Biopharmaceutical News and Research

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AMRI to reduce US workforce by 10%

AMRI today announced that it is repositioning itself to meet a continued shift in demand from customers for services in Asia and Europe. Overall for 2009 and 2010, the company anticipates investing in excess of $30 million on international facility and capability expansions and estimates its non-US workforce will increase by approximately 180 positions in order to meet known and anticipated customer demand.

26 May 2010

Immunomedics announces receipt of $5M from Nycomed for reaching clinical milestone

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced the receipt of $5 million from Nycomed for reaching a clinical milestone under the license and collaboration agreement, entered into on July 11, 2008.

26 May 2010

Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that Phase IIb data for its lead drug candidate Soluble Ferric Pyrophosphate (SFP) have been accepted for presentation at the XLVII European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress, organized in collaboration with the Deutsche Gesellschaft fur Nephrologie (DGfN) in Munich, Germany, June 25-28, 2010.

25 May 2010

CoDa Therapeutics reports positive results from Phase 2 study of NEXAGON for chronic venous leg ulcers

CoDa Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of therapeutics for wound care and tissue repair, today announced positive results from its Phase 2 NOVEL Study of NEXAGON® in patients with chronic venous leg ulcers. NEXAGON® is a topically applied, novel therapeutic candidate, with the potential to revolutionize the wound healing treatment paradigm by leveraging a new mechanism and target involved in the healing process.

25 May 2010

Clovis Oncology, Avila Therapeutics announce development agreement for NSCLC EMSI program

Clovis Oncology, Inc., a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents, and Avila Therapeutics, Inc., a biotechnology company designing targeted covalent drugs, announced today an agreement for the development and commercialization of Avila's epidermal growth factor receptor (EGFR) mutant-selective inhibitor (EMSI) program, currently in pre-clinical development for the treatment of non-small cell lung cancer (NSCLC).

25 May 2010

ImmunoGen to present clinical data on IMGN388 solid tumor compound at 2010 ASCO

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, announced today that there will be several clinical data presentations for compounds utilizing the Company's Targeted Antibody Payload (TAP) technology at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago on June 4-8, 2010.

25 May 2010

t2c001 product obtains certificate under EMA regulations for ATMPs

t2cure GmbH, a biopharmaceutical company developing and marketing stem cell-based regenerative therapies, announced today that the quality of its lead product t2c001 has been certified by the European Medicines Agency.

25 May 2010

New HPLC-Chip introduced to address N-glycan analysis in biopharmaceutical market

Agilent Technologies Inc. today introduced a new HPLC-Chip to address N-glycan analysis in the emerging biopharmaceutical market.

25 May 2010

OnePath Gaucher Application available for patients with Type 1 Gaucher disease

Shire plc, the global specialty biopharmaceutical company, today announced the availability of the OnePath Gaucher Application. The first and only application developed specifically for patients in the U.S. with Type 1 Gaucher disease, it is free and ready for download at the iTunes Application store.

24 May 2010

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

Shire plc, the global specialty biopharmaceutical company, today announced new findings on once-daily INTUNIV (guanfacine) Extended Release Tablets, the first selective alpha-2A agonist approved for the treatment of Attention Deficit Hyperactivity Disorder, at a major psychiatric meeting.

24 May 2010

Updates on Micromet's BiTE antibody development programs to be made at two medical conferences

Micromet, Inc., a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced that updates on several of its BiTE antibody development programs will be made at two upcoming medical conferences.

21 May 2010

Provectus to present further positive data from PV-10 Phase 2 clinical trial for metastatic melanoma at ASCO

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has announced further positive data on the first forty subjects in its Phase 2 clinical trial of PV-10 for metastatic melanoma, with an objective response ("OR") observed in 61% of subjects and a mean Progression Free Survival ("PFS") of at least 11.1 months among those subjects achieving an OR.

21 May 2010

Data from three Phase II clinical trials of PS-targeting antibody to be presented at 2010 ASCO Annual Meeting

Peregrine Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing innovative monoclonal antibodies for the treatment of cancer and viral infections, will present data from three Phase II clinical trials highlighting the clinical potential of its unique phosphatidylserine -targeting antibody bavituximab for the treatment of solid tumors.

