Recon: Merck to buy OncoImmune for $425M; FDA approves first drug for Progeria

• AstraZeneca to seek FDA authorization for vaccine based on foreign trial data (Politico)
• FDA approves first drug for rare disease that causes premature aging in children (Boston Globe) (FDA)
• FDA approves Xofluza for post-expousre prevention (FDA)
• US infectious disease group backs Gilead's remdesivir for COVID-19 treatment (Reuters)
• Trump unveils plan linking drug payments to cheaper overseas prices (Politico) (STAT) (NYTimes)
• New Trump Medicare drug-price rules denounced as political revenge by industry (Reuters)
• Merck adds experimental COVID-19 therapy with OncoImmune deal (Reuters) (STAT)
• COVID-19 shots could reach first Americans by mid-December, top health official says (Reuters)
• Moderna to charge $25-$37 for COVID-19 vaccine: CEO tells paper (Reuters)
• FDA grants emergency use of Covid treatment given to Trump (Politico) (Reuters)
• Now the U.S. Has Lots of Ventilators, but Too Few Specialists to Operate Them (NYTimes)

• AstraZeneca Covid-19 vaccine is 70% effective on average, early data show (STAT) (Reuters 1, 2, 3, 4, 5) (NYTimes) (BBC)
• EU plans easier access to generics in potential blow to big drugmakers (Reuters)
• UK medicine regulator will make Pfizer vaccine decision in "shortest time possible" (Reuters)
• WHO says $4.3 billion urgently needed for vaccine sharing scheme (Reuters)
• Wealthy countries block COVID-19 drugs rights waiver at WTO (Reuters)
• G20 leaders pledge to ensure global access to Covid vaccines (FT)
• Update on remdesivir - EMA will evaluate new data from Solidarity trial (EMA)

• Politics, Science and the Remarkable Race for a Coronavirus Vaccine (NYTimes)
• 2 Companies Say Their Vaccines Are 95% Effective. What Does That Mean? (NYTimes)
• Vaccine contracts shrouded in secrecy despite massive public funding (FT)
• How thousands of scarce Covid shots could go to waste (Politico)
• Antibodies Good. Machine-Made Molecules Better? (NYTimes)
• Should researchers shelve plans to deliberately infect people with the coronavirus? (Science)
• Brazil to start production of AstraZeneca vaccine by January, says biomedical center (Reuters)
• Brazil signs letter of intent to purchase five COVID vaccines (Reuters)
• Germany may start COVID-19 vaccine programme in December: health minister (Reuters)
• Canada expects six million COVID-19 vaccine doses early in 2021 (Reuters)
• Serum Institute to focus on supplying COVID-19 vaccine to India first (Reuters)
• India says local COVID-19 vaccine final trials could end within two months (Reuters)
• Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives interim authorization from Health Canada as a treatment for COVID-19 (Press)

• Raging at the pandemic, a VC raises $800M for a company that aims to transform biotech manufacturing (STAT)
• Belgium biotech argenx nabs Bayer speedy review voucher for a cool $98M (Fierce)
• TimesAmazon’s drugs unlikely to prove fatal to pharmacies, say experts (FT)
• A new startup wants to use natural killer cells to fight cancer (STAT)
• TCR pioneer Immunocore scores a first with a landmark PhIII snapshot on overall survival for a rare melanoma (Endpoints)
• Plot thickens around Legend Biotech, GenScript with founder Frank Zhang's arrest (Endpoints)
• Tech billionaire Peter Thiel backs a leading psychedelic drug developer (Endpoints)
• Bristol Myers fronts new Schrödinger alliance with $55M upfront, expanding precision oncology profile (Endpoints)
• GSK starts phase 3 study of RSV maternal candidate vaccine (Press)

• US FDA Adds 14 New Regulatory Tools To Help It Review Medical Devices (MedtechInsight)
• FDA approves Hologic's 2-in-1 HIV test for both diagnosis and viral load monitoring (Fierce)
• Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource (Press)

• NIH fails to disclose enough details about drug licensing, watchdog report finds (STAT)
• NIH-Licensed Patents Don’t Account For Substantial Drug Spending, GAO Finds (Pink Sheet)
• Reviewing Pre-PREP Act Mass Vaccination Cases (Drug & Device Law)