Search Results for: Other News to Note
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Affymax Crashes on Omontys Recall, Hypersensitivity Data
Though decried as an overreaction by analysts at the time, Affymax Inc.'s intraday share drop earlier this month on reports of mild allergic reactions in a pilot study of erythropoiesis-stimulating agent (ESA) Omontys (peginesatide) turned out to be an omen of bad news to come. (See BioWorld Today, Feb. 15, 2013.) In an announcement released over the weekend, the Palo Alto, Calif.-based firm and partner Takeda Pharmaceutical Co...Piper Jaffray's Somaiya said he estimates an incremental $300By Jennifer Boggs | BioWorld Today | Tuesday, February 26, 2013 -
Other News To Note
In connection, it entered into a loan and security agreement with Biotech Investment Group LLC, relating to the funding of certain tenant improvements, relocation costs, security deposit, portions of rents related to the leased San Diego facility and certain other cash needs...Cangene plans to advance the program in its pipeline with the goal of developing an immune therapeutic for Alzheimer's targeting the toxic form of amyloid beta that is believed to cause the disease...Exelixis Inc., of South SanBioWorld Today | Monday, February 25, 2013 -
Pharma: Other News To Note
The approval will expand Lupin's range of Suprax dosage forms available to treat approved indications in appropriate patients...Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended market approval for Sanofi Pasteur's 6-in-1 pediatric vaccine Hexyon/Hexacima, the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping coughBioWorld Today | Monday, February 25, 2013 -
Other News To Note
Defibrotide will continue to be available to patients under a named patient program...The goal is to modulate the half-life of the therapy to increase efficacy of treatmentBioWorld Today | Friday, February 22, 2013 -
Pharma: Other News To Note
as a first-line agent or concomitantly with other topical ophthalmic drugs in open-angle glaucoma or ocular hypertension...Sucampo's wholly owned subsidiary, Sucampo Pharma Americas Inc., licensed the commercialization rights to Rescula, a BK channel activator, from R-Tech Ueno in 2009...As part of the transaction, Eisai transferred the new drug application for Targretin to Valeant, which assumed responsibility for pursuing the product's regulatory approval in the U.S. Eisai retained its rights toBioWorld Today | Friday, February 22, 2013 -
Pharma: Other News To Note
Ltd., of Seoul, South Korea, entered an agreement to develop and commercialize multiple pre-specified and undisclosed biosimilar candidates...and Europe to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adults with active psoriatic arthritis and for active axial spondyloarthritisBioWorld Today | Thursday, February 21, 2013 -
Pharma: Other News To Note
The approval was based on a liver transplant study showing that Zortress plus reduced tacrolimus led to comparable efficacy and 10mL/min higher renal function as measured by estimated glomerular filtration rate for Zortress compared to standard tacrolimus at 12 monthsBioWorld Today | Wednesday, February 20, 2013 -
Other News To Note
NeurOp is working with Emory to accelerated N-methyl D-aspartate, or NMDA, receptor research in the three-year collaboration...and six other countries under an expanded access program...co-promotion rights for Kineret (anakinra) to Savient Pharmaceuticals Inc., of Bridgewater, N.J. Under the agreement, Sobi will remain responsible for all commercial drug manufacturing, supply, safety and regulatory activities involving Kineret, which is indicated in the U.SBioWorld Today | Wednesday, February 20, 2013 -
Pharma: Other News To Note
patents relating to Exalgo to sell Actavis' 32-mg product beginning May 15, 2014...16 to $2 per share but did not change previously reported non-GAAP results. (See BioWorld Today, Aug. 22, 2008, and March 10, 2009BioWorld Today | Friday, February 15, 2013 -
Other News To Note
The FDA advised the firm to apply for fast-track designation when it submits its IND, which is expected to come in the fourth quarter of 2013...MorphoSys may sublicense the targets to third parties, and is eligible to receive license fees, milestones and royalties on any Ylanthia antibody developed by HeptaresBioWorld Today | Thursday, February 14, 2013 -
Pharma: Other News To Note
