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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
The US Food and Drug Administration says that a recent clinical trial with Doribax (doripenem) being conducted by health care giant Johnson & Johnson's (NYSE: JNJ) Janssen subsidiary was stopped early because of significant safety concerns. 9 January 2012
Pharmaceutical
US drugmaker Endo Pharmaceuticals (Nasdaq: ENDP) has signed a worldwide license and development agreement with USA-based BioDelivery Sciences International (Nasdaq: BDSI) for BEMA Buprenorphine, a now off-patent narcotic analgesic compound. 8 January 2012
Pharmaceutical
Italy-headquartered R&D firm Newron Pharmaceuticals (SIX: NWRN) yesterday revealed that it has agreed with Japan's Meiji Seika Pharma, a subsidiary of the Meiji Holdings, on the principal terms and conditions of a license transaction covering the research, development, manufacturing and marketing of Parkinson's disease drug candidate safinamide in Japan and key Asian territories. Financial details of the transaction were not disclosed. 6 January 2012
Biotechnology
Australian biotech firm Bionomics (ASX: BNO) entered into a collaboration, research and licensing agreement with USA-based Ironwood Pharmaceuticals (Nasdaq: IRWD) that will enable the latter to develop and commercialize Bionomics' investigational anti‐anxiety compound BNC210 and other related compounds. 6 January 2012
Pharmaceutical
French companies Oncodesign and Ipsen (Euronext: IPN) have entered into a research collaboration to discover and develop innovative LRRK2 kinase inhibitors as potential therapeutic agents against Parkinson's disease and for potential additional uses in other therapeutic areas. Oncodesign, a drug discovery company and oncology pharmacology service provider, and Ipsen will leverage their respective expertise to bring innovative therapeutic solutions to Parkinson patients. 5 January 2012
Pharmaceutical
US drugmaker Alkermes (Nasdaq: ALKS) yesterday released positive early clinical results for a central nervous system (CNS) drug candidate, ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression, and accelerated next steps for clinical trials with this novel compound. 4 January 2012
Generics
Iceland-based generic drugmaker Actavis says that it recently received approval from the US Food and Drug Administration to market methylphenidate hydrochloride extended-release capsules (LA) CII, USP, 20mg, 30mg, and 40mg. Actavis has first-to-file exclusivity on these dosage forms and says distribution of the product has commenced. 4 January 2012
Pharmaceutical
Privately-held US company Ossianix announced a strategic investment by Danish CNS drug specialist Lundbeck A/S (LUND: DC) in the form of a Convertible Promissory Note. The proceeds from Lundbeck's investment, the amount of which is not specified, is expected to allow Ossianix to generate biopharmaceuticals for the treatment of nervous system disorders by utilizing the US firm's proprietary single domain antibody platform modeled on the shark vNAR structure. 3 January 2012
Pharmaceutical
Sweden's Karo Bio (STO: KARO) saw its shares rocket 80% to 1.67 Swedish ronor on December 24, after the company said it had entered into a research collaboration agreement with global pharma behemoth Pfizer (NYSE: PFE) to discover and develop novel small molecule RORgamma modulators for the treatment of autoimmune diseases. 28 December 2011
Pharmaceutical
Japanese drug major Eisai (TYO: 4523) says that it has re-submitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the US Food and Drug Administration (FDA) on December 22, 2011. 28 December 2011
Generics
Danish CNS drug specialist Lundbeck (LUND: DC) says it has entered into an agreement with USA-based niche generic drugmaker Akorn (Nasdaq: AKRX) to sell a portfolio of three off-patent, branded, hospital-based injectables products comprising Nembutal (pentobarbital sodium injection, USP), Cogentin (benztropine mesylate injection) and Intravenous Sodium Diuril (chlorothiazide sodium). 23 December 2011
Pharmaceutical
California-based Exelixis (Nasdaq: EXEL) says it has granted US drug giant Merck & Co (NYSE: MRK) an exclusive worldwide license to its PI3K-delta R&D program, including XL499, the company's most advanced preclinical PI3K-delta inhibitor and other related compounds. Under the agreement, Merck will have a worldwide exclusive license and have sole responsibility to research, develop, and commercialize compounds originating from the program. 22 December 2011
Pharmaceutical
Danish CNS drug specialist Lundbeck (LUND: DC) revealed yesterday that it has submitted a marketing authorization application to the European Medicines Agency for Selincro (nalmefene), the company's novel opioid receptor ligand in development for alcohol dependence and the dossier has been accepted for review by EMA. 22 December 2011
Generics
Iceland-headquartered generics major Actavis Group, via its US subsidiary, has entered into a binding letter of intent with Australian firm QRxPharma (ASX: QRX) to commercialize MoxDuo IR in the USA. 21 December 2011
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZ) had a double dose of bad news, when the company said that its investigational compound olaparib will not progress into Phase III development for the maintenance treatment of serous ovarian cancer. In addition, it announced that the second RENAISSANCE Phase III study of TC-5214 (licensed from Targacept under a potential $1.24 billion deal) for patients with major depressive disorder did not meet its primary end point. 21 December 2011
Pharmaceutical
The US Food and Drug Administration (FDA) has completed a safety review of French drug major Sanofi's (Euronext: SAN) heart drug Multaq (dronedarone), concluding that the drug increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). 20 December 2011
Pharmaceutical
Acquisitive Canadian drugmaker Valeant Pharmaceuticals International (TSX: VRX) has entered into another hostile takeover attempt, this time revealing that it has offered to buy USA-based ophthalmic and allergy drug firm ISTA Pharmaceutical (Nasdaq: ISTA) for $6.50 a share, or around $314 million in total, plus the assumption of $13 million of debt, bringing the total enterprise value to some $327 million. 19 December 2011
Generics
US medical products and generic drugmaker Covidien (NYSE: COV) says that it plans to spin off its pharmaceuticals business - which generates around $2 billion in annual sales - into a stand-alone public company. The decision comes after several years of evaluating options which, according to observers, included talks to sell the drugs business for $3-$4 billion that failed to materialize. The news saw Covidien's shares rise 3.3% to $43.55 by close yesterday. 16 December 2011
Biotechnology
US neuro drug discovery firm Intellect Neurosciences (OTCBB: ILNS) says that it has filed an appeal regarding a preliminary decision of the European Patent Office (EPO) to revoke the company's ANTISENILIN monoclonal antibody platform patents. 15 December 2011
Pharmaceutical
include a second collaboration in a different therapeutic area. Financial terms were not disclosed. 15 December 2011
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