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Label change for Elan's MS-drug permits safer use
24.01.12 Weston/Dublin - The focus for Tysabri, the MS drug jointly developed by Irish Elan and US-Biogen, has become a little more accurate. The US Food and Drug Administration (FDA) stated that the occurrence of antibodies against the JC-virus marks a higher risk of developing progressive multifocal leukoencephalopathy (PML). A new label identifies anti-JCV antibody status as a third risk factor for developing PML. Tysabri (natalizumab) increases the risk of PML, an opportunistic viral infection of the brain which in most cases leads to death or severe disability. With the label update, which the companies say was inspired by their own research, physicians now have others factor at hand when weighing the risks and benefits of applying Tysabri. “We welcome the inclusion of PML risk stratification in the U.S. label as it significantly supports our aim to provide the information patients and physicians need to make a more informed treatment decision,” said Kelly Martin, CEO of Elan. Tysabri is approved in about 65 countries and results in a 68% relative reduction in the annualised relapse rate when compared with placebo, according to studies conducted by Elan.
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Novartis loves and fears EMA
23.01.12 Basel – Good and bad news for Swiss drugmaker Novartis. First a look on the bright side: Signifor, for the treatment of Cushing's disease, is on its final stretch to approval. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the multi-receptor targeting somatostatin. We are now one step closer to being able to offer patients in Europe the first approved medical treatment for Cushing´s disease , said Hervé Hoppenot of Novartis Oncology. Cushing´s syndrome is an endocrine disorder caused by excessive cortisol. Cushing´s disease is rare (one to two patients per million) but may result in weight gain, moon face, severe fatigue and weakness. But EMA has had bad tidings for The Swiss also: The agency said it started a review of Gilenya, its compound for multiple sclerosis. There are rumours that the drug could be connected to 11 deaths among patients that received treatment. These include seven unexplained deaths, three heart attacks and one due to disruption of heart rhythm. Up to now Gilenya's role in these incidents is not clear, the ageny said.
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4SC gets a confidence boost in clinic and stockmarket
20.01.12 Martinsried - SHELTER is responsible for the fact that the stocks of 4SC behaved like a rodeo horse on Thursday. The shares rose in several stages up to 63%, only to settle at a mere 43% rise at the end of the day. SHELTER is a clinical Phase II study with the cancer drug resminostat (http://www.eurobiotechnews.eu/clinical-trials/articledetail/?tx_ttnews[pointer]=2 tx_ttnews[tt_news]=13763 tx_ttnews[backPid]=11527 cHash=c607c07ec0) as a second-line therapy for patients with advanced liver cancer (hepatocellular carcinoma, HCC) which has reached its primary endpoint well ahead of schedule. This open-label, two-arm,international study investigated the safety and efficacy of resminostat both as a monotherapy and in combination with sorafenib. All patients had exhibited radiologically proven tumour progression under first-line therapy with sorafenib prior to study entry. According to the data now presented, the compound managed to halt the further progression of this relatively aggressive cancer in at least 20% of the patients treated and for at least 12 weeks. In 2011 Resminostat already proved its efficacy in patients with non Hodgkin's Lymphoma. Now the hopes are high in Munich that a comprehensive approval of Resminostat is on the horizon.
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Swedish DuoCort Pharma snatched up by US Viropharma
17.11.11 Exton/Helsingborg – A Swedish specialist for improving glucocorticoid replacement therapy has attracted transatlantic attention. DuoCort Pharma AB, based in Helsingborg, was bought by ViroPharma Incorporated, an US-based biopharmaceutical company. ViroPharma paid an upfront of €25 million. In the best case for DuoCorts's former owners, the Americans will pay €97 million in milestones associated with manufacturing, sales thresholds and territory expansion.
