Recon: Pfizer to boost US vaccine deliveries as EU secures more doses; Tango to go public in $353M SPAC deal

• CDC to weigh rare clot risk with J&J's COVID-19 vaccine as use paused (Reuters) (NYTimes)
• Biden officials bracing for possibility of weekslong disruption to J&J vaccine supply (Politico)
• FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots (Reuters)
• Pfizer to deliver 10% more doses to US by end of May- CEO (Reuters)
• Moderna says protection from its COVID-19 vaccine still strong six months on (Reuters)
• Justice Department backs extending ban on fentanyl copycats (Reuters)
• Overdose Deaths Have Surged During the Pandemic, CDC Data Shows (NYTimes)
• Federal prosecutors launch Alnylam marketing probe, demanding Onpattro documents (Fierce)
• Tango Therapeutics to go public in $353 million SPAC deal (STAT) (BioPharmaDive)
• White House Expands List of Potential FDA Commissioners (WSJ) (Law360)
• A US appeals court upholds the FTC view of controversial pay-to-delay settlements (STAT) (Endpoints)

• EU to raise COVID vaccine supplies from Pfizer in second quarter to 250 million doses (Reuters)
• In world first, Denmark ditches AstraZeneca's COVID-19 shot (Reuters)
• EU Commission to end AstraZeneca and J&J vaccine contracts at expiry – paper (Reuters)
• CanSinoBIO says no serious blood clots from its vaccine (Reuters)
• AstraZeneca's drug Tagrisso gets China nod for early lung cancer (Reuters)
• UK trial on switching COVID-19 vaccines adds Moderna and Novavax shots (Reuters)
• Brazil justice gives health regulator 30 days to decide on Sputnik vaccine (Reuters)

• France says to administer J&J COVID-19 vaccine as planned (Reuters)
• Sweden pauses plans for J&J COVID-19 vaccinations, awaits review (Reuters)
• Stalled Pfizer deal clouds Israel's hopes of swift herd immunity (Reuters)
• Canada reports first case of rare blood clotting after AstraZeneca COVID shot: ministry (Reuters)
• Armenia to receive 1 million doses of Russia's Sputnik V shot: TASS (Reuters)
• South Africa suspends J&J vaccine rollout after U.S. pause (Reuters)
• South Africa says downpayments to J&J, Pfizer not refundable (Reuters)
• OHT-7’s Q1 2021 Report Card on EUA Reviews (FDA Law Blog)
• TGA grants provisional determination to Glaxo SmithKline Australia Pty Ltd for COVID-19 monoclonal antibody treatment – SOTROVIMAB (TGA)
• Lucira gets FDA nod for OTC molecular COVID-19 test (MedtechDive)

• Lilly, Arch join Deerfield in backing new gene therapy biotech Jaguar (BioPharmaDive)
• Eli Lilly seeds a well-connected China neuro startup with drugs aiming at where Biogen, Voyager missed (Endpoints)
• FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer (FDA)
• Novavax CFO Greg Covino to step down (Reuters)
• Former head of FDA’s medical and scientific affairs on Covid: ‘FDA has never been tested like this’ (Endpoints)
• PhRMA chief talks strategy — and he’s surprisingly optimistic about drug pricing reform (STAT)
• Can Biosimilars Compete With ‘Unbranded Biologics’ In The US Market? (Pink Sheet)
• Gross-to-Net Bubble Update: Net Prices Drop (Again) at Six Top Drugmakers (Drug Channels)
• Lilly Closes Dermira’s Menlo Park Facility, Cutting 163 Jobs in the Process (BioSpace)
• After being goaded to sell the company, Alexion's CEO set some ambitious new goals for investors. Then Pascal Soriot came calling (Endpoints)
• Forxiga accepted for use within NHS Scotland for chronic heart failure (Pharmafile)
• NICE publishes new guidance on chronic pain management (PharmaTimes)
• Pfizer, Myovant begin dosing in relugolix contraceptive study (PharmaTimes)
• Meet Benchling, the latest unicorn seeking to revolutionize the way scientists do work with the help of the cloud (Endpoints)
• Amylyx to move forward with ALS program in Europe, but FDA wants another look; Humacyte adds $50M in debt financing (Endpoints)
• Launched by MIT grads, a small startup gets $20M to back a robotics revolution in cell therapy manufacturing (Endpoints)
• Nearly a year after Audentes' gene therapy deaths, the trial continues. What happened remains a mystery (Endpoints)
• Anti-aging biotech upstart plucks a drug from Amgen's discard pile, pivoting from heart failure to muscle conditions (Endpoints)

• Mid-sized medtechs hit hardest by pandemic, though sector seen resilient: poll (MedtechDive) (Emergo)
• Roche, Biocorp begin French rollout of add-on device connecting insulin pens to smartphone apps (Fierce)
• Medtronic launches 7-day diabetes infusion tubing set in Europe (Fierce)
• AstraZeneca, Sanguina to develop app for bloodless blood testing (Fierce)
• TFDA releases details about transition to new Taiwanese medical device regulations (Emergo)
• TGA presentation: The regulation of medical device software, February 2021 (TGA)

• 4th Circ. Revives Antitrust Suit Over Actelion's Drug Tracleer (Law360)
• Federal Court Halts Implementation of 340B Dispute Resolution Rule (Harvard Bill of Health)