Recon: FDA approves Sarepta’s third DMD drug; Health Canada authorizes AstraZeneca vaccine

• FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected (Reuters) (STAT) (FT)
• During COVID-19, FDA’s Vaccine Advisory Committee Has Worked To Boost Public Trust – It Can Still Do More (Health Affairs)
• Sarepta wins new drug approval for patients with Duchenne muscular dystrophy, its third marketed treatment (STAT) (Endpoints) (FDA)
• Biden wants a review of the API supply chain. Will that parlay into an effort to 'onshore' drug manufacturing? (Endpoints)
• US to buy at least 100,000 doses of Lilly's COVID-19 antibody therapy (Reuters)
• White House planning to forecast vaccine shipments months in advance (Politico)
• CDC balks at watchdog’s push to remake Covid-19 tracking (Politico)
• ‘Repeal and replace’ is dead. Republicans can’t figure out what comes next. (Politico)

• Canadian regulator authorizes AstraZeneca vaccine (AP) (Health Canada)
• J&J Shot to Get EU Nod in Early March, Easing Supply Squeeze (Bloomberg)
• Facing long fight with COVID variants, EU pushes to step up vaccinations (Reuters) (Politico) (FT)
• Germans Clamor for Covid Vaccines, but Shun AstraZeneca’s Offering (NYTimes)
• French government opens door to AstraZeneca vaccine for the elderly (Politico)
• AstraZeneca, Sputnik vaccines face hurdles if COVID shots become annual affair (Reuters)
• EU regulator advises use of Regeneron antibody cocktail for COVID-19 (Reuters)
• AstraZeneca-Amgen drug could widen treatment options for severe asthma (Reuters) (Endpoints)
• Japan's Takeda sells four diabetes products to Teijin Pharma for $1.25 billion (Reuters)
• Risk of human spread of H5N8 bird flu deemed low: WHO (Reuters)

• Why AstraZeneca and J&J’s Vaccines, In Use Elsewhere, Are Still on Hold in America (KHN)
• Dexamethasone in Hospitalized Patients with Covid-19 (NEJM) (Editorial)
• COVID-19 Tests: How The EU Rules Are Changing And Where Questions Still Lie (MedtechInsight)
• Argentine lab says agrees deal to produce Russia's Sputnik V vaccine (Reuters)
• Vietnam says panel recommends Sputnik V, Moderna vaccines for use (Reuters)
• 'Made in Taiwan' COVID-19 vaccines could be ready in July, says minister (Reuters)
• Brazil to buy 20 million COVID-19 vaccines from India's Bharat Biotech (Reuters)
• Australia considers approving Pfizer Covid vaccine for standard cold storage (The Guardian)
• Japan Might Ease Temperature Requirements for Pfizer Vaccine (PharmaJapan)
• FDA tells Merck to show more data for its OncoImmune COVID-19 drug as EUA pushed back (Fierce)

• Top Moderna executive to leave company later this year (BioPharmaDive)
• EMA Works On Defining Metadata From RWD Sources (Pink Sheet)
• US FDA Gives Industry An Extension On Nitrosamine Risk Assessments (Pink Sheet)
• China Lays Out Requirements For Biosimilar Extrapolation (Pink Sheet)
• Bluebird reveals new details on cancer cases in gene therapy trial (BioPharmaDive)
• NICE recommends routine funding for Novartis’ Kisqali (PharmaTimes)
• The vial is not half empty: New report lays out ways to address the issue of discarded drugs (STAT)
• Gossamer pushes ahead with failed asthma drug; Cullgen gets $50M Series B for protein degraders (Endpoints)
• Roivant parlays a $450M chunk of equity in biotech buyout, grabbing a computational group to drive discovery work (Endpoints) (Fierce)
• Intercept Commits To Resubmitting NASH NDA, But Analysts See Conflicting Signs (Scrip)
• Perceptive's fourth — yes, fourth — SPAC jumps to Nasdaq as the blank check tree continues to ripen (Endpoints)
• Genentech plots $53M discovery quest aimed at sparking a 'Holy moly' pivot in neuro R&D (Endpoints)
• In search of 'household healthcare brands of the future,' Foresite Capital raises $969M to satiate a tech-heavy appetite (Endpoints)
• Avid Bioservices, with recent IPO and Covid-19 partnership in hand, launches 2nd phase of facility expansion (Endpoints)
• Mark Mallon charts post-Ironwood course by taking CEO job at NeoGenomics; GlaxoSmithKline vet Feng Ren joins Insilico as CSO (Endpoints)
• NK cell therapy player Artiva makes some more noise, pulling in $120M Series B less than a month after Merck deal (Endpoints)
• US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols (Pink Sheet)
• Regeneron's Inmazeb Overcame FDA Combo Product Requirements With Nonclinical Evidence (Pink Sheet)
• European Medicines Agency Accepts Pfizer’s Marketing Authorization Application For Its Investigational 20-Valent Pneumococcal Conjugate Vaccine For Adults 18 Years Of Age Or Older (Press)
• Ema Accepts Marketing Application For Somatrogon To Treat Pediatric Patients With Growth Hormone Deficiency (Press)

• FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts (FDA)
• iRhythm still faces reimbursement uncertainty after meetings with Medicare rate negotiator (MedtechDive)
• FDA's enforcement discretion for digital health is more ambiguous than ever in 2021 (mobihealthnews)
• Diabetes wearables look resilient through pandemic into 2021, bucking broad medtech trends (MedtechDive)
• NuVasive buys Simplify Medical in play for $2.6B cervical spine market (MedtechDive)
• Axonics adds incontinence device to portfolio in $200M Contura takeover (MedtechDive)
• Targeted letter: Implantable orthopaedic devices manufactured by Implants International Ltd trading as Xtremity Solutions Ltd. (MHRA)
• Singapore Prepares UDI System, Malaysia Seeks Regulatory Improvements And Indonesia Adjusts To Changing Environment (MedtechInsight)

• Sen. Cassidy explains why he’s backing a bill aimed at drug-resistant bacteria (STAT)
• Tribunal Upholds CMA's Antidepressant Market Rigging Fine (Law360)
• Small Odds Humira Patents All Invalid 'Worries' 7th Circ (Law360)
• The Southern District of Mississippi Gets It Right in Mesh Summary Judgment Decision (Drug & Device Law)