Recon: AstraZeneca COVID vaccine 79% effective in US trial; FDA raises safety concerns ahead of tanezumab adcomm

• AstraZeneca US trial data a confidence booster for COVID-19 shot (Reuters) (NYTimes) (STAT) (Press)
• Covid-19 Vaccine Manufacturing in US Races Ahead (WSJ)
• Russia says unnamed US firm violated patent rights on Sputnik V vaccine (Reuters)
• Vaccine mystery: Why J&J’s shots aren’t reaching more arms (Politico)
• Push to make Covid vaccines causes US drug shortages (FT)
• Pfizer has run 41 trials over 15 years for tanezumab. As adcomm nears, the FDA remains unimpressed — and more than a little worried (Endpoints) (Fierce)
• PhRMA attacks New Mexico’s ‘short on detail’ plan for Canadian drug imports (Endpoints)

• As vaccine battle with UK deepens, EU blames AstraZeneca (Reuters)
• AstraZeneca expects EU to approve Dutch vaccine factory by early April, executive says (Reuters)
• European trust in AstraZeneca COVID-19 vaccine plunges, poll shows (Reuters)
• Scientists probe new theories on whether AstraZeneca shot linked to blood clots (Reuters)
• European Medicines Agency set to visit Russia on April 10: health minister (Reuters)
• EU has 'absolutely no need' of Sputnik V vaccine, commissioner says (Reuters)
• India's Serum to delay further vaccine shipments to Brazil, Morocco, Saudi: source (Reuters)
• Drug companies defend vaccine monopolies in face of global outcry (Washington Post)

• China reaches 70 million COVID-19 vaccinations: state media (Reuters)
• TGA approves CSL - Seqirus to manufacture AstraZeneca COVID-19 vaccine in Australia (TGA)
• FDA grants EUA to COVID-19 screening device using machine learning (MedtechDive) (FDA)
• Egypt aims for deal to produce Sinovac COVID-19 vaccines (Reuters)
• Pakistan to start private imports of CanSino COVID-19 vaccine for sale (Reuters)
• Japan's KM Biologics begins clinical trial of COVID-19 vaccine candidate (Reuters)
• Thai-developed COVID-19 vaccine starts human trials (Reuters)
• India's Virchow Biotech to make Russia's Sputnik V shot in India (Reuters)
• The Hype Has Faded, but Don’t Count Out Convalescent Plasma in Covid Battle (KHN)

• José Baselga, renowned cancer researcher and AstraZeneca oncology R&D head, dies at 61 (STAT)
• With new results, Sarepta's 2nd gene therapy holds steady (BioPharmaDive)
• Roche’s Tecentriq improves disease-free survival in early lung cancer (PharmaTimes) (Press)
• FDA nod for Kiniksa’s Arcalyst in recurrent pericarditis (PharmaTimes)
• NICE recommends Kyprolis triple combination treatment for multiple myeloma (PharmaTimes)
• Elisabet de los Pinos and her team fuel up for a late-stage quest to deliver a safe eye cancer drug (PharmaTimes)
• Takeda takes a swing at RNA small molecules with discovery pact for multiple potential Evotec programs (Endpoints)
• Roche claims key win in the $12B early-stage checkpoint race (Endpoints)
• Innoforce gets $96M to build up China campus, including a new Thermo Fisher-partnered monoclonal antibody manufacturing facility (Endpoints)
• XyloCor finds new backing to push regenerative heart disease gene therapy deeper into the clinic (Endpoints)
• Those NDA plans Odonate had for mid-'21? They're being scrapped — along with the entire biotech — in a sudden implosion (Endpoints)
• Three biotechs set terms in a hunt for $475M-plus; Leap Therapeutics earns a trial win across DKK1 high expressing tumors (Endpoints)

• Digital therapeutics startups are ready for more regulation, not less (STAT)
• FDA Meeting Will Focus On Aggregating Patient-Generated Health Data (MedtechInsight)
• Neurostim device nets FDA breakthrough label to wean COVID-19 patients off ventilators (Fierce)

• ‘The public is being denied the truth’: A legal expert blasts Purdue’s bankruptcy plan to end opioid lawsuits (STAT)
• Wrong Court Redux – Novel Valsartan Predictions Defy Erie & Third Circuit Precedent (Drug & Device Law)
• HHS Halts 'Ticking Timebomb' Sunset Rule After Being Sued (Law360)