Search Results for “immune” – Page 48 – media

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
- 216
- November 29, 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
- 106
- November 27, 2023
Simcere and Connect sign licensing agreement for anti IL-4Rα AD drug

Simcere has entered a licensing agreement with Connect Biopharma for the development of a monoclonal antibody (MAb) candidate rademikibart (CBP-201) against allergic inflammation in autoimmune conditions such as atopic dermatitis (AD) and asthma. Under the deal, the Nanjing, China-headquartered company will have a licence for the development and commercialisation of rademikibart in mainland China, Macau, Taiwan, and Hong Kong. Connect retains its rights to the MAb outside Greater China. Rademikibart is a humanIgG4 MAb that binds to IL-4Rα, which can be administered as a subcutaneous or intravenous (IV) injection. Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) has dominated the AD drug market since it first gained a US Food and Drug Administration (FDA) approval in March 2017. Dupixent had generated $6.4bn in US sales up until 30 September, according to Regeneron’s Q3 2023 report. It is forecast to make over $11bn in global sales for all indications by the end of ...
- Source: drugdu
- 190
- November 26, 2023
EirGenix and Sandoz win EU approval for Herceptin biosimilar

The European Commission has granted marketing authorisation to EirGenix’s Herceptin (trastuzumab) biosimilar for marketing in the European Union. The biosimilar has been approved as a treatment for human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, as per a 22 November press release. Herceptin is a monoclonal antibody that binds to HER2 receptors, thereby priming these receptors for immune system targeting. The drug generated SFr1.26bn ($1.4bn) in year-to-date (YTD) sales in September, as per Roche’s Q3 financials. Sandoz is responsible for the worldwide commercialisation of EirGenix’s Herceptin biosimilar, except in Taiwan, China, Russia, and some Asian countries, based on the 22 November press release. Meanwhile, EirGenix holds the developmental, commercialisation and manufacturing rights for the biosimilar in countries not covered by Sandoz. In September, EirGenix’s Herceptin biosimilar received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
- Source: drugdu
- 178
- November 26, 2023
Darzalex Faspro in Multiple Myeloma, Imbruvica-Venclexta in Mantle Cell Lymphoma

By Tristan Manalac Ahead of the 65th Annual Meeting and Exposition of the American Society of Hematology, taking place Dec. 9 to 12, event organizers on Tuesday released late-breaking abstracts providing an early view of some of the most high-impact studies in blood disorders to be presented at the conference. Focus on two of those studies below. J&J, Genmab’s Darzalex Faspro Early data from the Phase III PERSEUS study showed that J&J and Genmab’s subcutaneous anti-CD38 antibody Darzalex Faspro (daratumumab and hyaluronidase-fihj) significantly prolonged progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM). PERSEUS enrolled 709 patients in total, of whom 355 were randomly assigned to receive Darzalex Faspro combined with bortezomib, lenalidomide and dexamethasone (VRd). At a median follow-up of 47.5 months, patients treated with the Darzalex Faspro regimen saw a significantly better PFS versus comparators who received VRd alone. The effect had a hazard ratio of ...
- Source: drugdu
- 121
- November 25, 2023
Boehringer Ingelheim to acquire T3 Pharmaceuticals in deal worth over $500m

Boehringer Ingelheim has said it will be acquiring bacterial cancer therapy specialist T3 Pharmaceuticals in a deal worth over $500m, marking a significant boost to its immuno-oncology portfolio. Boehringer said it is seeking to “significantly increase” the current 15 to 20% remission rate in cancer patients by utilising complementary immuno-oncology platforms such as T-cell engagers, oncolytic viruses and cancer vaccines. T3, founded in 2015 as a spinout from the University of Basel in Switzerland, has developed a proprietary therapy platform that uses live bacteria to deliver immune-modulating proteins directly to cancer cells and tumour micro-environments while sparing healthy tissues. The bacteria can be loaded with multiple immune-modulatory proteins of choice, allowing the design of immuno-oncology combination therapies in one single agent. Michel Pairet, member of the board of managing directors at Boehringer with responsibility for the Innovation Unit, said: “The acquisition of T3 Pharma will significantly expand our immuno-oncology pipeline ...
- Source: drugdu
- 106
- November 25, 2023
Merck to acquire Caraway Therapeutics in a deal worth up to $610m

