Search Results for “Biogen” – media

Sage and Biogen Halt Phase II Study After Novel Drug Shows No Significant Improvement in Treating Essential Tremor

Image Credit: Adobe Stock Images/Creative Cat Studio Data from the Phase II KINETIC 2 study, which evaluated SAGE-324 (BIIB124) as a treatment for essential tremor (ET), show the drug did not achieve the trial’s primary objectives. According to Sage Therapeutics and Biogen, the study aimed to determine the dose-response relationship of SAGE-324 by assessing changes from baseline to day 91 in the TETRAS Performance Subscale Item 4 total score, measuring upper limb tremor severity. Results found that SAGE-324 offered no statistically significant improvement across different doses compared to placebo. As a result, both companies have decided to halt the ongoing open-label safety study and cease further clinical development of SAGE-324 for ET.1 “There has been little innovation in the pharmacological treatment of essential tremor over the past 50 years, and people living with this debilitating condition have a pressing need for new treatment options. We are disappointed that the results ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 110
- July 27, 2024
Neuro Drug Passed Up by Biogen Posts Positive Data for Ionis, Setting Stage for Phase 3 Test

Ionis Pharmaceuticals is looking ahead to a Phase 3 study for an antisense medicine it is developing to treat Angelman syndrome, a rare neurodevelopmental disorder with no FDA-approved therapies. Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year. By Frank VinluanAn Ionis Pharmaceuticals drug in development for Angelman syndrome has mid-stage clinical trial results showing improvement across a range of measures of this rare neurodevelopmental disorder, and the company now plans to advance therapy to Phase 3 testing. Angelman is an inherited disorder that presents in infancy and leads to learning disability, muscle impairment, balance problems, and seizures. Patients typically develop little to no verbal ability. While Angelman patients can be treated with drugs that manage some of these symptoms, there are no FDA-approved therapies for the disease itself. The results announced Monday for the drug, ION582, come from the multiple-ascending dose portion of ...
- Source: drugdu
- 75
- July 24, 2024
Biogen completes $1.15bn HI-Bio acquisition to expand immunology presence

As Eli Lilly’s Kisunla (donanemab) enters the Alzheimer’s treatment space, its leading competitor Biogen is undergoing therapy diversification after completing its $1.15bn acquisition of Human Immunology Biosciences (HI-Bio). The deal, which was agreed upon in May this year and includes $650m in milestone payments, sees Biogen bolster its pipeline with US-based HI-Bio’s anti-CD38 monoclonal antibody candidate felzartamab. Biogen’s head of development Priya Singhal said the company is “very excited” about the addition of felzartamab to its rosters in a 2 July press release, adding that Biogen will advance the candidate to Phase III now the transaction is complete. Felzartamab has already demonstrated positive Phase II data in a range of immune-mediated diseases, including IgA nephropathy (IgAN), antibody-mediated rejection (AMR), and primary membranous nephropathy (PMN). The Phase III development plans are for all three diseases, according to Biogen. Felzartamab was originally developed by MorphoSys as a possible competitor to Johnson & ...
- Source: drugdu
- 84
- July 5, 2024
Ionis and Biogen discontinue experimental ALS drug after Phase I/II flop

Ionis and Biogen are halting the development of their experimental treatment for amyotrophic lateral sclerosis (ALS) after it failed to show improvement in patients in a Phase I/II study. Data from the 99-patient ALSpire study (NCT04494256) demonstrated that BIIB105 failed to significantly reduce neurodegeneration or improve functional measures such as breathing. BIIB105, an investigational antisense oligonucleotide was designed to reduce the expression of ataxin-2 (ATXN2) protein. Despite demonstrating statistically significant ATXN2 reductions in the study, the drug showed no evidence of clinical benefit in any subgroup evaluated in the study. This marks another setback in the search for new treatments for ALS, a progressive neurodegenerative disease that causes muscle weakness and paralysis. Last month, Amylyx Pharmaceuticals axed its ALS drug Relyvrio (AMX0035) from the market after its Phase III Phoenix trial failed to meet any of its endpoints. However, this trial failure does not mark the end of Ionis and ...
- Source: drugdu
- 103
- May 20, 2024
Biogen abandons Aduhelm efforts, focuses on Eisai-partnered Leqembi and pipeline drugs

More than two years after Aduhelm’s controversial and ill-fated FDA accelerated approval, Biogen is discontinuing the Alzheimer’s disease therapy after walking a rocky path. Wednesday, Biogen said it’s pulling all efforts from the first-of-its-kind anti-amyloid beta therapy to focus on Leqembi, its Eisai-partnered newer medicine, and its pipeline candidates. The newer drug, Leqembi, won a full FDA approval early last year, making the partners’ marketing efforts on the therapy much simpler than was the case with Aduhelm. Biogen is taking a $60 million charge and is discontinuing all development and sales of Aduhelm, the company said. It’s terminating the ENVISION clinical study, which sought to confirm the benefit of the medicine as required under its 2021 accelerated approval. The decision follows Biogen’s move to launch a strategic review in early 2023 under new CEO Chris Viehbacher, the former Sanofi chief who joined the Massachusetts drugmaker in November 2022. During that ...
- Source: drugdu
- 185
- February 2, 2024
Biogen returns ex-U.S. rights of MS drug Fampyra to Acorda

