Recon: Novartis buys Vedere Bio for $150M upfront; Gilead reports $873M in remdesivir sales

• A P value of 0.38? NEJM results raise new questions for Eli Lilly's vaunted Covid antibody (Endpoints) (NEJM)
• Regeneron Covid-19 Therapy Reduces Viral Load, Need for Care (Bloomberg) (Endpoints) (NBC)
• Antibody drugs seem to work. But the virus is moving faster than we can make them (STAT)
• Moderna on track to report late-stage COVID-19 vaccine data next month (Reuters)
• Moderna says it’s preparing global launch of Covid vaccine as it takes in $1.1 billion in deposits (CNBC)
• Analysis: US drugmakers, bracing for price cuts, shift election support toward Democrats (Reuters)
• Gilead’s Covid-19 Drug is Mediocre. It Will Be a Blockbuster Anyway. (NYTimes) (CNBC) (FT)

• WHO scheme may compensate people in poor countries against COVID vaccine side-effects (Reuters)
• Activists urge 'Big Pharma' to be transparent on COVID-19 vaccine costs (Reuters)
• Next crop of COVID-19 vaccine developers take more traditional route (Reuters)
• Russia's COVID-19 vaccine trial paused as clinics run short of shots (Reuters)
• Putin says equipment a problem in production of Russian COVID-19 vaccines (Reuters)
• Roche to make hundreds of millions of COVID-19 rapid tests monthly: CEO (Reuters)
• China's Kangtai starts mid-stage trial of its COVID-19 vaccine candidate (Reuters)
• Takeda to import 50 million doses of Moderna's COVID-19 vaccine, raises profit forecast (Reuters)
• Shionogi readies COVID-19 vaccine for December trial (Reuters)
• Novartis buys Vedere Bio, whose founders helped blind mice see (Reuters) (Endpoints) (Press)

• ‘Helping the president’: HHS official sought to rebrand coronavirus campaign (Politico)
• The ‘very, very bad look’ of remdesivir, the first FDA-approved COVID-19 drug (Science)
• Developing Safe and Effective Covid Vaccines — Operation Warp Speed’s Strategy and Approach (NEJM)
• Death Rates Have Dropped for Seriously Ill Covid Patients (NYTimes)
• COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification (MedtechInsight)
• White House advisers warn of 'unrelenting' COVID-19 spread in U.S. Midwest, West (Reuters)
• Singapore firm invents coronavirus breathalyser with results in seconds (Reuters)
• Coronavirus vaccination preparations underway in Germany, says Merkel (Reuters)
• Dr Reddy's partners with Department of Biotechnology for Sputnik V vaccine clinical trials in India (Economic Times)
• COVID-19 Vaccines: FDA’s Broad Authority To Craft Narrow EUAs May Push Agency Out Of Its Comfort Zone (Pink Sheet)
• US Buy Of Lilly’s COVID-19 Therapy Now Turns On FDA's Manufacturing Quality Assessment (Pink Sheet)
• MHLW Issues Notification on Establishing COVID-19 Vaccination Systems (PharmaJapan)
• No-Fault Compensation for Vaccine Injury — The Other Side of Equitable Access to Covid-19 Vaccines (NEJM)

• The Stressful Conclusion of a Clinical Trial (NYTimes)
• Opioid Crisis: Critics Say Trump Fumbled Response To Another Deadly Epidemic (NPR)
• Amgen Reports Third Quarter 2020 Financial Results (Press)
• GSK reassures on profits as standard vaccination levels recover (FT)
• Takeda FY2020 H1 Results (Press)
• FDA nails Pennsylvania generics maker with 2nd warning letter in a year (Fierce)
• Catalent continues big push into cell and gene therapies with Belgian facility buyout (Fierce)
• Next To No Uptake On UK Patient Preference Study Advice (Pink Sheet)
• PhRMA Makes 3-Pronged Proposal to Japan Govt, Calls for Fueling Innovation, Investment, and Digitalization (PharmaJapan)
• AbbVie’s JAK Inhibitor Rinvoq Filed for Atopic Dermatitis in Japan (PharmaJapan)
• Young US FDA Office Of New Drug Policy Faces Regulatory Crucible In COVID-19 (Pink Sheet)
• Flagship launches Senda Biosciences with $88M in backing, looking to pioneer the field of 'Intersystems Biology' (Endpoints)
• Sanofi teams up with Merck to pair Keytruda with a next-gen IL-2 candidate from the Synthorx buyout (Endpoints)
• AstraZeneca's Fasenra spares asthma patients from steroid use in large trial (Fierce)
• GSK's Hal Barron axes a once-prized drug from J&J, continuing shift away from respiratory (Endpoints)
• Gilead stops 3 filgotinib trials pending FDA feedback on faltering JAK1 inhibitor (Fierce) (Endpoints)
• Eli Lilly partner TVM Capital raises $478M for their new life sciences fund, a 'substantial' oversubscription (Endpoints)
• Q32 Bio grabs $60M to kick off human studies for next-gen complement drugs — with some Covid-19 tweaks along the way (Endpoints)
• Perceptive recruits A-list investors to back its in-house China startup with a mammoth $310M raise (Endpoints)
• Arcus and AstraZeneca partner on a high stakes anti-TIGIT/PD-L1 PhIII cancer study, looking to improve on a standard of care (Endpoints)
• Roche’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer (Press)

• MDUFA V talks kick off as FDA grapples with onslaught of COVID-19 submissions (MedtechDive)
• Boston Scientific sales not yet back to growth as Watchman hit compounds COVID-19 impacts (MedtechDive)
• Neovasc angina device fails to win FDA panel backing, stock tumbles 43% (MedtechDive)
• USPSTF proposes lowering colorectal cancer screening age in boost to Exact Sciences' Cologuard (MedtechDive)
• Baxter Reports Third-Quarter 2020 Results (Press)
• NICE recommends testing womb cancer patients for inherited condition (PharmaTimes)

• Drugmaker Wins Appeal On Myeloma Treatment Authorization (Law360)
• Pharmacies Sue FDA Over Compounded Drug Agreements (Law360)
• Biogen Says Fed. Circ. Patent Ax Ruling 'Breaks New Ground' (Law360)
• NY AG's Opioid Epidemic Jury Trial Set For Early 2021 (Law360)
• Fight Over Sackler Deal On Hold For Purdue Ch. 11 Plan Talks (Law360)