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FDA approves Alzheimer’s treatment

Jim Cornall — Fri, 07 Jul 2023 09:15:00 +0000

Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use. The decision makes LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression […]

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Biogen ALS drug gets FDA ok

Jim Cornall — Thu, 27 Apr 2023 09:15:36 +0000

The U.S. Food and Drug Administration (FDA) has approved Biogen’s QALSODY (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients […]

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9 neuroscience biotech companies you should know about

Willow Shah-Neville — Mon, 03 Apr 2023 14:00:11 +0000

Developing treatments for neurological diseases presents a huge challenge for neuroscience companies within the biotech industry. The central nervous system (CNS) is extremely complex and many neurological diseases can be difficult to treat due to the limited regenerative capacity of the CNS, and the fact that the blood-brain barrier – a specialized system of cells […]

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Talking about Alzheimer’s disease: current drugs, clinical trials, and the pipeline

Jim Cornall — Thu, 09 Feb 2023 10:58:33 +0000

Sometimes, there’s an interview that we do that’s just a bit long for the regular podcast. So we’re going to start an occasional series of podcasts where we look a bit more in depth at a condition, and what’s the current state of affairs in treatment. In this podcast, the first, we take a closer […]

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EMA accepts Marketing Authorization Application for lecanemab to treat early Alzheimer’s disease

Jim Cornall — Fri, 27 Jan 2023 12:54:10 +0000

BioArctic AB’s partner Eisai says the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab. Lecanemab, known as LEQEMBI in the U.S., is an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed […]

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‘Best hope yet’ as results from Alzheimer’s drug trial reveal huge step forward

Liza Laws — Wed, 30 Nov 2022 12:35:57 +0000

A huge step forward in dementia research has been hailed a truly historic moment by researchers working to find a cure for people with Alzheimer’s Disease. This is the first time a drug being trialed, lecanemab, has shown a reduction in the disease in the brain while slowing memory decline. Dr Susan Kohlhaas, director of […]

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Positive results from Eisai and Biogen Alzheimer’s trial

Jim Cornall — Thu, 29 Sep 2022 06:30:27 +0000

Eisai Co., Ltd. and Biogen Inc. have announced positive topline results from Eisai’s large global phase 3 confirmatory Clarity AD clinical trial of lecanemab to treat mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Lecanemab is an […]

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FDA Approval of Biogen’s Drug Boosts European Alzheimer’s Space

Victor Kotsev — Thu, 17 Jun 2021 09:19:13 +0000

The FDA shocked many life sciences observers by greenlighting Biogen’s treatment candidate for Alzheimer’s last week. Yet, for much of the Alzheimer’s disease community on both sides of the Atlantic, the decision also brings cautious hope. Controversy recently erupted when the FDA conditionally granted accelerated approval to Biogen’s aducanumab, making it the first approved treatment […]

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EMA Approvals for Multiple Sclerosis Highlight Treatment Shortfalls

Jonathan Smith — Tue, 27 Apr 2021 10:20:40 +0000

While the EU saw rapid-fire approvals in the multiple sclerosis space last month, the innovations centered mostly on improving existing approaches. Which areas of multiple sclerosis treatment need more options? At the end of March, the EMA made key decisions on three treatments for multiple sclerosis (MS), a chronic neurodegenerative disease affecting 2.5 million people […]

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Atlantic Healthcare’s Inflammatory Bowel Disease RNA Drug Fails Phase III

Jonathan Smith — Thu, 01 Aug 2019 13:47:17 +0000

Hopes of seeing an approved treatment for the inflammatory bowel condition pouchitis have been dashed as the UK company Atlantic Healthcare’s RNA drug has proved ineffective in a phase III trial. The trial tested Atlantic Healthcare’s RNA drug alicaforsen as a treatment for patients with pouchitis. Patients with this condition have their colon surgically replaced […]

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Biogen Acquires UK Biotech Developing Gene Therapy for Blindness

Jonathan Smith — Mon, 04 Mar 2019 14:46:55 +0000

The big US biotech Biogen has agreed to acquire Nightstar Therapeutics for €773M ($877M), including Nightstar’s candidate gene therapies for inherited blindness. Expected to be complete by mid-2019, Biogen’s acquisition of Nightstar bags it the UK company’s most advanced program. Currently in phase III, the therapy targets choroidemia, an incurable genetic condition which causes progressive […]

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Swiss Genomics Firm, Biogen and Microsoft Team Up to Treat Multiple Sclerosis

