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Biotechnology
Genzyme, which is now a wholly-owned subsidiary of French drug major Sanofi-Aventis Group (Euronext: SAN) reported additional five-year patient data from its completed Phase II multiple sclerosis (MS) trial showing that nearly two-thirds of alemtuzumab treated patients remained free of clinically-active disease as much as four years after most patients received their last course of the investigational drug. 18 April 2011
Pharmaceutical
A large percentage of US health plans (78%) will reimburse for emerging oral disease-modifying therapies for multiple sclerosis, despite the projected high cost associated with these agents, according to a report from advisory firm Decision Resources' HealthLeaders-InterStudy unit. 18 April 2011
Pharmaceutical
The UK government will introduce additional controls on the export to the USA of drugs used in lethal injections and is calling on the European Union to follow its lead. The necessary order to extend the controls will be laid before Parliament in the coming days. 15 April 2011
Pharmaceutical
Two more contenders for a share of the oral multiple sclerosis market, Israel's Eva Pharmaceutical Industries (Nasdaq: TEVA) and Swedish partner Active Biotech (NORDIC: ACTI) have announced positive results from the two-year Phase III ALLEGRO study of laquinimod, an oral, once-daily, investigational immunomodulator for the treatment of relapsing forms of MS. 14 April 2011
Pharmaceutical
The American Academy of Neurology has issued a new guideline on the most effective treatments for diabetic nerve pain, the burning or tingling pain in the hands and feet that affects millions of people with diabetes. The guideline is published in the April 11, 2011, on-line issue of Neurology , the journal of the American Academy of Neurology, and were presented this week at the American Academy of Neurology's Annual Meeting in Honolulu, Hawaii. 13 April 2011
Pharmaceutical
US drugmaker Biogen Idec (Nasdaq: BIIB) shares closed up 7.2% at $78.55 6.4% in heavy trading yesterday, after announcing positive top-line results from DEFINE, the first of two pivotal Phase III clinical trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with relapsing-remitting multiple sclerosis (RRMS). 12 April 2011
Pharmaceutical
Global drug behemoth Pfizer (NYSE: PFE) and partner Medivation (Nasdaq: MDVN) said yesterday that results from the Phase III HORIZON trial of the investigational drug Dimebon (latrepirdine) in patients with Huntington disease did not achieve statistical significance for either of the co-primary endpoints of the study. 12 April 2011
Pharmaceutical
Closely-held UK-based drug discovery firm Heptares Therapeutics has entered a two-year drug discovery collaboration with Japan's largest drugmaker, Takeda Pharmaceutical (TSE: 4502) focused on a single G-protein coupled receptor (GPCR) that plays an important role in the pathology of central nervous system disorders. 12 April 2011
Pharmaceutical
In what has been a couple of busy and mixed news days for Swiss drug major Novartis (NOVN: VX), this morning the company said it was discontinuing a Phase III trial of Tasigna (nilotinib). In addition, it was announced that it had in-licensed certain rights to the cannabis-based drug Sativex and also new clinical data supporting its oral diabetes drug Gilenya (fingolimod), as well as an update on Afinitor (everolimus). 11 April 2011
Generics
US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) last Friday confirmed that its subsidiary, Watson Laboratories, had filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market moxifloxacin hydrochloride ophthalmic Solution USP, 0.5%, a generic version of Alcon Vigamox, an antibiotic solution that is indicated for the treatment of bacterial conjunctivitis. 11 April 2011
Pharmaceutical
There was good news for UK-headquartered pharma companies - AstraZeneca (LSE: AZN) and GlaxoSmithKline (LSE: GSK), as well as the latter's partner XenoPort (Nasdaq: XNPT, (which saw its shares rocket 57% to $10 in extended trading yesterday) - with announcements of US Food and Drug Administration approval for each of their investigational drugs. 7 April 2011
Pharmaceutical
Danish drugmaker H Lundbeck A/S (LUN.CO: DC) has started the roll out of Sycrest (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults in Europe, with Denmark being the first country to launch. 6 April 2011
Pharmaceutical
Forest Laboratories, Inc. (NYSE: FRX) says that it has extended the expiration date of its tender offer for all outstanding shares of common stock of, and certain outstanding notes and warrants convertible into the common stock of, Clinical Data (Nasdaq: CLDA) to expire at 12:00 midnight, New York City time on Monday, April 11, 2011. 6 April 2011
Pharmaceutical
In line with recent guidance that it is viewing the sale of some non-core businesses, global drugs behemoth Pfizer (NYSE: PFE) has entered into an agreement whereby an affiliate of private investment firm Kohlberg Kravis Roberts (KKR) will acquire Pfizer's Capsugel business for $2.375 billion in cash (The Pharma Letter March 15). 5 April 2011
Pharmaceutical
Italy's Newron Pharmaceuticals (SIX: NWRN) has entered into an agreement that broadens the scope of its collaboration with Merck Serono, a division of German drug major Merck KGaA (MRK: DE). Newron's shares jumped 3.9% to 6.70 Swiss francs on the news. The two companies are already collaborating on the development of safinamide in Parkinson's disease. 4 April 2011
Pharmaceutical
Japanese drugmaker Dainippon Sumitomo Pharma (4506: JP) has entered into a licensing accord with Takeda Pharmaceutical (TSE: 4502) for the joint development and exclusive commercialization of the oral formulation of lurasidone, an atypical antipsychotic agent developed originally by DSP, for the treatment of schizophrenia and bipolar disorder. 1 April 2011
Pharmaceutical
Following a positive advisory panel earlier this year, the European Commission has granted marketing authorization for Trobalt (retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalization in adults aged 18 years and above with epilepsy. 31 March 2011
Biotechnology
Israel-based XTL Biopharmaceuticals (TASE: XTL), saw its sales jump 8.6% to 0.504 shekels after announcing on March 24 that, it had entered into a term sheet to acquire the activity of MinoGuard by obtaining an exclusive license to use MinoGuard's entire technology in return for royalties on sales and milestone payments throughout the clinical development process. Further financial terms were not disclosed. 28 March 2011
Generics
Watson Pharmaceuticals (NYSE: WPI) says that its subsidiaries, Andrx Labs and Watson Laboratories have filed Abbreviated New Drug Applications with the US Food and Drug Administration seeking approval to market oxycodone hydrochloride extended-release tablets in the 10,15, 20, 30, 40, 60 and 80mg strengths, a generic version of Purdue Pharma's OxyContin, which are indicated for the management of moderate to severe pain when continuous, around-the-clock opioid analgesic is needed for an extended period of time. 28 March 2011
Generics
Iceland-based generic drugmaker Actavis Group says it has received approval from the US Food and Drug Administration to market valaciclovir hydrochloride tablets, used to treat herpes virus infections. 25 March 2011
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
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