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EMA accepts Praluent (alirocumab) MAA for review

Regeneron and Sanofi today announced that the European Medicines Agency has accepted for review the Marketing Authorization Application for Praluent (alirocumab). Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is intended for the treatment of patients with hypercholesterolemia.

12 Jan 2015

Hikma prepares to launch colchicine 0.6mg capsules in the US market

Hikma Pharmaceuticals PLC, the fast growing multinational pharmaceutical group, today notes that Takeda Pharmaceuticals U.S.A. Inc. has been unsuccessful in appealing the decision by the United States District Court for the District of Delaware to deny Takeda's motion for a preliminary injunction in relation to the distribution of Hikma's colchicine 0.6mg capsules for the prophylaxis of gout flares in adults.

11 Jan 2015

Nuo signs licensing and distribution agreement with Rohto for Aurix wound care system

Nuo Therapeutics, Inc., a pioneer in biodynamic therapies, today announced that it has signed an exclusive licensing and distribution agreement for the Aurix System with Rohto Pharmaceutical Co., Ltd., one of Japan’s leading pharmaceutical, health and wellness companies.

9 Jan 2015

Crown Bioscience to double capacity of PRECOS facility, rename UK site

Crown Bioscience, Inc., a leading global drug discovery and development service company, has announced that it will double the capacity of the recently acquired PRECOS (Preclinical Oncology Services Limited) facility and will rename the site Crown Bioscience UK Ltd.

9 Jan 2015

Two new ODYSSEY trials meet primary efficacy endpoints

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that two new ODYSSEY trials, which are the first Phase 3 trials to assess alirocumab administered every four weeks, met their primary efficacy endpoints.

9 Jan 2015

Scientists discover potential solution to antibiotic resistance

A newly developed technique for screening microbes has led to the discovery of a powerful new antibiotic that can easily kill severe infections in mice, without causing side effects.

8 Jan 2015

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for HIV-related Kaposi's Sarcoma

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial evaluating the safety and efficacy of aldoxorubicin for the treatment of Kaposi's Sarcoma (KS) in HIV-infected patients.

8 Jan 2015

FDA approves RYTARY for Parkinson's disease treatment

Impax Pharmaceuticals, a division of Impax Laboratories, Inc., today announced that the U.S. Food and Drug Administration approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication.

8 Jan 2015

EMA recommends orphan designation to Magnus Growth's novel therapy for placental insufficiency

Magnus Life Science today announces that the European Medicines Agency's Committee for Orphan Medicinal Products has reached a positive decision on recommending orphan designation to Magnus Growth's novel therapy to treat placental insufficiency.

8 Jan 2015

BMI SYSTEM joins Veeva Network Partner Program

Veeva Systems and BMI SYSTEM today announced BMI SYSTEM joins the Veeva Network Partner Program. The companies also announced Veeva Network is now BMI SYSTEM's preferred customer master solution.

8 Jan 2015

Debiopharm receives FDA Fast Track designation for anti-infectious agent Debio 1450

Debiopharm Group, a Swiss-based global biopharmaceutical company, today announced that the US Food and Drug Administration granted Fast Track designation to its anti-infectious agent Debio 1450, a highly potent antibiotic specifically active against all Staphylococcus species.

8 Jan 2015

Carl Zeiss Meditec to invest in Oraya Therapy for treatment of wet AMD

Carl Zeiss Meditec AG and Oraya Therapeutics, Inc. jointly announced today that the companies have entered into a collaboration agreement under which Carl Zeiss Meditec will provide funding to Oraya over a period of up to two years for the implementation of Oraya’s growth strategy, and in turn receive rights in the company reaching up to a majority stake after two years.

8 Jan 2015

Ferrer partners with Cipher Pharmaceuticals to bring Ozenoxacin to the Canadian market

Ferrer, a privately-held Spanish pharmaceutical company, today announces that it has licensed commercialisation rights for Ozenoxacin one per cent cream in Canada to Cipher Pharmaceuticals Inc.

8 Jan 2015

Healthplex & Nutraceutical China 2015 to be held in Shanghai, China

From 24-26 June 2015, Healthplex & Nutraceutical China (HNC) will return to Shanghai, China, to serve the Asian health industry. This year, the event will take place on a larger scale, with more exhibitors and business opportunities for those in attendance.

7 Jan 2015

Kyowa Hakko Kirin and Syndax sign agreement to develop entinostat in Japan and Korea

Kyowa Hakko Kirin Co., Ltd., (Headquarters: Chiyoda-ku, Tokyo; president and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") and Syndax Pharmaceuticals, Inc., (Waltham, Mass.; president and CEO: Arlene M. Morris, "Syndax") today jointly announced that the companies have entered into a license agreement for the exclusive rights to develop and commercialize entinostat in Japan and Korea.

7 Jan 2015

Soligenix's SGX301 receives FDA 'Fast Track' designation for CTCL treatment

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received "Fast Track" designation from the US Food and Drug Administration.

7 Jan 2015

ContraVir granted Type B meeting with FDA to discuss proposal for FV-100 Phase 3 trial

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has been granted a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss its proposal for the design of a Phase 3 trial of ContraVir's lead antiviral candidate, FV-100.

7 Jan 2015

Novel drug delivery technique uses graphene to deliver two anticancer drugs sequentially to cancer cells

An international team of researchers has developed a drug delivery technique that utilizes graphene strips as "flying carpets" to deliver two anticancer drugs sequentially to cancer cells, with each drug targeting the distinct part of the cell where it will be most effective. The technique was found to perform better than either drug in isolation when tested in a mouse model targeting a human lung cancer tumor.

7 Jan 2015

EnGeneIC closes oversubscribed Series B financing

EnGeneIC, Ltd., an emerging biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutics, announced it has completed an oversubscribed $10 million Series B financing.

6 Jan 2015

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer.

6 Jan 2015

Pharmaceuticals News and Research

EMA accepts Praluent (alirocumab) MAA for review

Hikma prepares to launch colchicine 0.6mg capsules in the US market

Nuo signs licensing and distribution agreement with Rohto for Aurix wound care system

Crown Bioscience to double capacity of PRECOS facility, rename UK site

Two new ODYSSEY trials meet primary efficacy endpoints

Scientists discover potential solution to antibiotic resistance

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for HIV-related Kaposi's Sarcoma

FDA approves RYTARY for Parkinson's disease treatment

EMA recommends orphan designation to Magnus Growth's novel therapy for placental insufficiency

BMI SYSTEM joins Veeva Network Partner Program

Debiopharm receives FDA Fast Track designation for anti-infectious agent Debio 1450

Carl Zeiss Meditec to invest in Oraya Therapy for treatment of wet AMD

Ferrer partners with Cipher Pharmaceuticals to bring Ozenoxacin to the Canadian market

Healthplex & Nutraceutical China 2015 to be held in Shanghai, China

Kyowa Hakko Kirin and Syndax sign agreement to develop entinostat in Japan and Korea

Soligenix's SGX301 receives FDA 'Fast Track' designation for CTCL treatment

ContraVir granted Type B meeting with FDA to discuss proposal for FV-100 Phase 3 trial

Novel drug delivery technique uses graphene to deliver two anticancer drugs sequentially to cancer cells

EnGeneIC closes oversubscribed Series B financing

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

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