Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge).
The details can be read here.
Sunday, October 5, 2008
New Drug Application (NDA) for Lipsovir submitted to US FDA
Medivir has today submitted an NDA to the US FDA for Lipsovir, a topical product for prevention and treatment of cold sores.
Lipsovir is a patented combination of hydrocortisone (an anti-inflammatory agent) and aciclovir (an antiviral agent) in a proprietary cream base developed by Medivir.
The details can be read here.
Lipsovir is a patented combination of hydrocortisone (an anti-inflammatory agent) and aciclovir (an antiviral agent) in a proprietary cream base developed by Medivir.
The details can be read here.
AMT Intends to Incorporate Additional Data to its Marketing Authorization Dossier for Glybera
Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today that it intends to incorporate additional data into the Marketing Authorization Application (MAA) for Glybera(R) for Lipoprotein Lipase Deficiency (LPLD), a seriously debilitating and potentially lethal disease.
The details can be read here.
The details can be read here.
USFDA Approved the use of REYATAZ Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients
Bristol-Myers Squibb Company announced today that the USFDA approved the use of REYATAZ (atazanavir sulfate) 300 mg once-daily boosted with ritonavir 100 mg as part of combination therapy in previously untreated (treatment-naive) HIV-1 infected patients.
The details can be read here.
The details can be read here.
Arriva Pharmaceuticals Granted Protein Production Patent
Arriva Pharmaceuticals, a biopharmaceutical company focused on developing anti-inflammatory therapies, announced today that it had been granted a patent in the U.S. for methods to produce certain proteins in yeast. Among the proteins whose production is covered by the patent (United States Patent 7,419,801) is recombinant alpha 1-antitrypsin (rAAT), the protein used in Respriva™, the company’s lead product.
The details can be read here.
The details can be read here.
Milestone Scientific Acquires Additional Patent Rights for Painless Injections and Resolves Related Litigations
Milestone Scientific Inc., the recognized leader in advanced injection technologies, today announced that it has acquired additional patent rights with respect to painless anesthetic injections -- specifically rights related to controlling the flow rate or pressures used in providing these injections -- through issuance of 260,000 shares of restricted common stock.
The details can be read here.
The details can be read here.
Clopidogrel: Court rules in favor of Acino
The Acino Group has won yet another favorable court ruling in the legal proceedings regarding clopidogrel (original product: Plavix® / Iscover® by Sanofi-Aventis / Bristol-Myers Squibb).
The details can be read here.
The details can be read here.
Bioniche Pharma Receives FDA Approval for 10 mg/mL Strength of Ketamine Hydrochloride Injection, USP
Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, announced today the U.S. Food and Drug Administration's approval of its 10 mg/mL strength of Ketamine Hydrochloride Injection, USP, the generic equivalent of JHP Pharmaceuticals' Ketalar(R)CIII.
The details can be read here.
The details can be read here.
Watson Notified of OXYTROL Patent Challenge
Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed the receipt of a Paragraph IV Certification Notice Letter relating to an ANDA submitted to the USFDA by a generic filer requesting approval to market and sell a generic version of OYXTROL (Oxybutynin Transdermal System). In its Notice Letter, the filer alleges that patents covering OXYTROL are invalid, unenforceable and/or will not be infringed by their manufacture, use or sale of the product described in its ANDA.
The details can be read here.
The details can be read here.
Thursday, October 2, 2008
Court affirms Amgen EPO patents, blocks Roche drug
A U.S. court on Thursday affirmed a jury verdict upholding Amgen Inc patents on its blockbuster anemia drugs, effectively blocking Roche Holding AG from selling a rival drug in the United States, Amgen said.
The details can be read here.
The details can be read here.
New data shows better efficacy of eslicarbazepine acetate for epilepsy
Sepracor Inc announced that positive data from three phase-III studies presented at the 8th European Congress of Epileptology in Berlin, demonstrated that eslicarbazepine acetate, a novel once-daily anti-epileptic agent, significantly reduced the frequency of partial seizures in patients with refractory partial epilepsy, in combination with other anti-epileptic agents.
The details can be read here.
The details can be read here.
Once-yearly Aclasta approved in EU to treat osteoporosis in men
The European Commission has approved once-yearly Aclasta (zoledronic acid 5 mg) for the treatment of osteoporosis in men who are at increased risk of fractures, and broadened the Aclasta label to include reduction of new clinical fractures in both men and postmenopausal women with osteoporosis who have recently suffered a hip fracture.
The details can be read here.
The details can be read here.
PharmAthene gets $84 mn NIAID contract for anthrax vaccine programme
PharmAthene, Inc, a biodefense company developing medical countermeasures against biological and chemical threats, announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the Company a multi-year contract for up to $83.9 million for advanced development of a third generation recombinant protective antigen (rPA) anthrax vaccine.
The details can be read here.
The details can be read here.
Baxter's Antimicrobial IV Technology Now Shown to Kill Six Common Pathogens, Including MRSA and VRE
Baxter Healthcare Corporation today announced that it received 510(k) clearance for expanded labeling for the first antimicrobial needleless intravenous (IV) connector, V-Link Luer-activated device (LAD) with VitalShield protective coating. With a new federal policy restricting reimbursement for healthcare-associated infections (HAIs) taking effect on October 1, healthcare professionals are seeking effective techniques and technologies to reduce the risk of contamination from a broad array of pathogens (infection-causing agents) within their hospitals.
The details can be read here.
The details can be read here.
FDA Grants Lilly's Alimta (Pemetrexed for Injection) Third U.S. Approval
Eli Lilly and Company (NYSE:LLY) announced today it received approval from the U.S. Food and Drug Administration for the use of ALIMTA (pemetrexed for injection), in combination with cisplatin, in the first-line treatment of locally-advanced and metastatic non-small cell lung cancer (NSCLC), for patients with nonsquamous histology. ALIMTA is not indicated for treatment of patients with squamous cell non-small cell lung cancer. NSCLC is the most common form of lung cancer, resulting in more than 180,000 new cases in the U.S. each year.
The details can be read here.
The details can be read here.
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