QRX issued CRL. SUPN receives tentative FDA Approval. DVAX PDUFA set for February. ALXA files shelf. OMER offering. ATRS NDA filing due 1Q 2013 + MDVN
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today it received a Complete Response Letter (CRL) for MOXDUO in patients with moderate to severe acute pain. The Company has been granted a meeting with the FDA to clarify the steps required for approval.
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) received a tentative approval letter from the FDA for Trokendi XR, a once-daily extended release formulation of topiramate (formerly known as SPN-538). Final approval is conditioned on resolving a marketing exclusivity issue raised by the FDA regarding a specific pediatric population. The Company also learned that the FDA denied the Citizen’s Petition filed in 2011 by Upsher Smith Laboratories as it relates to its NDA on Trokendi XR.
Dynavax Technologies Corporation (NASDAQ: DVAX) today announced a PDUFA date of February 24, 2013 for its Biologics License Application (BLA) for HEPLISAV, for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age. It also expects to submit a European Marketing Authorization Application (MAA) during 3Q 2012. Upon approval of the HEPLISAV BLA, Dynavax plans to submit a supplemental BLA for an indication in patients with chronic kidney disease.
Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) filed a shelf allowing it to sell common stock, preferred stock, debt securities and/or warrants with a total value of up to $40m.
Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that Astellas has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for enzalutamide (formerly MDV3100) for the treatment of men with metastatic castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Omeros Corporation (NASDAQ: OMER) today announced its intention to offer shares of its common stock in a public offering.
Antares Pharma, Inc. (NASDAQ: ATRS) said that it remains on track to file its NDA of VIBEX Methotrexate (MTX) for the treatment of rheumatoid arthritis (RA), during 1Q 2013.