Catherine Sbeglia

Dr. Pnina Fishman’s research, which sought to explore what keeps muscle cancer free, led her to discover that substances secreted by muscles leave normal cells untouched while restricting the development of cancer cells. “Cancers almost never metastasize to muscle tissue, even though muscle makes up 65 percent of the human body. Muscle tissues activate a…

In a licensing deal potentially worth more than $1.2 billion, Janssen, Johnson & Johnson’s Biotech unit, has gained global rights—excluding South Korea—to Yuhan’s third-generation EGFR tyrosine kinase inhibitor (TKI) Lazertinib for the treatment of patients with non-small cell lung cancer (NSCLC). Janssen will make an upfront payment of $50 million for Lazertinib. Yuhan’s also will be eligible…

When Dyadic CEO Mark Emalfarb began the company, its focus was more centered on what people were putting on their bodies as opposed to in them. “The journey can be described as going from ‘Jeans to Genes,’” Emalfarb told R&D Magazine/Pharmaceutical Processing. The company took an intriguing path from supplying jeans manufacturers with pumice stones…

Eli Lilly and Company has successfully engineered a single molecule that acts on two receptors in the body: GIP and GLP. Earlier this month, the company released results from a phase 2b clinical trial of the dual receptor agonist molecule, revealing that the treatment shows meaningful blood sugar reduction and body weight loss in patients…

UCB and Biogen revealed that a Phase IIb study of the experimental drug dapirolizumab pegol (DZP) in adults with moderately-to-severely active systemic lupus erythematosus (SLE) failed to meet its primary endpoint. The study consisted of 182 adults with moderately-to-severely active SLE despite receiving standard-of-care treatment such as corticosteroids, anti-malarials, and non-biological immunosuppressants. Despite the trial’s failure…

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Sanofi’s tetravalent vaccine, Dengvaxia, for the prevention of dengue caused by dengue virus serotypes 1, 2, 3, and 4 in people who are between 9 and 45 years old, live in an endemic area, and already had a prior dengue virus infection.…

Affimed shares dropped 28 percent on Monday following a company announcement that early studies of AFM11 have been put on hold after three patients taking the experimental drug suffered serious adverse events, included one death. The studies were testing the drug in patients with types of non-Hodgkin lymphoma and acute lymphoblastic leukemia. The company stated…

The FDA approved Akcea Therapeutics’ Tegsedi (inotersen) for the treatment of polyneuropathy caused by hereditary transthyretin (hATTR)-mediated amyloidosis in adults. The self-administered RNA-targeting therapeutic was approved by European agencies three months ago. Tegsedi’s approval has come shorty after the FDA clearance of Alnylam Pharmaceuticals’ Onpattro (patisiran) for the treatment of adults with polyneuropathy due to hATTR, marking the first…

Last week, Xencor noted there was a “positive trend” on the primary endpoint in the company’s experimental systemic lupus erythematosus (SLE) drug XmAb5871; however, the drug ultimately failed to achieve the primary endpoint of a Phase II study. XmAb5871 did not significantly increase the proportion of SLE patients who maintained improvement, compared with placebo. Study author…

Genentech, a member of Roche Group, and Chugai Pharmaceutical announced the FDA approval of Hemlibra (U.S. generic name: emicizumab-kxwh), a treatment for hemophilia A created by Chugai, for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors. Hemlibra is now the only prophylactic treatment…

Earlier this week, Chugai Pharmaceutical and Eli Lilly entered into a license agreement for OWL833, Chugai’s oral non-peptidic GLP-1 receptor agonist. OWL833 is a Phase 1-ready asset that is being studied for the treatment of type 2 diabetes. Eli Lilly has agreed to make an upfront payment of $50 million for OWL833, and Chugai will also remain…

The FDA has entered a new agreement with the National Academies of Science, Engineering & Medicine (NASEM), and expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation (CERSIs) in an effort to inform the public and the agency’s policies regarding compounded drugs. The first study that NASEM…

Harvard Bioscience, Inc., a global life science manufacturing and distribution company, has developed a non-invasive beta cell screening system for diabetes research that leverages multielectrode arrays (MEAs) to take measurements from intact pancreatic islets cells, which produce insulin. The new Beta Cell-System’s use of multielectrode arrays offers a new route for type 2 diabetes drug…

CEO and President of Gilead Sciences John Milligan is looking forward to stepping down at the end of the year. Milligan who has served as CEO for two years, and according to Gilead Lead Independent Director John Cogan, has contributed to the company for nearly 30 years, commented, “I’m looking forward to a well-deserved break…

It seems that every part of the drug development and manufacturing process is moving toward automation, often improving processing speeds and information accuracy. Continuing this trend of increased automation is French company, Biocellvia, which provides intelligent, automated image analysis that identifies and evaluates candidate drug molecules for preclinical disease models. Pharmaceutical Processing spoke with Olivier…

As patients and manufacturers await the Trump administration’s massive cuts to drug prices, Pfizer has raised the prices of 100 of their products as of July 1. These price increases come only a short time after Trump hinted that pharmaceutical companies were only weeks away from announcing “voluntary massive” cuts to drug prices. A number…

The FDA granted priority review to Roche for baloxavir marboxil, their single-dose, oral treatment of uncomplicated influenza. The agency is expected to make a final decision by the end of December. Baloxavir marboxil, which is being developed by Roche and Shionogi under the terms of a 2016 agreement, gained approval in Japan in February, where…

Johnson & Johnson has entered a five-year alliance with Boston University to help fight lung cancer. Johnson & Johnson will establish an Innovation Lung cancer Center on the university’s campus to facilitate close collaboration between the two entities. According to a statement released by Johnson & Johnson, the goal of the alliance is to “develop…