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CMC Biologics' Bothell manufacturing and testing facilities receive cGMP compliance

CMC Biologics, a leading contract manufacturing organization (CMO) known for its technical excellence in process development and cGMP manufacture, has received a Certificate of Good Manufacturing Practice (GMP) Compliance for commercial manufacturing issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

18 Jun 2012

Ascepion, Debiopharm partner to develop and commercialize ASP-08126 for solid tumors

Debiopharm Group, a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, and Ascepion Pharmaceuticals, Inc., a privately-held, biopharmaceutical company dedicated to the discovery and development of breakthrough small molecule drugs for the treatment of oncology and related diseases, have entered into an exclusive worldwide license agreement concerning the development and commercialization of ASP-08126 (called Debio 1144 by Debiopharm) a multikinase inhibitor currently in pre-clinical development.

18 Jun 2012

Quintiles announces agreements to expand lab testing capabilities in China

In a ceremony underscoring the growing importance of China to the global biopharmaceutical industry, Quintiles executives and local dignitaries today announced agreements to establish a Quintiles regional headquarters for China in Shanghai and to significantly expand lab testing capabilities in China.

18 Jun 2012

St. Michael's to investigate new treatments for prevention of brain injury complications

St. Michael's Hospital has been awarded up to $700,000 from the Federal Economic Development Agency of Southern Ontario to investigate new treatments to prevent complications following certain brain injuries.

16 Jun 2012

Hay fever vaccine shows efficacy in phase IIa trial

A novel vaccine for grass pollen allergy has shown significant improvements for patients in a Phase IIa trial. The vaccine BM32 is based on an innovative recombinant peptide carrier technology that allows for fewer injections and shows fewer side effects compared with other immunotherapy treatments for allergy sufferers. BM32 has been developed by Biomay AG, an Austrian biopharmaceutical company specialized in the discovery and development of innovative allergy therapeutics. The company has already initiated a Phase IIb trial for BM32 with 180 allergic patients.

14 Jun 2012

Igenica raises $33M in Series C round of funding

Igenica, Inc., a leading biopharmaceutical company focused on the discovery and development of first-in-class antibodies, today announced that it has raised $33 million in a Series C round of funding.

12 Jun 2012

Ampio’s CRO completes Optina clinical trial for DME

Ampio Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, whose lead drugs treat inflammatory diseases, including osteoarthritis and complications of Diabetes Mellitus such as diabetic macular edema (and others) announced today that it's CRO has completed analysis of the primary end point in the Optina clinical trial for DME conducted at St Michael Diabetes Hospital in Toronto Canada.

11 Jun 2012

Zafgen announces new data from two Phase 1 studies of beloranib on obesity

Zafgen, Inc., the world's first biopharmaceutical company dedicated to addressing the unmet need of severely obese patients, today announced new data from two Phase 1 studies of beloranib, a selective methionine aminopeptidase 2 inhibitor (MetAP2), which showed significant weight loss and improvements in cardiometabolic risk markers in severely obese women.

11 Jun 2012

$6.4 million awarded to investigate mechanisms of allergy tolerance generated by Circassia’s ToleroMune Treatment

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that the United States’ National Institutes of Health (NIH) has awarded a $6.4 million grant to Professor Mark Larché of McMaster University, Canada, to study mechanisms of tolerance developed by patients treated with Circassia’s Toleromune® allergy therapy.

7 Jun 2012

DODAC to discuss ThromboGenics’ new BLA for ocriplasmin intravitreal injection

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) has notified the Company that its new biologic license application (BLA) for ocriplasmin intravitreal injection will be discussed at the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for July 26, 2012.

7 Jun 2012

Debiopharm announces results from Debio 0932 Phase I study on cancer

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, presented results of a Phase I open-label dose-escalation study with Debio 0932, an oral Heat Shock Protein 90 (HSP90) inhibitor in clinical development as an anti-cancer agent.

7 Jun 2012

Phase III study of AFOLIA, a biosimilar r-FSH meets its endpoint

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6 Jun 2012

BioLineRx receives two U.S. patent allowances for BL-1021 to treat neuropathic pain

BioLineRx, a biopharmaceutical development company, announced today that two Notices of Allowance have been issued by the United States Patent and Trademark Office (USPTO) for BL-1021, an orally available small molecule for treating neuropathic pain.

