New Drug Application News and Research

RSS

Mylan Pharmaceuticals and Matrix Laboratories enter into license agreement with Pfizer

Mylan Inc. today announced that the company's Mylan Pharmaceuticals and Matrix Laboratories subsidiaries entered into a settlement and license agreement with Pfizer Inc. relating to Voriconazole Tablets, 50 mg and 200 mg, the generic version of Pfizer's Vfend Tablets, a triazole antifungal agent.

15 Oct 2009

Jazz Pharmaceuticals to present Phase III sodium oxybate trial data at ACR 2009 meetings

Jazz Pharmaceuticals, Inc. announced that data from the company's first Phase III clinical trial of sodium oxybate (JZP-6) for the treatment of fibromyalgia will be presented during the American College of Rheumatology 2009 Annual Meeting (ACR) in Philadelphia, Pennsylvania and also in November during the US Psychiatric and Mental Health Congress (US Psych Congress) in Las Vegas, Nevada.

15 Oct 2009

Biosante Pharmaceuticals, Cell Genesys successfully complete merger

BioSante Pharmaceuticals, Inc. and Cell Genesys, Inc., today announced the successful completion of their previously announced merger of Cell Genesys with and into BioSante, with BioSante as the surviving company, under which BioSante now has acquired all of the outstanding shares of Cell Genesys common stock.

15 Oct 2009

Postive vote from FDA Advisory Committee for Fampridine-SR 10

Acorda Therapeutics, Inc. today announced the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use.

15 Oct 2009

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

ZIOPHARM Oncology, Inc. announced today positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed.

14 Oct 2009

Cequent Pharmaceuticals to provide details of its clinical program at BIOCOM conference

Cequent Pharmaceuticals, a pioneer in the development of novel products to deliver RNAi-based treatments to prevent and treat human disease, announced that Chief Executive Officer, Peter Parker, will provide details on Cequent's planned launch of its clinical program and highlight strategy and development goals in a company update scheduled for 3 p.m. on Tuesday, October 27, 2009, at the 2009 BIOCOM Investor Conference.

14 Oct 2009

FDA recommends approval for UI Pharmaceuticals to manufacture an aseptically filled sterile drug product

In September 2009, the Kansas City District Office of the Food and Drug Administration (FDA) submitted a recommendation of approval to the Center for Drug Evaluation and Research for The University of Iowa Pharmaceuticals (UIP) to manufacture and test an aseptically filled, sterile prescription drug product for a commercial client. The drug product contains a new chemical entity and is a sterile solution that is aseptically filled into vials.

14 Oct 2009

Shire settles pending ADDERALL XR litigation with Sandoz

Shire plc, the global specialty biopharmaceutical company, announces that it has settled all pending litigation with Sandoz, Inc. ("Sandoz") in connection with Sandoz's Abbreviated New Drug Application ("ANDA") and its attempt to market generic versions of Shire's ADDERALL XR(R) (mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder.

14 Oct 2009

Johnson & Johnson announces financial results for the third quarter of 2009

Johnson & Johnson today announced sales of $15.1 billion for the third quarter of 2009, a decrease of 5.3% as compared to the third quarter of 2008. Operational results declined 2.8% and the negative impact of currency was 2.5%. Domestic sales declined 8.1%, while international sales declined 2.5%, reflecting operational growth of 2.4% and a negative currency impact of 4.9%.

13 Oct 2009

Spectrum Pharmaceuticals receives Complete Response letter from the FDA for FUSILEV

Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for injection for treatment of patients with advanced metastatic colorectal cancer.

13 Oct 2009

QRxPharma signs contractual agreement with Patheon

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today a contractual agreement with Patheon to manufacture clinical supplies of QRxPharma's controlled release Dual-Opioid(TM) formulation (MoxDuo(TM)CR). MoxDuo(TM)CR is designed to provide 12 hours of pain relief in patients suffering from moderate to severe chronic pain (including cancer, lower back, osteoarthritis and neuropathic).

12 Oct 2009

Labopharm's trazodone API supplier Angelini resolves manufacturing facility deficiencies

Labopharm Inc. today announced that it has been informed by Angelini, the manufacturer of the active pharmaceutical ingredient (API) for the Company's novel trazodone formulation, that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that Angelini has appropriately addressed all deficiencies cited by the FDA following its inspection of the manufacturing facility in June and July of this year.

