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Business Strategy

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Competitive Dealmaking Market Shifts To Smaller M&A, Partnering

Dollars spent on biopharma M&A so far in 2024 may not be as high as in 2023, but dealmakers say deal volume is robust with many factors influencing the overall value of transactions this year.

BIO Deals

Sarepta Obtains Broader DMD Label For Elevidys

The gene therapy is now approved for all ambulatory boys with Duchenne muscular dystrophy ages 4 and older. The revised label also includes accelerated approval for non-ambulatory patients.

Approvals Gene Therapy

J&J Heats Up IL-23 Inflammatory Bowel Space With Tremfya Crohn's US Filing

AbbVie's rival interleukin-23 drug Skyrizi is now approved in the US for both principal types of inflammatory bowel disease – ulcerative colitis and Crohn’s disease. Tremfya may not be too far behind.

Gastrointestinal Drug Review

Finance Watch: SPACs Attempt A Comeback Ahead Of Full IPO Recovery

Public Company Edition: Several special purpose acquisition corporations have emerged, including various health care- and life science-focused SPACs. Also, Alvotech entered into a $965m refinancing agreement and Avidity grossed $461m in a follow-on offering, among other updates.

Financing Growth

Gilead’s Twice-Annual Sunlenca Posts Zero Infection Rate In PrEP Trial

Lenacapavir is halfway to the pivotal data needed to file for twice-annual administration in PrEP, after demonstrating superiority against both background incidence of HIV infections and Truvada.

Clinical Trials Business Strategies

Jazz’s Suvecaltamide Fails In Tremor Trial, But Parkinson’s Study Continues

A Phase IIb trial evaluating suvecaltamide failed to show a statistically significant benefit versus placebo on an assessment scale for essential tremor.

Clinical Trials Neurology

AbbVie Doubles Down In IBD With Skyrizi Ulcerative Colitis Approval

The US major's blockbuster is already well established as a treatment for Crohn’s disease but the latest thumbs-up from the US FDA means Skyrizi is the first interleukin-23 inhibitor approved for both principal types of inflammatory bowel disease.

Approvals Gastrointestinal

Parexel On Reimbursement Support, Federated Data Sharing, Diversity Through Communities

Parexel’s chief strategy officer, clinical EVP and India head share thoughts on a winner’s mindset for artificial intelligence, benefits of a “federated approach” to clinical data sharing, support for reimbursement and a cascading impact of obesity treatments, in a two-part interview with Scrip.

Research & Development Business Strategies

€80m Cash Boost Helps iOnctura Accelerate Eye Cancer Candidate

The proceeds from the impressive series B financing will help progress roginolisib through Phase II trials.

Cancer Financing

Intra-Cellular Poised To Add MDD To Caplyta’s Label

Caplyta succeeded in a second Phase III study as adjunctive therapy for major depression, putting the schizophrenia/bipolar disorder drug on track for sNDA filing later in 2024.

Clinical Trials Business Strategies

Merck’s Newly Approved Capvaxive Could Have Edge Over Prevnar 20 In Adults

The 21-valent pneumococcal vaccine will face an entrenched competitor in Pfizer’s Prevnar 20, but Merck believes Capvaxive has a competitive advantage because it protects against serotypes specific to adults.

Approvals Vaccines

Two Better Than One As Syncona Creates Spur

The merger of Freeline and SwanBio is establishing an entity with secure financing to advance their respective gene therapies for Gaucher’s disease and adrenomyeloneuropathy.

M & A Gene Therapy
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