21 May 2010

Toxcure granted U.S. patent for method of treating neoplasms with neurotoxins

Toxcure, LLC, an emerging specialty biopharmaceutical company, today announced the grant of U.S. Patent No. 7,709,440, which provides Toxcure with intellectual property protection for a method of treating various tumors with neurotoxins.

21 May 2010

Invida Group completes joint venture agreement with MUGI

Invida Group, the leading specialty biopharmaceutical company focused on the commercialization of healthcare products throughout Asia Pacific, today announced that it has completed a joint venture agreement with the Indonesian pharmaceutical manufacturer MUGI.

20 May 2010

NeuroTherapeutics Pharma closes $43 million Series B financing round

NeuroTherapeutics Pharma, Inc. (NTP), a biopharmaceutical company focused on developing novel therapies for central nervous system (CNS) disorders, announced today that it closed a $43 million Series B financing. New investors include Fidelity Biosciences, MPM Capital and SR One, who co-led the transaction, and Pfizer, Inc. Existing investors Novo Ventures and Thomas McNerney & Partners also participated in the round.

20 May 2010

Targacept commences Phase 2 clinical proof of concept trial of TC-5619 in adults with ADHD

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced that it has initiated a Phase 2 clinical proof of concept trial of TC-5619 in adults with attention deficit/hyperactivity disorder (ADHD). TC-5619 is a novel small molecule that is highly selective for the alpha7 neuronal nicotinic receptor, which Targacept refers to as NNR, and was discovered by Targacept scientists using Targacept's proprietary drug discovery platform known as Pentad (TM).

19 May 2010

USPTO issues Soligenix patent for use of beclomethasone dipropionate in treatment of IBS

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that the United States Patent Office (USPTO) has issued a patent (US 7,704,985) entitled "Treatment of Irritable Bowel Syndrome and Related Bowel Diseases." The patent claims the use of beclomethasone dipropionate (BDP) to treat irritable bowel syndrome (IBS), a painful gastrointestinal condition that affects approximately 15% of the population in the industrialized world.

19 May 2010

NeoStem, Vatican's Pontifical Council collaborate to expand raise awareness of adult stem cell therapies

NeoStem, Inc.,, an international biopharmaceutical company with operations in the US and China, and the Vatican's Pontifical Council for Culture, today announced a joint initiative that includes their charitable organizations to expand research and raise awareness of adult stem cell therapies.

19 May 2010

RegeneRx Biopharmaceuticals prices underwritten public offering at $0.41 per unit

RegeneRx Biopharmaceuticals, Inc., a biopharmaceutical company focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration in cardiovascular diseases, central nervous system injuries, ophthalmic indications and dermal wounds, announced the pricing of its previously announced underwritten public offering of 11,500,000 units of its securities at a public offering price of $0.41 per unit.

19 May 2010

Biopharmaceutical News and Research

AMRI to reduce US workforce by 10%

Immunomedics announces receipt of $5M from Nycomed for reaching clinical milestone

Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

CoDa Therapeutics reports positive results from Phase 2 study of NEXAGON for chronic venous leg ulcers

Clovis Oncology, Avila Therapeutics announce development agreement for NSCLC EMSI program

ImmunoGen to present clinical data on IMGN388 solid tumor compound at 2010 ASCO

t2c001 product obtains certificate under EMA regulations for ATMPs

New HPLC-Chip introduced to address N-glycan analysis in biopharmaceutical market

OnePath Gaucher Application available for patients with Type 1 Gaucher disease

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

Updates on Micromet's BiTE antibody development programs to be made at two medical conferences

Provectus to present further positive data from PV-10 Phase 2 clinical trial for metastatic melanoma at ASCO

Data from three Phase II clinical trials of PS-targeting antibody to be presented at 2010 ASCO Annual Meeting

Toxcure granted U.S. patent for method of treating neoplasms with neurotoxins

Invida Group completes joint venture agreement with MUGI

NeuroTherapeutics Pharma closes $43 million Series B financing round

Targacept commences Phase 2 clinical proof of concept trial of TC-5619 in adults with ADHD

USPTO issues Soligenix patent for use of beclomethasone dipropionate in treatment of IBS

NeoStem, Vatican's Pontifical Council collaborate to expand raise awareness of adult stem cell therapies

RegeneRx Biopharmaceuticals prices underwritten public offering at $0.41 per unit

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