NCBiotech News

FUJIFILM Diosynth Biotechnologies, a global contract development and manufacturing organization (CDMO) with major operations in North Carolina, has signed an agreement valued at over $3 billion to produce biologic medicines for Regeneron Pharmaceuticals. Under the terms of the 10-year agreement, FUJIFILM will provide U.S.-based manufacturing for Regeneron through current and planned expansions at its new biopharmaceutical production facility in Holly Springs, N.C., when the site begins operations later this year. “This agreement with an industry-leading biologic medicines company demonstrates that FUJIFILM Diosynth Biotechnologies is trusted by our partners to deliver through our technical expertise, talented team and operational readiness,” said Toshihisa Iida, director, corporate vice president, general manager of Life Sciences Strategy Headquarters and Bio-CDMO Division of FUJIFILM Corp.

The Piedmont Triad Regenerative Medicine Engine (PTRME) presented its first large-scale workshop, The Founders’ Journey, on April 14 and 15 to support biotech researchers, founders, and entrepreneurs. “PTRME’s top goal is to create a cooperative ecosystem in which researchers can commercialize their biotechnology and regenerative medicine solutions, create jobs and impact economic development—and that begins by establishing a strong entrepreneurial foundation,” said Tim Bertram, CEO of PTRME. “We have the unique opportunity to build an industrial-academic ecosystem focused on regenerative medicine commercialization that does not exist anywhere else in the world.”

William H. Janeway, who’s been involved in the technology and life sciences investing world for more than five decades, can easily recount the successes that date back to his early days as an investment banker in the 1970s. But what also stands out to the distinguished affiliated professor of economics at the UK’s Cambridge University is a notable miss. “We were given the opportunity to engage with Genentech in 1977, two years before its IPO [initial public offering], and we turned it down. We were wrong,” said Janeway, who offered his lessons learned over a 55-year career in life sciences and technology investing during a recent lecture at the North Carolina Biotechnology Center.

For many of us in the drug development industry, cell and gene therapies (CGT) can create intoxicating levels of hope for the patients who need them. This field is rapidly expanding, offering exciting possibilities for treating a wide range of diseases while providing veritable cures for some forms of hemophilia, sickle cell disease, blindness and deafness. However, the complexities of CGT trials present unique challenges for the trial sites that first bring these unapproved investigational drugs to test subjects. For trial sites, CGT trials often result in intense resourcing workflows and requirements, leading to under-resourced healthcare teams. This hinders the advancement of these potentially life-changing treatments.

Cambrex, a New Jersey-based global contract development and manufacturing organization (CDMO), celebrated the grand opening of its new Q1 Scientific stability storage facility in Durham, the company’s third facility and its first in the U.S. The event on Thursday, April 10, was attended by employees, local government representatives, trade organizations, and leaders from the life sciences industry, who were given the opportunity to tour the state-of-the-art cGMP facility. The tour included the environmentally controlled stability storage suite, analytical chemistry laboratories, and reference standards suite.

Better collaboration in agriculture-biotechnology would help propel the industry forward, a panel of experts said at the AgBio conference for North Carolina and Virginia ag-bio leaders. “I don’t think we should be innovating in silos,” said Toni Bucci, founder and CEO of Sable Fermentation, a Wake Forest biomanufacturer that helps food and ag-bio companies scale precision fermentation. “The food and ag industries are a little behind the pharmaceutical industry. If we really want to advance, we need to get past the barrier of working in silos and share information.” Collaboration between ag-bio companies and between industry and academia took center stage during an afternoon panel discussion at AgBio 2025: Innovating Agricultural Resilience.

Physicians treating patients suffering from severe, life-threatening lung damage don’t have many options. When patients develop acute respiratory distress syndrome (ARDS), putting them on a ventilator might not be sufficient. So doctors sometimes turn to a complicated and risky process called extracorporeal membrane oxygenation (ECMO) – but only if they happen to practice in one of the just 10% of U.S. hospitals that have an ECMO machine. A better option might be on the way, thanks to a Cary company that has secured more than $5 million in funding. VQ Biomedical, spun out of Duke University, has developed a novel, minimally invasive catheter designed to deliver oxygen directly to the bloodstream.

