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Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
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
The news that an advisory committee of the USA's Food and Drug Adminstration is set to review California-based drugmaker Vivus' New Drug Application (NDA) for Qnexa (phentermine plus topamax), for the treatment of obesity on July 15 saw the firm's share price rise 1.6% to $9.51 in late morning trading last Friday, having increased 14% and in the past month. 29 March 2010
Pharmaceutical
Valued at $84.4 billion, the central nervous system (CNS) disorders market posted a growth of 7.9% over the previous year. Market expansion was primarily driven by the growth in sales from CNS disorders such as Alzheimer's disease, epilepsy and attention-deficit hyperactivity disorder (ADHD), according to a new report from Business Insights. 29 March 2010
Generics
US drug behemoth Pfizer has been found by a jury yesterday to have committed racketeering fraud in the marketing of its epilepsy drug Neurontin ((gabapentin) and must pay $142.1 million in damages, according to multiple media reports. "The message, if there was a message, is that they acted in a fraudulent manner," said Hank Pierotti, foreman of the eight-person federal jury in Boston, after the verdict. "If you're fraudulent, you deserve to be punished,' he stated, noted Bloomberg. 26 March 2010
Pharmaceutical
UK-based Vernalis saw its share price plunge as much as 20% after the company reported top-line results of the 162-patient IN-STEP Phase IIb trial of indantandol in diabetic neuropathic pain (DNP) which indicated that a high placebo response rate caused the primary endpoint of change in pain score from baseline to be missed. 26 March 2010
Pharmaceutical
The UK's National Institute for Health and Clinical Excellence (NICE) has outlined the most effective drugs that health care professionals in general and community settings should prescribe adults with neuropathic pain, a potentially debilitating condition that affects thousands in the UK. This is the first time that a clinical guideline has been published in this area. 25 March 2010
Pharmaceutical
A study published yesterday outlines the medical conditions that US physicians reported treating with psychiatric drugs. The research was conducted by Thomson Reuters, sponsored by the federal Substance Abuse and Mental Health Services Administration (SAMHSA; part of the Department of Health and Human Services.), and published in the journal CNS Drugs. 23 March 2010
Pharmaceutical
Anglo-Swedish drug major AstraZeneca says that a jury in a New Jersey state court in the USA ruled in favor of the company by rejecting a Louisiana plaintiff's claims that its antipsychotic drug Seroquel (quetiapine) had caused his alleged injuries, ie, diabetes. Seroquel is the company's second-biggest selling drug, generating revenues of some $4.9 billion globally last year. 19 March 2010
Pharmaceutical
US drugmaker Alpharma, a subsidiary of King Pharmaceuticals, has agreed to pay $42.5 million to resolve False Claims Act allegations in connection with the marketing of the morphine-based drug, Kadian, the US Justice Department announced yesterday. The settlement resolves allegations that, between January 1, 2000 and December 29, 2008, Alpharma paid health care providers to induce them to promote or prescribe Kadian, and made misrepresentations about the safety and efficacy of the drug, which is used to treat chronic moderate to severe pain. 17 March 2010
Generics
UK drugmaker Shire says that it has received a Paragraph IV Notice Letter from Israeli-owned Teva Pharmaceuticals USA advising that the latter had filed an Abbreviated New Drug Application with the US Food and Drug Administration for a generic version of Shire's attention deficit hyperactivity disorder (ADHD) drug Intuniv (guanfacine HCl). Extended release tablets 1mg, 2mg, 3mg, and 4mg. 17 March 2010
Pharmaceutical
Azur Pharma says it has signed a definitive agreement with fellow Ireland-headquartered Elan to acquire the worldwide rights (excluding Europe) to the latter's analgesic, Prialt (ziconotide intrathecal infusion). Financial terms of the deal were not disclosed. 15 March 2010
Biotechnology
Swiss biotechnology firm Actelion revealed yesterday afternoon that it has received a complete response letter from the US Food and Drug Administration for its supplemental New Drug Application for Zavesca (miglustat) requesting additional preclinical and clinical information. The sNDA had applied for approval of the drug ' which is already marketed gor Gaucher's disease - for the treatment of progressive neurological manifestations in adult and pediatric patients with Niemann-Pick type C (NP-C) disease, a rare, neurodegenerative genetic disorder. 10 March 2010
Biotechnology
Rome-based Lay Line Genomics SpA says that, after the termination of the exclusive license agreement with fellow Italian firm BioXell SpA, all rights to the humanized antiTrkA monoclonal antibody named BXL1H5 are now fully back in its hands. 10 March 2010
Pharmaceutical
Anglo-Swedish drug major AstraZeneca is under investigation for breaches of the UK Prescription Medicines Code of Practice Authority (PMCPA) rules relating to the promotion of its blockbuster anti-psychotic drug Seroquel (quetiapine). 9 March 2010
Pharmaceutical
Phase III failure last week for Medivation/Pfizer's Dimebon (latrepirdine) is a major setback, however hope remains for Alzheimer's sufferers and their carers, says Ben Greener, lead health care analyst at Datamonitor. 9 March 2010
Generics
The US District Court for the District of Columbia has upheld the Food and Drug Administration's decision reaffirming that UK drugmaker Shire's Vyvanse (lisdexamfetamine) is entitled to 5-year market exclusivity for the treatment of attention-deficit hyperactivity disorder (ADHA). 5 March 2010
Pharmaceutical
USA-based Medivation saw its shares price nose dive after it announced, with development partner drug behemoth Pfizer, that two Phase III trials of the investigational drug Dimebon (latrepirdine) in patients with Alzheimer's disease did not meet co-primary or secondary efficacy endpoints compared to placebo. Co-primary endpoints were measures of cognition and global function. Medivation's stock tumbled 69%, to $12.40 ahead of yesterday's market opening, and closing the day at $13.10. Pfizer's shares dipped just 1% to $17.44 in early trading. 4 March 2010
Pharmaceutical
Confirming a trend of mega-licensing deals that has been in evidence for a couple of years as pharmaceutical companies struggle to get the necessary results from their own research efforts, US drug major Bristol-Myers Squibb has entered into a deal with fellow USA-based Allergan to acquire rights to AGN-209323, a Phase II-ready, orally-administered small molecule in clinical development for neuropathic, or chronic pain, which is common in people with arthritis, cancer and nerve damage. The drug can be given orally. 4 March 2010
Pharmaceutical
French drug major Sanofi-Aventis and USA-based Novalar Pharmaceuticals have entered into an exclusive license and distribution agreement in which Sanofi-Aventis Deutschland will have the right to commercialize and market Novalar's OraVerse in Germany with options to extend the license to additional European countries. 4 March 2010
Pharmaceutical
UK specialty pharmaceutical firm ProStrakan says that Solasia Pharma, the group's partner for Sancuso in various Asian markets, has entered into a license agreement with Japan's Kyowa Hakko Kirin, granting the latter exclusive right to market and sell the product in Taiwan, Hong Kong, Singapore and Malaysia. 4 March 2010
Pharmaceutical
In the world's major pharmaceutical markets, emerging oral atypical antipsychotics will compete against each other and against established drugs for the same niche patient population in the treatment of schizophrenia, notes USA-based research and advisory firm Decision Resources. 25 February 2010
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