Biopharmaceutical News and Research

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Yale, Debiopharm partner to develop and commercialize Debio 1036 for inflammatory diseases

Debiopharm Group, a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, and Yale University, a premier university with a long tradition of both basic and clinically directed biomedical research, announce an exclusive worldwide license agreement concerning the development and commercialization of Debio 1036, a first-in-class inhibitor for autoimmune and inflammatory diseases.

4 May 2011

Nile Therapeutics initiates cenderitide Phase I trial in heart failure

Nile Therapeutics, Inc., a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced dosing of the first patient in a Phase I clinical trial investigating the use of subcutaneous cenderitide.

3 May 2011

Ipsen first quarter sales increase 6.1% to €285.8 million

Ipsen reported today its sales for the first quarter 2011.

3 May 2011

Oragenics announces availability of oral care probiotics for children and adults

Florida-based biopharmaceutical company Oragenics, Inc. has announced that its oral care probiotics for children and adults will be available in Australia and New Zealand through an exclusive agreement with Australian Pharmaceutical Industries, owner of the Priceline pharmacy retail chain, and one of the leading service providers to the pharmacy industry.

3 May 2011

Sanofi Pasteur, EnGen Bio and Dyadic Nederland sign research deal for vaccine development

Dyadic International, Inc., a global biotechnology company focused on the discovery, development, manufacture and sale of enzyme and protein products for the biopharmaceutical, biofuels and industrial enzyme industries, announced today that its research and development subsidiary, Dyadic Nederland B.V., has entered into a research agreement with Sanofi Pasteur, the vaccines division of sanofi-aventis Group, and EnGen Bio, Inc.

3 May 2011

Bioniche Life Sciences opens new livestock vaccine manufacturing facility

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today officially opened its new Animal Health and Food Safety Vaccine Manufacturing Centre at its corporate headquarters in Belleville, Ontario, Canada.

30 Apr 2011

Winner of MDEA Lifetime Achievement Award announced

UBM Canon's Medical Design Excellence Awards has announced the winner of the Medical Design Excellence Awards Lifetime Achievement Award. This award honors an individual whose contributions during a long career have had a demonstrable impact on technological, business, and cultural advancements in medical devices.

30 Apr 2011

Keryx Biopharmaceuticals reports net loss of $6.4 million for first quarter 2011

Keryx Biopharmaceuticals, Inc., a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease, today announced its results for the first quarter ended March 31, 2011.

30 Apr 2011

NeurogesX first quarter revenue is $3.2 million for 2011

NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported results for its first quarter ended March 31, 2011.

30 Apr 2011

MorphoSys reaches second clinical milestone with OncoMed Pharmaceuticals

MorphoSys AG announced today that it has received a milestone payment from OncoMed Pharmaceuticals in connection with the FDA acceptance of an IND for a HuCAL-derived, fully human antibody. The antibody OMP-18R5, which targets the Wnt signaling pathway, will be evaluated in a Phase 1 trial in the US in patients with advanced solid tumors.

29 Apr 2011

FDA approves orphan drug designation for Cytrx’s INNO-206 to treat pancreatic cancer

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that its tumor-targeting pro-drug candidate INNO-206 has been approved for orphan drug designation for the treatment of patients with pancreatic cancer by the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA). CytRx holds the exclusive worldwide development and commercialization rights to INNO-206.

28 Apr 2011

Positive results from Otonomy's OTO-104 Phase 1b study in Meniere's disease

Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced positive data from a Phase 1b study of the company's lead product candidate, OTO-104, in patients with Meniere's disease.

28 Apr 2011

Positive results from Shire's Vyvanse clinical trial in schizophrenia

Shire plc, the global specialty biopharmaceutical company, today announced positive results from a signal-finding study of Vyvanse(R) Capsules assessing its effect in a prospective examination of adults with negative symptom predominant schizophrenia.

28 Apr 2011

FDA grants orphan drug status to Provectus' PV-10 for liver cancer treatment

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has received orphan drug designation by the U.S. Food and Drug Administration for Rose Bengal, the active ingredient in its novel oncology drug PV-10, for the treatment of hepatocellular carcinoma, the most common form of primary liver cancer.

