psychiatry

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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FDA clears J&J’s twice-yearly Invega for schizophrenia

One of the biggest challenges to treating schizophrenia is non-compliance with treatment, but Johnson & Johnson’s pharma unit Janssen is trumpeting a new version of its Invega drug that could solve that problem. The FDA has just approved Janssen’s Invega Hafyera (paliperidone), a twice-yearly injectable formulation that extends the company’s big-selling brand and offers the …

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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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Predicting and improving clinical trial enrolment: A problem for psychiatry

Patient enrollment is a common issue across many therapeutic areas in clinical research. Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment. The reasons behind this problem, however, are rarely studied or understood. Despite this, new strategies devised over the last five years are beginning to reverse the …

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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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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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Study finds “alarming” hike in antidepressant costs during COVID-19

Researchers in the UK have found that there was a four million rise in prescriptions for antidepressants in England during 2020, adding £139 million to NHS costs. The team from the University of Huddersfield said the findings highlight an “urgent need” for new mental health strategies to make sure antidepressants are being used appropriately, particularly …

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After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The US regulator approved Lybalvi (olanzapine/samidorphan) for both indications sought – schizophrenia and bipolar I disorder – with data on its …

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Tribunal maintains Lexon’s £1.2m fine for breaking competition law

Pharmaceutical wholesaler Lexon (UK) has lost its appeal against a £1.2 million fine in a case that accused it of exchanging commercially sensitive information about prices for nortriptyline tablets.  Lexon had appealed against a ruling by the UK’s Competition and Markets Authority (CMA) that it had exchanged information with King Pharmaceuticals and Alissa Healthcare Research …

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US eyes permanent change to digital health regulatory path

Developers of digital health tools have benefited from a truncated route to market during the COVID-19 crisis, and that could be made permanent if new FDA guidance is adopted. Pandemic emergency provisions were put in place in March last year to allow certain medical devices to be launched for use by patients without having to …

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Biogen bulks up pipeline with Sage drugs in $3bn deal

With the prospects for its Alzheimer’s drug aducanumab still up in the air, Biogen has moved to shore up its late-stage pipeline with a $3 billion licensing deal with Sage that adds drugs for depression and neurological disorders. The licensing agreement gives Biogen rights to Sage’s zuranolone (SAGE-217) for psychiatric disorders including depression, and SAGE-324 …

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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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