The maker of the mpox vaccine is looking at ways to dramatically scale up its production capacity to prepare for a potential threat from smallpox. Bavarian Nordic CEO Paul Chaplin said the rapid spread of mpox last year was a wake-up call for the company, which is based in Denmark. “If it wasn’t mpox but it was smallpox, we are completely at the wrong scale,” Chaplin told CNBC in an interview. “We’re looking at ways we can dramatically change the way we manufacture to increase our scale,” he said. Mpox is in the same virus family as smallpox. Bavarian Nordic’s Jynneos vaccine is approved by the U.S. Food and Drug Administration to protect against both pathogens. Previously known as monkeypox, the World Health Organization changed the name to mpox last year to reduce stigma. Bavarian Nordic plans to simplify its production process so ...
Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year. Pfizer’s vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria — seven more than the company’s prior Prevnar 13 version. It has been approved in adults since 2021. Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers. While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the U.S. each year. In response, Pfizer, Merck and others have worked to develop new shots that offer better protection, particularly against strains that weren’t ...
Delilah AlvaradoAssociate Editor A general view of the Pfizer Headquarters sign on November 10, 2020 in Tadworth, England. Dan Kitwood via Getty Images Dive Brief: Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year. Pfizer’s vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria — seven more than the company’s prior Prevnar 13 version. It has been approved in adults since 2021. Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers. Dive Insight: While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the ...
Gwendolyn Wu Reporter Biotechnology venture firms have become more selective about where to invest in recent months, wary of the headwinds currently blowing against the industry. But that newfound caution hasn’t hurt Orbital Therapeutics, which said Wednesday it raised $270 million in biotech’s largest Series A round this year. The funds will help Orbital, which emerged from stealth last year partnered with gene editing pioneer Beam Therapeutics, to build its team and select a lead program. It claims its technology could be applied in many different directions, from use in next-generation RNA vaccines to protein replacement therapies or drugs for autoimmune diseases and cancer. Based in Cambridge, Massachusetts, Orbital has not yet named specific disease areas it’s prioritizing. However, the financing positions the company to submit its first regulatory filing, like an application to begin human testing, in the next two to four years, CEO Giuseppe Ciaramella said. “The ...
A three-judge panel decided mifepristone’s FDA approval shouldn’t be revoked, but its decision could still make the drug much harder to obtain. An appellate court has blocked a ruling that would have suspended the approval of a decades-old abortion pill, but decided the medicine should only stay on the market with strict limitations. The 2-1 decision from the U.S. Court of Appeals for the 5th Circuit upholds the Food and Drug Administration’s 2000 approval of mifepristone, a medicine used in more than half of all U.S. abortions and to treat miscarriages. But the panel also unwound long-running efforts by the regulator to expand access to mifepristone in recent years. Since 2016, the FDA has enabled the drug to be used through ten weeks of gestation, instead of seven. The agency has also allowed the medication to be delivered by mail and prescribed through a teleheath visit, rather than ...
Biotechnology company ImmuneBridge has raised $12m seed financing to advance new natural killer (NK) cell-based immunotherapies. Co-led by global investors Insight Partners and M Ventures, the financing round has also seen participation from Gaingels and One Way Ventures. ImmuneBridge is developing allogeneic NK cell-based immunotherapies to treat solid tumours and hematologic malignancies. According to the company, NK cells represent a platform for allogeneic immunotherapy as they are potent cancer killers, with less risk profile. The company’s orthogonal approach leverages an expansion technology and a diverse clinic-ready source for accelerating the discovery and translation of potent cell therapies. Its expansion technology expands hematopoietic stem cells (HSCs), which are natural NK cells precursors. ImmuneBridge CEO and co-founder Peretz Partensky said: “Cell therapy is a new pillar of medicine and is inextricably human. Cell therapy developers fear donor-to-donor variability, yet we humans are unapologetically diverse in our innate ...
The pharma is handing back two experimental cancer medicines amid a retreat from cell therapy research. GSK has outlined a deal to send two cancer immunotherapies back to biotechnology company Adaptimmune Therapeutics, a move that follows the larger drugmaker’s recent decision to stop investing in cell and gene therapy research. Adaptimmune announced last October that it would regain rights to the two programs, each of which are in development for solid tumors. On Tuesday, the biotech revealed terms of the agreement. It will get about $37 million in cash from GSK, and receive all materials, data and trial sponsorship responsibilities related to the drugs later this year. The agreement will formally end a partnership between GSK and Adaptimmune that dates back to 2014. That year, the two began working on a program called lete-cel, which works by genetically modifying cells to detect NY-ESO, a protein expressed on several ...
[Before the Sartorius buyout, Polyplus had itself been expanding through multiple acquisitions. (Sartorius)] As the biopharma industry struggles with a dire shortage of viral vectors to make cell and gene therapies, contract manufacturers are busy beefing up their capabilities. In the latest example of biopharma’s ongoing investment in cell and gene therapy production, Sartorius has agreed to acquire French company Polyplus for 2.4 billion euros ($2.6 billion), the German CDMO said Friday. The deal gives Sartorius additional know-how in nucleic acid delivery, including transfection reagents and plasmid DNA design, all of which are key elements in the production of viral vectors for building cell and gene therapies. Formed in 2001, Polyplus employs about 270 people in several locations in France, Belgium, the U.S. and China. Before the Sartorius buyout, Polyplus had itself been expanding through M&A deals. In 2021, Polyplus bought Asia-Pacific-focused reagent supplier Biowire. ...
A new test based on gene targeting technology CRISPR could diagnose Covid-19 infections in 45 minutes. It was recently outlined in a paper in the journal Nature Biotechnology.
GlaxoSmithKline (GSK) and Vir Biotechnology have expanded their existing COVID-19 collaboration to include a new research and development agreement, focused on therapies for influenza and other respiratory viruses. The expanded collaboration will give GSK exclusive rights to collaborate with Vir on the development of monoclonal antibodies (mAbs) for the prevention or treatment of influenza. That includes an investigational mAb – VIR-2482 – designed as a universal prophylactic for influenza A, which has completed a Phase I trial. The agreement will also includes next-generation antibodies for the prevention or treatment of influenza during a three-year research period. While GSK will have the exclusive option to co-develop VIR-2482, following Vir’s completion and report of the Phase II trial outcomes, the company will share development costs for all other influenza mAbs. The companies will also conduct two additional research programmes as part of the expanded agreement. The first of these is an expansion ...
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