España
en bionvest pintan muy bien a ANTH
eso sí, a tener en cuenta q su cartera trader dice "designed to take advantage of short-term opportunities throughout the biotech sector" ... "the time frame for most investments will be weeks to months"
ja! a -58.2% este año, en más de una están bien pillados!!
por si a alguien le interesa la compañia
http://www.investopedia.com/articles/markets/022116/5-things-know-buying-anthera-pharmaceuticals-anth.asp?partner=YahooSA
ANTH
con un -40% en el sector se esta pillado en todas partes
AMGN
El impacto de una noticia así es limitado en una biotech ya consolidada, pero no deja de ser una buena noticia...
Amgen and UCB announce positive top-line results from phase 3 study evaluating Romosozumab in men with osteoporosis
http://wwwext.amgen.com/media/news-releases/2016/03/amgen-and-ucb-announce-positive-top-line-results-from-phase-3-study-evaluating-romosozumab-in-men-with-osteoporosis/
- Study Met Primary and All Secondary Endpoints
- Results Add to Growing Body of Positive Late-Stage Data Evaluating Efficacy and Safety of Romosozumab in Patients With Osteoporosis
Has leído esto? Viene bastante a cuento de lo comentabáis el viernes. Desconozco quien es la Dra Susan O'Brien. En todo caso, con solo 17 pacientes los datos hay que tomarlos con cautela:
Novel BTK, PI3K Inhibitors on Horizon for Relapsed CLL
TGTX
Gracias, no, no había leído el artículo. Es un buen resumen de la situación de las nuevas moléculas para CLL y donde se encuentra TGR1202. Prometedor pero no exento de riesgo
Horizon Pharma plc Receives Health CANADA Approval for RAVICTI(R) (glycerol phenylbutyrate) Oral Liquid for the Treatment of Urea Cycle Disorders in Patients Two Years of Age and Older
DUBLIN, IRELAND -- (Marketwired) -- 03/21/16 -- Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that Health Canada has issued a Notice of Compliance (NOC) for RAVICTI® (glycerol phenylbutyrate) Oral Liquid for use as an adjunctive therapy for chronic management of adult and pediatric patients two years of age and older with Urea Cycle Disorders (UCDs).
Last month Horizon announced that the Therapeutic Products Directorate of Health Canada had determined that RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid is eligible for data protection as it is an "innovative drug" as defined by section C.08.004.1 of the Food and Drug Regulations. Based on the approval, RAVICTI will be added to the Register of Innovative Drugs and receive data protection for a term of up to eight years from the date of the issuance of the NOC.
UCDs, which impact approximately 200 people in Canada, are inherited metabolic diseases caused by a deficiency of one of the enzymes or transporters that constitute the urea cycle. The urea cycle involves a series of biochemical steps in which ammonia, a potent neurotoxin, is converted to urea, which is excreted in the urine. UCD patients may experience episodes where they get symptoms from the ammonia in their blood being excessively high -- called hyperammonemic crises -- which may result in irreversible brain damage, coma or death. UCD symptoms may first occur at any age depending on the severity of the disorder, with more severe defects presenting earlier in life.
"The approval of RAVICTI in Canada is a significant milestone for Horizon Pharma as it continues to expand the accessibility of important medicines to patients with unmet treatment needs," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "I commend Health Canada for acknowledging the importance of this innovative medicine and the company intends to rapidly pursue funding and reimbursement. Horizon will soon be filing clinical and cost effectiveness submissions to the respective health technology assessment agencies in Canada and engaging with public and private drug plans to ensure that patients with Urea Cycle Disorders who may benefit from treatment are able to access RAVICTI as quickly as possible."
Additionally, Horizon will provide RAVICTI via compassionate access until the end of 2016 for those without access to private or public insurance. It is anticipated that most private drug plans will provide coverage as soon as RAVICTI is available inCanada. Due to the standard six to seven month health technology assessment review process, it is anticipated that public drug plan coverage may not be available until the end of 2016.
NVAX. Dejo aqui un interesantisimo post usano sobre gestion de los biorreactores a la hora de fabricar. Muy interesante. Similar post fue subido hara cosa de un dos años, lo recuerdo porque fue cuando aprendi (a ver si lo digo bien), que si bien para el RSV hace falta solo UN biorreactor, para la cuadrivalente son necesarios CUATRO, uno por cepa.
“You multiply the latest yield of one 1000L bioreactor by the number of 1000L bioreactors they have on premises. That would be your output in mcg of antigen in 11 weeks (since it takes 11 weeks per batch). If it’s RSV you’re making, and the dose is 90 mcg, then you divide the yield by 90 to get the number of RSV doses per 11 weeks. If it’s quadrivalent seasonal flu, and since NVAX uses 15 mcg/dose/strain, then that’s 60 mcg/shot. You divide the yield by 60. However, in reality, since each batch can produce one type of strain at a time, and if you have 4 bioreactors, then the yield is bla, bla, bla. It’s very simple math, if you know how many bioreactors they have and the size of each bioreactor. This is easy info to obtain. Just ask NVAX. But, keep in mind that NVAX has plenty of floor space. When they need to increase production capacity, all they have to do is buy more bioreactors and filters. The only secret that NVAX guards is the yield of one batch from one 1000L Xcellerex bioreactor. That yield differs from one flu strain to another, and from one virus type to another. Also, the yield is being improved over time (That’s one of the reasons for the optimization work). NVAX is in a position now to easily increase capacity to 50 million pandemic flu doses within 6 month. That’s not at all standing in the way of NVAX and BARDA agreeing on something. The contract with BARDA is for 50 million pandemic flu doses, not seasonal. For seasonal (quadratic) the dose is 60 mcg (15*4). For pandemic, since it would be only one strain, the dose would be perhaps 45 mcg if non-adjuvanted, and perhaps 6 mcg if adjuvanted. The only thing delaying resumption of the flu contract with BARDA is because NVAX keeps perfecting the manufacturing process and keeps improving on the design of the flu vaccine. You can’t start (you shouldn’t start) flu phase 3 until you have made up your mind to stop making improvements and stick with what you have. Stan will tell us in 2-6 weeks.”
VRX
Halted, news pending
