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Japanese companies Teijin Limited and JCR Pharmaceuticals have decided to terminate their co-development and Japan licensing agreement aimed at developing JTR-161, an allogeneic regenerative medical product containing dental pulp stem cells (DPCs) for the intended purpose of helping patients recover from acute cerebral infarctions (strokes). 19 April 2022
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended Vumerity (diroximel fumarate), a next-generation, oral fumarate, from US biotech Biogen for the treatment of adults living with active relapsing-remitting multiple sclerosis (RRMS) in England, Wales, and Northern Ireland. 13 April 2022
Pharmaceutical
Lundbeck recently completed a global Phase IV, randomized, comparative study exploring the role of vortioxetine as a treatment option between SSRIs and serotonin–noradrenaline reuptake inhibitors (SNRIs), the Danish CNS specialist announced today. 11 April 2022
Pharmaceutical
Danish CNS specialist Lundbeck said on Friday it has has appointed Joerg Hornstein as chief financial officer (CFO) and member of its executive management. He will assume the role no later than September 1, 2022, and he will be registered with the Danish Business Authority. 11 April 2022
Biotechnology
Among regulatory news last week, the US Food and Drug Administration on Monday advised Alnylam Pharmaceuticals of a three-month delay to its review of the New Drug Application for amyloidosis drug vutrisiran. AstraZeneca released strong results from a Phase IIb trial of its cholesterol lowerer AZD8233. Troubled US biotech bluebird bio last Tuesday announced a significant restructuring program, which would involve a 30% reduction in its workforce. US pharma giant Pfizer announced its first M&A deal this year, agreeing a $525 million bid for RSV vaccine developer ReViral. Also, Biogen reacted angrily to the US Centers for Medicare & Medicaid Services’ (CMS) decision to limit coverage of its Alzheimer’s disease drug Aduhelm. 10 April 2022
Biotechnology
The US Centers for Medicare & Medicaid Services (CMS) has stuck by its earlier stance of restricting access to the Alzheimer’s drug Aduhelm (aducanumab). 8 April 2022
Biotechnology
US CNS specialist Aptinyx lost nearly half of its market value on Thursday after announcing a second Phase II failure of NYX-2925 in painful diabetic peripheral neuropathy (DPN). 8 April 2022
Biotechnology
Japan’s SanBio Group has announced that SB623 met the primary endpoint and demonstrated a trend toward maintaining the improvement of function and activities of daily living in the final, one-year analysis of the Phase II STEMTRA trial, which evaluated the efficacy and safety of SB623 compared to sham surgery in patients with chronic motor deficit from traumatic brain injury (TBI). 8 April 2022
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca and Merck & Co’s Koselugo (selumetinib) for use by the National Health Service (NHS) in England. 6 April 2022
Pharmaceutical
The US Food and Drug Administration has just approved Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorders in adults. The drug was developed by Connecticut, USA company BioXcel Therapeutics. 6 April 2022
Biotechnology
Tetraneuron, a Spanish biotech taking a multifactorial approach to Alzheimer's through gene therapy, is to start a new round of financing. 6 April 2022
Biotechnology
The latest results from the Phase III CHAMPION-MG trial open-label extension showed that Ultomiris (ravulizumab-cwvz) demonstrated long-term efficacy in adults with anti-acetylcholine receptor (AChR) antibody-positive generalised myasthenia gravis (gMG). 6 April 2022
Biotechnology
Swiss pharma giant Roche has announced new Ocrevus (ocrelizumab) data that show its benefit on disease progression and cognitive outcomes in primary progressive multiple sclerosis (PPMS) and secondary progressive MS (SPMS). 4 April 2022
Biotechnology
Last week was a tumultuous one for US company Amylyx Pharmaceuticals and its amyotrophic lateral sclerosis (ALS) candidate, AMX0035, a fixed dose combination product of sodium phenylbutyrate and taurursodiol. 4 April 2022
Biotechnology
Regulatory developments last week included good news for Belgium’s largest drugmaker UCB, which on Monday announced the US Food and Drug Administration had approved its Fintepla for Lennox-Gastaut syndrome (LGS), a rare form of childhood epilepsy. FDA news was not so good for Amylyx Pharmaceuticals, as an FDA advisory panel voted against approval of its amyotrophic lateral sclerosis candidate AMX0035. On the deal-making front, the USA’s IGM Biosciences announced a major deal with France’s Sanofi on the development of IgM antibodies against oncology and immunology targets. Also, Swiss pharma giant Roche announced a setback last Wednesday, with its lung cancer candidate tiragolumab missing co-primary endpoint in a Phase III trial. 3 April 2022
Pharmaceutical