Breckenridge launched its abbreviated new drug application (ANDA) prior to patent expiration pursuant to a settlement of patent litigation with Osaka, Japan-based Takeda Pharmaceutical Co...and Takeda Pharmaceuticals North America Inc., which granted Breckenridge and Synthon a license to applicable patents to sell and distribute its ANDABioWorld Today | Thursday, February 14, 2013 -
Pharma: Other News To Note
Reddy expects to settle the offer on Feb. 13, to acquire the remaining shares of OctoPlus under the same terms during a post-closing acceptance period and to terminate the company's listing (Euronext Amsterdam:OCTOBioWorld Today | Wednesday, February 13, 2013 -
Ode on 'Accretion' Urn: Biogen Pays $3.25B for Tysabri Rights
plc to the blockbuster multiple sclerosis (MS) therapy Tysabri (natalizumab) didn't take long for analysts to applaud, though Wall Street traders spent time digesting the $3.25 billion deal, which includes contingent payments...As others took the opportunity to note, Biogen's "strength is commercial execution and smart business development deals," Yee wroteBy Randy Osborne | BioWorld International | Wednesday, February 13, 2013 -
Pharma: Other News To Note
The complaint alleges that Daiichi Sankyo pays female sales employees less than male employees for performing the same work, promotes or advances female sales employees at a slower rate than male sales employees, treats pregnant employees and working mothers of young children adversely compared to other employees and subjects women to other discriminatory terms and conditions of employmentBioWorld Today | Tuesday, February 12, 2013 -
Other News To Note
That drug is designed to treat acute myeloid leukemia, with potential applications in other hematological and solid tumors...Tranzyme Inc., of Research Triangle Park, N.C., said its board decided to explore and evaluate strategic alternatives, including the possibility of a merger, sale or other form of business combination, or other transaction to maximize value to its stockholdersBioWorld Today | Monday, February 11, 2013 -
Pharma: Other News To Note
As part of the settlement, Shire will make a one-time cash payment to Impax of $48 million, which was recorded as a liability on Dec. 31, 2012...Inc., of Woodcliff Lake, N.J., over an abbreviated new drug application filed by Anchen for a generic version of Amitiza (lubiprostone) oral capsules claiming infringement of six patents due to expire between 2020 and 2027...Taro Pharmaceutical Industries Ltd., of Yakum, Israel, and Sun Pharmaceutical Industries Ltd., of Mumbai, India, agreed to terminateBioWorld Today | Monday, February 11, 2013 -
Pharma: Other News To Note
GlaxoSmithKline plc, of London, said it submitted a marketing authorization application to the European Medicines Agency (EMA) for trametinib (ME) as a monotherapy and in combination with dabrafenib (BRAF) for the treatment of adults with unresectable or metastatic melanoma with a BRAFV600 mutation...Ipsen SA, of Paris, and Braintree Laboratories Inc., of Braintree, Mass., said that Eziclen/Izinova (BLI-800) completed the European decentralized registration procedure, giving member states 30 daysBioWorld Today | Friday, February 8, 2013 -
Other News To Note
The CRADA was initiated to complement ongoing R&D work funded previously by a Department of Defense grant to broaden the safety profile of perfluorocarbon-based emulsions to treat traumatic brain injury...In addition to the biochemical effects, VS-5584 also exhibited broad antitumor efficacy, including tumor regression, across multiple human tumor modelsBioWorld Today | Thursday, February 7, 2013 -
Ode on 'Accretion' Urn: Biogen Pays $3.25B for Tysabri Rights
plc to the blockbuster multiple sclerosis (MS) therapy Tysabri (natalizumab) didn't take long for analysts to applaud, though Wall Street traders spent time digesting the $3.25 billion deal, which includes contingent payments...As others took the opportunity to note, Biogen's "strength is commercial execution and smart business development deals," Yee wroteBy Randy Osborne | BioWorld Today | Thursday, February 7, 2013 -
'Safari,' So Good: Africa Tracks to Become Pharma Hot Spot
Other, sub-Saharan countries are at the very beginning...They wouldn't have to do this in a mature market, or in some of the other emerging markets, whether it's about education, or a secure distribution, or even pharmacovigilance, which they will have to build their own systems forBio Perspectives | Wednesday, February 6, 2013
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