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By 2030, GlobalData has predicted that promising pipeline drugs Zygel (cannabidiol gel), zatolmilast, trofinetide, and acamprosate calcium SR will offer new treatment options for people with Fragile X Syndrome (FXS), a rare genetic disorder that is the leading cause of inherited intellectual disability. 22 February 2022
Pharmaceutical
The bipolar disorder market is expected to grow from $4.1 billion in 2020 to $4.9 billion by 2030 across the eight major markets (8MM: the USA, France, Germany, Italy, Spain, UK, Japan and Canada) at a compound annual growth rate (CAGR) of 1.7%. 21 February 2022
Biotechnology
The long-awaited confirmation from the US Senate of Robert Califf’s nomination to become Food and Drug Administration Commissioner was announced last Tuesday, but on a tight vote. On the research front, Sage Therapeutics and Biogen announced confident results for their depressive disorder candidate zuranolone but questioned were raised on its commercial potential. Regulatory developments included the FDA granting accelerated approval for Agios Pharmaceuticals’ Pyrukynd (mitapivat) for a rare form of anemia. But BioMarin had a setback last Thursday when the FDA said it needed more information to lift the clinical hold on the firm’s gene therapy BMN 307 clinical trial. 20 February 2022
Pharmaceutical
Russia may be faced with a shortage of Convulex (valproic acid) - one of the most popular drugs for the treatment of epilepsy – as its manufacturer, the Canadian firm Bausch Health, has stopped exports of the drug to the Russian market. 17 February 2022
Biotechnology
US biotech companies Sage Therapeutics and Biogen have announced that the CORAL study in people with major depressive disorder (MDD) met the trial objectives. 16 February 2022
Biotechnology
Privately-held UK biotech Curve Therapeutics today announces a global research collaboration with US pharma giant Merck & Co, known as MSD outside the USA and Canada, to discover and validate modulators of up to five therapeutic targets using its Microcycle technology, initially for oncology and neurology indications. 16 February 2022
Biotechnology
French biopharma Aelis Farma has raised 25 million euros ($28.4 million) in an initial public offering (IPO). 16 February 2022
Biotechnology
Privately-held drug discovery company Aquinnah Pharmaceuticals has announced an agreement with Swiss cancer giant Roche in neurodegenerative diseases. 16 February 2022
Pharmaceutical
The potential Food and Drug Administration acceptance of US biopharma Anavex Life Sciences’ AVATAR as a pivotal Phase III trial would have an important bearing on the Rett syndrome market, as it could enable blarcamesine to launch at a similar time as Australia-based Neuren Pharmaceuticals’ trofenitide, which is a major future competitor. 16 February 2022
Pharmaceutical
Shares of specialty drugmaker BioDelivery Sciences International shot up 52% to $3.64 in pre-market trading today, after it agreed to be acquired by fellow USA-based Collegium Pharmaceuticals. 14 February 2022
Biotechnology
The US Food and Drug Administration (FDA) has blocked attempts to halt trials of Cassava Sciences’ experimental Alzheimer’s drug simufilam. 14 February 2022
Biotechnology
US biotech Biogen has put further pressure on the Centers for Medicare & Medicaid Services (CMS) over guidance that it issued last month in relation to Aduhelm (aducanumab). 11 February 2022
Biotechnology
Aduhelm (aducanumab) co-developer Eisai has submitted its response to a much-anticipated reimbursement decision from the US Centers for Medicare & Medicaid Services (CMS). 10 February 2022
Biotechnology
US biotech firm Ventus Therapeutics, which is developing small molecule therapeutics across a broad range of disease indications, announced today the closing of a $140 million Series C financing. 9 February 2022
Generics
Israeli drugmaker Teva Pharmaceutical Industries reported its fourth-quarter and full-year 2021 financial results on Wednesday. 9 February 2022
Biotechnology
US neurological diseases specialist Ovid Therapeutics and AI-powered drug discovery company Healx have announced a strategic partnership. 8 February 2022
Pharmaceutical
Positive signs from a post hoc analysis of the Phase II NOSTRA and Phase III NOSTRA III studies have shown the way forward for Germany’s vasopharm. 8 February 2022
Biotechnology
US biotech company Biogen’s troubles over the Alzheimer’s product Aduhelm (aducanumab) show no sign of abating. 7 February 2022
Biotechnology
