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Zeftera problems weigh down Basilea
Specialist Swiss pharma company Basilea has announced a doubling of its revenues in 2009, thanks to the launch of its new eczema treatment Toctino.Revenues and other income rose to CHF 26.8 million compared to CHF 12.0 million in 2008. Toctino was launched...
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Dendreon: To Short or Not to Short?
I "made my bones" with a bullish and complicated call on Dendreon (DNDN) several years ago, predicting it would get a thumbs up from an FDA panel for its advanced prostate cancer treatment Provenge.Only one other biotech analyst with a public audience...
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Dendreon - To Short or Not to Short
I "made my bones" with a bullish and complicated call on Dendreon (DNDN) several years ago, predicting it would get a thumbs up from an FDA panel for its advanced prostate cancer treatment Provenge, Only one other biotech analyst with a public audience...
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Basilea reports 2009 financial results
- Basilea Pharmaceutica Ltd.(SIX: BSLN) announces 2009 financial results reflecting first full year of Toctino sales in its initial launch countries, and focused investments to support phase III development of isavuconazole globally and U.S. alitretinoin ...
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GSK's TYKERB Receives Accelerated Approval For First-line Combination Treatment Of Hormone Receptor Positive,
Breast Cancer News Main Category: Breast Cancer Also Included In: Regulatory Affairs / Drug Approvals; Clinical Trials / Drug Trials; Pharma Industry / Biotech Industry email to a friend printer friendly view / write opinions Current Article Ratings:...
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Repros Receives Guidance from FDA Regarding Continued Development of Androxal in Hypogonadal Men
- Repros Therapeutics Inc.(NasdaqCM:RPRX) today announced that the Company and its consultants participated in a teleconference with the Division of Reproductive and Urologic Products of the FDA on January 25, 2010. The primary purpose of the meeting...
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Repros Receives Guidance From FDA Regarding Continued Development Of Androxal(R) In Hypogonadal Men
Repros Therapeutics Inc.(NasdaqCM:RPRX) announced that the Company and its consultants participated in a teleconference with the Division of Reproductive and Urologic Products of the FDA on January 25, 2010. The primary purpose of the meeting was to...
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Repros Receives Guidance From FDA Regarding Continued Development Of Androxal(R) In Hypogonadal Men
Repros Therapeutics Inc.(NasdaqCM:RPRX) announced that the Company and its consultants participated in a teleconference with the Division of Reproductive and Urologic Products of the FDA on January 25, 2010. The primary purpose of the meeting was to...
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EMEA validates NicOx's naproxcinod marketing authorisation application
NicOx SA announced that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for naproxcinod, which was submitted through the centralized procedure in December 2009.NicOx is seeking approval for an indication...
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Duke University publishes research in biopharmaceuticals
Data detailed in 'Statistical assessment of biosimilar products' have been presented.According to recent research from the United States, 'Biological products or medicines are therapeutic agents that are produced using a living system or organism. Access...
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Repros Receives Guidance from FDA Regarding Continued Development of Androxal in Hypogonadal Men
THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc.(NasdaqCM: RPRX) today announced that the Company and its consultants participated in a teleconference with the Division of Reproductive and Urologic Products of the FDA on January 25, 2010...
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Repros Receives Guidance from FDA Regarding Continued Development of Androxal in Hypogonadal Men
THE WOODLANDS, Texas-- (BUSINESS WIRE) -- (NasdaqCM:RPRX) today announced that the Company and its consultants participated in a teleconference with the Division of Reproductive and Urologic Products of the FDA on January 25, 2010.The primary purpose...
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NicOx announces EMEA validation of naproxcinod MAA
announces EMEA validation of naproxcinod MAA submission Bookmark this site Latest announces EMEA validation of naproxcinod MAA submission Friday 22nd January 2010 today announced that the European Medicines Agency (EMEA) has validated the...
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Novartis oral MS therapy FTY720 shows reduced risk of confirmed disability progression
rom TRANSFORMS and FREEDOMS studies show significant efficacy in reducing relapses, disability progression and MRI lesions in MS26 Jan 2010 - Results of the TRANSFORMS] and FREEDOMS studies, the two pivotal Phase III clinical trials with oral FTY720 (fingolimod...
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NicOx - EMEA Validation of Naproxcinod MAA Submission
- www.nicox.com - NicOx S.A.(NYSE Euronext Paris: COX) today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for naproxcinod, which was submitted through the centralized procedure in...
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NicOx announces EMEA validation of naproxcinod MAA submission
-NicOx S.A.(NYSE Euronext Paris: COX) today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for naproxcinod, which was submitted through the centralized procedure in December 2009. NicOx...
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FDA warning on widely used drug against obesity
A widely known anti-obesity drug, Sibutramine, has come under the scanner of the US regulatory body, (FDA), which has suggested that patients with a history of high-risk diseases should avoid it.The (EMEA) has already suspended its usage,...
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NicOx announces EMEA validation of naproxcinod MAA submission
NicOx today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorisation Application (MAA) for naproxcinod, which was submitted through the centralized procedure in December 2009.NicOx is seeking approval for an...
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Consumer Advocates Petition FDA to Ban Fibromyalgia Drug
Public Citizen, a Washington, DC-based nonprofit public health advocacy organization, petitioned the Food and Drug Administration (FDA) on Jan 20 to remove the drug Savella (milnacipran) from the market immediately.Savella was the third drug after...
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Novartis oral MS therapy shows reduced risk of confirmed
Results of the TRANSFORMS[1] and FREEDOMS[2] studies, the two pivotal Phase III clinical trials with oral FTY720 (fingolimod), have been published in The New England Journal of Medicine, providing comprehensive evidence to support the efficacy and safety...
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NicOx announces EMEA validation of naproxcinod MAA submission
Let the jobs come to you!NicOx S.A! (NYSE Euronext Paris: COX) today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for naproxcinod, which was submitted through the centralized...
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NicOx receives EMEA approval for naproxcinod MAA
NicOx S.A.(NYSE Euronext Paris: COX) today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for naproxcinod, which was submitted through the centralized procedure in December 2009. NicOx...
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NicOx SA (NCOX.F) Announces European Medicines Evaluation Agency Validation Of Naproxcinod MAA Submission
- Highlighted Links www.nicox.com NicOx S.A.(NYSE Euronext Paris: COX) today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for naproxcinod, which was submitted through the centralized...
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Novartis oral MS therapy FTY720 shows reduced risk of confirmed disability progression as published in New Eng
Let the jobs come to you!Combined data from TRANSFORMS and FREEDOMS studies show significant efficacy in reducing relapses, disability progression and MRI lesions in MS In FREEDOMS, FTY720 0.5 mg dose reduced the risk of 3-month and 6-month confirmed...
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EU agency urges ban on Abbott diet drug
-0400 (Reuters Health) * EMEA tells doctors to stop prescribing sibutramine * FDA says drug raises heart risks for some * Abbott shares down 1.2 pct By Lisa Richwine WASHINGTON (Reuters) - European authorities urged a halt to sales of an Abbott...
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