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Phase III GOG-212 clinical trial of CTI's OPAXIO for ovarian cancer: Enrollment to continue

Cell Therapeutics, Inc. announced today that CTI received a statement on March 1, 2010 from the Gynecologic Oncology Group (GOG) leadership that the phase III GOG-212 clinical trial of CTI's OPAXIO™ used as maintenance therapy for ovarian cancer remains a high priority and enrollment will continue. The GOG made the statement to clarify that the recent results of the GOG-218 clinical trial bevacizumab in maintenance therapy for ovarian cancer has not influenced the importance of completing the GOG-212 clinical trial.

4 Mar 2010

Data from FAME Phase 3 study for Iluvien presented at Angiogenesis 2010

pSivida Corp., a leader in the development of ophthalmic sustained release drug delivery products, with two of the only three such products approved by the FDA for treatment of back of the eye diseases, today said that 24-month data from the FAME Phase 3 study for Iluvien presented at Angiogenesis 2010 included additional efficacy and safety data that reinforced the positive top-line results reported in December 2009 by pSivida and its licensee, Alimera Sciences, Inc.

4 Mar 2010

Covidien: Mallinckrodt launches Oral Transmucosal Fentanyl Citrate

Covidien, a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has launched its Oral Transmucosal Fentanyl Citrate (CII) to distributors serving retail pharmacies across the country.

3 Mar 2010

$Phase 3 trial: Cabazitaxel improves survival in patients with metastatic hormone-refractory prostate cancer$

Phase 3 trial: Cabazitaxel improves survival in patients with metastatic hormone-refractory prostate cancer

Sanofi-aventis announced today results from a Phase 3 trial which demonstrated cabazitaxel, an investigational compound, plus prednisone/prednisolone significantly improved overall survival and progression-free survival in patients with metastatic (advanced) hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel-based chemotherapy.

3 Mar 2010

CPEX Pharmaceuticals' fourth-quarter 2009 revenues up 23%

CPEX Pharmaceuticals, Inc. today reported financial results for the fourth quarter and year ended December 31, 2009. For the quarter CPEX reported revenues of $5.2 million and a net loss of $498,000. For the year CPEX reported revenues of $18.7 million and a net loss of $3.0 million.

3 Mar 2010

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Data from two Phase III studies of Merck’s investigational fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) were presented by researchers today in two poster presentations at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

3 Mar 2010

FDA approves Mylan Pharmaceuticals' ANDA for Ursodiol Capsules

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Ursodiol Capsules USP, 300 mg, the generic version of Watson's gastrointestinal agent Actigall® Capsules.

3 Mar 2010

Shionogi, QuatRx Pharmaceuticals enter into worldwide license agreement to develop and market ospemifene

Shionogi & Co., Ltd. and QuatRx Pharmaceuticals Company, a privately-held pharmaceutical company, today announced that they have entered into a worldwide license agreement to develop and market ospemifene, a selective estrogen receptor modulator ("SERM").

3 Mar 2010

Impax Laboratories' generic FLOMAX ANDA: FDA grants final approval

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules. The Company also announced that it is commencing shipment through Global Pharmaceuticals, Impax’s generic division.

3 Mar 2010

EMA accepts the filing of Lux Biosciences' MAA for Luveniq

Lux Biosciences, Inc. today announced that the European Medicines Agency has accepted the filing of the company’s Marketing Authorization Application (MAA) for the company’s lead product, Luveniq™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

3 Mar 2010

Antares Pharma completes enrollment in Phase 3 clinical trial of Anturol for OAB

Antares Pharma, Inc. announced today that it has completed enrollment in the double-blind portion of the Company’s Phase 3 clinical trial of Anturol™, its transdermal oxybutynin ATD™ gel for the treatment of overactive bladder (OAB). Top line data from this pivotal trial, which is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA), is expected in the third quarter of this year.

2 Mar 2010

National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

PDS Biotechnology Corporation today announced that the company has been awarded a $1.28M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The contract provides funding to complete studies required to file an Investigational New Drug Application (IND) with the FDA for the company's lead human papillomavirus (HPV)-cancer product late in 2010.

2 Mar 2010

MAP Pharmaceuticals announces net loss of $13.4M for fourth-quarter 2009

MAP Pharmaceuticals, Inc. today announced financial results for the fourth quarter and year ended December 31, 2009.

2 Mar 2010

InterMune seeks European marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.

2 Mar 2010

FDA approves CombinatoRx's NDA for Exalgo extended-release tablets

CombinatoRx, Incorporated today announced that the U.S. Food and Drug Administration has approved the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl) extended-release tablets, 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.

2 Mar 2010

Archimedes Pharma raises GBP65 million in new funding

Archimedes Pharma, the leading specialty pharma company, today announced that it has raised GBP65 million (approx US$100 million) in new funding. The round was led by new investor Novo Growth Equity, the growth equity fund of Novo A/S, and included participation by major current investor, Warburg Pincus, a global private equity firm. Archimedes also announced the appointment of a new President and Chief Executive Officer, Jeffrey H. Buchalter, formerly President and Chief Executive Officer of US-based Enzon.

2 Mar 2010

FDA's ODAC to review CTI's pixantrone NDA on March 22, 2010

Cell Therapeutics, Inc. announced today that the U.S. Food and Drug Administration's ("FDA") Oncologic Drugs Advisory Committee ("ODAC") will review CTI's New Drug Application ("NDA") for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL") on March 22, 2010.

2 Mar 2010

ChemGenex Pharmaceuticals' OMAPRO review: FDA reschedules ODAC meeting to 22 March, 2010

ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has rescheduled the previously postponed Oncologic Drugs Advisory Committee (ODAC) meeting to 22 March 2010.

1 Mar 2010

Biodel seeks FDA marketing approval for VIAject

Biodel Inc. announced today that the U.S. Food and Drug Administration has accepted for review the company’s new drug application (NDA) seeking approval to market VIAject® for the treatment of diabetes. VIAject® is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs.

1 Mar 2010

FDA accepts for filing VIVUS' Qnexa NDA

VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its investigational drug, Qnexa®, for the treatment of obesity. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010.

1 Mar 2010