6 Jun 2012

VGXI, OncoSec partner to produce interleukin-12 plasmid DNA

OncoSec Medical Inc., which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, announced today that the Company has entered into an exclusive cGMP manufacturing agreement with VGXI Inc. (VGXI) for the production of interleukin-12 plasmid DNA.

6 Jun 2012

Chatham, Baxter partner to develop and commercialize hemophilia B gene therapy treatment

Baxter International Inc. today announced that it has entered into an exclusive global agreement with Chatham Therapeutics, LLC, an affiliate of Asklepios BioPharmaceutical, Inc. (AskBio), for the development and commercialization of potential treatments for hemophilia B utilizing Chatham's gene therapy technology.

From Baxter International Inc. 5 Jun 2012

Positive results from BioSpecifics’ XIAFLEX Phase III clinical program on Peyronie's disease

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in Europe and Eurasia, today announced positive top-line results from the IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) Phase III clinical program of XIAFLEX for the treatment of Peyronie's disease, which was conducted by BioSpecifics' partner Auxilium Pharmaceuticals, Inc.

5 Jun 2012

Antisense Pharma presents data from trabedersen Phase I/II cancer study at ASCO 2012

The biopharmaceutical company Antisense Pharma today presents trabedersen complete data from its clinical Phase I/II study in patients with advanced pancreatic cancer, malignant melanoma or colorectal cancer at the international cancer congress ASCO 2012 in Chicago, USA.

5 Jun 2012

Polynoma initiates POL 103A Phase III trial in melanoma

Polynoma LLC, a U.S. oncology-focused biopharmaceutical company within Hong Kong-based CK Life Sciences Int'l., today announced the start of a Phase III clinical trial program for POL 103A, the Company's novel melanoma vaccine. Polynoma's global, multi-center, double-blind, placebo-controlled Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) is designed to enroll a total of 1059 patients with resected Stage IIb, IIc or III melanoma.

4 Jun 2012

Positive results from Auxilium’s XIAFLEX phase III studies on Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive top-line results 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).

4 Jun 2012

Results from Puma’s PB272 Phase I combination trial on metastatic HER-2 positive breast cancer

Puma Biotechnology, Inc., a development stage biopharmaceutical company, announced that results from an ongoing Phase I clinical trial of its lead drug candidate PB272 (neratinib) given in combination with the anticancer drugs paclitaxel and trastuzumab in patients with metastatic HER-2 positive breast cancer were presented in a poster presentation at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting.

4 Jun 2012

Biopharmaceutical News and Research

CMC Biologics' Bothell manufacturing and testing facilities receive cGMP compliance

Ascepion, Debiopharm partner to develop and commercialize ASP-08126 for solid tumors

Quintiles announces agreements to expand lab testing capabilities in China

St. Michael's to investigate new treatments for prevention of brain injury complications

Hay fever vaccine shows efficacy in phase IIa trial

Igenica raises $33M in Series C round of funding

Ampio’s CRO completes Optina clinical trial for DME

Zafgen announces new data from two Phase 1 studies of beloranib on obesity

$6.4 million awarded to investigate mechanisms of allergy tolerance generated by Circassia’s ToleroMune Treatment

DODAC to discuss ThromboGenics’ new BLA for ocriplasmin intravitreal injection

Debiopharm announces results from Debio 0932 Phase I study on cancer

Phase III study of AFOLIA, a biosimilar r-FSH meets its endpoint

BioLineRx receives two U.S. patent allowances for BL-1021 to treat neuropathic pain

VGXI, OncoSec partner to produce interleukin-12 plasmid DNA

Chatham, Baxter partner to develop and commercialize hemophilia B gene therapy treatment

Positive results from BioSpecifics’ XIAFLEX Phase III clinical program on Peyronie's disease

Antisense Pharma presents data from trabedersen Phase I/II cancer study at ASCO 2012

Polynoma initiates POL 103A Phase III trial in melanoma

Positive results from Auxilium’s XIAFLEX phase III studies on Peyronie's disease

Results from Puma’s PB272 Phase I combination trial on metastatic HER-2 positive breast cancer

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