With sales declining for aging multiple sclerosis (MS) drug Fampyra, Biogen has exercised an option to return licensing rights outside of the United States to Acorda Therapeutics. The move, which becomes effective on January 1 of 2025, ends a 15-year arrangement between the companies. The drug was approved by the FDA in 2010, six months after Acorda of Ardsley, N.Y., signed over its ex-U.S. rights to Biogen. Acorda said it will assume commercialization responsibilities this year as marketing authorization transfers and distribution arrangements are finalized for each territory. “We are excited to bring Fampyra in-house, which we believe will add significant value to Acorda, and allow us to continue to provide access to this important medication for people with MS around the world,” Acorda’s CEO Ron Cohen, M.D., said in a release. The extended-release tablet was the first of its kind upon its approval, allowing patients with MS to have ...
- Source: drugdu
- 145
- January 15, 2024
Biogen’s Aduhelm headache returns as appeals court revives part of investor lawsuit

For more than a year, Biogen has been working to turn the page from its Aduhelm fiasco and focus on its newer Eisai-partnered Alzheimer’s disease medicine Leqembi. But a new ruling from the U.S. Court of Appeals for the First Circuit will make that effort a little tougher. After Biogen last year won the dismissal of an investor lawsuit surrounding disclosures into its Aduhelm research, the appeals court has reversed the ruling—in part—by focusing on one statement made by Biogen’s former chief medical officer Al Sandrock. Specifically, the appeals court flagged Sandrock’s statement from the company’s second-quarter earnings call in 2020. During the call, Sandrock stated that “[Y]ou really need to get to the higher dose,” adding, “I think our data are all consistent with that.” The court dubbed this the “all data” statement and painstakingly broke down the context behind the remark. To refresh readers’ memory, Biogen in March ...
- Source: drugdu
- 132
- October 14, 2023
Biogen Lays Off 113 Reata Employees Weeks After Completing $7B Acquisition

By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is laying off 113 employees from Reata Pharmaceuticals’ Plano, Texas site, according to a Worker Adjustment and Retraining Notification notice. The layoffs, set to take effect in late November, come just months after Reata was acquired by Biogen for $7.3 billion in July 2023. At the time, Biogen had just launched a sweeping cost-reduction program which involved terminating around 1,000 employees in an effort to save $1 billion in operating expenses by 2025. Late last month, Biogen completed the acquisition of Reata. In an emailed statement to Endpoints News, a Biogen spokesperson confirmed the job cuts which will mostly affect “roles where there are existing synergies at Biogen.” The positions include general and administrative services, as well as some development-focused jobs. “We are retaining those colleagues who have been essential to the launch of Skyclarys to ensure ...
- Source: drugdu
- 221
- October 14, 2023
Biogen lays off staffers at newly acquired Reata, with 113 set to lose positions

Biogen just closed its Reata Pharmaceuticals buyout in September. Now, 100-plus Reata staffers are losing their jobs because their roles were already covered at the Massachusetts Big Biotech. That didn’t take long.Just two weeks after Biogen completed its buyout of Reata Pharmaceuticals, the combined company is trimming its staff. In a recent Worker Adjustment and Retraining Notification (WARN) notice sent to state officials in Texas, Reata said it’s cutting 113 positions. The layoffs will take effect late next month. Reata employed 321 people at the start of the year, an annual Securities and Exchange Commission filing (PDF) shows, so the layoffs are set to affect about a third of the acquired company’s staff. Biogen inked its Reata buyout in July, picking up the potential blockbuster Skyclarys, which is approved by the FDA to treat the rare, inherited neurological disorder Friedreich ataxia. The companies completed the deal in September. At the ...
- Source: drugdu
- 149
- October 13, 2023
FDA Approves Sandoz Biosimilar to Biogen’s MS Therapy Tysabri

By Tristan Manalac Pictured: Novartis office in Switzerland/iStock, Michael Derrer Fuchs The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis. Tyruko is also indicated for inducing and maintaining clinical response and remission in patients with Crohn’s disease with evidence of inflammation, and who are either unable to tolerate or show an inadequate response to conventional therapies. Sandoz is the generics and biosimilars arm of Swiss pharma Novartis, which in August 2022 announced that it was spinning the division off into a standalone entity, scheduled for the fourth quarter of this year. With Thursday’s approval, Tyruko becomes “the first biosimilar product indicated to treat relapsing forms of multiple sclerosis,” Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said in a statement. The regulator’s decision will also contribute ...
- Source: drugdu
- 107
- August 29, 2023

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