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Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Biotechnology
A patient in Neurogene’s ongoing Phase I/II trial for Rett syndrome—who was dosed on November 5 with 3E15 vg of NGN-401—has now died from a treatment-related serious adverse event (SAE). 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical announced that it has entered into an exclusive worldwide licensing agreement with Ionis Pharmaceuticals for rights to manufacture and market Ionis' ulefnersen (ION363), a drug candidate under development for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by mutation of the fused in sarcoma (FUS) gene. 23 November 2024
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
Sunovion Pharmaceuticals, a wholly-owned US subsidiary of Japanese drug major Dainippon Sumitomo Pharma (TYO: 4508) and privately-held US biotech firm Afraxis have signed a partnership agreement to utilize the unique Enhanced Spine Platform (ESP) developed by Afraxis, to accelerate Sunovion's preclinical central nervous system (CNS) drug discovery process. 14 August 2013
Pharmaceutical
USA-based Albany Molecular Research (Nasdaq: AMRI) has been informed by its license partner US drug major Bristol-Myers Squibb (NYSE: BMY) of its decision to halt the development of an investigational drug for depression, with the news sending Albany's shares falling 14% to $10.80. 13 August 2013
Pharmaceutical
USA-based Pacira Pharmaceuticals (Nasdaq: PCRX) has reported results from its second pivotal, Phase III clinical trial assessing the safety and efficacy of Exparel (bupivacaine liposome injectable suspension) in intercostal nerve block for posterolateral thoracotomy showing that the drug did not achieve its primary endpoint of a reduction of cumulative pain scores over 72 hours. 2 August 2013
Generics
Denmark CNS drug specialist Lundbeck (LUND: CO) and partner Japanese drug major Takeda Pharmaceutical's (TYO: 4502) emerging antidepressant Brintellix (vortioxetine) will attain blockbuster status for unipolar depression in the major markets of the USA, France, Germany, Italy, Spain, the UK and Japan by 2022, according to a new report from health care advisory firm Decision Resources. 2 August 2013
Biotechnology
Australian biotech firm Bionomics (ASX: BNO) has entered an agreement with US pharma giant Merck & Co (NYSE: MRK) to discover and develop novel small-molecule candidates for the treatment of chronic pain, including neuropathic pain. 1 August 2013
Generics
US generics major Actavis (NYSE: ACT) has launched new formulations of Fioricet (butalbital, acetaminophen and caffeine capsules, USP) and Fioricet with Codeine (butalbital, acetaminophen, caffeine and codeine phosphate, USP) containing a lower dose of acetaminophen, designed to provide a safer treatment option for patients suffering from tension (or muscle contraction) headaches. 30 July 2013
Biotechnology
Privately-held Acetylon and US biotech firm Celgene (Nasdaq: CELG) have entered into an exclusive strategic collaboration for Acetylon's pipeline of selective histone deacetylase (HDAC) inhibitors with $100 million cash upfront and a time-bound option for Celgene to acquire Acetylon. 30 July 2013
Generics
Israel-based generics giant Teva Pharmaceutical Industries ((NYSE: TEVA) said on Friday (July 26) that the US Court of Appeals for the Federal Circuit has affirmed the judgment of the US District Court for the Southern District of New York in the appeal filed by Momenta Pharmaceuticals (Nasdaq: MNTA), Sandoz (the generics unit of Swiss drug major Novartis [NOVN: VX]) and Mylan Laboratories (Nasdaq: MYL) and Indian drugmaker Natco Pharmaceuticals regarding the validity and infringement of four patents for Teva's relapsing-remitting multiple sclerosis (RRMS) product, Copaxone (glatiramer acetate injection) that expire in May 2014. 28 July 2013
Pharmaceutical
US drugmaker Forest Laboratories (NYSE: FRX) and France-based independent Pierre Fabre Laboratories have gained US Food and Drug Administration for their co-developed Fetzima (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), for the treatment of major depressive disorder (MDD) in adults. 26 July 2013
Pharmaceutical
The European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) has recommended changes to the use of metoclopramide-containing medicines in the European Union, including restricting the dose and duration of use of the drugs to minimize the known risks of potentially serious neurological side effects. 26 July 2013
Biotechnology
The market for disease-modifying multiple sclerosis (MS) therapies will expand at an annual rate of 10% through 2018, peaking at nearly $21 billion in that year in the top seven nations, according to health care advisory firm Decision Resources. 26 July 2013
Generics
US generics firm Mylan (Nasdaq: MYL) and Finland-based drugmaker Orion Corp (Nasdaq OMX Helsinki: ORNAV) have resolved litigation over Mylan's Abbreviated New Drug Application filing with the US Food and Drug Administration for carbidopa/levodopa/entacapone tablets. 26 July 2013
Generics
US generic drugmaker Mylan (Nasdaq: MYL) today (July 23) announced that the US Third Circuit Court of Appeals has reversed a summary judgment ruling dismissing Mylan's claim for breach of contract against UK pharma giant GlaxoSmithKline (LSE: GSK) relating to paroxetine hydrochloride extended-release (ER) tablets, an antidepressant marketed by GSK as Paxil and Seroxat. 23 July 2013
Biotechnology
USA-based biopharma company MediciNova (Nasdaq: MNOV), which is also listed in Japan (TYO: 4875) has received funding and regulatory approval of a US National Institutes of Health-based grant for a Phase IIb trial of MN-166 (ibudilast) in subjects with progressive multiple sclerosis (progressive MS). 19 July 2013
Pharmaceutical
US biotech firm Biogen Idec (Nasdaq: BIIB) says that its marketing applications for Plegridy (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS), have been accepted for review in the USA and European Union. 19 July 2013
Pharmaceutical
Ireland-based Elan Corp (NYSE: ELN) says that the US Food and Drug Administration has granted Fast Track Designation to its development program for ELND005 which was submitted for the treatment of neuropsychiatric symptoms (NPS) in Alzheimer's disease (AD). 18 July 2013
Pharmaceutical
US drugmaker Alkermes (Nasdaq: ALKS) has unveiled three new drug candidates for the treatment of multiple sclerosis, cancer and pain. 18 July 2013
Pharmaceutical
Danish CNS specialist Lundbeck (LUN: CO) and Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) presented the first clinical data on the investigational drug Lu AE58054, a selective 5-HT6 receptor antagonist, in Alzheimer's disease at the Alzheimer's Association International Conference 2013 (AAIC 2013) in Boston, USA. 17 July 2013
Generics
A US court has dismissed claims that US generic drugmaker Mylan (Nasdaq: MYL) infringed four patents held by Israel-based Teva Pharmaceuticals Industries (NYSE: TEVA) in its Abbreviated New Drug Application for its generic version of Copaxone (glatiramer acetate) for multiple sclerosis. 17 July 2013
Biotechnology
US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) says that Soliris (eculizumab), the company's first-in-class terminal complement inhibitor, has received a positive opinion for orphan medicinal product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) for the treatment of neuromyelitis optica (NMO), a life-threatening, ultra-rare neurological disorder. 16 July 2013
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