Search Results for “antibody” – Page 54 – media

Takeda Withdraws Dengue Vaccine Application After FDA Request for More Data

Takeda has voluntarily withdrawn the Biologics License Application for its dengue vaccine candidate TAK-003 following discussions with the FDA regarding additional data collection, the Japanese pharma company announced Tuesday. According to Takeda, it will not be able to address the regulator’s concerns within the current BLA review cycle. The company is currently assessing its future options and plans for TAK-003, as well as evaluating the requirements for a potential BLA resubmission in the U.S., a spokesperson told Fierce Pharma. The FDA accepted Takeda’s BLA for TAK-003 in November 2022 and put the application under Priority Review, which typically results in a decision within six months versus the standard 10-month review period. “We will continue to progress regulatory reviews and provide access for people living in and traveling to dengue-endemic areas while we work to determine next steps in the U.S.,” Gary Dubin, president of Takeda’s vaccines business unit, said in a statement. TAK-003 is a tetravalent live-attenuated vaccine ...
- Source: drugdu
- 124
- July 14, 2023
BeiGene Signs $1.3bn Deal with DualityBio for Investigational Solid Tumour ADC

BeiGene has acquired an exclusive option for a global licence to one of DualityBio’s investigational, preclinical antibody-drug conjugates (ADC) for solid tumours. Though few details of the agreement were disclosed, it has been confirmed that DualityBio will receive undisclosed upfront payments from BeiGene and will be eligible to receive certain development, regulatory, and commercial milestone payments totalling up to $1.3bn. ADCs are a class of cancer therapies that combine the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy cells. BeiGene’s global head of research and development, Lai Wang, said: “Through this strategic partnership with DualityBio, we are well positioned to advance this asset globally alongside our initial internally discovered ADC assets with our ...
- Source: drugdu
- 127
- July 14, 2023
FDA Puts Clinical Hold on Hemogenyx’s CAR-T AML Therapy

The FDA has placed a clinical hold on Hemogenyx Pharmaceuticals’ investigational HEMO-CAR-T, which is being trialed for the treatment of acute myeloid leukemia (AML), the UK-based biotech announced Monday. In its full review letter, the FDA pointed to manufacturing problems as the reason for the regulatory pause. In particular, the regulator flagged a “splicing deficiency” that arises during the production of the lentivirus that is used to create the CAR-T cells for Hemogenyx’s candidate, according to the company’s press release. Hemogenyx has already found the source of the splicing issue and has come up with a method to solve it. CEO Vladislav Sandler said in a statement that the company is “confident” that it will “be able to address the FDA’s questions and concerns” regarding HEMO-CAR-T’s Investigational New Drug (IND) application. The company submitted its IND seeking to launch a Phase I trial for HEMO-CAR-T in May 2023. In its letter to Hemogenyx, the ...
- Source: drugdu
- 144
- July 12, 2023
CMS Expands Medicare Coverage for Leqembi After FDA Traditional Approval

Pictured: Sign of U.S. Department of Health & Human Services at its headquarters in Washington/iStock, JHVEPhoto The Centers for Medicare and Medicaid Services will now provide broader coverage for Eisai and Biogen’s Alzheimer’s disease therapy Leqembi (lecanemab), the federal agency announced Thursday. The Medicare coverage expansion comes after Leqembi won the FDA’s traditional approval, making it the first anti-amyloid and disease-altering treatment to do so. Eisai and Biogen were granted accelerated approval for Leqembi in January and soon commenced their bid for full approval with data from the Phase III Clarity-AD study. According to CMS, only patients enrolled in Medicare and with physicians participating in a qualified registry will be eligible for reimbursement—provided their doctors collect their data as real-world evidence for Leqembi and submit it to a registry. Coverage is restricted to those who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with evidence of beta-amyloid deposits in the brain. “With FDA’s decision, CMS will ...
- Source: drugdu
- 131
- July 11, 2023
Sales of Alzheimer’s Drug Leqembi may be Slow Initially But Could Pick up in 2024

Sales of the Alzheimer’s drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S. Wall Street is chewing over the Food and Drug Administration’s Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn’t a cure. Leqembi, from drugmakers Eisai and Biogen, is the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. Medicare on Thursday announced it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, broadening access for those who can’t afford the drug’s hefty $26,500-a-year price tag. But coverage comes with several conditions. Analysts believe certain Medicare requirements and new guidance on Leqembi’s prescription label could potentially weigh on sales of the ...
- Source: drugdu
- 117
- July 11, 2023
Astellas Gains FDA Priority Review for Gastric Cancer Therapy BLA

