Recon: Moderna to seek EU rolling review for COVID-19 vaccine; Regeneron requests EUA for COVID-19 antibodies

• Moderna Vows to Not Enforce Covid-19 Vaccine Patents During Pandemic (WSJ)
• Regeneron Asks FDA for Emergency Approval for Drug That Trump Claimed Cured Him (NYTimes) (Bloomberg) (Endpoints) (Reuters)
• Trump says ‘no president’s ever pushed’ the FDA like him, vaccine coming ‘very shortly’ (CNBC)
• Regeneron antibodies in demand after Trump treatment, doctors seek more data (Reuters)
• Enough doses of COVID-19 vaccine could be made for US by March to April: HHS (Reuters)
• In a First, New England Journal of Medicine Joins Never-Trumpers (NYTimes) (NEJM)
• FDA documents raise opioid abuse potential but pave a path toward badly-needed approval for Alkermes (Endpoints) (Pink Sheet)
• FDA investigating whether Intercept Pharma drug is tied to potential liver injury risk (STAT)

• Moderna to apply for EU's rolling approval for COVID-19 vaccine (Reuters)
• EU's potential COVID-19 vaccine doses top a billion with J&J deal (Reuters)
• AstraZeneca vaccine document shows limit of no-profit pledge (Financial Times) (Reuters)
• Europe stocks up on Gilead's remdesivir as COVID-19 infections spike (Reuters)
• Eli Lilly in deal to supply COVID-19 drugs to low-income countries (Reuters)
• Roche ships supplies from Germany to plug UK tests shortfall (Reuters)
• EU must wean itself off Asia for key drug ingredients (Reuters)
• How hot is Hong Kong's biotech IPO market? Two biotechs just raised $800M total (Endpoints)

• Harris, Pence spar over COVID-19 vaccine (The Hill) (Politico)
• Saying human trials aren’t enough, researchers call for comparison of COVID-19 vaccines in monkeys (Science)
• Ironic Twist: In Spring, Trump Halted Research Key To COVID-19 Drug He's Now Taken (NPR)
• Fosun unit to begin U.S. trial of COVID-19 antibody treatment soon (Reuters)
• Pfizer, BioNTech bring on Germany's Rentschler for purification of mRNA-based coronavirus shot (Fierce)
• Vaxart inks manufacturing pact with Kindred Bio for oral vaccines to battle COVID-19, other viruses (Fierce)
• India declines proposal to test Sputnik-V Covid vaccine in large study (Economic Times)
• Russia's R-Pharm retools arthritis drug for COVID-19 patients in clinical trial (Reuters)
• BioNTech expects pre-reserved vaccine bottling capacity to be freed up (Reuters)
• UAE company nears end of Chinese Covid-19 vaccine trial (Reuters)
• Germany says secured nine million COVID-19 antigen tests per month (Reuters)
• Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications: Guidance (Health Canada)

• Pfizer presents growth hormone data ahead of FDA filing (Fierce)
• Pfizer and Sangamo, after rival's setback, kick off late-stage gene therapy trial (BioPharmaDive)
• Takeda drops $300M cash to kick off $1B RNAi alliance with Arrowhead, shooting for first-in-class rare disease drug (Endpoints) (Fierce)
• Amgen's big cardiovascular bet with Cytokinetics hits PhIII primary but dramatically disappoints investors (Endpoints) (STAT)
• ABPI calls on UK government to create non-COVID clinical research strategy (PharmaTimes)
• CRISPR-Based ALS Treatment Being Developed by Scribe and Biogen (GEN)
• Fujifilm to Expand Viral Vector CDMO Biz to Europe (PharmaJapan)
• Celgene shareholders are parsing blurry photos in search of a payday (STAT)
• Gene Therapies Dominate New Crop Of EU PRIME Recipients (Pink Sheet)
• In another PhIII, Albert Bourla continues to build case for a once-flopped GHD drug (Endpoints)
• As Moderna doubles down on vaccines, Merck pulls out of a long-running collaboration (Endpoints)
• J&J, Cigna back a vant’s quest to go deeper into the data and start connecting the dots (Endpoints)
• Not two weeks after closing a Series D round, Galecto files for $100M IPO (Endpoints)

• European Commission ‘Will Not Delay IVDR, Nor MDR Any Further’ (MedtechInsight)
• Why Apple needed the FDA to sign off on its EKG but not its blood oxygen monitor (The Verge)
• Analysts predict Zimmer Biomet M&A in 2021 to speed growth (MedtechDive)
• Genentech taps Imbio to develop AI programs for scanning lung diseases (Fierce)
• Avail raises $100M to let medtech reps remotely oversee surgeries (MedtechDive)
• Turkey’s $2.6Bn Hospital Medtech Debts Create Problems On Top Of COVID-19 (MedtechInsight)

• Generics Worry Fed. Circ. Blew Up 'Routine' Labeling Practice (Law360)
• Regeneron Says Feds' Kickback Theory Makes Charity Illegal (Law360)
• Gilead Accused Of Antitrust Scheme Over HIV Meds (Law360)
• Changing sponsor details in Product Information (PI) and labels of prescription medicines (TGA)