Among last week’s notable news, Pfizer and Ionis pulled the plug on the development of their cholesterol candidate vupanorsen, with rights to the drug returned to Ionis. US biotech Biogen last week exercised its option to co-develop cancer candidate mosunetuzumab, paying Roche a one-time fee of $30 million to do so. Separately, Biogen also released financial results for 2021, along with business development plan as it tries to overcome the disappointment of its Alzheimer’s treatment Aduhelm. Also, cell therapy developer Orchard Therapeutics gained clearance in England and Wales for its gene therapy Libmeldy for a rare disease affecting babies, which at a list price of around $3.8 million is seen as the most expensive drug in the world, although this has been heavily discounted. 6 February 2022
Biotechnology
US biotech major Biogen today reported fourth quarter and full year 2021 financial results and provided an earnings forecast that was below expectations, sending the firm’s shares down 4.3% to $215.28 in pre-market trading. 3 February 2022
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
US neuroscience-focused biopharma Neurocrine Biosciences presented new data from more than 300 patients diagnosed with tardive dyskinesia and treated with Ingrezza (valbenazine) capsules at the 2024 Psych Congress in Boston. 5 November 2024
Pharmaceutical
Privately-held German drugmaker Boehringer Ingelheim and researchers from the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard, are collaborating on a project to tackle the urgent and unmet needs of people living with mental health conditions. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
The US subsidiary of Israel’s Teva Pharmaceutical Industries has announced new, positive data on social functioning and quality of life from the Phase III subcutaneous olanzapine extended-release injection study (SOLARIS) trial evaluating TEV-'749 in adult patients diagnosed with schizophrenia. 2 November 2024
Pharmaceutical
US pharma major AbbVie and Hungary’s Gedeon Richter have announced a new discovery, co-development and license agreement to advance novel targets for the potential treatment of neuropsychiatric conditions. 1 November 2024
Biotechnology
Dyno Therapeutics has recently announced the formation of a new strategic partnership with Swiss pharma giant Roche to develop adeno-associated virus (AAV) gene therapy vectors to target neurological diseases. 1 November 2024
Biotechnology
UCB has reported Phase IIa data from the TOGETHER (AH0003) study, investigating the safety, efficacy, and tolerability of bepranemab - an investigational anti-tau antibody targeting the mid-region of the tau protein - in people living with prodromal to mild Alzheimer’s disease. 1 November 2024
Biotechnology
Boston, USA-based biotech Axonis Therapeutics, which is focused on the development of novel neuromedicines, has announced the successful completion of an oversubscribed $115 million Series A financing. 31 October 2024
Biotechnology
US biotech companies Biogen and Neomorph have announced a research collaboration to discover and develop molecular glue degraders for priority targets in Alzheimer’s, rare neurological, and immunological diseases. 30 October 2024
Pharmaceutical
Swiss pharma giant Novartis revealed rising sales and earnings in its third-quarter financial results on Tuesday. 29 October 2024
Biotechnology
South Korea’s GemVax & KAEL has reported positive top-line results from a Phase IIa trial of GV1001, for progressive supranuclear palsy (PSP). 29 October 2024
Biotechnology
US Pharma major AbbVie has reached a definitive agreement to acquire Aliada Therapeutics, a biotech advancing therapies using a novel blood-brain barrier (BBB)-crossing technology to address challenging central nervous system (CNS) diseases. 29 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Pharmaceutical
Finnish pharma group Orion has announced it is discontinuing development of ODM-111, a pain management drug candidate, following a toxicology study suggesting it may not be suitable for long-term use. 25 October 2024
Biotechnology
US artificial intelligence (AI) to gene therapy focussed biotech Dyno Therapeutics today announced its second research collaboration with Roche to develop next-generation adeno-associated virus (AAV) vectors for gene therapies targeting neurological diseases. 24 October 2024
Biotechnology
Shares of Californian clinical-stage biotech Alto Neuroscience plummeted 70% to $4.36 yesterday, as is announced disappointing trial results for depression candidate. 24 October 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. 23 October 2024
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