Recon: Lilly acquires Protomer in deal worth up to $1B; Some private insurers will refuse to cover Aduhelm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Several private insurers won’t cover Biogen’s Alzheimer’s drug (STAT)
- US health official says COVID-19 boosters could risk more serious side effects (Reuters)
- US pharmacies strike first deals with counties over opioids (Reuters)
- US Senate Democrats agree to $3.5T for budget reconciliation bill (Reuters)
- US drug overdose deaths rose to record 93,000 last year (The Hill)
- Lilly wagers up to $1B on a biotech's plan for a new type of insulin (BioPharmaDive) (Endpoints) (Press)
- Insulin makers and pharmacy benefit managers must face racketeering claims in a lawsuit (STAT)
- EU undecided on mix-and-match, boosters for COVID-19 shots (Reuters)
- Italy approves GSK-Vir antibody to treat COVID-19 (Reuters)
- UK nod paves way for AstraZeneca-Alexion deal to close next week (Reuters) (Endpoints)
- EMA and ECDC update on COVID-19 (EMA)
- Thailand considering limits on AstraZeneca vaccine exports (Reuters)
- Vietnam says Pfizer to provide 20 mln vaccine doses, consider tech transfer (Reuters)
- Hong Kong says no personal data shared in vaccine deal with Fosun (Reuters)
- NICE to develop guideline for rare blood clots associated with COVID-19 vaccination (PharmaTimes)
- Biogen chases rivals with another bet on emerging class of multiple sclerosis drugs (BioPharmaDive)
- ‘Aduhelm left room’: Lilly CEO eyes competition with Biogen Alzheimer’s drug (STAT)
- Biogen’s new Alzheimer’s drug could cost Medicaid up to $2.2 billion a year (STAT)
- Prime Medicine raises $315M to fuel 'search-and-replace' gene editing work (BioPharmaDive)
- WHO Consults On Evaluating mRNA Vaccines For Infectious Diseases (Pink Sheet)
- FDA mulls regulatory action on Sprout's 'female Viagra' after adverse events spike (Endpoints)
- Biohaven CEO on migraine drug's fast launch, TikTok ads and battling big pharma (BioPharmaDive)
- IPOs and venture investing rock on in Q2 as SPAC attack takes a break. But what happened to the deals and M&A? (Endpoints)
- A couple months after landing $100 million in funding, Cellares grabs partner for its Cell Shuttle (Endpoints)
- Nkarta signs its name to an ambitious future with manufacturing hub for not one but multiple marketed drugs (Endpoints)
- Tessera Therapeutics taps former BeiGene CFO Howard Liang to join race to CRISPR 3.0 (Endpoints)
- Activists' attempt to take over infamous Martin Shkreli company fails, as ‘Pharma Bro’ votes from prison (Endpoints)
- AI startup Entos looks to one-up the rest of the field by folding quantum mechanics into its discovery platform (Endpoints)
- Astellas signs on pluripotent stem cell partners at ExCellThera; Little Unicycive brings home $25M after floating a small IPO (Endpoints)
- Flush with cash, computational chemistry pioneer Nimbus considers next steps. Is an IPO in the future? (Endpoints)
- Curia, on heels of rebrand, snaps up CDMO Integrity Bio to expand westward (Fierce)
- Eisai Taps Continuous Manufacturing for Tazverik, Eyes Its Use for Other Oncology Assets Too (PharmaJapan)
- CURE ID Moves to Automated Data Collection in Light of COVID Pandemic (FDA)
- Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of All Sterile Compounded Drug Products Due to A Lack of Sterility Assurance (FDA)
- Drug Sponsors Invited To Trial Pre-Submission Meetings With South African Agency (Pink Sheet)
- Eargo Launches 5th Generation Hearing Aid On Heels Of Proposed Rule For OCT Hearing Aids (MedtechInsight)
- Another Italian Notified Body Is Designated Under The MDR (MedtechInsight)
- FDA Reviewers Raise Concerns About Value Of TransMedic’s OCS Liver System Trial Data (MedtechInsight)
- In reversal, employers, union groups push for Congress to allow Medicare to negotiate drug prices (Endpoints)
- West Virginia to vote against Purdue Pharma bankruptcy plan (The Hill)
- What To Watch As EU Clinical Trial Compliance Changes (Law360)
- Cherokees Say McKinsey Opioid Suit Shouldn't Head To MDL (Law360)
- PTAB Won't Review Amgen Patent On Chemotherapy Drugs (Law360)
- Teva Says Rival Hoarding Drug To Slow Generic Development (Law360)
- Pharma Co. Asks 9th Circ. To Revive Opioid Coverage Dispute (Law360)
- Roche Invalidates Competitor's Insulin Pump IP In UK Suit (Law360)
- German Court Ruling Opens The Way To New European Patent Court (Pink Sheet)
- KEI Comments on NIH Exclusive License to Panacea for Gene Therapy (KEI)
- KEI and UACT Joint Comments to the NIH Regarding Exclusive License to Syncopation for CAR Therapy (KEI)
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