Search Results for “EC” – Page 73 – media

Eli Lilly advances small molecule drug portfolio with Prism Biolab partnership

Eli Lilly is building on its small drug molecule portfolio with a partnership with Prism Biolab to develop and commercialise small molecules that modulate targets picked by Lilly. As part of the agreement, Prism will receive upfront payments and up to $660m based on preclinical, clinical, and commercial development milestone payments, along with royalty payments. This alliance will utilise Prism’s PepMetics technology platform to discover oral protein-protein interaction (PPI) targets. Lilly has made several moves in the last couple of years to develop small-drug molecules. Earlier this month, the company was one of the investors in Alto Neuroscience’s $45m Series C financing round, which will support Alto’s clinical programme of four small-molecule CNS candidates to treat psychiatric disorders including depression and post-traumatic stress disorder. Alto is expecting positive topline data from Phase II studies investigating two of the molecules, ALTO-100 and ALTO-300, in H2 2024 and H1 2025, respectively. In ...
- Source: drugdu
- 99
- December 1, 2023
FDA opens investigation into secondary cancer risk with CAR-T therapies

The US Food and Drug Administration (FDA) has started an investigation to review the safety of chimeric antigen receptor (CAR)-T cell immunotherapies following reports of T cell malignancies in patients who received these immunotherapies. The therapies under investigation include six approved B cell maturation antigen (BCMA)- or CD19-directed CAR-T cell therapies. The investigation follows reports collected from clinical trials and post-marketing adverse event surveillance. The FDA had required companies to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies as part of the respective therapy’s approval. The risk of post-therapy malignancies applies to all FDA-approved BCMA- or CD19-directed CAR-T cell therapies, as per a 28 November press release. The agency added that although the therapy benefits “continue to outweigh their potential risks for their approved uses”, the FDA is evaluating the need for regulatory action regarding the risk of T-cell ...
- Source: drugdu
- 96
- December 1, 2023
AstraZeneca’s rare disease unit receives NICE recommendation for Wolman disease therapy in infants

AstraZeneca’s rare disease unit has received a recommendation from the National Institute for Health and Care Excellence (NICE) for the use of its enzyme replacement therapy in infants with Wolman disease. Alexion’s Kanuma (sebelipase alfa), which has been specifically recommended for use in patients who are aged two years or younger when administration begins, will now become the first treatment available on the NHS for the rapidly-progressive rare genetic disease. Occurring in around one in 350,000 births, Wolman disease causes a build-up of fat in cells in the liver, heart, blood vessels and digestive system. Symptoms in infants include enlarged liver and spleen, poor weight gain, low muscle tone, jaundice, vomiting, diarrhoea, developmental delay and anaemia. Until now, standard care for the disease has been palliative and limited to managing symptoms, with patients normally not surviving past the age of one without treatment. Administered as weekly intravenous infusions which can ...
- Source: drugdu
- 97
- November 30, 2023
FDA investigates ‘serious risk’ of secondary cancer following CAR-T treatment

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. The FDA unveiled the probe Tuesday. The agency said it has received reports of T-cell malignancies, including CAR-positive lymphoma, among patients who received BCMA- or CD19-directed CAR-T cell immunotherapies. Some patients involved have had to be hospitalized or died, according to the agency. The cases stem from clinical trials and postmarketing adverse event surveillance, the FDA said. The FDA has determined that the potential risk is applicable to all currently approved CAR-T therapies, as T-cell malignancies have occurred after patients received several different products. The FDA is now weighing potential regulatory action—even as the potential risk of developing secondary cancer is already included as a class warning on the labels of the CAR-T therapies. Currently marketed CD19 CAR-Ts include Yescarta and Tecartus from Gilead ...
- Source: drugdu
- 225
- November 30, 2023
Biodegradable patch holds promise of correcting congenital heart defects in infants

Using laboratory engineered tissue, scientists at the University of Colorado Anschutz Medical Campus have created a full thickness, biodegradable patch that holds the promise of correcting congenital heart defects in infants, limiting invasive surgeries and outlasting current patches. The findings were published this week in the journal Materials Today. Jeffrey Jacot, PhD, study’s senior author, associate professor of bioengineering, University of Colorado School of Medicine, said, “The ultimate goal is to make lab-grown heart tissue from a patient’s own cells that can be used to restructure the heart to correct for heart defects.” About 10,000 babies are born with a complex congenital heart defect every year in this country, requiring surgery in the first year of life. Some of these operations require the implantation of a full-thickness heart patch. But the current materials used in the patch are non-living and non-degradable. They don’t grow with the patient and often fail ...
- Source: drugdu
- 156
- November 29, 2023
FDA grants second orphan drug designation to Priothera’s mocravimod

