Search Results for “Takeda” – media

Degron Therapeutics, Takeda Ink Exclusive License and Collaboration Agreement to Develop Molecule Degraders Targeting Multiple Indications

Don Tracy, Associate Editor Joint venture expected to utilize Degron’s GlueXplorer platform to identify, validate, and optimize molecular glue degraders. Degron Therapeutics announced that it has agreed to terms on a collaboration with Takeda, which will utilize its GlueXplorer to develop molecular glue degraders targeting oncology, neuroscience, and inflammation. Upon completion of the initial stages, Takeda will take over for further development and commercialization. Under terms of the deal, Degron will receive an upfront payment, with the opportunity to receive up to $1.2 billion in milestone payments and tiered royalties on sales. The deal also includes an equity investment by Takeda in Degron and the option to expand to additional targets.1 “We are excited to collaborate with Takeda, expanding the use of our platform into new therapeutic areas,” said Lily Zou, PhD, co-founder, CEO, Degron Therapeutics, in a press release. “Degron’s differentiated and powerful GlueXplorer platform has been validated by ...
- Source: drugdu
- 75
- May 28, 2024
Takeda, Astellas & Sumitomo Mitsui Form Joint Venture to Lift Japanese Innovation From ‘Valley of Death’

Two Japanese pharmaceutical companies and a bank are teaming up to form a joint venture to advance therapeutic discoveries from academia. The focus will be innovation from universities in Japan. By Frank Vinluan Academic labs are starting points for many biopharmaceutical industry innovations, and Japan’s universities are no exception. But academic scientists often struggle to find the financing and support to turn their discoveries into new companies, leaving the research to languish in what is sometimes referred to as “the valley of death.” Now Takeda Pharmaceutical, Astellas Pharma, and Sumitomo Mitsui Banking Corporation are teaming up to form a joint venture intended to advance academic discoveries, primarily innovation from Japan. All three are sharing ownership in the joint venture, whose name has not yet been determined. The joint venture’s founders say the valley of death has become more pronounced in recent years. In response to this challenge, the companies said they engaged ...
- Source: https://medcitynews.com/author/fvinluan/
- 92
- May 2, 2024
FDA Approves Takeda’s Subcutaneous Form of Entyvio as a Maintenance Therapy in Adults with Moderately to Severe Crohn Disease

Don Tracy, Associate Editor Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio. The FDA has approved Takeda Pharmaceuticals’ subcutaneous (SC) form of Entyvio (vedolizumab) as a maintenance therapy for adults with moderately to severely active Crohns disease (CD) following initial intravenous (IV) induction therapy. The expanded approval for an SC form of the drug was based on results from the randomized, double-blind, placebo-controlled Phase III VISIBLE 2 trial, which evaluated 409 patients who were treated with an injection of Entyvio or placebo every two weeks. At the end of the trial, 48% of patients treated with Entyvio experienced clinical remission.1,2 “Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve ...
- Source: drugdu
- 104
- April 23, 2024
FDA Grants Accelerated Approval to Takeda’s Iclusig for Ph-Positive Acute Lymphoblastic Leukemia

Davy James Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia. The FDA has granted accelerated approval to Takeda’s supplemental New Drug Application for Iclusig (ponatinib) plus chemotherapy to treat adults with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL).1,2 Iclusig is the only pan-mutational, third-generation tyrosine kinase inhibitor (TKI) that targets BCR::ABL1, an abnormal tyrosine kinase expressed in Ph-positive ALL and chronic myeloid leukemia (CML). Iclusig can also treat all known single, treatment-resistant mutations, including T315I. “This label expansion for Iclusig is an incredibly exciting milestone, allowing US adult patients with newly diagnosed Ph-positive ALL to have an approved, targeted treatment option in the frontline,” Awny Farajallah, MD, chief medical officer, oncology at Takeda, said in a press release. “We are thrilled that the FDA has recognized the potential of Iclusig to fill a large gap in care for these ...
- Source: drugdu
- 158
- March 21, 2024
AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda

AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug. By FRANK VINLUAN AstraZeneca is bolstering its rare disease pipeline with a deal to buy Amolyt Pharma, a biotech company in late-stage development with a therapy designed to treat a rare hormone deficiency whose only FDA-approved treatment will soon cease production. According to deal terms announced Thursday, AstraZeneca is paying Amolyt shareholders $800 million up front. Another $250 million is tied to the achievement of a regulatory milestone that was not disclosed. Considering that the drug is in Phase 3 testing, that milestone could be a regulatory approval. Lyon, France-based Amolyt is developing a therapy for hypoparathyroidism, a disease in which the parathyroid glands do not produce enough parathyroid hormone. This ...
- Source: drugdu
- 155
- March 18, 2024
Takeda picks up 2nd FDA-approved indication for immune globulin treatment HyQvia

