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July 14, 2021
by Michael Mezher

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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