27 Apr 2011

Caliber opens world's largest plant-made pharmaceutical facility in Bryan

Caliber Biotherapeutics, a fully-integrated biopharmaceutical company, announced the opening of the world's largest plant-made pharmaceutical manufacturing facility in Bryan, Texas, with the capability of producing 10-100 million doses of infectious vaccines per month, and hundreds of thousands of doses of protein biotherapeutics such as monoclonal antibodies.

26 Apr 2011

Kadmon Pharmaceuticals and Nano Terra announce worldwide licensing agreement

Kadmon Pharmaceuticals LLC, and Nano Terra, Inc., today announced that they have entered into an agreement under which Kadmon has been granted a perpetual, worldwide exclusive license to three novel, clinical-stage product candidates owned by Nano Terra as well as rights to Nano Terra’s drug discovery platform, Pharmacomer™ Technology. The product candidates and technology platform will be transferred to a newly formed joint venture, NT Life Sciences (“NT Life”), co-owned by Kadmon and Nano Terra, which will act as the licensor and recipient of any licensing or royalty fees subject to the agreement. Terms of the agreement were not disclosed.

25 Apr 2011

MonoSol Rx, KemPharm enter development and commercialization partnership for ADHD prodrug

MonoSol Rx, LLC, the developer of PharmFilm® drug delivery technology, today announced that the Company has entered into a development and commercialization partnership with KemPharm, a biopharmaceutical company focused on the discovery and development of new, safer therapies for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), pain, and cardiovascular disease.

25 Apr 2011

Molecular Templates to present preclinical data of ETB platform technology at 5th RNAi and miRNA World Congress

Molecular Templates, Inc., a biopharmaceutical company focused on the discovery and development of a new class of small biologic therapies called Engineered Toxin Bodies (ETB), announced today that it will present preclinical data in a poster presentation at the 5th Annual RNAi and miRNA World Congress in Boston, MA during April 26-27, 2011.

22 Apr 2011

USPTO issues patent to Oragenics ProBiora3 for oral care

Florida-based biopharmaceutical company Oragenics, Inc. announced today the issuance of patent number 7931892 from the United States Patent and Trademark office for ProBiora3, a proprietary blend of naturally occurring oral bacteria shown to produce a wide range of oral care benefits.

22 Apr 2011

Repligen anticipates 30% increase in total revenues for 2011

Repligen Corporation today announced preliminary financial results for fiscal year 2011 which ended March 31, 2011. Total revenue for the year is expected to be $27.3 million compared to $21.0 million in the prior fiscal year, an increase of 30%.

21 Apr 2011

Biopharmaceutical News and Research

Yale, Debiopharm partner to develop and commercialize Debio 1036 for inflammatory diseases

Nile Therapeutics initiates cenderitide Phase I trial in heart failure

Ipsen first quarter sales increase 6.1% to €285.8 million

Oragenics announces availability of oral care probiotics for children and adults

Sanofi Pasteur, EnGen Bio and Dyadic Nederland sign research deal for vaccine development

Bioniche Life Sciences opens new livestock vaccine manufacturing facility

Winner of MDEA Lifetime Achievement Award announced

Keryx Biopharmaceuticals reports net loss of $6.4 million for first quarter 2011

NeurogesX first quarter revenue is $3.2 million for 2011

MorphoSys reaches second clinical milestone with OncoMed Pharmaceuticals

FDA approves orphan drug designation for Cytrx’s INNO-206 to treat pancreatic cancer

Positive results from Otonomy's OTO-104 Phase 1b study in Meniere's disease

Positive results from Shire's Vyvanse clinical trial in schizophrenia

FDA grants orphan drug status to Provectus' PV-10 for liver cancer treatment

Caliber opens world's largest plant-made pharmaceutical facility in Bryan

Kadmon Pharmaceuticals and Nano Terra announce worldwide licensing agreement

MonoSol Rx, KemPharm enter development and commercialization partnership for ADHD prodrug

Molecular Templates to present preclinical data of ETB platform technology at 5th RNAi and miRNA World Congress

USPTO issues patent to Oragenics ProBiora3 for oral care

Repligen anticipates 30% increase in total revenues for 2011

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