Recon: MiNA enters $1.25B partnership with Eli Lilly; EU launches new lawsuit against AstraZeneca in vaccine spat

• FDA Authorizes Pfizer-BioNTech Vaccine for Children 12 to 15 (NYTimes) (Politico) (FDA)
• US children ages 12 to 15 could begin COVID-19 vaccinations Thursday (Reuters)
• Novavax delays timelines for COVID-19 vaccine regulatory filings, production (Reuters) (The Hill)
• Inovio to start global late-stage COVID-19 vaccine trial this summer (Reuters)
• Florida releases genetically modified mosquitoes in hopes to reduce spread of disease (Reuters)
• Inside Pear’s ambitious plan to become the most dominant player in digital therapeutics (STAT)
• Lilly enlists a long-incubating RNA upstart in new $1.25B partnership (Endpoints) (Fierce)
• Biogen enlists under-the-radar AAV engineers as it pumps gene therapies into the pipeline (Endpoints) (BioPharmaDive)

• EMA head sees OK for BioNTech vaccine in 12-year-olds potentially in late May (Reuters)
• EU opens new front in AstraZeneca legal fight that may lead to fines (Reuters 1, 2)
• Germany wants EU to order COVID-19 booster vaccines from four companies – letter (Reuters)
• Canada's Alberta province halts AstraZeneca vaccine first shots due to supply issue (Reuters)
• Mexico to start phase III clinical trials for China's Walvax COVID vaccine (Reuters)
• Brazil chief health regulator disagrees with president on vaccines, masks (Reuters)
• Britain open to talks over vaccine waivers with US, others at WTO (Reuters)
• Dutch advisory group says Zolgensma shouldn’t be covered unless Novartis halves price (STAT)
• Takeda says it may double imports of Moderna shots to help accelerate Japan vaccination (Reuters)

• Pandemic plateauing with deaths and cases declining – WHO (Reuters)
• WHO says India Covid variant of 'global concern' (BBC)
• CDC’s slow, cautious messaging on Covid-19 seems out of step with the moment, public health experts say (STAT)
• US looking at joint production of Johnson and Johnson's COVID vaccine in India (Economic Times)
• MHLW to Fund 7 Development Projects for COVID-19 Therapies (PharmaJapan)
• Vietnam seeks mRNA tech transfer amid COVID-19 vaccine supply issues (Reuters)
• One AZ COVID-19 vaccine dose gives 80% lower death risk - English data (Reuters)
• Brazil states halt vaccination of pregnant women after Rio death (Reuters)
• Brazil to spend an extra $1 bln on producing, acquiring COVID-19 vaccines (Reuters)
• Mexico says US ready to share AstraZeneca vaccines after testing them (Reuters)
• France to allocate more than 5% of its COVID vaccines to WHO-backed COVAX programme (Reuters)
• Bolivia seeks to import COVID-19 vaccines from Biolyse, if Canada grants them a compulsory license (KEI)

• AIDS virus used in gene therapy to fix ‘bubble baby’ disease (AP)
• AstraZeneca chief suffers investor rebellion over pay (FT)
• Is Big Pharma’s influence on US trade policy dead? (FT)
• FDA unexpectedly grounds a gene therapy for a rare heart disease (BioPharmaDive)
• MHRA approves label extension for Vertex’s Kaftrio combo (PharmaTimes)
• Flagship startup Laronde hopes to use ‘endless RNA’ to produce new treatments (STAT)
• RWE upstart maps a new global plan as investors pour in the latest mega-round (Endpoints)
• Fixed Combinations Of ‘Old Antibiotic’ Plus New Moiety Eligible For NCE Exclusivity, US FDA Says (Pink Sheet)
• Changing Standards Of Care Trip Up Companies At US FDA Advisory Committees (Pink Sheet)
• Abbvie psoriatic arthritis drug approved for use in Scotland (Pharmafile)
• New Drugs Could Help Treat Obesity. Could They End the Stigma, Too? (NYTimes)
• AZ, Amgen file first-in-class asthma drug with the FDA (PMLive)
• Product Accepted Twice On PRIME Marks A First For EMA (Pink Sheet)
• Ginkgo Bioworks resizes the definition of going big in biotech, raising $2.5B in a record SPAC deal that weighs in with a whopping $15B-plus valuation (Endpoints)
• The incubator that hatched a Jennifer Doudna CRISPR startup blueprints new 'destination for life science entrepreneurship' (Endpoints)
• An AbbVie clinical vet heading early oncology jumps ship to build his own team at NK cell-focused biotech (Endpoints)
• Months after emerging from stealth, Nuvalent follows up with $135M Series B — backed by some active players on the biotech IPO scene (Endpoints)
• Nobel laureate David Baltimore throws his weight behind I/O startup looking to craft off-the-shelf CAR therapies (Endpoints)
• Ex-Purdue Pharma chief Mark Timney, named in dozens of opioid lawsuits, nabs another biotech CEO gig (Endpoints)
• After winding down Quench Bio with a bold dose of honesty, Sam Truex finds 'perfect fit' at Atlas Venture (Endpoints)
• The fight against drug-resistant bacteria marches forward as Adaptive Phage earns $40M+ Series B (Endpoints)
• Is remote work here to stay for biopharma? Early indications point to yes (Endpoints)
• Amgen Canada Launches Adalimumab Biosimilar (Big molecule watch)
• Arthropharm Pty Ltd fined $13,320 for alleged breaches of therapeutic goods legislation (TGA)
• Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions (FDA)

• OIG calls on EPA to review ethylene oxide cancer risks, possibly delaying new regulations until 2022 (MedtechDive)
• Targeted communication: CE mark suspended for all MAGEC systems manufactured by NuVasive Specialized Orthopedics, Inc. (MHRA)
• Mayo Clinic AI algorithm proves effective at spotting early-stage heart disease in routine EKG data (Fierce)
• DaVita taps into Baxter’s connected peritoneal dialysis system for home kidney care (Fierce)
• FDA greenlights Bigfoot Biomedical's insulin recommending diabetes management system (MobiHealthNews)
• Sprinting To Approval: Insider Tips On FDA’s Breakthrough Devices Program (MedtechInsight)

• FTC Returns Nearly $60 Million to Those Suffering from Opioid Addiction Who Were Allegedly Overcharged in Suboxone Film Scheme (FTC)
• Biden: 1 million Americans sign up for healthcare in special enrollment period (Reuters)
• Ginkgo Bioworks Valued At $15B In SPAC Deal Led By 3 Firms (Law360)
• Full Fed. Circ. Won't Review Becton's Wins On Drug Dosing IP (Law360)
• Justices Must Resolve Off-Label Drug Warning Predicament (Law360)
• GSK Gets Fines Slashed In UK Pay-For-Delay Case (Law360)