Merck & Co – known as MSD outside the US and Canada – has entered into a definitive agreement to acquire Caraway Therapeutics, with the deal worth up to $610m. The acquisition gives Merck access to the preclinical biopharma’s pipeline of small-molecule therapeutics for genetically defined neurodegenerative and rare diseases. Mutations that impair cellular clearance pathways are associated with multiple neurodegenerative and rare diseases, including neurodegenerative disorders characterised by cognitive dysfunction, according to Caraway. The company focuses on discovering small molecules that activate cellular recycling processes to clear toxic materials and defective cellular components by modulating lysosomal function. George Addona, senior vice president, discovery, preclinical development and translational medicine at Merck Research Laboratories, said: “Caraway’s multidisciplinary approach has yielded important progress in evaluating novel mechanisms of modulation of lysosomal function with potential for the treatment of progressive neurodegenerative diseases. “We look forward to applying our expertise to build upon this ...
- Source: drugdu
- 230
- November 25, 2023
InDex Scraps Phase III Ulcerative Colitis Trial on Disappointing Data

By Tristan Manalac InDex Pharmaceuticals on Tuesday announced that it is discontinuing the Phase III CONCLUDE program, which was evaluating its investigational immunomodulatory therapeutic cobitolimod in ulcerative colitis. The decision to terminate the late-stage study is in line with the recommendations of an Independent Data Monitoring Committee, which found during a planned dose selection, safety and futility analysis that cobitolimod is “unlikely” to meet the study’s primary endpoint, according to the company’s announcement. At the same time, InDex noted that the committee’s advice to discontinue the study was not due to any safety concerns. InDex CEO Jenny Sundqvist in a statement called the committee’s recommendation “surprising and disappointing,” adding that cobitolimod’s failure in CONCLUDE highlights the “complexity of the disease” and points to the need for more research to address the “high unmet medical need” in ulcerative colitis. The company’s stock was trading approximately 59% lower on Wednesday morning in ...
- Source: drugdu
- 144
- November 24, 2023
Q&A With William Ho, CEO of IN8bio

Mike Hollan Ho discusses how gamma-delta T cells can improve cancer treatments. Pharmaceutical Executive: Can you provide some background on gamma-delta T-Cells? William Ho: I’ve been in the biotech industry for over 22 years, and much of that was spent on the Wall Street side (investor banking, equity research, and as an investor). I co-founded the company together in 2016, and today we’re one of the leading companies developing gamma-delta T-Cells in oncology as a cellular therapy. Much of our work is based on Dr. Lamb’s lifetime of research on these t-cells. He was the first to describe them as being associated with better survival outcomes back in the 1990s. They were first identified in the mid 1980s. Dr. Lamb spent the better part of 25 years or so trying to figure out how to make that observation into a therapeutic. He needed to figure out how to manufacture, scale, ...
- Source: drugdu
- 104
- November 22, 2023
Merck Expands Keytruda’s Label as a First-Line Option for Gastric Cancer

By Tristan Manalac Pictured: Merck Research Laboratories building in California The FDA on Thursday approved Merck’s anti-PD-1 blockbuster Keytruda (pembrolizumab) for the first-line treatment of adult patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Thursday’s label expansion is Keytruda’s seventh approval in gastrointestinal cancer and its 38th indication overall in the U.S., according to Merck’s announcement. This latest approval covers patients with HER2-negative cancers and authorizes the use of the PD-1 blocker in combination with fluoropyrimidine- and platinum-containing chemotherapy. Previously, Keytruda was indicated for gastric cancer only in patients who had progressed after at least two prior lines of systemic therapy, including fluoropyrimidine- and platinum-containing chemotherapy. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, in a statement called Keytruda’s label expansion an “important milestone” in the care of gastric or gastroesophageal junction adenocarcinoma. Data from the Phase ...
- Source: drugdu
- 101
- November 21, 2023

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