Clara Rodríguez Fernández — Mon, 16 Oct 2017 11:55:30 +0000

BC Platforms and Microsoft will be working with Biogen and the Accelerated Cure Project to study the genetics of multiple sclerosis and accelerate research. The Swiss firm BC Platforms has built a platform to facilitate access to and analysis of large volumes of genomic and clinical data. Since September, the company has been collaborating with Microsoft, […]

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How Close Are We to Curing ALS? A Review of Biotech’s Efforts

Ute Boronowsky — Tue, 03 Oct 2017 05:00:57 +0000

May 5, 2017, saw the first FDA approval for an amyotrophic lateral sclerosis (ALS) drug in 20 years, when Edaravone/Radicava, developed by Japanese company MT Pharma, received orphan drug registration. Still, available therapies only slow down the progression of the disease. Isn’t it time now to find a cure? Amyotrophic lateral sclerosis (ALS), also known […]

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German Biotech Unveils Positive Phase II Results for Alzheimer’s

Melanie De Almeida — Mon, 12 Jun 2017 11:36:12 +0000

Probiodrug has disclosed encouraging results of its latest Phase IIa trial to assess its lead candidate PQ912 in patients with early Alzheimer’s Disease. The German biotech Probiodrug is pioneering new approaches to eliminate pyroglutamate (pGlu)-Abeta, a peptide that has been linked to the formation of toxic oligomers involved in Alzheimer’s disease. Now, the biotech came out […]

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How Biotech is Mastering Multiple Sclerosis: A Review

Diana Kwon — Tue, 25 Apr 2017 06:00:59 +0000

With last month’s FDA approval, Ocrevus (ocrelizumab), became the first drug for primary-progressive multiple sclerosis. Roche may be the first, but others in the biotech community are also working hard to bring their own therapeutics for the disease to market. Multiple sclerosis (MS) is an autoimmune disease that affects the nervous system, and around 2 […]

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Following Eli Lilly’s Failure, what’s Next in Alzheimer’s Treatments?

Evelyn Warner — Mon, 19 Dec 2016 07:00:38 +0000

Hopes for an Alzheimer’s cure took a hit with Eli Lilly’s recent failure, but it’s not over yet. Probiodrug explains the failure and response. Alzheimer’s Disease devastates families and represents one of the largest financial burdens in society. Now the sixth leading cause of death for all age groups, the neurodegenerative disease cost the US […]

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Interview: GeNeuro’s CFO explains its Unique Multiple Sclerosis Treatment

Clara Rodríguez Fernández — Fri, 30 Sep 2016 06:00:45 +0000

GeNeuro is developing a unique treatment for multiple sclerosis. We interviewed Miguel Payro, the company’s CFO, who explained its advantageous position against big pharma. GeNeuro raised €33M in its Euronext IPO in April and is currently competing against giants like Novartis and Biogen. Despite 2016’s dubious honor as “the worst year for IPO in 20 years”, this Switzerland-based company has managed to go […]

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Rare Disease Biopharma can now sell Hemophilia treatment across whole of EU

Denise Neves Gameiro — Tue, 17 May 2016 14:13:39 +0000

Sobi has received market approval by the European Comission for Alprolix, a long-duration protein therapy that protects hemophilia B patients from uncontrolled bleeding. With a focus on rare diseases, Swedish Orphan Biovitrum (Sobi) has clinical programmes in diseases like alkaptonuria, tyrosinaemia and hemophilia – a disease with which Sobi is particularly invested. Its candidate for hemophilia […]

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Sanofi-Genzyme: Still successful 5 years after the acquisition?

Dani Bancroft — Thu, 11 Feb 2016 15:13:02 +0000

Back in 2011, France’s biggest Pharmaceutical company Sanofi decided to purchase Genzyme Corp. for more than $20 billion, thus becoming the latest global drug giant to acquire a big biotech to foster its R&D pipeline. 5 years later, what’s the situation for Genzyme and Sanofi? So often when a large Pharma acquires a smaller Biotech, […]

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Also Using PD-L1 Cancer Treatments to Attack Alzheimer’s Disease

Dani Bancroft — Mon, 25 Jan 2016 13:24:32 +0000

What updates have occurred in the Neurodegenerative disease field as of late? New appointments by the Dementia Discovery Fund, which widens its international reach – and new ‘out of the box’ ideas from Israel and South Korea. The Dementia Discovery Fund (DDF), an innovative global investment fund managed by SV Life Sciences and launched in October […]

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