Veldig spennende om bl.a utregning av LOA for ulike sykdommer. Mulig den har blitt postet før.
Studie publisert i nature review drug discovery som har undersøke konsekvensen av breakthrough therapy designation:
Oppsumert:
In summary, among novel anticancer agents approved by the FDA between 2013 and 2015, we found that drugs with breakthrough designation reached the market more quickly than those without the designation owing to faster pre-market development and review times. We also found that considerably more breakthrough-designated drugs were approved via the accelerated approval pathway than non-designated drugs, and that breakthrough-designated drugs were more often approved on the basis of Phase I or Phase II trials. Thus, we conclude that the breakthrough designation is helping to speed patient access to innovative new cancer treatments. We also conclude that, owing to the large number of accelerated approvals among breakthrough-designated drugs, the FDA is more willing to take measured risks in approving drugs that show early evidence of substantial improvement over available therapy.
Ikke akkurat noen bombe, men alltids greit å få bekreftende signaler på at breakthrough therapy designation faktisk har en positiv effekt.
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Morsom bivirkning. Noen som trenger? 
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Sei fra når den gir MEIR hår… 
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Omtrent som den bivirkningen til den hjertemedisinene… som senere ble kjent som viagra;)
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Det er en fantastisk historie. 
Kunne trenge den ja… 
Synes Medistim begynner å se spennende ut snart… Noen med innsikt om vi kan vente oss fortsatt økte inntekter (som Q1-17 vs. Q1-16)?
Noen tanker rundt Immune Pharmaceuticals?
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Er vel en ganske fin kjøps anledning nå? Ned en del siste tiden
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Oasmia Pharmaceutical AB
Inside information
Oasmia Pharmaceutical receives market approval for its Anti-Cancer Drug Doxophos® in Russia
Uppsala, Sweden, 2017-08-08 08:40 CEST (GLOBE NEWSWIRE) – Oasmia Pharmaceutical AB (NASDAQ: OASM), a developer of a new generation of drugs within human and veterinary oncology, announced today that it has received marketing approval of Doxophos in Russia, a key milestone following the recently established relationship with Hetero Group, its new marketing and distribution partner.
Doxophos has been approved for use in the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, chronic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma, multiple myeloma, osteogenic sarcoma, Ewing’s sarcoma, soft tissue sarcoma, neuroblastoma, rhabdomyosarcoma, Wilms’ tumor, breast carcinoma, endometrial cancer, ovarian carcinoma, germ cell tumors, prostatic carcinoma, lung cancer, gastric carcinoma, head and neck cancer and thyroid carcinoma.
Doxophos is a hybrid and novel nanoparticle formulation of doxorubicin, one of the most commonly used anti-cancer substances in the world, well-recognized for its treatment of lung, breast and prostate cancer, among others. Doxorubicin is the active substance in the prominent oncology family of brands including Adriamycin® and Doxil®, totaling an estimated market value of $800 million USD in 2015 and expected to reach $1.4 billion by 2024.
As is its current practice with Paclical, Oasmia’s leading and previously commercialized cancer treatment product, Hetero Group will be responsible for the marketing and distribution of Doxophos in Russia.
“We are pleased that we were able to follow through on our previously stated objective of commercializing Doxophos, a product that we believe represents important high growth market opportunity, in Russia” said Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical AB. ”We are also confident that this product will add significant value to the marketing and distribution efforts of Hetero, our new partner with whom we look forward to work in these regions and presumably others in the future.”
Notes to editors:
About Doxophos
Doxophos is a novel nanoparticle formulation of doxorubicin in combination with Oasmia’s patented technology XR17. Doxorubicin is one of the oldest and most widely used anti-cancer substances in the world and is used to treat a variety of different forms of cancer such as acute lymphoblastic leukemia, acute myeloblastic leukemia, chronic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma, multiple myeloma, osteogenic sarcoma, Ewing’s sarcoma, soft tissue sarcoma, neuroblastoma, rhabdomyosarcoma, Wilms’ tumor, breast carcinoma, endometrial cancer, ovarian carcinoma, germ cell tumors, prostatic carcinoma, lung cancer, gastric carcinoma, head and neck cancer and thyroid carcinoma.
About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops, manufactures, markets and sells new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ Capital Markets (OASM.US), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ Stockholm (OASM.ST).
For more information:
Julian Aleksov, Executive Chairman
Tel: +46 18 50 54 40
E-mail: [email protected]
Attachments:
Doxophos Russia Approval - Final.pdf
This news release was distributed by GlobeNewswire, www.globenewswire.com – a Nasdaq company
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http://www.edisoninvestmentresearch.com/research/report/orexo21221/preview/
Legit? Altså, jeg vet det er en bestilling, men noen som kjenner selskapet?
Mye rødt også i biotek i dag.
Opprettet en ny tråd for CRNO-B:
Noen som har kunnskap om Cereno Scientific?
Ser den har gått ca 40% opp siden 1. august uten nyheter, noe på gang?
Svart deg litt nå.