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Generics
In a judgment issued last month, Spain's Barcelona Commercial Court Number 4 rejected the infringement and unfair competition actions brought by Danish drugmaker Lundbeck (LUND: DC) against several companies selling generic escitalopram medicaments in Spain. 2 September 2011
Pharmaceutical
The US Food and Drug Administration is warning that serious allergic reactions have been reported with the use of drug giant Merck & Co's (NYSE: MRK) antipsychotic Saphris (asenapine maleate), used to treat symptoms of schizophrenia and bipolar disorder, saying that the drug's label has been revised to include information about this risk and to inform health care professionals that Saphris should not be used in patients with a known hypersensitivity to the drug. 2 September 2011
Pharmaceutical
Consistent evidence that adjunctive treatment with epilepsy drug Vimpat (lacosamide) was generally well tolerated and associated with a sustained reduction in partial onset seizures for up to eight years, was presented this week at the 29th International Epilepsy Congress taking place in Rome, Italy, by Belgium's largest drugmaker UCB ( UCB: BR). 1 September 2011
Pharmaceutical
UK-based specialty drugmaker Sinclair IS Pharma (AIM: SPH.L) has signed a license agreement with Israel's Teva Pharmaceutical Industries (Nasdaq: TEVA) its oncology supportive care product, Episil (benzydamine hydrochloride). 1 September 2011
Pharmaceutical
In the USA, similar percentages of private health plan lives have formulary access to Pfizer's (NYSE: PFE) serotonin-norepinephrine reuptake inhibitor Pristiq (desvenlafaxine succinate), and Eli Lilly's (NYSE: LLY) antidepressant Cymbalta duloxetine), according to the findings of HealthLeaders-InterStudy and Fingertip Formulary. 31 August 2011
Pharmaceutical
Japanese drug major Eisai (TYO: 4523) presented new data at the International Epilepsy Congress taking place in Rome, Italy, regarding its epilepsy drug portfolio, notably: Zonegran (zonisamide) monotherapy and pivotal pediatric clinical trial results; a clinical update on Zebinix (eslicarbazepine acetate) and new global Phase III perampanel results, including the latest findings from Study 305. 31 August 2011
Pharmaceutical
Shares in USA-based NuPathe (Nasdaq: PATH) plunged as much as 56% to $1.80 in morning trading yesterday after the company revealed that it has received a Complete Response Letter from the US Food & Drug Administration regarding the New Drug Application for its sumatriptan-based migraine patch Zelrix (NP101). The active ingredient, now off patent, was developed by UK pharma giant GlaxoSmithKline and sold as Imitrex. 30 August 2011
Generics
Israel-headquartered Teva Pharmaceutical Industries (Nasdaq: TEVA) says that the US District Court for the Southern District of New York has issued a favorable set of claim construction rulings in the company's patent infringement law suit against Swiss drug major Novartis's (NOVN: VX) generics unit Sandoz and Momenta Pharmaceuticals, and Mylan/Natco regarding Teva's multiple sclerosis product, Copaxone (glatiramer acetate). 30 August 2011
Pharmaceutical
US health care giant Johnson & Johnson (NYSE: JN) group company Janssen Pharmaceuticals says that the US Food and Drug Administration has approved the marketing of Nucynta ER (tapentadol), an oral analgesic taken twice daily, for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. 30 August 2011
Pharmaceutical
There was a boost for US specialty drug firm Allergan (NYSE: AGN) yesterday when the company revealed that it has received approval from the Food and Drug Administration for Botox (onabotulinum toxin A) injection, better known as a facial wrinkle reducer, to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have over-activity of the bladder. The firm's shares rose 3% to $77.90. 25 August 2011
Generics
The Vice President of Brazil's Superior Court of Justice (STJ), Minister Felix Fischer, has restored the power of the National Health Surveillance Agency (ANVISA) to grant registration of generic medicines and the like, based on the active ingredient escitalopram, an antidepressant. 24 August 2011
Pharmaceutical
Tumor necrosis factor (TNF) inhibitors indicated for the treatment of rheumatoid arthritis, psoriasis and inflammatory bowel disease formed the largest share of the market, according to a new report available on companiesandmarkets.com. The top three products: Johnson & Johnson's Remicade (infliximab), Abbott Labs' Humira (adalimumab) and Amgen/Pfizer's Enbrel (etanercept) accounted for 40.1% of the market in 2010. 23 August 2011
Pharmaceutical
US specialty drug firm BioDelivery Sciences International (Nasdaq: BDSI) says that its pain drug Onsolis (fentanyl buccal soluble film) will debut in Canada during this quarter. 22 August 2011
Pharmaceutical
USA-based Endo Pharmaceuticals (Nasdaq: ENDP) says that it is terminating its research program and collaboration with independent German drugmaker Grunenthal related to the development of axomadol. 19 August 2011
Generics
Canada's Intellipharmaceutics International (TSX:I) and US generic drugmaker Par Pharmaceuticals (NYSE: PRX) have added the development and commercialization of additional strengths of generic Focalin XR (dexmethylphenidate HCl) for the US market to their existing agreement, which applied to the development and commercialization of the 5, 10, 15 and 20mg strengths of generic Focalin XR, used in the treatment of attention-deficit hyperactivity disorder (ADHD). 19 August 2011
Generics
US generic drugmaker Mylan (Nasdaq: MYL) yesterday confirmed that the company and its subsidiary Mylan Pharmaceuticals have been sued by Endo Pharmaceuticals (NasdaqGS: ENDP) in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for frovatriptan succinate EQ, 2.5mg base tablets, a copy version of Endo's Frova, which is indicated for the treatment of symptoms associated with acute migraine headaches, with or without aura, in adults. 17 August 2011
Pharmaceutical
UK drug developer Phytopharm (LSE: PYM) yesterday presented its interim management statement for the four and a half months to August 16, noting the progress being made with its lead drug candidates, Cogane (PYM 50028) and Myogane (PYM 50018). 17 August 2011
Pharmaceutical
USA-based Impax Pharmaceuticals, the branded products division of Impax Laboratories, (Nasdaq: IPXL), and UK drugs giant GlaxoSmithKline (LSE: GSK) have announced top-line results of the ASCEND-PD Phase III clinical study of IPX066 versus carbidopa-levodopa plus entacapone (CLE), in patients with advanced Parkinson's disease (PD). 16 August 2011
Generics
California, USA-based Avanir Pharmaceuticals (Nasdaq: AVNR) has filed law suits in the US District Court for the District of Delaware against Par Pharmaceutical (NYSE: PRX) and Icelandic generic drugmaker Actavis with respect to patent infringement of the firm's Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), an agent launched in the USA for the treatment of pseudobulbar affect (pathological crying or laughing) in late January 2011. 12 August 2011
Pharmaceutical
Citing slow recruitment into its two Phase III studies, German biopharmaceutical company Paion's (FSE: PA8) partner, Denmark-based Lundbeck (LUND: DC), has guided to a delay in the stroke project desmoteplase, which it says will now not be filed for US approval until the first half of 2014. The two companies extended their original 2005 agreement on desmoteplase last year, to include access to potential follow up products (The Pharma Letter October 18, 2010). 11 August 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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