Search Results for “antibody” – Page 27 – media

Jazz Pharmaceuticals Completes Biologics License Application for Zanidatamab for HER2-Positive Metastatic Biliary Tract Cancer

Don Tracy, Associate Editor Approval would mark first HER2-targeted therapy for biliary tract cancer in the United States. Jazz Pharmaceuticals announced that it has completed its Biologics License Application (BLA) for zanidatamab, an investigational bispecific antibody treatment targeting HER2-positive metastatic(BTC). Aiming for accelerated approval, zanidatamab has the potential to be the first HER2-targeted therapy indicated for BTC in the United States. According to the company, the BLA was based on findings from the Phase IIb HERIZON-BTC-01 trial for zanidatamab. The primary study endpoint of confirmed objective response rate (cORR) by independent central review (ICR) was deemed a success, as the 80 enrolled patients demonstrated a cORR of 41.3%. The HERIZON-BTC-302 Phase III started recently and is currently in the process of enrollment.1 “This important milestone brings us one step closer to delivering zanidatamab, a targeted treatment option, to patients living with HER2-positive BTC, a type of cancer that is associated ...
- Source: drugdu
- 133
- April 5, 2024
Alexion’s Voydeya gains FDA approval for extravascular haemolysis

Alexion, AstraZeneca Rare Disease has received approval from the US Food and Drug Administration (FDA) for Voydeya (danicopan) as an add-on therapy to treat extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH). A first-in-class, oral Factor D inhibitor, Voydeya has been developed for patients who continue to suffer from EVH despite treatment with C5 inhibitors such as Ultomiris (ravulizumab) or Soliris (eculizumab). The FDA’s decision is grounded in the positive outcomes of the ALPHA Phase III trial, which demonstrated that Voydeya met its primary endpoint of haemoglobin change from baseline to week 12, alongside all key secondary endpoints. The drug was generally well-tolerated with no new safety concerns. As part of the ALPHA double-blind, placebo-controlled, multiple-dose trial, patients were enrolled and randomised to receive Voydeya or placebo apart from their ongoing Soliris or Ultomiris therapy over 12 weeks. It aimed to assess the superiority of Voydeya as an ...
- Source: drugdu
- 129
- April 4, 2024
Ipsen joins the ADC club with deal worth up to $900m

Ipsen has joined the slew of companies developing antibody-drug conjugates (ADC) with the announcement of a new global licensing agreement with Sutro Biopharma for the development of the latter’s STRO-003. Ipsen declared that the deal would give it exclusive worldwide rights to develop and commercialise the ROR1-targeting ADC STRO-003. Ipsen is accountable for Phase I preparations, including investigational new drug application (IND) submissions. The Paris, France-headquartered company will also be responsible for the later clinical development and global commercialisation of STRO-003. Under the partnership, Sutro Biopharma could receive up to $900m in prospective upfront, development, and commercial milestone-based payments. This is inclusive of $90m in near-term payments in the form of tiered royalties on global sales, and an equity investment, dependent on Ipsen’s successful development and commercialisation strategy. STRO-003 is one of three named ADCs being developed in Sutro’s clinical pipeline. In June 2023, Sutro announced plans to submit INDs ...
- Source: drugdu
- 153
- April 4, 2024
Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12

Don Tracy, Associate Editor Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies. Gilead Sciences and Xilio Therapeutics announced that they have agreed to terms on a licensing agreement regarding XTX301, Xilio’s Phase I tumor-activated IL-12. According to Gilead, the partnership aims to expand the company’s focus in immuno-oncology, leveraging Xilio’s novel tumor-activation platform to improve its therapeutic nature and build a consistent pipeline of tumor-activated molecules. As per the deal, Xilio will receive an upfront payment of $43.5 million, with $30 million in cash and an equity investment of $13.5 million provided by Gilead in common stock. Overall, Xilio will have the opportunity to earn up to $604 million based on specified development, regulatory, and sales-based milestones.1 “Xilio’s novel tumor-activation platform naturally complements Gilead’s clinical development program in difficult-to-treat cancers and expands our focus in immuno-oncology,” said Bill Grossman, MD, PhD, SVP, ...
- Source: drugdu
- 95
- April 3, 2024
IASO Bio Announces NMPA’s IND Approval for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma

SHANGHAI and NANJING, China and SAN JOSE, Calif., March 29, 2024 /PRNewswire/ — IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for Equecabtagene Autoleucel (IASO Bio R&D code: CT103A), a self-developed fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma (R/RMM) patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide. The New Drug Application (NDA) for FUCASO ® (Equecabtagene Autoleucel) was approved by NMPA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent on June 30, 2023. The NDA approval was based on the ...
- Source: drugdu
- 89
- April 3, 2024
Hengrui’s Clinical Application for New Drug Indicated for Psoriasis Approved