8 Oct 2009

Biostar Pharmaceuticals' new drug application granted clearance for clinical trials

Biostar Pharmaceuticals, Inc. ("Biostar" or "the Company"), a Xianyang-based developer, manufacturer and supplier of pharmaceutical products and medical nutrients addressing a variety of diseases and conditions, today announced that the Chinese Military Drug Administration has granted clearance to begin clinical trials on the Company's new drug application, the Zushima Analgesic Aerosol Spray.

7 Oct 2009

Cipher Pharmaceuticals enrolls first patient in Phase III study of CIP-ISOTRETINOIN

Cipher Pharmaceuticals Inc. today announced that it has enrolled the first patient in its Phase III safety study of CIP-ISOTRETINOIN, the Company's novel, patented formulation of isotretinoin, which is used in the treatment of severe, nodular acne.

7 Oct 2009

FDA approves Daiichi Sankyo's sNDA for Welchol

Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy.

7 Oct 2009

FDA provides Genzyme a complete response letter for Clolar NDA

Genzyme Corporation announced today that the FDA provided a complete response letter regarding the company's supplemental New Drug Application for Clolar® (clofarabine) in previously untreated older adult patients with acute myeloid leukemia (AML) and at least one unfavorable baseline prognostic factor. The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.

7 Oct 2009

OncoGenex' OGX-011 receives additional FDA Fast Track Designation for treating metastatic prostate cancer

OncoGenex Pharmaceuticals, Inc. announced today that OGX-011, also known as custirsen sodium, received an additional Fast Track Designation from the U.S. Food & Drug Administration (FDA) for progressive metastatic prostate cancer in combination with first-line docetaxel treatment.

6 Oct 2009

FDA accepts ProStrakan's Abstral NDA filing for review

Orexo AB (STO:ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK), has announced that the New Drug Application (NDA) filing for Abstral has been accepted for review by the US Food and Drug Administration (FDA).

6 Oct 2009

Vivaldi receives US patent for live attenuated influenza vaccines

Vivaldi Biosciences Inc. (Vivaldi), a biotechnology company focused on development of vaccines for influenza, today announced that the United States Patent and Trademark Office has issued US Patent 7,588,768 covering live attenuated influenza vaccines (LAIVs) with modifications to the viral NS1 gene, and methods for producing the vaccines in cell culture systems.

6 Oct 2009

Alnara to announce Phase 3 study results of liprotamase for treating cystic fibrosis at the 23rd NACFC

Alnara Pharmaceuticals, Inc., a pharmaceutical company developing novel, non-systemic orally-delivered protein therapeutics for the treatment of metabolic diseases, announced today that results from a landmark, international Phase 3 study of the long-term safety and nutritional benefits of liprotamase for the treatment of pancreatic insufficiency in patients with cystic fibrosis (CF) will be presented at the 23rd Annual North American Cystic Fibrosis Conference (NACFC) being held October 15-17, 2009 in Minneapolis, Minnesota.

5 Oct 2009

New Drug Application News and Research

Mylan Pharmaceuticals and Matrix Laboratories enter into license agreement with Pfizer

Jazz Pharmaceuticals to present Phase III sodium oxybate trial data at ACR 2009 meetings

Biosante Pharmaceuticals, Cell Genesys successfully complete merger

Postive vote from FDA Advisory Committee for Fampridine-SR 10

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

Cequent Pharmaceuticals to provide details of its clinical program at BIOCOM conference

FDA recommends approval for UI Pharmaceuticals to manufacture an aseptically filled sterile drug product

Shire settles pending ADDERALL XR litigation with Sandoz

Johnson & Johnson announces financial results for the third quarter of 2009

Spectrum Pharmaceuticals receives Complete Response letter from the FDA for FUSILEV

QRxPharma signs contractual agreement with Patheon

Labopharm's trazodone API supplier Angelini resolves manufacturing facility deficiencies

Biostar Pharmaceuticals' new drug application granted clearance for clinical trials

Cipher Pharmaceuticals enrolls first patient in Phase III study of CIP-ISOTRETINOIN

FDA approves Daiichi Sankyo's sNDA for Welchol

FDA provides Genzyme a complete response letter for Clolar NDA

OncoGenex' OGX-011 receives additional FDA Fast Track Designation for treating metastatic prostate cancer

FDA accepts ProStrakan's Abstral NDA filing for review

Vivaldi receives US patent for live attenuated influenza vaccines

Alnara to announce Phase 3 study results of liprotamase for treating cystic fibrosis at the 23rd NACFC

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

Latest News