US brain health specialist Sage Therapeutics has announced the presentation of data from the Phase II LUMINARY Study that showed SAGE-718, a first-in-class, oral, positive allosteric modulator of the NMDA receptor, was generally well-tolerated and associated with improvement on multiple tests of executive performance and learning and memory in patients with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). 2 April 2022
Pharmaceutical
Expected bad news for Amylyx Pharmaceuticals will not deter the company’s efforts to secure approval for its amyotrophic lateral sclerosis (ALS) candidate, AMX0035. 1 April 2022
Pharmaceutical
At AMCP 2022 in Chicago, new data from Janssen, the pharma arm of Johnson & Johnson (NYSE: JNJ), support the value of switching certain people with schizophrenia onto a long-acting treatment regimen. 31 March 2022
Biotechnology
Precision medicine company Neuron23 has raised $100 million in a series C financing round led by SoftBank Vision Fund 2. 30 March 2022
Biotechnology
Alector, a Californian company pursuing an immunological approach to targeting neurological conditions, has appointed a new chief medical officer. 30 March 2022
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Pharmaceutical
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Pharmaceutical
New York-based Mind Medicine, a company developing MM120, a form of LSD (lysergide d-tartrate), for mental health conditions, has announced the appointment of Gregg Pratt, as chief regulatory and quality assurance officer. 19 November 2024
Biotechnology
Last week saw US pharma major AbbVie release disappointing Phase II trial results on its emraclidine in schizophrenia, which benefited Bristol Myers Squibb. Also on the research front, Germany’s Merck KGaA and Abbisko’s pimicotinib showed positive results in tenosynovial giant cell tumor (TGCT). M&A news saw German BioNTech punting $800 million upfront to acquire China based oncology focused Biotheus. Also of note, US drugmaker Halozyme Therapeutics made an unsolicited takeover bid for Evotec, valuing the German firm, at around 2 billion euros. 17 November 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024
Pharmaceutical
Germany’s Merck KGaA was trading 5% lower as Thursday’s trading day neared its end, after the company announced its third-quarter financial results and outlook for the rest of the year. 14 November 2024
Biotechnology
Swiss clinical-stage biopharma AC Immune saw its shares gain 8% to $3.38 in US trading this morning, after it released positive interim safety and immunogenicity data from the Phase II VacSYn clinical trial evaluating ACI-7104.056. 14 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
Pharmaceutical
Digital therapeutics company GAIA has announced the signing of a licensing agreement for attexis with fellow German firm MEDICE Arzneimittel Pütter. 14 November 2024
Biotechnology
Cambridge, USA-based Vesalius Therapeutics has entered into a multi-target strategic alliance with the UK’s GSK to discover and develop novel treatments for Parkinson's disease, and another undisclosed neurodegenerative indication. 13 November 2024
Biotechnology
Neurogene has announced positive interim clinical data in the first four participants in the low-dose cohort of its ongoing Phase I/II open-label trial designed to evaluate NGN-401 gene therapy for the treatment of female pediatric patients with Rett syndrome. 13 November 2024
Biotechnology
Trace Neuroscience, a newly launched biopharma based in San Francisco, aims to advance treatments for neurodegenerative diseases, starting with amyotrophic lateral sclerosis (ALS). 12 November 2024
Pharmaceutical
US drugmaker AbbVie was trading more than 11% lower early on Monday afternoon in New York. 11 November 2024
Pharmaceutical
The Parkinson’s disease (PD) therapeutic landscape is heavily genericized, leaving substantial unmet needs in neuroprotective and disease-modifying therapies (DMTs), says data and analytics company GlobalData in an overview of ongoing PD research.. 11 November 2024
Pharmaceutical
Life science investors can be divided into two groups: those who bought Novo Nordisk stock before GLP-1s hit the big time, and those who wish they had. 10 November 2024
Pharmaceutical
Jazz Pharmaceuticals has reported third-quarter revenue of $1 billion, a 9% increase over the prior year, fueled by strong performance in its key sleep and epilepsy portfolios. 7 November 2024
Biotechnology
US clinical-stage drug developer Acumen Pharmaceuticals has appointed Amy Schacterle as chief regulatory officer and head of quality, reporting to Jim Doherty, president and chief development officer at Acumen. 7 November 2024
Pharmaceutical
Intra-Cellular Therapies has announced positive results from Study 304 evaluating the efficacy and safety of Caplyta (lumateperone) 42mg for the prevention of relapse in adult patients with schizophrenia. 6 November 2024
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