central nervous system

Amylyx preps filing for its ALS drug after FDA feedback

Just a few months ago, Amylyx was talking about having to complete another clinical trial before it could file for FDA approval of its drug for neurodegenerative disease amyotrophic lateral sclerosis (ALS). It’s now accelerating those plans, citing favourable discussions with the US regulator. The company revealed today that it will submit its marketing application …

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First subject dosed in psilocybin trial for rare headache disorder

The first patient has received a low dose of Beckley Psytech’s psychedelic medicine psilocybin in a clinical trial for short-lasting unilateral neuralgiform headache attacks (SUNHA), a rare disorder. The UK company says that SUNHA is a debilitating condition that is estimated to affect 40,000 patients in US and Europe. It is characterised by short, extremely …

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Beckley Psytech raises $80m for psychedelic meds development

UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinical development of its psilocybin-based therapies. The Oxford-based company had originally hoped to raise $50 million from the series B, and the scale of the financing is further evidence that repurposing …

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Ipsen tries again in Parkinson’s disease with $363m IRLAB deal

French drugmaker Ipsen has made another foray into the Parkinson’s disease category, licensing rights to an oral dopamine D3 receptor antagonist from Sweden’s IRLAB for $28 million upfront.  The deal gives Ipsen worldwide rights to the mid-stage drug – called mesdopetam – and puts the company on the hook for another $335 million in development, …

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FDA staffers defend Aduhelm approval in JAMA editorial

Three FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm have defended their actions, arguing that to do otherwise would have left millions of patients in limbo for years. The trio say that the decision to approve Aduhelm (aducanumab) was extremely challenging as “evidence was strongly …

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Biogen builds MS pipeline via $125m deal with China’s InnoCare

Biogen has moved to shore up its besieged multiple sclerosis franchise by licensing a BTK inhibitor from Chinese biotech InnoCare currently in mid-stage clinical testing. InnoCare gets $125 million upfront in return for sharing rights to orelabrutinib, an orally-active BTK drug that is able to cross the blood-brain barrier and penetrate the central nervous system. …

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US starts review of Aduhelm coverage amid fears of Medicare hit

The US government has started a review of how Biogen and Eisai’s pricey new Alzheimer’s disease therapy Aduhelm will be covered by Medicare, to see if a national strategy needs to be adopted. At the moment, the coverage for $56,000-a-year Aduhelm (aducanumab) is currently determined at the local level by Medicare administrative contractors representing 12 …

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ICER revises its view of Aduhelm’s price – but not by much

The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range …

ICER revises its view of Aduhelm’s price – but not by much Read More »

ICER revises its view of Aduhelm’s price – but not by much

The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range …

ICER revises its view of Aduhelm’s price – but not by much Read More »

Biogen abandons tau antibody for Alzheimer’s after phase 2 miss

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The decision comes on the back of the phase 2 TANGO study of gosuranemab (also known as BIIB092), which showed that the antibody was unable to show a benefit …

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Consumer group seeks resignation of top FDA staffers over Aduhelm okay

With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy about the FDA’s approval of the drug – and it wants the scalps of those responsible. In a letter to Secretary of Health and Human Services Xavier Becerra, the director …

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Sage/Biogen’s zuranolone works in depression, but maybe not enough

Sage Therapeutics and Biogen’s antidepressant candidate zuranolone has hit its objectives in a phase 3 trial, but a falloff in efficacy over time has raised concerns about the commercial potential of the drug. The WATERFALL trial of zuranolone showed that a two-week course of the oral GABAA receptor modulator significantly reduced symptoms of depression compared …

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And then there were three: another FDA adcomm member quits over Aduhelm

The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning in protest.  The latest to depart the FDA’s Peripheral and Central Nervous System Drugs panel is Aaron Kesselheim of Harvard Medical School, joining fellow committee members Joel Perlmutter and David …

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Double resignation over Aduhelm approval depletes FDA’s CNS adcomm

Two members of an FDA advisory committee have now resigned in protest over Monday’s approval of Biogen’s Alzheimer’s disease drug Aduhelm despite an overwhelming vote against doing so. Washington University neurologist Joel Perlmutter was the first to announce he was stepping down from the Peripheral and Central Nervous System Drugs Advisory Committee on the day …

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Aduhelm approval could signal new era for CNS drugs; analysts

The unexpected approval and lofty pricing of Biogen’s Alzheimer’s therapy Aduhelm is clearly the biopharma event of the year so far, but what are the broader implications for the industry as a whole? Analysts at RBC Capital Markets say that the decision points to an unprecedented shift in position for the FDA when it comes …

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Biogen bolsters ischaemic stroke pipeline with thrombolytic from TMS

Biogen has licensed a new drug from Japanese biotech TMS that it hopes could provide a big advance on an old treatment approach – using clot-busting thrombolytic drugs to treat ischaemic stroke.  The US company has exercised an option to acquire TMS-007, which it described as a next-generation thrombolytic that could offer safety and efficacy …

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AI drug discovery firm Valence joins Parkinson’s disease push

Canada’s Valence Discovery has joined a University of Montreal-led project to try to find new drugs to treat the involuntary movement complications that can accompany treatments for Parkinson’s disease.  The go-to treatment for the five million people worldwide with Parkinson’s is levodopa, which replaces the activity of the dopamine neurotransmitter dopamine that gets depleted by …

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Lilly cuts a $960m deal with Rigel on RIP kinase

Eli Lilly has become the latest drugmaker to have a go at developing RIP kinase inhibitors, a new class of drugs with potential in autoimmune and inflammatory disease, paying $125 million upfront for rights to a lead candidate from Rigel Pharma. Rigel’s clinical-stage R552 is the main asset in the deal – which also includes …

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Switzerland’s Synendos raises CHF 20m for CNS drug development

Swiss startup Synendos Therapeutics has raised CHF 20 million (almost $22 million) in first-round financing that will be used to develop its endocannabinoid drugs for central nervous system disorders. The Basel-based biotech – which was incubated in Switzerland’s BaseLaunch accelerator – is concentrating on developing a new class of small-molecule drugs for anxiety, mood and …

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Blue Oak taps AI specialist Exscientia for CNS drug discovery

US startup Blue Oak Pharma has joined a lengthening list of companies turning to Exscientia of the UK for its expertise in applying artificial intelligence to drug discovery. Waltham, Massachusetts-based Blue Oak –  led by neurobiologist and former Eli Lilly and Sunovion executive Tom Large – will work with Exscientia on new classes of neuropsychiatric …

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Biogen teams up with gene-editing startup Scribe on ALS programme

Scribe Therapeutics, a start-up focusing on gene-editing using CRISPR/Cas9, has burst onto the biotech scene with a $415 million deal with Biogen. Jennifer Doudna Scribe – which counts new Nobel Prize for chemistry winner Jennifer Doudna among its founders – is getting $15 million upfront from Biogen for an alliance focusing on the development of …

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