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Cellares, which last year became the first company to receive the FDA’s new advanced manufacturing technology designation, expects to support clinical production this year and offer commercial-scale manufacturing services in 2027.
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Attendance at the Biotech CEO Sisterhood’s annual photo of women leaders and allies in Union Square doubled this year. There’s still more work to do.
After winning a surprise approval for its hereditary angioedema drug Ekterly, KalVista is confident the oral offering will capture the lion’s share of the market for on-demand use.
Biohaven has suffered a few setbacks in recent months, including an FDA rejection and a missed $150 million benchmark payment, but CEO Vlad Coric looked for the brighter side at JPM, specifically emphasizing a serendipitous discovery that could get the company in the obesity game.
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Flagship Pioneering launched a new company called Inzen Therapeutics, which will discover and develop a new class of medicines based on a new area of biology that will provide new therapeutic approaches to multiple types of diseases.
The two companies will work together to use dendritic cells to develop immune tolerance.
The COVID-19 pandemic that has upended life across the globe has also ignited a reawakening to the value of vaccines, and Hu believes the momentum will carry forward into the new year.
Slaoui will stay on as an adviser for one month. His resignation from the vaccine program was made at the request of the incoming Biden administration.
In an interview with BioSpace, Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, outlined Bayer’s thought process for opening its purse strings and diving into the deep end of the cell and gene therapy space.
The collaboration, which will leverage Enara’s Dark Antigen™ discovery platform, will work toward discovering and validating novel “Dark Antigens” in up to three tumor types in both lung and gastrointestinal cancer.
The novel immune checkpoint inhibitor Sanofi deemed worthy of such an investment is BND-22, a humanized IgG4 antagonist antibody targeting the Ig-like transcript 2 (ILT2) receptor, an inhibitory receptor expressed on both innate and adaptive immune cells.
The U.S. Food and Drug Administration is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services, the department that oversees the agency and its operations.
BioSpace takes a look at some of the announcements that occurred Monday and will continue to update throughout the week.
As an immigrant, female, mid-30’s CEO in the biotech world, Leen Kawas is used to being told no. She’s familiar with doubts being cast on her ideas, eyebrows raised at her push for innovation and some flat out telling her it won’t work. And she’s comfortable with all of that. It’s that grit that’s gotten her to where she is now.