Regeneron Looks To Use CRISPR Inside/Outside The Liver With Intellia Pact

Under partnership with Intellia, Regeneron will use gene-editing technology to develop novel therapeutics against up to 10 targets, and will make a $50m equity investment in the biotech.

Regeneron Pharmaceuticals Inc. became the latest biopharma to acquire rights to use CRISPR-Cas9 gene-editing technology in its discovery and development work April 11 under a six-year collaboration with privately held Intellia Therapeutics Inc., bringing the biotech $75m up front as well as a $50m equity investment commitment.

Separately, Intellia announced plans to file for a $120m initial public offering, although pricing is not yet set. In an...

More from United States

US Policy Shift Sparks German Contingency Plans For Accessing ClinicalTrials.gov, PubMed

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.

Indegene Exec On DTP Distribution As A ‘Tactical Solution’, Feasibility Of MFN Model

 

Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion

Best Laid Plans: A Chronology Of Post-Pandemic COVID-19 Vaccines

 

Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.

Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions

 

The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.

More from North America

GLP-1s In Crosshairs As Employers Worry About Health Costs – And Their Own Reliance On Rebates

 
• By 

Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.

US FDA Maintaining Approval Output Despite Losing Staff

 

Reviewers were not targeted by the FDA reduction in force, but increasing attrition and difficulties hiring new staff still do not seem to have impacted new and generic drug approval totals.

Lilly’s Direct-To-Consumer Portal Implicated In Texas Anti-Kickback Suit

 
• By 

Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.