Durham-based Atsena Therapeutics has raised $150 million to advance gene therapies for preventing or reversing types of inherited blindness. Proceeds from the Series C financing will be used to advance the company’s lead program, ATSN-201, for the treatment of X-linked retinoschisis (XLRS), a genetic retinal disorder typically diagnosed in childhood that leads to blindness later in life. The proceeds will also support Atsena’s preclinical pipeline of first-in-class therapies and expand the use of its novel gene therapy platform. “Closing our Series C marks a pivotal moment for Atsena as we advance our transformative ocular gene therapies and fuel our next phase of growth, innovation and clinical progress,” said Patrick Ritschel, chief executive officer of Atsena.

GreenLight Biosciences, Inc., a Boston-based agtech company with lab, office and greenhouse space in RTP, has closed a Series C funding round, including a $25 million investment from a new investor, Just Climate, which invests in climate solutions, and support from other new and existing shareholders, according to a company news release. The new capital supports GreenLight Bio’s commercial momentum following the successful launch of Calantha, which is registered in the United States and Ukraine. It is the first registered RNA-based crop protection spray. Calantha offers potato growers an alternative to conventional chemical pesticides, according to the company. "This strategic investment from Just Climate and others represents a powerful endorsement of our RNA platform’s potential to revolutionize agriculture while addressing environmental challenges, including pollinator health," said Dr. Andrey Zarur, CEO of GreenLight Bio.

Durham-based Precision BioSciences Inc. has received investigational new drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for PBGENE-HBV, an in vivo gene editing program designed to cure chronic hepatitis B virus (HBV) infection. It is the first investigational in vivo gene editing therapy for treating chronic hepatitis B to be cleared for clinical trials in the U.S. Over a million people in the U.S. have chronic hepatitis B, and while antiviral treatments can suppress the virus and reduce liver damage, they don’t fully eliminate the infection. PBGENE-HBV addresses this challenge by targeting the main source of HBV replication and deactivating integrated HBV DNA in liver cells. “IND clearance to expand the ELIMINATE-B trial for chronic hepatitis B is a first for the gene editing space,” said Michael Amoroso, president and CEO of Precision BioSciences.

The field of gene editing recently got a major boost from Massachusetts-based Beam Therapeutics, and the company’s Durham operation is poised to help build on that success. On March 10, Beam announced data and proof-of-concept results from an early-stage clinical trial of its potential treatment for a rare genetic disorder affecting the lungs and liver. Nine patients were involved in the trial of BEAM-302, intended to treat alpha-1 antitrypsin (AATD) deficiency. AATD can lead to severe lung and liver complications, including emphysema and cirrhosis. The trial showed that BEAM-302 corrected a disease-causing mutation at the DNA level. AATD patients with lung disease were given a single intravenous infusion of the therapy and reported no significant adverse effects.

vTv Therapeutics, a biopharmaceutical company based in High Point, has received clearance from the U.S. Food and Drug Administration to resume clinical testing of a potential therapy for type 1 diabetes.

The FDA lifted a clinical hold on the company’s development of cadisegliatin, a first-in-class oral adjunctive therapy for the disease.

410 Medical, Inc., a medical device company focused on innovative technologies for emergency and critical care, has completed a $14 million Series B financing. Existing investor Hatteras Venture Partners led the funding round with participation from Orlando Health Ventures, Ballad Ventures, OSF Healthcare, WakeMed, Rex Health Ventures, CU Healthcare Innovations Fund, and Sarnova. “We are thrilled to add Rex Health Ventures, CU Healthcare Innovations, and Sarnova to our 410 Medical investor syndicate,” said Kyle Chenet, Chief Executive Officer at 410 Medical. “This funding accelerates our ability to expand access to LifeFlow, ensuring that critically ill patients receive timely and effective resuscitation. To date, clinicians have used LifeFlow to treat over 50,000 patients across the country in a wide variety of care settings. Patient outcomes and user feedback have been outstanding. The growing clinical adoption and positive provider feedback reinforce the need for effective resuscitation tools.”

North Carolina's life sciences ecosystem is thriving, thanks in no small part to the leadership and innovation of women shaping its future. From groundbreaking research in biotechnology to executive roles, women leaders across the state are driving advancements that make a global impact. 

Their contributions span startups, research institutions, and large corporations, fueling economic growth and scientific progress. These women are not just participating—they are leading the charge.

The North Carolina Biotechnology Center has been named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025. The annual list shines a spotlight on businesses that are shaping industry and culture through their innovations to set new standards and achieve remarkable milestones in all sectors of the economy, according to the magazine. Alongside the World’s 50 Most Innovative Companies, Fast Company recognizes 609 organizations across 58 sectors and regions. NCBiotech was among the 10 companies in the Economic Development company category.