Biopharmaceutical News and Research

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Investissement Québec provides financial support to Algorithme Pharma

Algorithme Pharma Inc., a Canadian clinical contract research organization, with facilities in Laval Québec, Montréal Québec, and through its sister company Simbec Research Limited in Merthyr Tydfil UK, today announced having secured the support of Investissement Québec in the form of a loan.

21 Mar 2011

Shire announces FDA PDUFA date for FIRAZYR NDA in treatment of acute attacks of hereditary angioedema

Shire plc, the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of August 25, 2011 for the review of the New Drug Application (NDA) for FIRAZYR(R) (icatibant) for the treatment of acute attacks (Types I and II) of hereditary angioedema (HAE). This 6 month review timeline is consistent with review as a Class II resubmission.

21 Mar 2011

Almac, Exco InTouch enter exclusive integrated patient management alliance

The Almac Group and Exco InTouch announced today that Almac's Clinical Technologies business unit, the leading provider of IXRS(R) (Interactive Voice and Web Response) services relating to patient and drug supply management, has formed an exclusive integrated patient management alliance with Exco InTouch, an innovative firm specializing in patient recruitment, retention, compliance and ePRO services.

21 Mar 2011

Tiny Locked Nucleic Acid-based compounds inhibit entire disease-associated microRNA families

A study published online in this week's Nature Genetics demonstrates that tiny Locked Nucleic Acid (LNA)-based compounds developed by Santaris Pharma A/S can inhibit entire disease-associated microRNA families. This provides a potential new approach for treating a variety of diseases including cancer, viral infections, cardiovascular and muscle diseases.

21 Mar 2011

CytRx commences INNO-206 Phase 1b trial in advanced solid tumors

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that it has initiated an open-label Phase 1b safety and dose escalation clinical trial with INNO-206 at the Sarcoma Oncology Center in Santa Monica, California. The clinical trial will include up to 24 patients with advanced solid tumors who have failed standard therapies.

17 Mar 2011

MorphoSys inks manufacturing agreement with Boehringer Ingelheim

MorphoSys AG and Boehringer Ingelheim announced today the signing of a biopharmaceutical manufacturing agreement for therapeutic antibodies. The agreement covers the process development and manufacturing of additional clinical material for MorphoSys's proprietary MOR208 program and other drug candidates. MOR208, a potent monoclonal anti-CD19 antibody, is in development for the treatment of chronic lymphocytic leukemia and potentially other B-cell malignancies. The program is currently being evaluated in a phase 1 clinical trial in the USA by MorphoSys's partner Xencor Inc.

16 Mar 2011

Montreal Heart Institute and Cerenis commence CER-001 Phase 2 study in acute coronary syndrome

The Montreal Heart Institute today announced the start of the Phase 2 CHI-SQUARE (Can HDL Infusions Significantly QUicken Atherosclerosis REgression?) study of CER-001 in patients with acute coronary syndrome (ACS), in collaboration with Cerenis Therapeutics, a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and metabolic diseases.

16 Mar 2011

Omeros fourth quarter net loss increases to $7.2 million

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, bleeding and disorders of the central nervous system, today announced financial results for the fourth quarter and year ended December 31, 2010.

15 Mar 2011

Chelsea uses PHT's LogPad, SitePad Tablet for clinical study to treat Parkinson's patients with NOH

PHT Corporation announced that Chelsea Therapeutics is using PHT's LogPad System and SitePad Tablet for its ongoing clinical study in Parkinson's disease patients with symptomatic neurogenic orthostatic hypotension.

15 Mar 2011

Cerenis commences CER-001 Phase 2 CHI-SQUARE study in patients with ACS

Cerenis Therapeutics, a biopharmaceutical company developing novel high-density lipoprotein therapies to treat cardiovascular and metabolic diseases, today announced the start of the Phase 2 CHI-SQUARE study of CER-001 in patients with acute coronary syndrome.

15 Mar 2011

Omthera to fund Epanova Phase 3 development with $33.9 million in Series B funding

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that it has raised $33.9 million in a Series B funding round, led by new investor, New Enterprise Associates ("NEA"), one of the world's leading venture capital firms. Existing investor, Sofinnova Partners, also participated in the financing.

14 Mar 2011

SOM Biotech closes first financing round and files patent application

SOM Biotech, a biopharmaceutical start-up company with a business model centered on the identification and development of drug repurposing opportunities, reports significant progress on its trajectory towards pipeline development and candidate outlicensing.

14 Mar 2011

Bill Gates and Schrödinger co-founder invest in Nimbus to advance large B-cell lymphoma programs

Nimbus Discovery LLC, a biopharmaceutical company using state-of the-art computational technology to discover novel medicines against exciting but difficult-to-drug disease targets, today announced an extension of its seed round with an investment by Bill Gates and Dr. Richard Friesner, the co-founder of Schrödinger and Professor of Chemistry at Columbia University. Atlas Venture, the founding investor, also participated.

11 Mar 2011

CytRx reports $0.4M net income for 2010 vs. $4.8M net loss for 2009

CytRx Corporation, a biopharmaceutical company specializing in oncology, today reported financial results for the 12 months ended December 31, 2010, and provided a business update.

11 Mar 2011

BioSpecifics 2010 net loss decreases to $1.5 million

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the fourth quarter and full year ended December 31, 2010.

11 Mar 2011

Halozyme Therapeutics 2010 net loss decreases to $53.2 million

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the fourth quarter and year ended December 31, 2010.

11 Mar 2011

Synta fourth-quarter total collaboration revenue decreases to $3.0 million

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today reported fourth-quarter and full-year 2010 financial results, provided an update on recent progress with its programs, and announced 2011 objectives.

11 Mar 2011

Simcere files IND with SFDA of China for APX003 to treat cancer

Apexigen, Inc., an emerging biopharmaceutical company focusing on the development of monoclonal antibody therapeutics, announced today that its partner, Simcere Pharmaceutical Group, a leading pharmaceutical company in China, filed an Investigational New Drug application with the State Food and Drug Administration of China to evaluate APX003 as a potential cancer therapy.

11 Mar 2011

PNP reaches several major objectives in cancer therapeutic product development

PNP Therapeutics, Inc. — an early-stage Birmingham-based biopharmaceutical company created from research conducted at Southern Research Institute and The University of Alabama at Birmingham — today announced that several major objectives have been reached in the development of its therapeutic technology platform and proprietary products for the treatment of cancer.

11 Mar 2011

Positive preliminary results from Sinovac EV71 vaccine phase I trial in adults

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today the unblinding of the Phase I clinical trial results for the adult population for its proprietary inactivated vaccine against human enterovirus 71, which causes hand, foot, and mouth disease.

10 Mar 2011