Here are the latest stories being discussed in biopharma today:

“`html

Healthcare Market News

Gilead’s Twice-a-Year Injection Fully Prevents HIV in Phase 3 Study with Cisgender Women

Gilead’s pioneering twice-a-year HIV preventive injection exhibited complete efficacy in a Phase 3 trial involving over 2,000 cisgender women. The study demonstrated that no participants contracted HIV, leading an independent panel to recommend ending the study early and offering the treatment to all. The injection, lenacapavir, showed superior outcomes compared to Truvada, the daily prevention pill currently in use.

Scientists Discover New Genetic Insight for Delaying Alzheimer’s Disease

Researchers have unearthed a significant genetic clue from a large Colombian family known for a hereditary form of early-onset Alzheimer’s disease. The discovery centers around a rare mutation dubbed Christchurch, which has been found to delay cognitive impairment by approximately five years in carriers. This finding is propelling new avenues in drug development aimed at combating Alzheimer’s.

Zealand Pharma’s Amylin Weight Loss Candidate Achieves Early Efficacy Success

Zealand Pharma’s amylin analogue, petrelintide, demonstrated promising results in a Phase 1b trial, helping patients achieve an average weight loss of 8.6%. The results surpass initial goals and pave the way for further trials, positioning petrelintide as a potential contender against current GLP-1 receptor agonists, potentially with fewer side effects. Zealand plans to move forward to mid-stage trials with these promising findings.

FDA Eases Path for Biosimilars to Obtain Interchangeability Tags

The FDA has simplified the process for biosimilar developers to achieve interchangeability designations with brand-name biologics. Previously, extensive studies comparing the safety and efficacy of switching between the biosimilar and the reference product were required. Now, comparative analytical and clinical data can suffice, reducing the cost and time required for approval.

CBER Chief Proposes Rare Disease Hub for Better Cross-Center Communication

Peter Marks, the head of the FDA’s Center for Biologics, has suggested the formation of a rare disease hub to facilitate better collaboration between the agency’s drug and biologics experts. This proposal aims to create a centralized resource to address the complex needs of rare disease treatments, without the complications of a more formal center of excellence.

FDA Labels Synapse’s CRO Studies as ‘Unacceptable’

The FDA has declared studies conducted by India-based CRO Synapse as “unacceptable” due to significant data integrity issues. The agency has instructed pharmaceutical sponsors that any studies conducted by Synapse must be re-evaluated and potentially redone, following findings of substantial discrepancies in the data used to support generic drug applications.

Takeda Allocates $230 Million for California Plasma Therapy Facility Expansion

Takeda has announced a $230 million investment to expand its plasma therapy manufacturing facility in California. This expansion is aimed at increasing the production capacity of plasma-derived therapies and supports the company’s commitment to meeting growing patient demand.

Emergent Offloads Baltimore Facility for $30 Million

Emergent Biosolutions has sold its Baltimore manufacturing facility for $30 million. This move comes as part of a strategic realignment to focus on core competencies and streamline operations, following challenges related to production issues at the site.

Samsung Bio and Baxter Expand Manufacturing Deal to $223 Million

Samsung BioLogics and Baxter have significantly increased their manufacturing agreement to $223 million, enhancing their collaboration on producing crucial biologic medicines. This expanded deal aims to bolster Baxter’s production capabilities and meet the rising demand for biologic therapies worldwide.

Silence Therapeutics: siRNA Candidate for Cardiovascular Disease Shows Promise in Phase 2 Trial

Silence Therapeutics’ siRNA candidate continues to show positive results in treating cardiovascular disease in a Phase 2 trial. The ongoing success of this candidate demonstrates its potential in addressing cardiovascular conditions by silencing specific genetic targets, opening new therapeutic pathways.

AstraZeneca’s Truqap Combo Fails in Phase 3 Triple-Negative Breast Cancer Trial

AstraZeneca’s combinatory treatment Truqap did not meet its primary endpoint in a Phase 3 trial for triple-negative breast cancer, underscoring the challenges in treating this aggressive cancer type. The company remains committed to exploring alternative solutions for this difficult-to-treat condition.

Counterfeit Ozempic Found Amid Soaring Demand for Weight Loss Drugs

As the popularity of weight loss drugs skyrockets, counterfeit batches of Ozempic have been detected in Brazil, the UK, and the US. The WHO has issued alerts after identifying three fake batches, highlighting the risks associated with growing demand and the need for vigilant safety measures.

“`