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Biotechnology
US biotech major Biogen has released disappointing top-line results from its pivotal Phase III VALOR study of tofersen (BIIB067), an investigational antisense drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). 18 October 2021
Biotechnology
Seattle, USA-based cell therapy company Immusoft has signed a research collaboration and license option agreement with Japan’s Takeda Pharmaceutical to discover, develop and commercialize transformative cell therapies in rare inherited metabolic disorders with central nervous system (CNS) manifestations and complications using Immusoft’s Immune System Programming (ISP) technology platform, which modifies a patient’s B cells and instructs the cells to deliver gene-encoded therapies. 18 October 2021
Biotechnology
Significant regulatory news last week included Swiss pharma giant Roche gaining Breakthrough Therapy designation from the US Food and Drug Administration for its Alzheimer’s candidate gantenerumab. Also, Eli Lily last Wednesday was granted FDA approval for its CDK 4/6 inhibitor Verzenio in an early breast cancer indication. Swiss biotech Idorsia suffered a setback last Monday when the firm reported that its Fabry disease hopeful lucerastat missed endpoints in a Phase III trial. An FDA advisory panel last Thursday voted in favor of approving Moderna’s COVID-19 vaccine – Spikevax - to be used for booster jabs. And on Friday the AdCom also backed booster jabs of Johnson & Johnson’s vaccine. 17 October 2021
Biotechnology
German pharma and life science firm Merck KGaA has shared data in an oral presentation from a Phase II post-hoc analysis, demonstrating that the oral, central nervous system (CNS)-penetrant, fully covalent Bruton’s tyrosine kinase inhibitor (BTKi) evobrutinib impacted brain lesions associated with chronic inflammation in the CNS. 15 October 2021
Biotechnology
A new biotech company has been launched with the goal of taking on one of the world’s rarest neurodegenerative diseases. 14 October 2021
Biotechnology
Shares of USA/Israel-based biotech Brainstorm Cell Therapeutics were up 7% at $3.15 pre-market, but dropped back as regular trading came into play. 14 October 2021
Biotechnology
Swiss pharma giant Roche has announced new longer-term efficacy and safety data for the approved therapy Enspryng (satralizumab). 14 October 2021
Pharmaceutical
The US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti (brexpiprazole) and has granted the drug’s makers – Japan’s Otsuka Pharmaceutical Denmark’s Lundbeck Priority Review. 14 October 2021
Biotechnology
Swedish neurological specialist CombiGene’s shares traded as high as 14.10 Swedish kronor on Tuesday, from the morning's opening price of 6.29 kronor, after it revealed that it has entered into an exclusive collaboration and licensing deal with Spark Therapeutics on its CG01 project, a gene therapy that aims to treat drug resistant focal epilepsy. 13 October 2021
Pharmaceutical
CNS disease specialist Supernus Pharmaceuticals and fellow USA-based Adamas Pharmaceuticals have entered a definitive agreement for Supernus to acquire Adamas, whose share shot up 75% to $8.07 by close of trading on Monday. 12 October 2021
Biotechnology
US drugmaker AbbVie’s Qulipta (atogepant) recently became the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of migraine approved by the US Food and Drug Administration. 12 October 2021
Pharmaceutical
French drugmaker Ipsen has appointed Mari Scheiffele as executive vice president and president, Specialty Care International, effective November 1, 2021. 11 October 2021
Biotechnology
Germany-based biotech atai Life Sciences today announced the launch of PsyProtix, a new platform company formed with Chymia, a Duke University biotechnology spinout. 11 October 2021
Biotechnology
Breakthrough Therapy designation (BTD) has been granted by the US Food and Drug Administration for gantenerumab in the treatment of people living with Alzheimer’s disease (AD). 11 October 2021
Biotechnology
Last week’s deal-making news featured Johnson & Johnson’s Janssen unit signing an agreement with US biotech Xencor for the latter’s XmAb B-cell targeting antibody plamotamab, potentially worth $1.3 billion. AstraZeneca last week filed for emergency use of its AZD7442 for the prophylaxis of symptomatic COVID-19 with the US Food and Drug Administration. On Wednesday, Japanese drug major Takeda admitted a setback with its orexin agonist program, when it paused a trial of TAK-994 after a safety issue. Also, US biotech Allogene had a disappointment last Thursday with the FDA placing a clinical hold on its ALLO-501A Phase III trial in cancer. 10 October 2021
Pharmaceutical
UK-based medical cannabis R&D company Kanabo Group has signed a partnership agreement with MedoCann Pharma for the development of unique new products with exclusive distribution rights into the German and UK markets. 7 October 2021
Biotechnology
Neumora Therapeutics, a US clinical-stage biotech focussed on brain diseases through the integration of data science and neuroscience, announced its launch today. 7 October 2021
Biotechnology
The value of US gene therapy company Voyager Therapeutics doubled in Wednesday’s early trading following news of a deal with the world’s largest pharma company. 6 October 2021
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical saw its shares fall 6.4% to 3,340 yen this morning, after it revealed that a safety signal has emerged in Phase II studies of TAK-994, an investigational oral orexin agonist. 6 October 2021
Biotechnology
Ireland-headquartered biotech Horizon Therapeutics has announced the publication of a post-hoc analysis from the N-MOmentum Phase II/III pivotal trial of Uplizna (inebilizumab-cdon), which highlights a sustained effect on attack risk with no new safety signals in people with neuromyelitis optica spectrum disorder (NMOSD) who received the treatment for four or more years. 5 October 2021
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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