Nicole DeFeudis Editor Biogen is calling it quits on a late-stage Parkinson’s trial as part of an ongoing R&D reorganization. The Cambridge, MA-based biotech announced Monday morning that it’s discontinuing a Phase III program evaluating BIIB122 as a treatment for patients with Parkinson’s disease related to LRRK2 mutations with partner Denali Therapeutics. The study, dubbed LIGHTHOUSE, kicked off in September; it was slated for completion in 2031. Biogen said the decision was made in consideration of the study’s “complexity including the long timeline.” “These modifications are not based on any safety or efficacy data from studies of BIIB122,” the company said in a statement. “Denali and Biogen have a strategic collaboration to jointly develop and commercialize small molecule inhibitors of LRRK2 and remain committed to advancing the development of BIIB122.” Back in 2020, Biogen shelled out more than $1 billion upfront — including $560 million in cash and $465 million ...
While Biogen’s attempts to resurrect a crucial Tecfidera patent in the U.S. floundered, the company is chalking up a win in Europe. The European Commission has ruled that Biogen’s multiple sclerosis drug Tecfidera will have market protections until February 2025, Biogen revealed in a filing. This comes after a March decision from the European Union’s Court of Justice that went in Biogen’s favor and blocked generic versions of Tecfidera. The appeal ruling made the drug entitled to European market protections through at least February 2024, which Biogen swiftly sought to enforce against would-be generic rivals. Meanwhile in the U.S., Biogen took its Tecfidera patent case all the way to the Supreme Court after a court ruled the patent invalid in 2020. The patent was originally slated to expire in 2028 until a district judge decided in Viatris’ favor, agreeing with the argument that Biogen didn’t adequately describe its invention. With that, Viatris’ generic was cleared ...
The FDA has approved another Biogen drug for a neurological disorder. And, unlike the controversial go-ahead for Aduhelm, the agency’s neuroscience division didn’t go against its external advisers’ advice this time. Tuesday, the FDA granted an accelerated approval to Biogen and Ionis’ tofersen to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the SOD1 gene. The drug will be sold under the brand name Qalsody. The move follows the recommendation from an FDA advisory committee in March. At that time, nine experts agreed that Qalsody’s ability to reduce plasma neurofilament light (NfL), a biomarker of nerve injury and neurodegeneration, provides enough basis for a conditional approval. However, thanks to a phase 3 trial flop, the panel voted against full approval. SOD1-ALS is a small subset of ALS, affecting fewer than 500 patients in the U.S. and about 2% of all 168,000 ALS patients ...
Biogen has stopped or paused several drug programs as part of a larger effort to cut costs and prioritize certain research. The decision, disclosed Tuesday in the company’s latest earnings report, comes as sales of its marketed medicines for brain and nervous system disorders continue to fall. Biogen recorded $2.46 billion in total revenue between January and March, a 3% decline from the same period a year prior. Revenue was down across most business segments, with the company’s flagship multiple sclerosis franchise taking the biggest hit, decreasing by 19%. Christopher Viehbacher, the former chief executive at Sanofi and the recently minted CEO of Biogen, is now trying to reshape a research and development organization that, for many years, revolved around high-risk, high-reward neuroscience programs. ““Having a few of those projects in our pipeline is good,” he said in February, “having 100% … is challenging.” On Tuesday, Biogen ...
In a breakthrough finding, revealed through the final analysis of a mid-stage trial, Japanese pharmaceutical firm, Eisai Co and Biogen Inc’s drug for Alzheimer’s proved beneficial for patients who received the highest dose.
The questionnaire raised queries on the basis of key parameters like empathy for healthcare providers, quality content and motivation for patients. However, qualities like credible scientific content and values not related to promotional activities emerged as strong criterion for building trust.
Biogen expects to launch IMRALDI in Europe on October 16, 2018 Biogen will be the first company to offer biosimilars of all three major anti-TNF therapies in Europe
As Pfizer clears house of its unwanted neuro assets, Biogen has become a buyer for one, namely a phase 2-ready schizophrenia drug.
Biogen (Nasdaq:BIIB) and Alkermes plc (Nasdaq:ALKS) today announced that they have entered into a global license and collaboration agreement to develop and commercialize ALKS 8700, a novel, oral, monomethyl fumarate (MMF) small drug molecule in Phase 3 development for the treatment of relapsing forms of multiple sclerosis (MS).
Biogen (NASDAQ: BIIB) announced that it has increased the profit potential on aducanumab, its Phase 3 investigational treatment for early Alzheimer’s disease, by reducing the potential royalty payment on potential commercial sales of aducanumab to Neurimmune Holding AG. In exchange for a 15 percent reduction in the previously negotiated royalty rates, Biogen agreed to make a one-time $150 million payment to Neurimmune Holding AG.
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.