The US Food and Drug Administration (FDA) has awarded priority review for Astellas Pharma’s biologics licence application (BLA) for zolbetuximab to treat gastric cancer patients. Zolbetuximab is an investigational monoclonal antibody that acts on Claudin 18.2 (CLDN18.2). It is intended for use as a first-line therapy for HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that is locally advanced, unresectable or metastatic, with tumours that are CLDN18.2-positive. Zolbetuximab is the first treatment targeting CLDN18.2 to be offered in the region for such patients. A decision on the approval by the regulatory agency is anticipated on 12 January 2024. The application is based on the Phase III SPOTLIGHT and GLOW clinical trial findings. Zolbetuximab was assessed along with a regimen comprising oxaliplatin, leucovorin and fluorouracil (mFOLFOX6) in the SPOTLIGHT trial. The GLOW trial analysed zolbetuximab in combination with a chemotherapy regimen comprising capecitabine and oxaliplatin (CAPOX). Astellas immuno-oncology development ...
- Source: drugdu
- 121
- July 11, 2023
Takeda and F-star announce immunotherapy partnership worth over $1bn

Takeda and F-star Therapeutics have announced a strategic collaboration and licence agreement focused on developing next-generation multi-specific immunotherapies for patients with cancer, with the deal potentially worth over $1bn. Though few details of the partnership were disclosed, the two companies said they will jointly research and develop antibodies for new immuno-oncology targets using F-star’s proprietary fully-human Fcab and tetravalent mAb2 platforms. Takeda will then have an exclusive option to take select candidates arising from the collaboration forward, with F-star retaining the rights to research, develop,and commercialise antibodies incorporating certain other Fcab domains. F-star will receive an undisclosed upfront payment and research funding for the period of the collaboration and will also be eligible to receive future payments of up to $1bn “if all milestones across multiple programmes are reached during the term of the agreement” plus royalties. The agreement marks the third deal between the two companies, with licence agreements ...
- Source: drugdu
- 110
- July 10, 2023
FDA grants traditional approval for Eisai-Biogen’s Alzheimer’s therapy

The US Food and Drug Administration (FDA) has granted traditional approval for Eisai and Biogen’s Leqembi (lecanemab-irmb) 100mg/mL injection to treat Alzheimer’s disease (AD) in adults. With the approval of the supplemental biologics licence application (sBLA), Leqembi becomes the first therapy to slow disease progression rate and cognitive and functional decline in AD patients. This development is based on findings from the Phase III portion of Eisai’s Clarity AD clinical trial. Trial data showed that the product met the Leqembi primary endpoint and all crucial secondary endpoints, and also demonstrated clinical benefit. In January 2023, the regulatory agency granted accelerated approval for Leqembi. Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and amyloid beta’s (Aβ) insoluble forms. Eisai CEO Haruo Naito stated: “The FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown ...
- Source: drugdu
- 109
- July 9, 2023
Transcenta Received Approvals from China CDE and South Korea MFDS to Initiate TranStar 301 Global Phase III Pivotal Trial of Osemitamab (TST001)

SUZHOU, China, July 7, 2023 /PRNewswire/ — Transcenta Holding Limited (“Transcenta”) (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has received approvals from China CDE (Center for Drug Evaluation) and South Korea MFDS (Ministry of Food and Drug Safety) to initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy for the first-line treatment of patients with HER2 negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. In addition, we are in the process of EU and FDA regulatory interaction. Gastric cancer (GC) is the 4th leading cause of cancer death worldwide, accounting for about 7.7% of all cancer related mortality. The five year survival rate for gastric cancer is still around 30%. Nivolumab, an anti-PD-1 antibody, has been approved globally for the first line treatment ...
- Source: drugdu
- 178
- July 9, 2023
Boehringer’s spesolimab shows promise in generalised pustular psoriasis prevention

Boehringer Ingelheim has shared positive new 48-week data from a phase 2b trial of its anti-interleukin-36 receptor (IL-36R) antibody in patients with generalised pustular psoriasis (GPP). The results from the EFFISAYIL 2 trial, presented by the company at this year’s World Congress of Dermatology, show that spesolimab reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. The trial also demonstrated no flares after week four of spesolimab treatment in the high dose group, Boehringer said. GPP is a rare and chronic neutrophilic skin disease, which is genetically and clinically distinct from plaque psoriasis. GPP is caused by neutrophils – a type of white blood cell – accumulating in the skin, causing painful, sterile pustules all over the body. Despite the varying severity of GPP flares, if left untreated they can be life-threatening due to complications such as sepsis and multisystem organ failure, and the unpredictability ...
- Source: drugdu
- 199
- July 6, 2023

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