Recon: EMA hit by cyberattack; Supply shortfall could slow Biden vaccine plans

• Biden Promises 100M Vaccine Shots in 100 Days, but Shortage Worries Rise (NYTimes) (Reuters)
• US could face months of vaccine shortages amid global competition (Politico)
• Millions of Americans receive drugs by mail. But are they safe? (NBC)
• Pfizer CEO confident of getting USadvisory panel nod for COVID-19 vaccine (Reuters)
• FDA Head Stephen Hahn On What's Next For Pfizer Vaccine In Fast-Moving Process (NPR)
• CDC advisers to review data on Pfizer-BioNTech COVID-19 vaccine (Reuters)
• Blunders Eroded US Confidence in Early Vaccine Front-Runner (NYTimes)
• Teva settles remaining Intuniv pay-for-delay claims (Reuters)
• Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug (STAT)
• Trump takes vaccine victory lap at White House summit (STAT)

• Health Canada approves Pfizer and BioNTech's COVID-19 vaccine (Reuters) (Health Canada)
• Cyberattack on the European Medicines Agency (EMA)
• Canada confident in vaccine deliveries even if US blocks exports (Reuters)
• UK warns people with serious allergies to avoid Pfizer vaccine after two adverse reactions (Reuters 1, 2) (FT)
• UK medicine regulator to assess best dose regimen of Oxford/AstraZeneca COVID vaccine (Reuters)
• UAE Is First Government to Approve a Chinese Coronavirus Vaccine (NYTimes) (Bloomberg) (NPR)
• India denies it rejected emergency AstraZeneca shot approval (Reuters 1, 2)
• Amnesty: rich countries have bought too many COVID-19 vaccines (Reuters) (BBC)
• The threat of antibiotic resistance — in charts (FT)
• Covid delays India’s attempts to curb widespread overuse of antibiotics (FT)

• As US companies push to get workers vaccinated, states disagree on who's essential (Reuters)
• Roche joins Moderna to include antibody test in COVID-19 vaccine trial (Reuters)
• Placebo-Control Strategy After EUA Remains Big Question For Pfizer/BioNTech COVID-19 Vaccine (Pink Sheet)
• Crimped U.S. dry ice supply complicates rural U.S. vaccine release (Reuters)
• Russia and China have not sought EMA's authorisation for vaccines (Reuters)
• AstraZeneca partners with Halix to manufacture COVID-19 vaccine in Netherlands (Reuters)
• Sanofi won’t use its Canadian facility to make a COVID vaccine (iPolitics)
• Israel receives initial shipment of Pfizer coronavirus vaccine (Reuters)
• Indonesia's Bio Farma says not yet able to determine Sinovac vaccine efficacy (Reuters)
• South African trial of AstraZeneca vaccine still months from efficacy results (Reuters)
• Don't mix Sputnik vaccine with alcohol, says Russian official. Some recoil (Reuters)

• McKinsey Issues a Rare Apology for Its Role in OxyContin Sales (NYTimes)
• Oncology, Rare Disease Drugs Dominate New China Approvals (Pink Sheet)
• The eCTD v4.0 Q&A v1.4 reaches Step 4 of the ICH process (ICH)
• Project Orbis: Strengthening International Collaboration for Oncology Product Reviews, Faster Patient Access to Innovative Therapies (FDA)
• Former FDA Commissioners Muse On Vaccine Surveillance – And The Next Operation Warp Speed (Pink Sheet)
• ‘I just white-knuckle it’: Hemophilia patients pin their hopes on the revival of Vioxx to fill a void in pain relief (STAT)
• Eli Lilly is rapidly approaching its Trulicity doomsday, but it may have a nice consolation prize in tirzepatide (Endpoints)
• bluebird bio’s beta thalassaemia gene therapy Zynteglo scores promising long-term data (PMLive)
• Assembly Bio scraps microbiome programs; InveniAI, Kyowa Kirin expand partnership to focus on novel targets (Endpoints)
• AbbVie chases its next golden goose in a post-Humira future with new ulcerative colitis data for Rinvoq (Endpoints)
• Boehringer Ingelheim bags a contract manufacturer, adding muscles for cancer vaccine, oncolytic virus programs (Endpoints)
• With plans to bring surufatinib stateside, Chi-Med vastly scales up manufacturing with new Chinese plant (Endpoints)
• In another blow to MSCs developer, Pluristem terminates a failed lead program (Endpoints)
• 'Scale and speed': Hillhouse puts its weight behind China startup eyeing cutting-edge tech from around the world (Endpoints)
• RA Capital backs Oxford spinout PepGen with a $45M Series A, seeking to treat Duchenne and other similar diseases (Endpoints)
• Novo and Abingworth back a $95M Series B for Reneo Pharmaceuticals, which aims to treat diseases of the mitochondria (Endpoints)
• Little Evelo sees big promise in its first cut of data from a tiny study on atopic dermatitis (Endpoints)
• Novartis' CDK4/6 med Kisqali, firmly the sales underdog against Pfizer's Ibrance, drops big OS data (Endpoints)
• Beating Merck, Pfizer gets priority review as the first Prevnar follow-up heads to the FDA (Endpoints)

• GE medical imaging devices impacted by critical cyber vulnerability (MedtechDive)
• Shares of medical device maker Penumbra tank after short seller releases critical report (CNBC)
• Boston Scientific's Lotus ditch creates 'duopoly' in growing TAVR market (MedtechDive)
• Medtronic launches first neonatal dialysis machine in the U.S. (Fierce)
• Qiagen ups outlook, predicts double-digit non-COVID product growth amid analyst skepticism (MedtechDive)
• Early Cancer Detection: Will New Screening Technology Disrupt Cancer Care? (MedtechInsight)
• Apple's ECG feature can detect A-Fib with high HR thanks to new FDA clearance (mobihealthnews)
• CBT digital therapeutic for IBS patients receives FDA De Novo clearance (mobihealthnews)

• Trump Team Proposes A Rule That Could Stall Biden's Health Care Agenda (NPR)
• Par Sues Generic Cos. Over Blood Pressure Drug (Law360)
• Oklahoma Backs $465M Opioid Win Against J&J (Law360)
• Fed. Circ. Mulls Undoing Mylan Win In Biogen Drug IP Fight (Law360)
• AbbVie Wants Allergan Merger Docs Out Of Opioid MDL (Law360)
• Broad Institute Loses Appeal in European Patent Office, Patents Remain Revoked (Patent Docs)
• Federal Circuit Limits Venue in Hatch Waxman Patent Litigation (FDA Law Blog)
• Connecticut Court Strikes Failure to Warn Claims against Non-NDA Holder (Drug & Device Law)