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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
Generics
In the UK, needless use of anti-psychotic drugs is widespread in dementia care and contributes to the death of many patients, according to a review commissioned by the government. About 180,000 patients a year are given the drugs in care homes, hospitals and their own homes to manage aggression. 13 November 2009
Biotechnology
US health care major Abbott says it has signed a definitive agreement to acquire the global rights to Dutch firm PanGenetics BV's early-stage PG110 fully-humanized antibody to Nerve Growth Factor (NGF), aiming to expand the company's pain care portfolio and leveraging its expertise in biologics. 13 November 2009
Pharmaceutical
The world's largest drugmaker, USA-based Pfizer, denies that it may have altered or omitted unfavorable study results relating to potential expanded uses of Neurontin (gabapentin), indicating the medicine worked better than internal company documents showed, as alleged in a report published in the New England Journal of Medicine yesterday. 12 November 2009
Pharmaceutical
Swiss drug major Roche has reported positive results from a 320 patient Phase II proof-of-concept study with its investigational glycine transporter-1 inhibitor RG1678. The study showed that the compound improved both the negative symptoms and the personal and social functioning of patients with schizophrenia reaching statistical significance on primary and secondary endpoints. The drug is being co-developed with Roche's majority-owned Japanese subsidiary Chugai. 12 November 2009
Biotechnology
France's Sanofi-Aventis and USA-based Regeneron Pharmaceutical have entered into an agreement to expand and extend their existing global collaboration to discover, develop, and commercialize fully-human therapeutic monoclonal antibodies through 2017, which would cost the French drug major over $1 billion over the eight years to expand its foot-print in biotechnology. 11 November 2009
Generics
Israel's Teva Pharmaceutical Industries says it is seeking to amend its existing complaint against Momenta Pharmaceutical and Swiss drug major Novartis' US Sandoz unit to include patent infringement of three additional patents related to the characterization of its multiple sclerosis drug Copaxone (glatiramer acetate injection). The proposed updated complaint has been filed under seal with the US District Court for the Southern District of New York along with a motion requesting that the Court grant Teva leave to amend. 11 November 2009
Pharmaceutical
Switzerland-headquartered Nycomed says it welcomes the decision by the Scottish Medicines Consortium (SMC) on Instanyl, (intranasal fentanyl), the only fast-acting intranasal treatment licensed for breakthrough cancer pain. The SMC decision means that cancer patients in Scotland will now have another option for the treatment of breakthrough cancer pain within the National Health Service in Scotland, the privately-owned drugmaker notes. 10 November 2009
Pharmaceutical
The US Justice Department is investigating Abbott Laboratories‘ sales and marketing activities for its anti-seizure drug Depakote (divalproex), its third top-selling drug, the US health care major revealed in a regulatory filing. It said that the US Attorney for the Western District of Virginia is seeking to determine whether Abbott‘s marketing activities violated civil or criminal laws, including the Federal False Claims Act, the Food and Drug Cosmetic Act, and the Anti-Kickback Statute "in connection with Medicare and/or Medicaid reimbursement to third parties."Abbott spokeswoman Adelle Infante said the company is cooperating with the investigation, but declined further comment. Sales of Depakote, which is approved to treat bipolar disorder and seizures and to prevent migraine headaches, have been declining recently due to generic competition. They plunged 70% to $354 million for the first nine months of 2009, having reached annual revenues of around $1 billion previously. 9 November 2009
Pharmaceutical
Business Monitor International calculates that pharmaceutical sales in Portugal reached 3.61 billion euros ($5.31 billion) in 2008. It calculates that the sales of prescription and over-the-counter medicines will see a constant annual growth rate (CAGR) of 2.79% in local currency terms. It notes that, as a result of the weakening euro, drug market expenditure in US dollar terms will experience a decline in 2009, 2010, 2011 and 2012, before reaching a value of $5.11 billion by 2013, equating to a CAGR of -0.77%. 9 November 2009
Pharmaceutical