Today (March 29), according to the official website of CDE, Guangdong Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as “Hengrui Pharmaceutical”) class 1 new drug SHR-1139 injection indicated for psoriasis application obtained approval. Psoriasis is a chronic inflammatory skin disease that is stimulated by environmental factors, genetic control, and immune media. According to relevant data, there are more than 7 million psoriasis patients in China. Fhstrilin predicts that China’s psoriasis market will increase to US $ 9.5 billion in 2030, with a compound annual growth rate of 27.1%. Globally, the number of patients with psoriasis is on the rise. At present, biopharmaceuticals have gradually become one of the mainstream therapies of psoriasis in China. Related drugs are mainly focused on targets such as TNF-α and IL families. Hengrui Pharmaceutical also deployed psoriasis therapy drugs, of which Fu Niqizumab (SHR-1314) targets IL-17A targets. Following the CDE acceptance of the listing of ...
- Source: drugdu
- 92
- April 2, 2024
Roche wins FDA approval for first molecular malaria blood donor screening test

Dive Brief Roche has received Food and Drug Administration approval for the first molecular test to screen U.S. blood donors for malaria, the company said Tuesday. In 2022, the FDA recommended preventing people from giving blood for a time after they return from an area with malaria because there was no licensed test to screen donors. Other countries including Australia, England and France use antibody testing to avoid excluding potential donors. Roche’s Cobas malaria molecular test screens whole blood samples for the five main species of parasites that cause infections. The company is pitching the test as a way to improve the safety and availability of blood. Dive Insight Around 2,000 people are diagnosed with the mosquito-borne disease in the U.S. each year, typically after traveling to a country where malaria transmission occurs. The potential for donors to unknowingly pass the parasite on to recipients of their donations led the ...
- Source: drugdu
- 140
- April 1, 2024
Jacobio Pharma Announces 2023 Annual Results

Beijing, Shanghai & Boston, Mar. 28, 2024 — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its 2023 annual results. The revenue was RMB63.5 million, the R&D investment was RMB372 million, the cash and cash equivalent at the end of 2023 was RMB 1.2 billion. Jacobio Pharma also announced its recent business progress and expected milestones. Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma, said: “In the past year, Jacobio continued to make progress in our projects. We received approval for registrational phase III clinical trial of the combination therapy between our SHP2 inhibitor JAB-3312 and KRAS G12C inhibitor glecirasib. Our JAB-3312 became the first SHP2 inhibitor to enter into registrational trial. This milestone is consistent with our mission of ‘drugging the undruggable’. Meanwhile, the patient enrollment for pivotal trial of our core product glecirasib has been completed, and the NDA application expected to ...
- Source: drugdu
- 93
- March 30, 2024
Mabwell reaches the Oversea Market of South Asia and Africa

Mabwell announced a supply and commercialization agreement with an Indian pharmaceutical company for 9MW0813 (aflibercept intraocular injection, Eylea® biosimilar). According to the agreement, the cooperative company has obtained the exclusive rights to import, produce, register, market and sell 9MW0813 in India, and has the right to obtain non-exclusive rights in 10 countries, including some countries in South Asia and Africa. 9MW0813 is a biosimilar of Eylea® and has completed phase III enrollment in clinical studies in China. Based on the principles of comparative and incremental development and comprehensive evaluation of drugs, pharmaceutical, non-clinical and clinical comparison results indicate that 9MW0813 is highly similar to the originator product in terms of quality, safety and effectiveness. About 9MW0813 9MW0813 is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein, indicated for diabetic macular edema and neovascular (wet) age-related macular degeneration. 9MW0813 is a biosimilar of aflibercept (Eylea®). It is a fusion ...
- Source: drugdu
- 197
- March 29, 2024
Beijing Municipal Party Secretary Yin Li Met with Novartis Global CEO Wansheim

On the afternoon of March 25, Yin Li, Secretary of the Municipal Party Committee of Beijing, met with Novartis Global CEO Wansheim, Pfizer Chairman and CEO Eberle, and Danaher Global President and CEO Bjørnen. Yin Li introduced the economic and social development of Beijing and the health condition of its residents. He said that the Beijing Municipal Government attaches great importance to residents’ health, vigorously develops health care, gives full play to the advantages of rich scientific and technological talent resources, and continuously improves the level of medical services for the people in the city. Beijing’s pharmaceutical and health industry has a good foundation and a perfect system. In recent years, it has laid out its biopharmaceutical industry in key areas such as cellular genes, nucleic acid drugs, new antibodies, etc., and has formed international leading source innovative varieties in the fields of antibody drugs and immunotherapy drugs. Beijing’s science ...
- Source: drugdu
- 116
- March 29, 2024

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