It was a decade and four companies ago that HyQvia was first approved by the FDA for primary immunodeficiency (PI). Ten years later, Takeda’s subcutaneous immune globulin treatment has scored its second indication, as the FDA has approved it as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). A progressive neurological disorder, CIDP causes weakness and reduced feeling in the arms and legs. In 2014, when it was owned by Baxter, HyQvia was endorsed to treat adults with PI, an umbrella term referring to 400-plus rare diseases that can affect the immune system. Then in April of last year, Takeda won a label expansion to treat children ages 2 to 16. The approval for CIDP was based on a phase 3 trial that enrolled 122 adults. The study showed that 14% of those on HyQvia relapsed, compared with 32% of those on placebo. Another phase 3 trial assessed the ...
- Source: drugdu
- 153
- January 18, 2024
Novartis drops subpoena request in trade-secret spat with Takeda

Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade secrets theft. Novartis originally filed the complaint in Massachusetts Superior Court in October. The Swiss pharma wanted to find out whether a former employee in Egypt took sensitive documents to his new job with Takeda. After being “stonewalled” by Takeda, Novartis resorted to legal action, attempting to subpoena the Japanese pharma’s business records and depose an employee. Takeda, on Nov. 10, filed a motion to dismiss the complaint for recovery. According to Novartis, a former employee named Khaled Shams Eldin transferred some 10,000 files to his personal email before departing the company in May. After leaving his post as operations lead for cell and gene therapy at Novartis’ Egyptian unit, Eldin joined Takeda in July in a similar position, the company said. Earlier this week, Novartis dropped the case, according to a court ...
- Source: drugdu
- 112
- November 24, 2023
Takeda’s enzyme replacement therapy approved by FDA for rare blood clotting disorder

Takeda’s Adzynma (ADAMTS13, recombinant-krhn) has been approved by the US Food and Drug Administration (FDA) as the first therapeutic option for congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare inherited blood clotting disorder. Estimated to affect fewer than 1,000 people in the US, cTTP is caused by a deficiency in the ADAMTS13 enzyme that regulates blood clotting. Patients with cTTP can experience severe bleeding episodes, strokes and damage to vital organs, and mortality rates are high if left untreated. “Without treatment, cTTP is ultimately fatal,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He continued: “[The] approval reflects important progress in the development of much-needed treatment options for patients affected by this life-threatening disorder.” Until now, cTTP treatment has typically involved plasma therapy, which Takeda has previously described as “insufficient in restoring ADAMTS13, time-consuming and costly”. Adzynma, which has been authorised for use as a preventative ...
- Source: drugdu
- 96
- November 16, 2023
Takeda’s Fruzaqla receives FDA approval for metastatic colorectal cancer

Takeda’s Fruzaqla (fruquintinib) has been approved by the US Food and Drug Administration (FDA) for use in certain patients with previously-treated metastatic colorectal cancer (mCRC). Fruzaqla, which inhibits all three VEGF receptor kinases, has been specifically authorised for use in adults with mCRC who have been previously treated with chemotherapy, an anti-VEGF therapy, and in some cases, an anti-EGFR therapy. The FDA’s decision makes Fruzaqla the first targeted treatment options approved in the US for metastatic CRC regardless of biomarker status or prior therapies in more than a decade and was supported by results from the late-stage FRESCO and FRESCO-2 trials, which evaluated Fruzaqla plus best supportive care versus placebo plus best supportive care in previously-treated mCRC patients. Both trials met their primary and key secondary efficacy endpoints and showed consistent benefit among a total of 734 patients treated with Fruzaqla, Takeda said, adding that the drug demonstrated a “manageable ...
- Source: drugdu
- 96
- November 14, 2023
Takeda Wins FDA Approval for Fruquintinib in Certain Colorectal Cancer Patients

The FDA on Wednesday approved Takeda’s fruquintinib for previously treated adults patients with metastatic colorectal cancer. The oral targeted therapy of the VEGF-1, -2 and -3 receptors will carry the brand name Fruzaqla. Fruzaqla’s label covers patients who had received prior lines of treatment with fluoropyrimidine, oxaliplatin and irinotecan chemotherapy, as well as an anti-VEGF agent. In wild-type RAS metastatic colorectal cancer (mCRC), and if medically appropriate, the therapy is also indicated for patients who had previously received anti-EGFR treatment. Wednesday’s approval comes more than 20 days before its scheduled target action date and makes Fruzaqla the “first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC regardless of biomarker status,” according to Takeda’s announcement. “Fruzaqla is the first novel chemotherapy-free treatment option approved for patients in the U.S. regardless of biomarker status in more than a decade,” Teresa Bitetti, president ...
- Source: drugdu
- 108
- November 13, 2023

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