Biopharmaceutical News and Research

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Zalicus commences first of two Z160 Phase 2a clinical studies for chronic neuropathic pain

Zalicus Inc., a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that it has initiated the first of two Phase 2a clinical studies with Z160, its first-in-class, oral, state-dependent, selective N-type calcium channel blocker for the treatment of chronic neuropathic pain indications.

5 Sep 2012

Biokine, BioLineRx sign license agreement to develop and commercialize BL-8040 for AML

BioLineRx Ltd., a biopharmaceutical drug development company, announced today that it has signed an exclusive, worldwide license agreement with Biokine Therapeutics Ltd., a Clal Biotechnology Industries portfolio company, for the development and commercialization of BL-8040 (formerly BKT-140), a Phase II ready drug candidate for the treatment of acute myeloid leukemia (AML), as well as other types of hematological cancer.

4 Sep 2012

GE Healthcare introduces KUBio factory

GE Healthcare, the healthcare business of GE, today introduced KUBio, an innovative off-the-shelf, modular factory designed to save manufacturers of biopharmaceuticals both time and money.

4 Sep 2012

Dysfunctional RyRs play a role in stress-induced cognitive dysfunction

ARMGO Pharma, Inc., a biopharmaceutical company developing innovative small molecule drugs known as "Rycals™," which act on the ryanodine receptor calcium-release channel (RyR), announced that a study published today in the prestigious scientific journal Cell reveals the underlying role of calcium leak through the RyR as an important contributor to stress-induced cognitive dysfunction.

1 Sep 2012

Soligenix’s RiVax induces greater ricin neutralizing antibody levels in humans

Soligenix, Inc., a development stage biopharmaceutical company, announced today the results of a Phase 1B clinical trial of an aluminum hydroxide (Alum) adjuvanted formulation of RiVax, designed to improve the immunogenicity of the vaccine.

31 Aug 2012

Protalex announces results from PRTX-100 Phase 1b trial on active rheumatoid arthritis

Protalex, Inc., a clinical stage biopharmaceutical company focused on the development of a class of drugs designed to treat autoimmune and inflammatory diseases including rheumatoid arthritis (RA), today announced results from its recently completed Phase 1b randomized, multiple-dose, dose-escalation study.

30 Aug 2012

FDA grants orphan designation to Aerial BioPharma’s ARL-N05 for treatment of narcolepsy

Aerial BioPharma, a biopharmaceutical company focused on developing biologics and small molecules for conditions in the central nervous system, has received orphan drug designation for its narcolepsy drug in development.

30 Aug 2012

Charles River announces acquisition of Accugenix

Charles River Laboratories International, Inc. announced today that it has acquired Accugenix, Inc., the premier global provider of cGMP-compliant contract microbial identification testing, for approximately $17 million in cash.

30 Aug 2012

Top-line results from Rexahn’s Archexin Phase II study on metastatic pancreatic cancer

Rexahn Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing multi-indication therapeutics in oncology and CNS, today announced top-line results from a Phase II clinical study of Archexin, its clinical-stage oncology drug candidate.

29 Aug 2012

Additional data from Auxilium XIAFLEX phase III studies on Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced that additional data will be presented from its IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the phase III studies that assessed XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease (PD).

27 Aug 2012

FDA approves Mallinckrodt's EXALGO (32 mg) sNDA to manage opioid-related pain

Zalicus Inc., a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) filed by Mallinckrodt Inc., a subsidiary of Covidien plc, for the 32 mg dose strength of EXALGO (hydromorphone HCl) Extended-Release Tablets (CII), for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

27 Aug 2012

Debiopharm initiates enrollment in triptorelin phase III study for central precocious puberty

Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, today announced that the first patient has been enrolled in an open-label phase III study to investigate the efficacy, safety, and pharmacokinetics of the sustained release triptorelin pamoate 22.5 mg 6-month-formulation in children with central precocious puberty (CPP), a rare disease.

27 Aug 2012

Mylan, Pfizer partner to develop and market generic drugs in Japan

Pfizer Inc. and Mylan Inc. today announced that they have signed a definitive agreement to establish an exclusive long-term strategic collaboration to develop, manufacture, distribute and market generic drugs in Japan. The collaboration is designed to build upon each company's highly complementary strengths and quality assets.

23 Aug 2012

EMD Millipore enters definitive agreement to acquire Biochrom

EMD Millipore, the Life Science division of Merck KGaA of Darmstadt, Germany, today announced that it has entered into definitive agreements to acquire Biochrom AG located in Berlin, Germany.

From Biochrom Ltd. 23 Aug 2012

Bile duct cancer chosen as next indication for PCI Biotech

PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that it has chosen bileduct cancer as the next indication for the use of its PCI (photochemical internalisation) localised cancer therapy. In this indication PCI Biotech’s proprietary photosensitiser Amphinex® will be used in combination with the generic cytotoxic agent gemcitabine. The aim is to start the clinical Proof of Concept study within end of 1H 2013.

21 Aug 2012

Ipsen, Inspiration partner to commercialize IB1001 and OBI-1 for hemophilia

Inspiration Biopharmaceuticals Inc. today announced new license, development and commercialization agreements with its strategic partner, Ipsen.

21 Aug 2012

Preliminary results from Lexicon’s Phase 1 studies of LX2931 and LX7101 for RA

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, today reported preliminary results from Phase 1 studies of LX2931 and LX7101.

17 Aug 2012

Medicago, IDRI receive FDA approval to commence Phase 1 H5N1 vaccine trial

The Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, and Medicago Inc., a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announce that they have been cleared by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for an H5N1 Avian Influenza VLP vaccine candidate.

16 Aug 2012

3SBio files APX001 IND application with SFDA in China

Apexigen, Inc., an emerging biopharmaceutical company focused on the discovery and development of monoclonal antibody therapeutics, announced today that its partner, 3SBio [SSRX] of Shenyang, China, filed an Investigational New Drug (IND) application for APX001, also known as SSS07, with the State Food and Drug Administration (SFDA) in China.

16 Aug 2012

AstraZeneca enters agreement with Pfizer for OTC NEXIUM

Pfizer Inc. today announced that it has entered into an agreement with AstraZeneca for the over-the-counter (OTC) rights for NEXIUM (esomeprazole magnesium), a leading prescription drug currently approved to treat the symptoms of gastroesophageal reflux disease (GERD).

14 Aug 2012