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EC adopts CHMP recommendation to change terms of marketing authorisation for Ruconest
Pharming Group announced that the European Commission adopted the CHMP recommendation to include the treatment of HAE attacks in adolescents with HAE and to remove the requirements for rabbit IgE testing that formed part of the EU label for RUCONEST.
Drug Research > Drug Delivery > News
Lumos Pharma raises $34m in Series B financing
Lumos Pharma, a biotechnology company focused on developing therapeutics for orphan diseases, has completed a $34m Series B financing.
Drug Research > Drug Delivery > News
XBiotech's Xilonix marketing application granted accelerated review in Europe
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted accelerated review for marketing authorization of XBiotech's Xilonix true human monoclonal (IgG1k) antibody to treat advanced colorectal cancer.
Drug Research > Drug Delivery > News
Bristol-Myers wins positive CHMP opinion for Opdivo in combination with Yervoy to treat advanced melanoma
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol-Myers Squibb's Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Drug Research > Drug Delivery > News
Taiho’s TAS-102 meets primary endpoint of improving overall survival in phase III study in patients with refractory mCRC
Taiho Pharmaceutical Co., Ltd. of Tokyo announced on April 1 results from its Phase III TERRA study on its oral combination anticancer drug TAS-102 (product name in Japan and the US LONSURF, nonproprietary names: trifluridine (FTD) and tipiracil (TPI)) in Asian(China, South Korea and Thailand) patients with refractory metastatic colorectal cancer (mCRC).
Drug Research > Drug Delivery > News
Humanwell Healthcare and PuraCap Pharmaceutical to buy Epic Pharma
Humanwell Healthcare Group and PuraCap Pharmaceutical have entered into a definitive agreement to acquire 100% of the membership interests of Epic Pharma, LLC of Laurelton, NY for $550m.
Drug Research > Drug Delivery > News
EMA validates Bristol-Myers Squibb's application for expanded use of Opdivo cancer drug
By PBR Staff Writer
The European Medicines Agency (EMA) has validated Bristol-Myers Squibb's application, called a type II variation, seeking approval of Opdivo (nivolumab) to treat patients with classical Hodgkin lymphoma (cHL) after prior therapies.
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Herantis Pharma secures European orphan designation of CDNF to treat ALS
The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on the application of Herantis Pharma for orphan drug designation of recombinant human Cerebral Dopamine Neurotrophic Factor (CDNF) for treatment of amyotrophic lateral sclerosis (ALS).
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Mylan launches generic Ultram extended-release tablets in US
Mylan announced the US launch of Tramadol Hydrochloride Extended-release Tablets USP, 100 mg, 200 mg and 300 mg, which is the generic version of Valeant's Ultram Extended-release Tablets.
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Synairgen unveils positive results from ongoing collaboration with Pharmaxis
Synairgen announced positive results from its ongoing collaboration with Pharmaxis (ASX: PXS) to develop a lysyl oxidase type 2 enzyme (LOXL2) inhibitor as a novel treatment for the fatal lung disease idiopathic pulmonary fibrosis (IPF).
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Evotec spins off auto-immune disease company as Topas Therapeutics
Evotec announced the formation of a spin-off company in the field of nanoparticle-based therapeutics to treat immunological disorders.
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LEO Pharma gets scientific approval of Enstilar to treat Psoriasis in EU
LEO Pharma has received scientific approval of Enstilar (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) for the treatment of psoriasis vulgaris in patients 18 years of age or older.
Drug Research > Drug Delivery > News
PixarBio unveils USFDA OPD submission of NR-SCI for orphan drug designation for spinal cord injury
PixarBio has filed an application with the US FDA Office of Orphan Products Development, for orphan drug status of its NeuroRelease SCI (NR-SCI) a novel drug candidate for the treatment of Spinal Cord Injury (SCI).
Drug Research > Drug Delivery > News
New Cancer Drugs Fund provides faster access to effective cancer treatments
New arrangements for the Cancer Drugs Fund (CDF), approved today by NICE’s Board, will see patients benefitting as promising new and innovative treatments are considered earlier.
Drug Research > Drug Delivery > News
Repros activates process for securing marketing authorization for enclomiphene
Repros Therapeutics has formally activated the process for obtaining marketing authorization for enclomiphene in the treatment of secondary hypogonadism by the European Medicines Agency (EMA).
Drug Research > Drug Delivery > News
136-150 of 2292 results