Category Archives: Global News Feed

Japan is the first country in the world to approve NexoBrid for people of all ages; pediatric and adult populations

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MediWound Expands NexoBrid’s Global Presence with Marketing Approval in Japan

SYDNEY, AUSTRALIA, Dec. 23, 2022 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the results of a positive follow-up Type C meeting with the US Food and Drug Administration (FDA) regarding late-stage clinical development plans for its first-in-class soluble LAG-3 protein, eftilagimod alpha (“efti”), in conjunction with standard-of-care chemotherapy for the treatment of metastatic breast cancer (MBC). The Company and the FDA have agreed to an integrated Phase II/III trial design that will help inform a Biologics License Application (BLA).

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Immutep Announces Successful Meeting with the FDA on Eftilagimod Alpha plus Chemotherapy for the Treatment of Metastatic Breast Cancer

Basel, 23 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment. Lunsumio will be available in the United States in the coming weeks. “This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, M.D., Ph.D., Haematologic Oncologist and Associate Professor, City of Hope Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, and Lunsumio clinical trial investigator. “As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio’s high response rates and fixed-duration could change the way advanced follicular lymphoma is treated.”“Despite treatment advances, follicular lymphoma remains incurable and relapse is common, with outcomes worsening following each consecutive treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Lunsumio represents our first approved T-cell engaging bispecific antibody and builds on our legacy of more than 20 years of innovation in blood cancer.”The FDA approval is based on positive results from the phase II GO29781 study of Lunsumio in people with heavily pre-treated FL, including those who were at high risk of disease progression or whose disease was refractory to prior therapies. Results from the study showed high and durable response rates. An objective response was seen in 80% (72/90 [95% confidence interval (CI): 70-88]) of patients treated with Lunsumio, with a majority maintaining responses for at least 18 months (57% [95% CI: 44-70]). The objective response rate is the combination of complete response (CR) rate (a disappearance of all signs and symptoms of cancer) and partial response rate (a decrease in the amount of cancer in the body). The median duration of response among those who responded was almost two years (22.8 months [95% CI: 10-not reached]). A CR was achieved in 60% of patients (54/90 [95% CI: 49-70]). Among 218 patients with haematologic malignancies who received Lunsumio at the recommended dose, the most common adverse event (AE) was cytokine release syndrome (CRS; 39%), which can be severe and life-threatening. The median duration of CRS events was three days (range: 1-29). Other common AEs (?20%) included fatigue, rash, pyrexia and headache.Lunsumio is administered as an intravenous infusion for a fixed-duration, which allows for time off therapy, and can be infused in an outpatient setting. Hospitalisation may be needed to manage select AEs, should be considered for subsequent infusions following a Grade 2 CRS event, and is recommended for subsequent infusions following a Grade 3 CRS event.Lunsumio was developed based on the Roche Group's broad expertise in creating bispecific antibodies. Lunsumio is designed to address the diverse needs of people with blood cancer, physicians, and practice settings, and is part of the company’s robust bispecific antibody clinical programme in lymphoma. Lunsumio is being further investigated as a subcutaneous formulation (i.e., administered under the skin) and in phase III studies that will expand the understanding of its impact in earlier lines of treatment in people with non-Hodgkin lymphoma.About the GO29781 studyThe GO29781 study [NCT02500407] is a phase II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab-axgb) in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include complete response rate (best response) by independent review facility (primary endpoint), objective response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints).About follicular lymphomaFollicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.1 It typically responds well to treatment but is often characterised by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, approximately 13,000 new cases of FL will be diagnosed in 2022 and more than 100,000 people are diagnosed with FL each year worldwide.1,2About Lunsumio® (mosunetuzumab-axgb)Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab) and Lunsumio® (mosunetuzumab-axgb). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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FDA approves Roche’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma

- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the BLA -

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Coherus and Junshi Biosciences Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or...

- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the BLA -

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Junshi Biosciences and Coherus Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or...

New York, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough CNS immunomodulation approaches to enhance the functionality of Treg-based therapies, announced today that the Company plans to present at the Biotech Showcase and host institutional investor and partnering meetings at this event, as well as at the LifeSci Corporate Access Event. Both in-person events are taking place January 9-10, 2023 in San Francisco, California.

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Tiziana to Participate in January Investor Meetings

If approved, etranacogene dezaparvovec would be the first licensed gene therapy in Europe for people living with hemophilia B If approved, etranacogene dezaparvovec would be the first licensed gene therapy in Europe for people living with hemophilia B

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uniQure announces positive CHMP opinion for etranacogene dezaparvovec – gene therapy for adults with hemophilia B

POMPANO BEACH, FLORIDA., Dec. 16, 2022 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTCQB: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics, is pleased to announce that its common shares have been successfully up-listed from the OTC Pink Sheet Open Market to the OTCQB Venture Market (the “OTCQB”) by the OTC Markets Group Inc. (“OTC Markets”). The Company’s common shares will begin trading on the OTCQB under the symbol “BSEM” as of the opening of market on December 16, 2022.

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BioStem Technologies Announces Up-Listing to the OTCQB Venture Market

Dupixent® (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis

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Press Release: Dupixent® (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis

MADRID, Spain and BOSTON, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today the approval by the EU-intergovernmental organization EUREKA secretariat of funding for the BRAVE Project (Breaking immune Resistance of Advanced cancers by HERV-K Vaccination and Epigenetic modulation) under the Eurostars-3 program. This project will be developed in collaboration with two European partners: the Danish company ImProTher and the University of Copenhagen, and will evaluate the role of iadademstat in several immunotherapy strategies, including checkpoint inhibitors and/or oncological vaccines, in solid tumors.

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ORYZON Awarded EU Grant to Further Explore the Role of Iadademstat in Oncological Immunotherapy Approaches