Biopharmaceutical News and Research

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Seven new biopharmaceutical companies join PhRMA, Forbes reports

Forbes recently reported that seven new biopharmaceutical companies have now joined the Pharmaceutical Research and Manufacturers of America (PhRMA).

From CSL Ltd 9 Jan 2010

Synta Pharmaceuticals announces pricing of public offering of shares

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced the pricing of an underwritten public offering of 5,555,556 shares of its common stock at a price to the public of $4.50 per share for gross proceeds of approximately $25 million.

8 Jan 2010

Novelos Therapeutics to conclude pivotal Phase 3 trial in advanced non-small cell lung cancer

Novelos Therapeutics, Inc., a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the 725th event (patient death) has been reached in its pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy.

8 Jan 2010

3Sbio submits registrational clinical trial application for Feraheme injection

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use.

8 Jan 2010

Laureate Pharma and Iconic Therapeutics complete manufacturing hI-con1 recombinant Fc-Factor VII fusion protein

Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company specializing in the development and GMP manufacture of monoclonal antibodies, fusion proteins and other therapeutic protein products, and Iconic Therapeutics, a company focused on the development of treatments for wet adult macular degeneration (wet AMD) and other ophthalmic diseases, today announced the completion of the manufacture of the first GMP lot of hI-con1(TM) recombinant Fc-Factor VII fusion protein.

8 Jan 2010

FDA issues Fast Track Designation to Sopherion Therapeutics' Myocet

Sopherion Therapeutics, LLC, a biopharmaceutical company focused on the development and commercialization of anti-cancer therapies, announced today that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for nonpegylated liposomal doxorubicin (Myocet(TM)) for first-line therapy of HER2 positive metastatic breast cancer.

7 Jan 2010

Drug companies still under great and growing pressure to bring more products to market

Although drug developers are improving R&D efficiency, in part by terminating more unpromising drugs earlier in development, their continued success will depend on how well they partner with other firms at specific points on the development spectrum, according to the Tufts Center for the Study of Drug Development.

7 Jan 2010

Eisai acquires AkaRx for approximately $255 million

Eisai Inc. (Headquarters: Woodcliff Lake, New Jersey, Chairman and CEO: Hajime Shimizu, "Eisai") today announces the successful completion of its acquisition of the biopharmaceutical company, AkaRx, Inc. (Headquarters: Bridgewater, New Jersey, CEO: Robert E. Desjardins), for approximately $255 million.

6 Jan 2010

Tumor Biology Center to initiate Phase 2 clinical trial with CytRx’s INNO-206

CytRx Corporation, a biopharmaceutical company, today announced that the Tumor Biology Center, Freiburg, Germany, plans to initiate a Phase 2 clinical trial with CytRx’s doxorubicin prodrug INNO-206 as a treatment for patients with advanced pancreatic cancer.

6 Jan 2010

Ensemble Discovery initiates strategic alliance with Pfizer

Ensemble Discovery today announced the initiation of a strategic alliance with Pfizer Inc. to discover and develop drug candidates of a novel class against a number of high-value pharmaceutical targets.

6 Jan 2010

Jumpstart and Portal Capital invest $500,000 in TheraVasc for PAD drug

JumpStart Inc., the Northeast Ohio venture development organization that accelerates the progress of high growth early-stage businesses, and Portal Capital, a Cleveland-based private equity firm investing in life science companies, each announce an investment commitment of $250,000 in TheraVasc Inc., for a total commitment of $500,000. The

6 Jan 2010

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

Biopharmaceutical News and Research

Seven new biopharmaceutical companies join PhRMA, Forbes reports

Synta Pharmaceuticals announces pricing of public offering of shares

Novelos Therapeutics to conclude pivotal Phase 3 trial in advanced non-small cell lung cancer

3Sbio submits registrational clinical trial application for Feraheme injection

Laureate Pharma and Iconic Therapeutics complete manufacturing hI-con1 recombinant Fc-Factor VII fusion protein

FDA issues Fast Track Designation to Sopherion Therapeutics' Myocet

Drug companies still under great and growing pressure to bring more products to market

Eisai acquires AkaRx for approximately $255 million

Tumor Biology Center to initiate Phase 2 clinical trial with CytRx’s INNO-206

Ensemble Discovery initiates strategic alliance with Pfizer

Jumpstart and Portal Capital invest $500,000 in TheraVasc for PAD drug

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

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

ARYx Therapeutics receives guidance in writing from FDA on tecarfarin

Elusys Therapeutics signs contract to complete the final development of Anthim

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

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

Santarus submits rifamycin SV MMX IND to the FDA

VIVUS submits a NDA to the FDA for obesity drug Qnexa

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

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