Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that a patent has been issued by the US Patent and Trademark Office (USPTO) covering its Oxycodone DETERx formulation. Additionally, an application has been ...
US-based biopharmaceutical company MannKind has resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking marketing authorization for its AFREZZA inhalation powder, indicated to improve glycemic control ...
Tags: Insulin Application, biopharmaceutical company MannKind
US-based clinical stage biopharmaceutical firm Heat Biologics has filed an investigational new drug application (NDA) with the US Food and Drug Administration (FDA) for its second product candidate, HS-410, which will be evaluated in ...
The US Food and Drug Administration (FDA) has accepted to review AstraZeneca's new drug application (NDA) for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridaemia. Omthera Pharmaceuticals, ...
Naturally Splendid has signed a non-disclosure agreement (NDA) with Calico Food Ingredients to test plant-based Omega products, H2Omega and HempOmega, developed by Boreal Technologies. HempOmega and H2Omega are patent pending, powder and ...
Tags: Omega Products, Naturally Splendid
The US Food and Drug Administration (FDA) has scheduled a meeting on 03 October 2013 to discuss QRxPharma's Moxduo new drug application (NDA) for the treatment of moderate to severe acute pain. The meeting is aimed at focusing on ...
Tags: Acute Pain Drug
The US Food and Drug Administration (FDA) has accepted for review the complete response submission made by Endo Health Solutions' subsidiary Endo Pharmaceuticals to the new drug application (NDA) for its testosterone undecanoate injection ...
Tags: Aveed Injection, Medicine
The National Dairy Authority (NDA) of Philippines has reported that the imports of milk and cream from abroad decreased 5.4% to 405,930 tons for the first quarter of 2013. The decline in imports was primarily due to increase in domestic ...
Tags: Dairy Imports, Agriculture
Clinical-stage biopharmaceutical company Pharmacyclics' new drug application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, has been accepted by the US FDA for two B-cell malignancy indications. ...
Tags: Solvay Group, Medicine
ProMetic Life Sciences has selected Alpha1-Antitrypsin (AAT) as its second plasma-derived therapeutic to develop and commercialise the product to address AAT deficiency. The company's PPPS process confirmed to produce AAT with three-fold ...
Biopharmaceutical development company Chelsea Therapeutics has announced the US FDA acceptance of Northera (droxidopa) new drug application (NDA) resubmission to treat symptomatic neurogenic orthostatic hypotension (NOH). The company is ...
Specialty pharmaceutical company Iroko Pharmaceuticals has announced the FDA acceptance for New Drug Application (NDA) filing of lower dose submicron Indomethacin, a non-steroidal anti-inflammatory drug. The proposed indication of the ...
Tags: FDA Acceptance, NDA Filing
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA)from DURECT, a specialty pharmaceutical company, for its Posidur (Saber-Bupivacaine) investigational candidate. Designed to offer up to three days of ...
Biopharmaceutical company Gilead Sciences has obtained priority review status for Sofosbuvir new drug application (NDA) from the FDA for the treatment of hepatitis C infection (HCV). The investigational product is an oral nucleotide ...
Tags: Gilead, Sofosbuvir NDA
OPEL Technologies Inc of Toronto, Ontario, Canada – which develops III-V semiconductor devices and processes through US affiliate OPEL Defense Integrated Systems (ODIS Inc) of Storrs, CT, USA – says that it has made significant ...
Tags: OPEL, Electrical