Biopharmaceutical News and Research

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China's SFDA grants production license to TPI anti-diabetic drug Gliclazide

Tianyin Pharmaceutical Co., Inc., a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and other pharmaceuticals today announced TPI has received the production license for its anti-diabetic drug Gliclazide Tablets from China's State Food and Drug Administration.

1 Jun 2011

Patrick K. Donnelly announces official launch of Aptiv Solutions

Chairman and CEO Patrick K. Donnelly today announced the official launch of Aptiv Solutions, a global biopharmaceutical and medical device development services company.

1 Jun 2011

CrystalGenomics begins enrollment in CG100649 Phase 2b osteoarthritis study

CrystalGenomics, Inc. and CG Pharmaceuticals, Inc., a biopharmaceutical company with 3 clinical stage candidates, has announced that the first patient has been enrolled for a Phase 2b clinical study of CG100649, CrystalGenomics' clinical stage novel NSAID candidate, in patients with knee or hip osteoarthritis.

1 Jun 2011

Heptares, AstraZeneca partner to discover and develop new GPCR drug targets

AstraZeneca and Heptares Therapeutics today announced they have entered a four-year collaboration focused on the potential discovery and development of new medicines targeting G-protein coupled receptors.

31 May 2011

ARCA plans to expand development program for Gencaro in atrial fibrillation

ARCA biopharma, Inc., a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that it is planning to expand the development of Gencaro, its lead cardiovascular drug candidate, to atrial fibrillation, a disease that affects more than 2.4 million patients in the United States.

27 May 2011

PAREXEL, Pfizer partner to provide clinical development services

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that it has been selected as one of two strategic partners by Pfizer Inc. to provide clinical development services.

From Parexel 27 May 2011

Lx Therapies, BioCis partner to form Laurantis Pharma

BioCis Pharma Oy and Oy Lx Therapies Ltd. announced today that the companies have combined to create Laurantis Pharma Oy, a clinical-stage specialty pharmaceutical development company.

26 May 2011

BPD expands existing bioprocess and scale-up laboratory in Poway, CA

Biologics Process Development Inc., a wholly-owned subsidiary of Viropro, will double the size of its existing bioprocess- and scale-up laboratory in Poway, CA.

25 May 2011

Patient accrual complete in Provectus PH-10 Phase 2C clinical trial for treatment of psoriasis

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has completed patient accrual in its Phase 2C clinical trial of PH-10 for the treatment of psoriasis. PH-10, an aqueous hydrogel formulation of Rose Bengal disodium for topical administration to the skin, is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis.

24 May 2011

Micromet's blinatumomab data to be presented at two upcoming medical meetings

Micromet, Inc., a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced that data on its lead product candidate blinatumomab will be reported at two upcoming medical meetings.

23 May 2011

New RHUCIN study data in acute HAE attacks presented at 7th C1 Inhibitor Deficiency Workshop

Santarus, Inc., a specialty biopharmaceutical company, today announced that new data from open-label studies evaluating the efficacy and safety of the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema were presented at the 7th C1 Inhibitor Deficiency Workshop on May 20 - 22, 2011 in Budapest, Hungary.

23 May 2011

Sosei to introduce NorLevo oral emergency contraceptive in Japan

Sosei Group Corporation, the biopharmaceutical company, today announced that Sosei Co., Ltd., its wholly owned Japanese subsidiary, will launch its emergency contraceptive pill, NorLevo(R) TABLETS 0.75mg, tomorrow 24 May, through the distribution network of its commercialization partner, ASKA Pharmaceutical Co., Ltd.

23 May 2011

CSL welcomes historic pandemic agreement

CSL Biotherapies welcomed news overnight of a decision by the World Health Assembly to adopt the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. The Framework is the culmination of several years work by a dedicated working group of the World Health Organisation (WHO) and paves the way for greater global collaboration between public and private stakeholders in preparing the world for possible future influenza pandemics.

19 May 2011

Advantagene reaches SPA agreement with FDA for ProstAtak Phase 3 trial to prevent prostate cancer recurrence

Advantagene, Inc., a Massachusetts-based biopharmaceutical company, announced today that it reached an agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of ProstAtak™, its lead agent for patients with newly diagnosed prostate cancer.

19 May 2011

Metabolex commences arhalofenate Phase 2 clinical trial for treatment of hyperuricemia and gout

Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced that it has initiated a Phase 2 clinical trial of arhalofenate (MBX-102), its product candidate for the management of hyperuricemia in patients with gout.

19 May 2011

USPTO grants four key patents for Alvine's proteases to detect celiac disease

Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, today announced that the United States Patent and Trademark Office has issued four key patents: 7,943,312; 7,928,056; 7,923,532; and 7,910,541, protecting various aspects of Alvine's core technology.

19 May 2011

Mpex, Synteract partner for cystic fibrosis fundraising event

Synteract, Inc., a full-service, global contract research organization, and Mpex Pharmaceuticals, a biopharmaceutical company developing new therapies to combat the growing issue of antibiotic resistance, have partnered for the second annual Great Strides fundraiser to benefit cystic fibrosis.

19 May 2011

CITN selects Cytheris' CYT107 for initial clinical trials at network institutions

Cytheris SA and the Cancer Immunotherapy Trials Network, a new initiative in immunotherapy funded by the National Cancer Institute with its Central Operations and Statistical Center headquartered at Fred Hutchinson Cancer Research Center, Seattle, Washington, today announced the selection of recombinant human interleukin-7, the investigational multifunctional cytokine under development by Cytheris, as one of the first immunotherapeutic agents proposed for initial clinical trials at network institutions.

18 May 2011

HII, CDISC launch new project to harmonize health research guidelines

A Project to harmonize health research guidelines was launched today by the Health Improvement Institute in partnership with the Clinical Data Interchange Standards Consortium.

17 May 2011

ProBioGen, Life Technologies' new cell line development kits now available for biologic drug production

Life Technologies Corporation and ProBioGen AG today announced the availability of Gibco Freedom Cell Line Development Kits, a new line of royalty-free products that integrate cells, reagents, culture media and protocols to bring simplicity and flexibility, eliminating up to two months in the earliest stages of new biological drug development.

17 May 2011