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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
Pharmaceutical
A 12% jump in the stock price of Avadel Pharmaceuticals on Monday reflects market confidence in the firm’s newly-approved cataplexy med Lumryz (sodium oxybate). 2 May 2023
Biotechnology
The US Food and Drug Administration (FDA) yesterday approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). 26 April 2023
Biotechnology
US biotech company Biogen beat analysts’ expectations with its first-quarter 2023 financial results, exceeding forecasts with both sales and earnings figures. 25 April 2023
Pharmaceutical
Swiss pharma giant Novartis was trading 3% higher on Tuesday afternoon after presenting its first-quarter 2023 financial results and latest full-year guidance. 25 April 2023
Biotechnology
Shares of New York, USA-based rare disease firm Applied Therapeutics closed up more than 16% yesterday at $1.10, despite releasing disappointing results from the ACTION-Galactosemia Kids study of govorestat (AT-007), a novel, oral, small molecule, central nervous system (CNS) penetrant aldose reductase inhibitor (ARI). 25 April 2023
Biotechnology
Long-term data from the ALITHIOS open-label extension study in relapsing multiple sclerosis (RMS) shows that up to five years, patients treated earlier and continuously with Kesimpta (ofatumumab) had fewer disability worsening events and low brain volume change versus those starting on teriflunomide who later switched to the Novartis drug. 20 April 2023
Pharmaceutical
Bold investments in the multiple sclerosis space are set to generate revenues of close to $30 billion per year by 2030, according to research from GlobalData. 19 April 2023
Pharmaceutical
The Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug Administration’s (FDA) on Friday discussed supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for the treatment of agitation associated with Alzheimer’s dementia (AAD). 17 April 2023
Biotechnology
Data from UCB’s Phase III studies of rozanolixizumab and zilucoplan in generalized myasthenia gravis (gMG) have been published in The Lancet Neurology. 13 April 2023
Biotechnology
US biotech major Biogen today announced that it has exercised its option to license Denali Therapeutic’s antibody transport vehicle (ATV): Amyloid beta program (ATV:Aβ), lifting the latter’s shares up 3% in early trading. 12 April 2023
Biotechnology
Japan’s largest drugmaker Takeda has linked up with little-known Canadian biotech Treventis for the further research, development, and commercialization of small molecules that target tau, a key protein in Alzheimer’s disease (AD). 12 April 2023
Biotechnology
Having received accelerated approval from US Food and Drug Administration (FDA) in January this year for their Alzheimer’s disease drug Leqembi (lecanemab), Japan’s Eisai and US biotech Biogen are now awaiting authorizations in the important markets of the European Union and Japan to solidify the drug’s position as the top-selling drug for Alzheimer's in the upcoming years. 6 April 2023
Pharmaceutical
A Citizen Petition (CP) has been filed on behalf of Swiss biotech Idorsia Pharmaceuticals, urging the USA’s Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data. 5 April 2023
Pharmaceutical
Spanish epigenetics firm Oryzon Genomics has announced encouraging results from a planned interim analysis of the Phase IIb PORTICO study. 4 April 2023
Pharmaceutical
Shares in Sweden’s Asarina Pharma looked set to close more than 2% higher based on results from its Phase IIa study of the endogenous neurosteroid sepranolone for the treatment of Tourette syndrome. 3 April 2023
Biotechnology
US drugmaker Eli Lilly has again shown that Eisai and Biogen are not the only players in town in the Alzheimer’s space. 3 April 2023
Biotechnology
Licensing deals featured in last week’s news, first with US pharma giant Pfizer handing back rights to immune-oncology drug Bavencio to Germany’s Merck KGaA in anticipation of potential antitrust problems relating to its proposed $43 billion acquisition of Seagen. Also, last Tuesday, Bicycle Therapeutics announced a collaboration with Swiss pharma giant Novartis on the development of oncology targets that could earn it up to $1.7 billion. On the research front, Novartis last Monday released strong new data for its Kisqali in early breast cancer. Also, Cytokinetics halted a Phase III study of its amyotrophic lateral sclerosis (ALS) candidate reldesemtiv on the advice of a monitoring committee due to futility. 2 April 2023
Biotechnology
US muscle biology specialist Cytokinetics’ shares closed up 2.9% at $35.19 on Friday, despite reporting that the Data Monitoring Committee (DMC) for the Phase III COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS) has recommended discontinuation of the clinical trial due to futility as a treatment for amyotrophic lateral sclerosis (ALS). 1 April 2023
Biotechnology
Japanese drugmaker Eisai and its partner Biogen have presented new analyses on Leqembi (lecanemab), the Alzheimer’s drug that gained US approval in January. 31 March 2023
Biotechnology
Massachusetts, USA-based clinical-stage CNS biotech EIP Pharma has entered a definitive all-stock merger agreement with Diffusion Pharmaceuticals forming a publicly traded company, sending the latter’s share up 5% pre-market. 30 March 2023
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