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Novartis fails with Phase III osteoporosis drug
16.11.11 Basel/Hervel – It may be the end of Novartis' lucky streak in osteoporosis. While the once a year osteoporosis injection Aclasta (a bisphosphonate) sells well, the Swiss pharma company had to break disastrous news from a three-year Phase 3 trial, Study 2303, conducted by its license partner Nordic Bioscience, assessing an oral formulation of calcitonin (SMC021) in the treatment of post-menopausal osteoporosis. Study 2303 failed to demonstrate a significant difference between treatment groups at three years for the primary endpoint, with no statistically significant treatment effect observed on the reduction of the occurrence of new vertebral fractures.
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Digna Biotech regains rights for inhibitor for systemic skin sclerosis
15.11.11 Madrid/Barcelona – It was a rare example of a partnership between the two competing regions of Castile and Catalonia. Now the alliance between Digna Biotech and ISDIN has come to an end. Digna Biotech announced that it has reached an agreement with ISDIN to regain full rights to Disitertide peptide’s (P144) topical formulation for the therapy of skin conditions.
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GSK launches €36 million life sciences fund for Canada
14.11.11 London – GlaxoSmithKline goes west. The British pharmaceutical company launched the $50-million GSK Canada Life Sciences Innovation Fund that will invest in “early-stage breakthrough research” in health care life science in Canada. It will be operated through SR One, the U.K.-based company’s venture capital arm. SR One invests globally in emerging life science companies. According to GSK, SR One has invested roughly $650 million in more than 140 companies since 1985. Canada has a significant innovation gap , said Paul Lucas, the head of GSK Canada.
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Merck Serono cheers Ablynx up with nanobodies pact
Ghent/Geneva - Ablynx rides the biotech rollercoaster. Only days after US-pharma company Pfizer pulled out of a rheumatoid arthritis pact (http://www.eurobiotechnews.eu/service/start-page/top-news/?no_cache=1 tx_ttnews[tt_news]=13844 tx_ttnews[backPid]=12 cHash=526a165901), the Belgian bipharmaceutical outfit expanded its relationship with Merck Serono. Ablynx entered into a third agreement to discover and develop Nanobodies together with the Swiss against two targets in osteoarthritis. Under the terms of the deal, Ablynx will receive an upfront payment of €20 million payable in two tranches over the next three months. Merck Serono is one of our most valued partners and the innovative and creative deal structure that we have put in place represents a win-win for both parties , said, Ablynx' CEO Edwin Moses.
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inventore vescica biotech, presto 30 organi
CITTA' DEL VATICANO, 10 NOV - Dopo la vescica prodotta in laboratorio, ci sono altri 30 fra organi completi o parziali che nel giro di qualche anno saranno pronti per essere impiantati sull'uomo. Li sta studiando Anthony Atala, pioniere della medicina rigenerativa, che ha esposto il suo lavoro alla conferenza sulle staminali adulte in corso in Vaticano, Promosso dal Pontificio Consiglio per la Cultura. Attualmente stiamo lavorando su 30 diverse linee - ha spiegato l'esperto - oltre alla vescica abbiamo ricreato e impiantato sull'uomo uretra, cartilagine, pelle, vasi sanguigni e altri organi di cui non posso parlare perche' i risultati non sono ancora stati pubblicati.
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Record attendance at BIO-Europe
03.11.11 Düsseldorf – BIO-Europe 2011 in Düsseldorf has again broken all previous records in terms of participants and company numbers. More than 3,000 representatives from 1,800 companies registered for Europe‘s largest partnering event. Svenja Schulze, the Innovation Minister of Germany’s federal state North Rhine-Westphalia (NRW) opened the meeting on October 31 at the fairgrounds in Düsseldorf. „BIO-Europe creates new opportunities – for the participating companies and therefore for the cluster in NRW,“ said the politician. Biotechnology can provide solutions for tomorrow’s problems: „Biotechnology is important per se“, said Schulze. Bernward Garthoff, manager of the NRW biotech cluster BIO.NRW, added: „BIO-Europe is a landmark event on the calendars of business development executives from North Rhine- Westphalia. It is a perfect platform to raise our international profile and forge stronger links with the innovators from around the world.“
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