NCBiotech News

Lindy Biosciences, a small drug-formulations company in Morrisville, has landed a big deal with one of the world’s largest pharmaceutical companies.

Lindy has entered into an exclusive global licensing agreement and strategic collaboration with Novartis Pharma AG, a subsidiary of the Swiss medicines giant Novartis AG. 

The newly FDA-approved brain cancer therapy Voranigo (vorasidenib) has its roots in North Carolina. It is the product of research by Duke University's Darell Bigner and Bert Vogelstein of Johns Hopkins University and underwent clinical trials at Duke. 

Vorasidenib has been shown to slow the growth of a type of brain cancer known as low-grade IDH-mutant glioma. Servier Pharmaceuticals, which sponsored the drug’s clinical trials and is bringing it to market, describes the medicine as the first breakthrough for this type of cancer in almost 25 years. 

Scientist and entrepreneur Juliana Blum, Ph.D., has been named CEO of Durham-based BioAesthetics Corp., a biomaterials company that received early funding from the North Carolina Biotechnology Center.

Blum officially joined BioAesthetics on Aug. 12 after 20 years as co-founder and executive vice president of corporate development at Humacyte, also of Durham.

A summit on data privacy and protection in the life sciences will draw up to 100 professionals to the North Carolina Biotechnology Center in Research Triangle Park (RTP) on Sept. 10 for a full day of presentations, panel discussions and networking.

Opus Genetics, a clinical-stage gene therapy company devoted to treating inherited retinal diseases, has been granted Rare Pediatric Disease designation by the U.S. Food and Drug Administration for one of its potential therapies. 

The Research Triangle Park-based company received the designation for OPGx-LCA5, an ocular gene therapy for treating patients with LCA5, a form of early-onset retinal degeneration that causes vision loss.

Pathalys Pharma, fresh off raising an additional $105 million, is poised to finalize clinical trials and pursue regulatory approval for its treatment for patients with end-stage kidney disease.

Over the course of my career, I've witnessed the remarkable evolution of North Carolina's biotechnology sector from its humble beginnings to a vibrant and influential ecosystem. 

In 1996, I had the privilege of collaborating with Robert M. Califf — who now leads the U.S. Food and Drug Administration (FDA) — as a member of the founding team of the Duke Clinical Research Institute. We tackled a crucial gap by leveraging academic methodologies to pioneer innovative strategies for clinical research.

Durham-based Atsena Therapeutics, a gene therapy company focused on reversing or preventing blindness, has received an incentive from the U.S. Food and Drug Administration (FDA) for its leading product candidate.

The FDA granted Rare Pediatric Disease designation for ATSN-201, Atsena’s gene therapy product candidate for the treatment of X-linked retinoschisis (XLRS), a rare genetic disease that causes blindness.

Graduating high school, taking a training class, and landing a new job made for a busy June 2023 for Jahmari Staton. Then the real excitement came.

A few months into his job on the pharmaceutical manufacturing line at Catalent Inc. in Greenville, Jahmari was at home when he noticed what medication his mother was taking.

“What’s crazy about it is that my mother takes the medication we make,” he said. “When I saw what she was taking, I told her, ‘Hey, I make this!’ It blew her mind.”

Durham-based Alcami Corp., a contract development and manufacturing organization (CDMO) with a growing presence in North Carolina, has expanded the capabilities of its new pharmaceutical-storage facility in Garner and expects to add 95 positions to its workforce in the state.

North Carolina has emerged as one of the most significant ag tech hubs in the United States and the world. Consequently, we are gaining the attention of scientists, entrepreneurs and investors from around the globe. So how did this happen and what is the secret? Amidst various contributing factors, two elements stand out as distinctly unique: our location and people. 

You’d be hard-pressed to find any corporate leaders as passionate about their companies’ mission and products as Nicole Bell, the former chief business officer of Galaxy Diagnostics who became its CEO in June.

Bell ascended to the helm of the Morrisville bioscience company co-founded by her predecessor, Amanda Elam, Ph.D., with an unambiguous vision born from personal tragedy and a determination to expand on Galaxy’s successes inherited from Elam, who remains a company advisor and board member.

Two companies in the drug-development industry, each with operations in Durham, have merged, forming a larger and more integrated contract development and manufacturing organization (CDMO) to serve the topical and transdermal pharmaceuticals sector.

It’s an exciting time in North Carolina as we witness the steady influx of life sciences companies and see the nearing completion of expansive high-tech manufacturing facilities. These developments mark a pivotal moment in our state's growth and innovation.

Summer’s sweltering heat makes autumn seem far away, but at CSL Seqirus in Holly Springs, N.C., it signals shipping time for the company’s portfolio of 2024-2025 seasonal influenza vaccines. On July 9, the company began shipping its vaccines to healthcare providers across the U.S. before fall’s annual flu vaccination campaigns. 

The Holly Springs site has been hard at work manufacturing influenza vaccines for this season since the World Health Organization announced the recommended influenza vaccine composition for the northern hemisphere on Feb. 23.