Recon: Lilly to seek accelerated approval for its Alzheimer’s drug; FDA to add warning about rare heart inflammation to Pfizer, Moderna vaccines

• Biogen working to speed up confirmatory study for approved Alzheimer's drug (Reuters)
• Biogen opens door to adjusting price of Alzheimer's drug amid outcry (The Hill)
• Lilly to seek accelerated FDA approval for Alzheimer's drug this year (Reuters) (STAT) (Press)
• Op-Ed: Here’s why we approved the 1st new Alzheimer’s drug in 2 decades (WaPo) (STAT)
• Heart Problems After Vaccination Are Very Rare, Federal Researchers Say (NYTimes) (FT) (STAT)
• FDA to add warning about rare heart inflammation to Pfizer, Moderna vaccines (Reuters) (Politico)
• House panels expand probe into Emergent Baltimore COVID-19 vaccine plant (Reuters) (The Hill)
• NIH begins clinical trial testing COVID-19 vaccine in pregnant women (Reuters)
• Eisai's drug for Alzheimer's with Biogen gets breakthrough status in US (Reuters)
• A Pfizer win in a heated anti-kickback case could lead to a ‘gold rush’ of biopharma companies subsidizing Medicare drugs, government says (Endpoints)
• The Supreme Court saved Obamacare. Now supporters want Biden to fix the law. (Politico)

• EU drug regulator positive on early data on mixing coronavirus vaccines (Politico) (The Hill)
• AstraZeneca, Pfizer vaccines effective against Delta COVID-19 variants-study (Reuters)
• Let down by rich and failing the poor, global vaccine scheme to be shaken up (Reuters)
• Directors General of WHO, WIPO and the WTO agree on intensified cooperation in support of access to medical technologies worldwide to tackle the COVID-19 pandemic (WHO)
• Pfizer halts anti-nicotine therapy’s circulation amid impurity concerns (Korea Biomedical Review)

• Scientist Finds Early Virus Sequences That Had Been Mysteriously Deleted (NYTimes) (Science)
• CDC group says there isn’t enough data yet to recommend Covid booster shots (CNBC)
• Vaccines For COVID Variants Will Require Clinical Data, US FDA Says (Pink Sheet)
• Behind the historic US vaccine effort is FDA's Peter Marks. The job is 'not for the faint of heart.' (USA Today)
• Africa CDC says continent not winning against 'brutal' COVID-19 pandemic (Reuters)
• Afrigen gears up to deliver Africa's first COVID-19 mRNA vaccine (Reuters)
• U.S. to send 3 million J&J COVID-19 vaccine doses to Brazil (Reuters)
• UK scientists identify antibody levels needed to prevent symptomatic COVID-19 (Reuters)
• TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran (TGA)

• 5 companies harnessing AI for drug discovery to watch (STAT)
• FDA slams Incyte's PD-1 over single-arm study, low response and trial deaths (Endpoints)
• Former Head Of Psychiatry Products At FDA Joins Psychedelic Drug Developer Cybin (Forbes)
• As 5 Blue Cross Blue Shield plans join to tackle drug prices, some remain skeptical (BioPharmaDive)
• MHLW Panel Roughly OKs Scheme for Generic Makers to Join Revlimid Risk Management Program (PharmaJapan)
• Japan Approves Verquvo, Evrysdi, 2 CGRP Migraine Meds and More (PharmaJapan)
• US FDA Investigating Auto-Injector Problems With Copaxone Generics (Pink Sheet)
• China’s First CAR-T Is From Fosun Kite; Overseas Data Played Key Role (Pink Sheet)
• MHRA and EC approve Leo Pharma’s Adtralza for atopic dermatitis (PharmaTimes)
• Senators call for hearing to examine how Medicare will handle Biogen's new Alzheimer's drug (Endpoints)
• Roche severs ties with 4D Molecular Therapeutics over blindness gene therapy, marking another setback for the field (Endpoints)
• Langer lab spinout Lyndra raises $60.5M in bid to replace existing HIV, schizophrenia, opioid abuse treatments (Endpoints)
• Can a cell therapy treat muscular dystrophy? A German billionaire's anti-aging startup is trying to find out (Endpoints)
• Monte Rosa takes this week's IPO lead as a nine-figure raise pushes industry total past $9B (Endpoints)
• EQRx and Exscientia, a pair of self-styled disruptors, team up to overturn the drug pricing apple cart (Endpoints)
• Arie Belldegrun's Vida Ventures goes back to the well with $825M megafund and its eyes set on more innovative meds (Endpoints)
• Arcus declares cryptic interim win for closely watched anti-TIGIT drug, but you'll have to wait for the data (Endpoints)
• Hutchmed/AstraZeneca lung cancer drug gets OK in China; Enanta reports PhIb data for their oral hepatitis B program (Endpoints)
• AstraZeneca’s Lynparza for prostate cancer approved in China (Pharmafile)
• FDA accepts application for Roche’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD) (Press)
• AbbVie Exercises Right to Acquire TeneoOne and Lead Asset TNB-383B for the Potential Treatment of Relapsed or Refractory Multiple Myeloma (Press)

• A no-brainer: CVRx plots $92M IPO for its neuro-stim implant for heart failure (Fierce)
• AdvaMed urges Biden to prioritize medical supplies as industries suffer shipping constraints (MedtechDive)
• How Firms Withdrawing ‘Old’ Products Or Producing Legacy Products Must Comply With MDR (MedtechInsight)
• Medicare lacks cyber oversight of hospitals' networked medical devices: OIG (MedtechDive)
• PerkinElmer, Qiagen latest medtechs to target rapidly growing CRISPR market (MedtechDive)
• At-home fertility test kit maker Proov expands to EU after landing CE clearance (mobihealthnews)
• Boston Scientific shells out a hearty $295M for Farapulse’s electric field-generating Afib treatment (Fierce)

• Judge Backtracks On Juror Vaccine Mandate In Opioid MDL (Law360)
• Calif. Jury Clears CVS In $121M Drug Overcharge Trial (Law360)