Recon: Executive shakeup at Emergent; Global drug spending to hit $1.6T by 2025, says IQVIA

• AstraZeneca on track to submit data for US vaccine approval, says chief (FT) (Reuters)
• AstraZeneca Struggles With Data Needed for Covid-19 Vaccine’s Approval (WSJ)
• FDA panel wrestles through multiday cancer drug meeting (Politico)
• Merck, Roche and Bristol Myers nab 4 of 6 positive ODAC votes for ‘dangling’ accelerated approvals (Endpoints)
• An Alzheimer's Drug May Boost Cognition In People With Fragile X Syndrome (NPR)
• House committee to grill AbbVie CEO next month on suppressing Humira competition (Endpoints)
• Shake-Up at Covid Vaccine Manufacturer That Tossed Millions of Doses (NYTimes) (Endpoints)
• Gilead’s Q1 revenues lifted by COVID-19 med Veklury as HIV drugs take a hit (PMLive)
• Top Senate Democrat heads back to drawing board on drug pricing (STAT)
• FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose (FDA)

• Global spending on medicines could hit $1.6 trillion by 2025 — and that doesn’t include Covid-19 vaccines (STAT) (PharmaTimes) (Endpoints)
• AstraZeneca says on track to deliver on COVID shots as sales hit $275 mln (Reuters) (Endpoints)
• Some EU nations still want Valneva COVID-19 vaccine deal – sources (Reuters)
• WHO expects assessment of Moderna and two Chinese vaccines by end of next week (Reuters)
• Indonesia approves Sinopharm COVID-19 vaccine for emergency use (Reuters)
• Pfizer begins exporting U.S.-made COVID-19 vaccine to Mexico (Reuters)
• Russian vaccine developer plans to sue Brazilian regulator for defamation (Reuters)

• South Africa regulator says J&J shot can be given to pregnant women (Reuters)
• Russia produces first batch of COVID-19 vaccine for animals -regulator (Reuters)
• ‘A tough call’: Biden considering mandatory Covid vaccines for U.S. troops (Politico)
• Novavax handed an extra $147M from legacy Warp Speed program as spotlight shines brighter (Fierce)
• TimesSome elderly patients still succumb to Covid despite jabs, UK study finds (FT)

• FDA hits Leo Pharma with a CRL for what the biotech says are questions about the 'device component' of eczema candidate (Endpoints)
• Biogen won’t explain why FDA slapped down their bid for new Tysabri formulation (Endpoints)
• AbbVie Reports First-Quarter 2021 Financial Results (Press)
• Vaccitech slides in US stock market debut (FT)
• J&J bids for EU OK on Legend CAR-T; FDA extends review period for Ardelyx's phosphorus control drug (Endpoints)
• The company behind AstraZeneca's Covid-19 vaccine just went public, weeks after completing monster Series B, as Werewolf also makes the Nasdaq leap (Endpoints)
• AstraZeneca drops BCMA drug after seeing early clinical data (Fierce)
• Bobbing on a sea of crises, bluebird's Nick Leschly sees his pay cut in half as the biotech prepares to split (Endpoints)
• Bristol Myers' Opdivo scores priority review in common bladder cancer, marking latest win in PD-1 battle with Keytruda (Endpoints)
• MHLW Revokes Approval for 12 Kobayashi Kako Products, Imposes Biz Improvement Order (PharmaJapan)
• MHLW to Set New Generic Target of 80% in Every Prefecture by FY2023-End (PharmaJapan)
• New Industry Vision to Reaffirm Pharmaceuticals as Growth Industry: MHLW Director (PharmaJapan)

• Hologic, Thermo Fisher cautious on COVID-19 test demand as vaccines roll out (MedtechDive)
• FDA clears augmented reality smartglasses for guiding knee replacement surgeries (Fierce)
• Molli Surgical wins FDA clearance for tablet-connected magnetic marker targeting breast cancer tumors (Fierce)
• CMS finalizes joint replacement pricing extension with input from medtech industry (MedtechDive)

• GlaxoSmithKline backs Amgen in PCKS9 patent fight, arguing court decision could 'devastate' R&D incentives (Fierce)
• Fed. Circ. OKs ITC Ruling That Bio-Rad Infringed 10x Patents (Law360)
• Drug Cos. In Opioid Bellwether Deny Any Duty To Halt Orders (Law360)
• Celgene Sues Hikma To Block Revlimid Generic (Law360)