Findings from a Pfizer-sponsored study, presented as late-breaker at American College of Chest Physicians annual meeting in San Diego, showed that 42.3% of smokers with mild-to-moderate chronic obstructive pulmonary disease (COPD) who took the firm's Champix (varenicline) were able to quit smoking and remain abstinent during the last four weeks of treatment (weeks 9-12) compared with 8.8% of those given placebo (p<0.0001). 6 November 2009
Generics
Generic erosion of branded atypical antipsychotics will cause the bipolar disorder drug market to decline from $6.3 billion in 2008 to around $5 billion in 2018 in the world's leading pharmaceutical markets, the USA, France, Germany, Italy, Spain, the UK and Japan, according to new research from Decision Resources. 6 November 2009
Pharmaceutical
The world market for medicines that treat addiction disorders is currently valued at US$3.2bn is set to increase by 19% by 2016 to $3.8bn, forecasts a new market report from URCH Publishing. 3 November 2009
Pharmaceutical
Shire, the UK's third largest drugmaker, posted revenues from continuing operations for the three months to September 30, 2009 down 14% to $667.0 million (2008: $778.6 million), due to the decline in branded Adderall XR (amphetamine and dextroamphetamine), used to treat narcolepsy and attention deficit hyperactivity disorder (ADHD), following the launch of an authorized generic version by Teva in April 2009. However, core product sales increased by 20% to $531.6 million, noted the company, which saw its share price rise 4.7% to 10.72 on the day of the announcement, October 30. 2 November 2009
Pharmaceutical
Antipsychotic drugs widely used in children and young adults caused weight gain of as much as 19 pounds on average after just 11 weeks on the medications, according to a new study published in the current issue of the Journal of the American Medical Association. The study results come as the US Food and Drug Administration is considering approving younger patients' use of a few of the drugs, which largely have been cleared only for adults. Atypical antipsychotics have limited approval for youths, doctors are free to prescribe them as they see fit and often give them to children and adolescents, say analysts and psychiatrists. 28 October 2009
Generics
The US Food and Drug Administration, following a thorough administrative review of governing statutory and regulatory standards and public comments, has affirmed its prior decision to grant five-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate - currently marketed by the US unit of UK-based drugmaker Shire for the treatment of attention-deficit hyperactivity disorder under the name Vyvanse. The five-year exclusivity period expires on February 23, 2012. Vyvanse is covered by US patents which remain in effect until June 29, 2023, the UK firm notes. 26 October 2009
Biotechnology
The European medicines Agency's (EMEA) Committee for Medicinal Products for Human Use, (CHMP) Committee has started a review of the benefits and risks of Tysabri (natalizumab), in view of reports of 23 cases of progressive multifocal leukoencephalopathy (PML) worldwide since Tysabri has been on the market. 26 October 2009
Biotechnology
The USA's research-based drug and biotechnology companies are working on nearly 1,000 life-changing medicines for diseases affecting women, according to a new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA). The medicines are awaiting approval by the US Food and Drug Administration or are in human clinical trials. 20 October 2009
Pharmaceutical
UK-based Phytopharm saw its share price rocket almost 350% to 26.75 pence, after the company announced encouraging results from two studies of its Cogane (PYM50028), a novel non-peptide, orally bioavailable neurotrophic factor inducer treatment for Parkinson's disease. 15 October 2009
Pharmaceutical
Independent German drug major Boehringer Ingelheim's Mirapexin/Sifrol (pramipexole) new prolonged-release, once daily tablet has been granted marketing authorization by the European Commission in all European Union/European Economic Area countries for the treatment of early and advanced idiopathic Parkinson's disease. 15 October 2009
Biotechnology
UK drug giant GlaxoSmithKline and Prosensa, a Dutch based biopharmaceutical company focusing on RNA modulating therapeutics, entered into an exclusive worldwide collaboration for the development and commercialization of RNA based therapeutics for Duchenne Muscular Dystrophy (DMD), a severely debilitating childhood neuromuscular disease that affects one in 3,500 newborn boys. 14 October 2009
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