COVID-19 vaccine issues (Science)
• A Federal Coronavirus Vaccine Contract Released At Last, But Redactions Obscure Terms (NPR)
• Why the approval of remdesivir to treat Covid-19 obscures bigger scientific failures (STAT)
• Verily’s COVID Testing Program Halted in San Francisco and Oakland (KHN)
• For Emergency Use, US FDA May Visit Rather Than Inspect COVID-19 Vaccine Manufacturing Sites (Pink Sheet)
• Adolescents In COVID-19 Vaccine Trials: As Pfizer Starts Dosing, US FDA Encouraging Other Sponsors (Pink Sheet)
• 5 takeaways from the FDA's closely watched coronavirus vaccine meeting (BioPharmaDive)
• Helix grabs boosted FDA emergency usage for COVID-19 test, can seek out asymptomatic carriers (Fierce)

• Mirati study results set new response bar for KRAS-blocking lung cancer drugs (STAT)
• How precision medicine paved the way to the first cystic fibrosis drug (Nature)
• Ultragenyx expands into Duchenne gene therapy with Solid Bio deal (BioPharmaDive)
• Health Canada releases final version of controversial regulations for controlling drug prices (STAT)
• Foghorn Therapeutics raises $120 million in IPO (STAT)
• Forma takes aim at Agios with new AML complete remission data (Endpoints)
• ‘Where is Rudy?’: Inside Giuliani’s checkered track record as a pharma consultant (STAT)
• Sanofi, Regeneron chase 4th Dupixent approval with rare esophageal disease data (Fierce)
• Aurobindo Pharma inks pact with New Mountain Capital to sell US unit for $550M (Economic Times)
• Novartis succeeds where Alexion failed, coming up with a win for a prized asset in a rare kidney disorder (Endpoints)
• With FDA decision looming, GSK sweetens the PD-1 pot for discovery partner AnaptysBio as Hal Barron moves to guard his oncology strategy (Endpoints)
• FibroGen’s new PhIII data set it up for quick OK, analysts say. But can it avoid a black box warning? (Endpoints)
• Biogen chair Stelios Papadopoulos takes his investing experience to the SPAC party, raising $100M for a blank check deal (Endpoints)
• Crinetics' acromegaly drug hits primary PhII endpoint, but investors can't make up their minds (Endpoints)
• BiondVax stock implodes after a big PhIII gamble for its universal flu vaccine fails (Endpoints)
• News briefing: AstraZeneca follows Amgen down KRAS/SHP2 combo path; Vallon Pharmaceuticals files for $17 million IPO (Endpoints)

• Neuromod devices at the fore in latest FDA breakthrough designations (MedtechDive)
• Early medtech Q3 results signal diagnostics boom, return to device growth (MedtechDive)
• FDA approves Foundation Medicine's diagnostic for Bayer's tumor-agnostic med Vitrakvi (Fierce) (FDA)
• Eisai doubles down on Cogstate digital cognitive tool pact (Fierce)
• FDA clears AI for Vida Diagnostics lung imagaging analysis software (MassDevice)
• Medtronic issues safety notice for InterStim SureScan MRI leads (MassDevice)
• FDA clears Abiomed compact cardiopulmonary bypass system (MassDevice)

• FY 21, FY 22 Appropriations and CDER Priorities (Alliance for a Stronger FDA)
• Lannett Drug Price-Fixing Settlement Gets Del. Judge's OK (Law360)