Recon: GAO to probe interference at CDC, FDA; Moderna expects interim COVID vaccine results in November

• Government watchdog will probe Trump officials’ interference at CDC, FDA (Politico)
• US FDA meeting on COVID-19 vaccines to discuss criteria for emergency nod (Reuters)
• California to independently review FDA-approved coronavirus vaccines (Axios) (Reuters)
• Moderna CEO Expects Covid-19 Vaccine Interim Results in November (WSJ) (Reuters)
• Kodak to Push Forward on Making Drug Ingredients Despite U.S. Loan Troubles (WSJ)
• Pharma contributed to attorneys general who want to repeal the Affordable Care Act (STAT)
• CVS to hire 15,000 workers ahead of flu season, COVID-19 vaccines (Reuters)

• UK plans COVID-19 "challenge" trials that deliberately infect volunteers (Reuters) (FT)
• Most people would get COVID-19 vaccine if offered by government or employer: poll (Reuters)
• COVID vaccine unlikely to be deployed widely in Britain before spring: adviser (Reuters)
• What language for COVID vaccines in the EU? Brussels opts for English (Reuters)
• Spain's Rovi to start manufacturing Moderna vaccine "very soon" if approved (Reuters)
• UK lab joins global network to compare coronavirus vaccine candidates (Reuters)
• Spain to receive 31.6 million doses of AstraZeneca COVID-19 vaccine (Reuters)
• Pfizer, BioNTech start combined trials of COVID-19 vaccine candidate in Japan (Reuters)
• Sinopharm says may be able to make over one billion coronavirus vaccine doses in 2021 (Reuters)
• China's Sinovac vaccine is safe, Brazil institute says (Reuters)
• First results of Russian coronavirus vaccine trial may include data from 5,000-10,000 people (Reuters)

• As FDA sets the stage for the first Covid-19 vaccine EUAs, some big players are asking for a tweak of the guidelines (Endpoints)
• UNICEF To Stockpile Over Half A Billion Syringes For Future COVID-19 Vaccine (NPR)
• WHO says expects to hear more soon on paused COVID-19 antibody trial (Reuters)
• France's Ose to enrol up to 400 for 'T-cell' coronavirus vaccine trials (Reuters)
• Will this be the most-watched FDA meeting ever? (STAT)
• Why this week’s meeting of an FDA advisory panel on Covid-19 vaccines matters (STAT)
• Coronavirus vaccine trial leader Larry Corey on the tough FDA, policy decisions to come (BioPharmaDive)
• UK To Go Ahead With Pre-Licensing Use Of COVID-19 Vaccines (Pink Sheet)
• WTO Holds Off On Waiving IP For COVID-19 Vaccines (Law360)
• Expediting The Expedited: How Rolling CMC Review Process Is Working For COVID-19 Vaccines (Pink Sheet)
• COVID-19 Vaccines Blaze New Path In the History Of Vaccine Development (Pink Sheet)
• US FDA Needs To Harmonize Postmarket Safety Plans For COVID Vaccines, CDC Advisors Urge (Pink Sheet)
• COVID Vaccine Postmarket Monitoring Will Depend On Which Adverse Events US FDA Wants To Watch (Pink Sheet)

• A Big Alzheimer's Drug Study Is Proceeding Cautiously, Despite The Pandemic (NPR)
• Woodcock's Prophesy Comes True: US FDA ANDA Approvals Decline From Record Levels (Pink Sheet)
• Emer Cooke Prepares To Take Over As Head Of EMA (Pink Sheet)
• UK life sciences industry does not want no-deal Brexit, says ABPI Chief (Pharmafile)
• Hiring In A Syndemic (LifeSciVC)
• BioSpecifics Jumps on Deal to Be Bought by Endo International (The Street)
• Pfizer plans to ditch Perth sterile injectables manufacturing site by 2024, endangering 470 positions (Fierce)
• Bristol Myers, Exelixis get in FDA fast lane for Opdivo-Cabometyx combo in kidney cancer (Fierce)
• Merck's rival to Pfizer's Prevnar 13 hits goal in phase 3 again (Fierce)
• AZ’s Tagrisso scores priority review from FDA (PharmaTimes)
• Intellia to kick-start first single-course 'curative' CRISPR shot, as it hopes to beat rivals Alnylam, Ionis and Pfizer (Fierce)
• News briefing: Merck preps FDA pitch after adding more data on V114; Bristol Myers, Exelixis get quick review for cancer combo (Endpoints)
• Agios' Tibsovo has an FDA green light in AML. Why did European regulators turn it back? (Fierce)
• Months after striking a deal with Sanofi, AbSci nails its largest fundraise yet to support its protein printing tech (Endpoints)
• Genentech taps Stanford University spinout for AI drug discovery partnership (Fierce)
• Roche finds a home for a new, $500M manufacturing logistics hub, promising 500 jobs (Endpoints)
• MD Anderson establishes new $50M+ biotech fund to choose the next promising cancer therapies (Endpoints)
• Left for dead after a failure in neuropathic pain, Aptinyx latches onto positive PhII data in PTSD (Endpoints)
• Cara lines up a $440M deal for US rights to its late-stage drug for severe itch, with $150M cash on the table (Endpoints)
• Bringing their genetically modified gamma delta T cells to Nasdaq, IN8bio files for $86M IPO (Endpoints)

• Philips Q3 connected care sales up 42%, but ventilators to decline next year (MedtechDive)
• FDA, medtechs envision new era for clinical trials amid COVID-19 shake-up (MedtechDive)
• Medtronic Announces Two New Trials To Expand TAVR Indications (MedtechInsight)
• Medtronic, The Foundry Invest In New Transcatheter Mitral Repair Technology (MedtechInsight)
• Natural Cycles submits FDA premarket notification for wearable birth control (mobihealthnews)

• Trump administration says Obamacare plan premiums 2% lower in 2021 (Reuters)
• High Court Won't Hear FDA Stimulant Seizure Suit (Law360)
• Lemonade from Lemons: Fairness in FDA Enforcement Actions (FDA Law Blog)