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IBI initiates Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090

Icon Bioscience, Inc., (IBI), a privately held biopharmaceutical company that specializes in the development and commercialization of novel ophthalmic pharmaceuticals announced today that it has initiated its Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090 in patients undergoing cataract surgery.

6 Jan 2010

Laureate Pharma, Selexis SA collaborate to provide streamlined access to complementary contract services

Laureate Pharma, Inc. a US based biopharmaceutical contract manufacturing organization and Selexis SA, a Swiss based contract developer of high performance production cell lines, jointly announced today their continued collaboration via a joint-marketing relationship. This expanded relationship provides streamlined access to a set of highly complementary contract services.

6 Jan 2010

ARYx Therapeutics receives guidance in writing from FDA on tecarfarin

ARYx Therapeutics, Inc., a biopharmaceutical company, today announced that is has received guidance in writing from the U.S. Food and Drug Administration (FDA) confirming that the existing development pathway remains acceptable to seek regulatory approval of ARYx’s novel anticoagulant agent, tecarfarin (ATI-5923).

5 Jan 2010

Elusys Therapeutics signs contract to complete the final development of Anthim

Elusys Therapeutics, Inc. (Elusys), a privately-held biopharmaceutical company, announced today that it has signed a contract potentially totaling up to $143 million to complete the final development, commercial manufacturing and licensure of Anthim, the company's late stage anthrax therapeutic.

5 Jan 2010

Dicerna Pharmaceuticals and Kyowa Hakko Kirin sign research collaboration and license agreement

Dicerna Pharmaceuticals, Inc., (Dicerna) a second generation RNA interference (RNAi) company developing novel therapeutics utilizing its proprietary Dicer Substrate Technology™ and Dicer Substrate siRNA (DsiRNA) molecules, and Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin), one of Japan's leading biopharmaceutical companies, announced today that the two companies have entered into a research collaboration and license agreement for the research, development and commercialization of drug delivery systems and DsiRNA pharmaceuticals for therapeutic targets in oncology.

4 Jan 2010

Final results of Maxygen's modified "Dutch Auction" tender offer announced

Maxygen, Inc., a biopharmaceutical company focused on the development of improved versions of protein drugs, today announced the final results of its modified "Dutch Auction" tender offer, which expired at 5:00 p.m., New York City time, on December 23, 2009.

31 Dec 2009

Santarus submits rifamycin SV MMX IND to the FDA

Santarus, Inc., a specialty biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to begin a Phase III clinical program evaluating rifamycin SV MMX® in patients with travelers’ diarrhea.

30 Dec 2009

VIVUS submits a NDA to the FDA for obesity drug Qnexa

VIVUS, Inc., a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

30 Dec 2009

NeurAxon closes the sale of $8.75 million of unsecured subordinated convertible debentures

NeurAxon, Inc., a development-stage pharmaceutical company that is designing and developing next-generation pain therapeutics targeting neuronal nitric oxide synthase (nNOS), today announced that it has closed the sale of approximately $8.75 million of unsecured subordinated 2.0% convertible debentures that are convertible under specified circumstances into existing class B preferred shares.

29 Dec 2009

Tego Biosciences sells intellectual property portfolio to Luna Innovations

Arrowhead Research Corporation today announced that its wholly owned subsidiary, Tego Biosciences, has completed a definitive asset purchase agreement for the sale of its non-cash intellectual property (IP) to Luna Innovations, Inc., a developer and manufacturer of new-generation products that include pharmaceutical nanomedicines

29 Dec 2009

SVA submits the first clinical trial application for HFMD vaccine in China

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has filed the application with China's State Food and Drug Administration (SFDA) to commence a human clinical trial for its vaccine against human enterovirus 71 (EV 71), which causes hand, foot, and mouth disease (HFMD). This is the first clinical trial application for HFMD vaccine submitted in China.

28 Dec 2009

Oxford Outcomes becomes a member of SAFE-BioPharma Association

Oxford Outcomes, an international health outcomes consultancy, has become a member of SAFE-BioPharma Association, the non-profit association that created and manages the global SAFE-BioPharma® digital identity and signature standard for the pharmaceutical and healthcare industries.

24 Dec 2009

Orexigen Therapeutics' Compensation Committee approves inducement grants

Orexigen(R) Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that on December 23, 2009 the Compensation Committee of the Company's Board of Directors approved the grant of inducement stock options to purchase a total of 64,000 shares of common stock to two new employees.

24 Dec 2009

Synta Pharmaceuticals initiates STA-9090 Phase 2 clinical trial for GIST

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it is initiating a Phase 2 clinical study of STA-9090 in patients with advanced gastrointestinal stromal tumors (GIST). This is the sixth clinical study of STA-9090, a potent, synthetic, small molecule Hsp90 inhibitor with a novel chemical structure.

23 Dec 2009

Positive results from Alimera Sciences' Iluvien FAME trial for DME

Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported top-line results from the month 24 readout of the FAME Study.

23 Dec 2009

Compugen, Pfizer enter into multi-target collaboration

Compugen Ltd. announced today that it has signed a collaboration agreement with Pfizer for the predictive discovery by Compugen of therapeutic peptide product candidates for three drug targets of interest to Pfizer. The discovery process, which will be based on various Compugen discovery platforms and funded by Pfizer, is expected to take a few months, following which the predicted molecules will be synthesized and delivered to Pfizer.

23 Dec 2009

Shire submits REPLAGAL BLA with the FDA

Shire plc , the global specialty biopharmaceutical company, today announced that it has submitted a BLA with the FDA for REPLAGAL(R) (agalsidase alfa), its enzyme replacement therapy for Fabry disease. REPLAGAL first received marketing authorization in the European Union in 2001, and is approved for the treatment of Fabry disease in 45 countries.

22 Dec 2009

Sinovac Biotech selected as Top 10 most competitive companies for 2009

Sinovac Biotech Ltd. (SVA), a leading provider of biopharmaceutical products in China, announced today that Sinovac was selected by China Business Media as one of China's Top 10 most competitive companies listed overseas for 2009.

22 Dec 2009

ADHD Support Twitter page from Shire

Shire plc, the global specialty biopharmaceutical company, announced the launch of its newest online Attention-Deficit/Hyperactivity Disorder (ADHD) resource, the ADHD Support Twitter(TM) page (http://twitter.com/adhdsupport), derived from the Shire award-winning online educational resource, ADHDSupport.com.

22 Dec 2009

Study results of CSL’s pandemic H1N1 2009 vaccine published in JAMA

CSL Limited, Australia’s leading biopharmaceutical company, announced the Journal of the American Medical Association (JAMA) has published data from a clinical trial conducted in Australia to study CSL’s pandemic H1N1 2009 ‘swine’ flu vaccine.

22 Dec 2009