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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
Japanese drug major Astellas Pharma (TOY: 4503) says that Regnite (gabapentin enacarbil) extended-release tablets, a treatment for restless legs syndrome (RLS), will be launched in Japan today (July 10). 10 July 2012
Biotechnology
Finland-based biotech firm Biotie Therapies' (OMX: BTH1V) retention of SYN120 rights after Roche decided not to opt-in to a development license (The Pharma Letter June 27) means the company now has three unencumbered Phase II ready assets available for global licensing, comment analysts at Edison Equity Research in a new report on the company. 8 July 2012
Pharmaceutical
Following two earlier rejections, the US Food and Drug Administration has now accepted Alexza Pharmaceuticals (Nasdaq: ALXA) resubmitted Adasuve (Staccato loxapine). New Drug Application (NDA) as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of December 21, 2012 (The Pharma Letter May 2). 8 July 2012
Pharmaceutical
Results published in the June online edition of Seizure from an independent multicenter study covering 19 epilepsy clinics in the UK showed that oral lacosamide - Belgian drugmaker UCB's (Euronext Brussels) Vimpat - administered as adjunctive therapy in refractory epilepsy is an effective and generally well-tolerated treatment, achieving seizure freedom for some patients. 8 July 2012
Pharmaceutical
US drug major Eli Lilly (NYSE: LLY) announced that it has met the US Food and Drug Administration requirements for pediatric exclusivity for Cymbalta (duloxetine HCl). Based on this decision by the FDA, Lilly has gained an additional six months of US market exclusivity for Cymbalta, which now will expire in December 2013. 8 July 2012
Pharmaceutical
The widely used diabetes drug metformin comes with a rather unexpected and alluring side effect: it encourages the growth of new neurons in the brain. The study reported in the July 6 issue of Cell Stem Cell also finds that those neural effects of the drug also make mice smarter. 8 July 2012
Generics
Switzerland-based generic drugmaker Actavis Group, now owned by US firm Watson Pharmaceuticals (NYSE: WPI) , says it has received tentative approval from the US Food and Drug Administration for guanfacine extended-release tablets 1mg, 2mg, 3mg and 4mg, a generic equivalent to UK drugmaker Shire's (LSE: SHPGY) Intuniv, used in the treatment of attention-deficit hyperactivity disorder (ADHD). 6 July 2012
Generics
Patent expiry of key blockbuster atypical antipsychotic drugs is likely to cause a decline in growth of the European bipolar disorder therapeutics market until 2013. However, approval of new drugs and improved depot formulations are expected to present growth opportunities from 2014 to 2018. 4 July 2012
Pharmaceutical
UK-based specialty drugmaker Sinclair IS Pharma (AIM: SPH.L) has returned the commercial rights for Episil( benzydamine hydrochloride), a patented oral spray indicated for local treatment of pain associated with oral mucositis, in the European Union to Sweden's Camurus AB, while retaining distribution rights in the UK and Ireland. 4 July 2012
Pharmaceutical
Belgium-based biopharma firm ThromboGenics (Euronext Brussels: THR) says that the US Food and Drug Administration has officially accepted the filing of the Biologics License Application for ocriplasmin intravitreal injection, 2.5mg/ml and granted it Priority Review. The proposed indication of ocriplasmin intravitreal injection is for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole. 3 July 2012
Pharmaceutical
Botulinum toxin may help prevent shaking or tremor in the arms and hands of people with multiple sclerosis (MS), according to new research published in the July 3, 2012, print issue of Neurology, the medical journal of the American Academy of Neurology. 3 July 2012
Pharmaceutical
Cognitive skills such as learning and memory diminish with age in everyone, and the drop-off is steepest in Alzheimer's disease. Texas, USA, scientists seeking a way to prevent this decline reported exciting results last week with a drug that has Polynesian roots. 2 July 2012
Biotechnology
Polish biotech firm Selvita (PL:SLV) says that its collaboration with Finland-based Orion Corp (Nasdaq OMX Helsinki: ORNAV) for the symptomatic treatment of Alzheimer's disease has reached the main research milestone and that the jointly discovered molecules from two different chemical families will progress into further preclinical characterization before the selection of a candidate into development. 1 July 2012
Biotechnology
Within the multiple sclerosis treatment arena, the availability of the anti-JC virus antibody assay appears to be contributing to the significant increase in overall satisfaction with Biogen Idec (Nasdaq: BIIB) and Elan's (NYSE: ELN) Tysabri (natalizumab), over the past year. 1 July 2012
Pharmaceutical
The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application for Australia-based QRxPharma's (ASX: QRX) MoxDuo (morphine and oxycodone) in the treatment of moderate to severe acute pain. 29 June 2012
Pharmaceutical
Eisai (TYO: 4523), a leading Japanese drugmaker, says it plans to expand its operations into Russia, with the approval of its first product in this market - the epilepsy treatment, Zonegran (zonisamide). 28 June 2012
Generics
USA-based specialty drug firm Supernus Pharmaceuticals (Nasdaq: SUPN) says it has received a tentative approval letter from the Food and Drug Administration for Trokendi XR, a once-daily extended release formulation of topiramate, the active ingredient of Johnson & Johnson's widely used epilepsy drug Topamax, which is now off patent. 27 June 2012
Pharmaceutical
Finland-based Biotie Therapies (OMX: BTH1V) said yesterday that it is retaining global development and commercialization rights to SYN120, following Swiss drug major Roche's (ROG: SIX) decision not to exercise its opt-in right due to strategic portfolio reasons. 27 June 2012
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today published new technology appraisals, updating on its previous decisions announced earlier this year. 26 June 2012
Generics
US generics drugmaker Watson Pharmaceuticals (NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market a generic version of pharma behemoth Pfizer's (NYSE: PFE) Pristiq (desvenlafaxine succinate) extended-release tablets, 50mg and 100mg, which is indicated for the treatment of major depressive disorder (MDD) in adults. 26 June 2012
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