The US Food and Drug Administration (FDA) has granted an orphan drug designation to Priothera’s mocravimod for leukaemia patients undergoing a stem cell transplant. The drug is indicated to help improve the outcome of patients with haematologic malignancies following a haematopoietic stem cell transplantation, according to a 27 November press release. Following the designation, the Dublin, Ireland-headquartered biotech will now be in line for tax credits for US-based clinical trials and, if the therapy is approved, have seven years of market exclusivity in the designated indication. Haematopoietic stem cell transplantation, also known as blood and bone marrow transplantation, is used to treat a wide range of blood cancers. There are nearly 60,000 new cases of leukaemia in the US each year. This is the second orphan drug designation for Priothera’s mocravimod. The first, granted in March 2022, was for the treatment of acute myeloid leukaemia (AML) in patients undergoing hematopoietic ...
- Source: drugdu
- 206
- November 29, 2023
EirGenix’s Breast Cancer Biosimilar Receives Marketing Authorization by EC

TAIPEI, Nov. 22, 2023 /PRNewswire/ — EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission (EC). The marketing authorization in the EU will cover the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, which are the same indications approved by the EC for the reference biologic, Herceptin®. Sandoz AG and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix Inc. will remain responsible for the development and manufacturing of trastuzumab while Sandoz will hold the rights to commercialize the medicine upon approval in the global market (excluding Taiwan, China, Russia, and some Asian countries). Breast and gastric cancers are among the most frequently occurring in Europe, and combined, are responsible for nearly 200,000 deaths ...
- Source: drugdu
- 108
- November 28, 2023
What 4 Execs Want People To Know About the Intersection Between the Justice System and Behavioral Health

About 44% of people in jail and 37% of people in prison have a mental illness. In addition, 63% of people in jail and 58% of people in prison have a substance use disorder. Yet, support is often lacking for this population. This was the topic of discussion on a recent panel of behavioral health experts at the Behavioral Health Tech 2023 conference in Phoenix. When asked what the healthcare industry should know about the intersection between the justice system and mental health, one panelist said that numerous players work with the incarcerated population and there needs to be better collaboration. “There are so many organizations — city-based, state-based, nationally-based — that are assisting this community,” said Darren Webb, CEO of Mindset, which helps those with mental illness and their caregivers apply for Social Security Disability benefits. “We’ve gone to partner with jails and we wouldn’t even know that there ...
- Source: drugdu
- 96
- November 28, 2023
AstraZeneca plans to exit ‘beating heart’ of Indian operations in Bangalore

Amid a corporate review of AstraZeneca’s global manufacturing and supply network, the company’s Indian subsidiary is planning to close up shop at the “beating heart” of its India operations in Bangalore. AstraZeneca Pharma India will exit its production plant in Bangalore, India, “in due course,” the company said in a filing on the Bombay Stock Exchange Thursday. AZ plans to auction off the site “in a fully operational manner” to a buyer who can also serve as a contract manufacturer for the AstraZeneca drugs made and packaged in Bangalore, AZ’s Indian subsidiary said. In the filing, AZ said it is “fully cognizant of the impact this change can bring,” adding that the company’s “first responsibility will be towards its employees and meeting the needs of its patients by ensuring an uninterrupted supply of medicines.” AstraZeneca has operated in India since 1979, the company says on its website. Aside from its ...
- Source: drugdu
- 102
- November 28, 2023
Heat shock protein protects bacteria from plasma treatment

A heat shock protein protects the cells against protein clumping. It degrades, however, over longer treatment periods. Plasmas are used, for example, in wound treatment against pathogens that are resistant to antibiotics. However, bacteria can defend themselves: They employ a heat shock protein that protects them. A research team headed by Professor Julia Bandow and Dr. Tim Dirks from the Chair for Applied Microbiology at Ruhr University Bochum, Germany, showed that bacteria that overproduce the heat shock protein Hsp33 can withstand plasma treatment more effectively than others. The researchers also demonstrated which components of the plasma activate the heat shock protein. The team published their findings in the Journal of the Royal Society Interface on October 25, 2023. All bacteria inactivated after three minutes When treated with plasma, proteins unfold, lose their natural functions and can clump together. Their clumping is toxic to cells and can lead to their inactivation. ...
- Source: drugdu
- 103
- November 27, 2023

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