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Noven Pharmaceuticals provides update on status of generic Lidoderm ANDA

Noven Pharmaceuticals, Inc. today provided an update on the status of its pending Abbreviated New Drug Application (ANDA) seeking approval to market a lidocaine topical patch 5%. Noven's lidocaine topical patch 5% is a generic version of Endo Pharmaceuticals' Lidoderm.

30 Jun 2012

Bayer receives priority review designation from FDA for regorafenib NDA

Bayer HealthCare and Onyx Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted priority review designation to Bayer HealthCare's New Drug Application (NDA) filed end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

29 Jun 2012

Gilead submits cobicistat NDA with FDA for treatment of HIV

Gilead Sciences, Inc. announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing.

29 Jun 2012

Gilead submits elvitegravir NDA with FDA for treatment of HIV-1 infection

Gilead Sciences, Inc. announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults.

28 Jun 2012

Astellas submits enzalutamide MAA with EMA for treatment of CRPC

Today, Astellas Pharma Inc. announces the submission of a European marketing authorisation application to the European Medicines Agency (EMA) for enzalutamide for the treatment of men with metastatic castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

27 Jun 2012

Pfizer, Wyeth and PF Prism file suit against Watson over generic Pristiq

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Desvenlafaxine Succinate Extended-release Tablets, 50 mg and 100 mg.

26 Jun 2012

MAP Pharmaceuticals completes End-of-Review meeting with FDA for LEVADEX NDA

MAP Pharmaceuticals, Inc. today announced that the Company completed an End-of-Review meeting with the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for LEVADEX (dihydroergotamine) inhalation aerosol.

25 Jun 2012

Pfizer, Bristol-Myers Squibb receive FDA CRL for ELIQUIS NDA

Bristol-Myers Squibb Company and Pfizer announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ELIQUIS (apixaban) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

25 Jun 2012

BV treatment: full enrolment for phase 2 and first phase 3 trial

Starpharma Holdings Ltd (ASX:SPL; OTCQX: SPHRY) is pleased to report that recruitment is now 100% complete for its Phase 2 clinical trial to investigate the ability of VivaGel® to prevent the recurrence of BV, and also for the first of two pivotal Phase 3 studies of VivaGel® for the treatment of BV.

25 Jun 2012

FDA issues CRL to Repligen's RG1068 NDA for treatment of pancreatitis

Repligen Corporation today announced that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for RG1068.

23 Jun 2012

Alexza resubmits ADASUVE NDA to U.S. FDA

Alexza Pharmaceuticals, Inc. announced today that it has resubmitted its ADASUVE New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2012.

22 Jun 2012

European CHMP adopts positive opinion for teduglutide to treat short bowel syndrome

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc., jointly announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product teduglutide (Revestive) as a once-daily treatment for adult patients with short bowel syndrome (SBS).

22 Jun 2012

Janssen receives FDA complete response letter for XARELTO sNDA

Janssen Research & Development, LLC (Janssen R&D) announced today the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS).

22 Jun 2012

Data from MAP Pharmaceuticals’ LEVADEX clinical studies to be presented at AHS meeting

MAP Pharmaceuticals, Inc. today announced that the Company will present data on LEVADEX (formerly MAP0004), an orally inhaled investigational drug for the acute treatment of migraine, at the 54th Annual Scientific Meeting of the American Headache Society (AHS) in Los Angeles, CA, June 21-24, 2012.

22 Jun 2012

FDA grants Orphan Drug Designation to Medgenics’ INFRADURE Biopump

Medgenics, Inc., the developer of Biopump, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that its INFRADURE Biopump has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for the treatment of hepatitis D.

21 Jun 2012

FDA ODAC votes in favor of Onyx’s Kyprolis

Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11-0 with 1 abstention that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis.

21 Jun 2012

FDA provides Orphan Drug Designation to Alnylam’s ALN-TTR02

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that the U.S. Food & Drug Administration (FDA) has provided Orphan Drug Designation to ALN-TTR02 as a therapeutic for the treatment of familial amyloidotic polyneuropathy (FAP), one of the predominant clinical manifestations of transthyretin (TTR)-mediated amyloidosis (ATTR).

20 Jun 2012

Delcath includes second-generation hemofiltration cartridge in chemosaturation system EAP

Delcath Systems, Inc. today announced that the Company has amended its Investigational New Drug (IND) application and its Expanded Access Program (EAP) to include the use of the second-generation hemofiltration cartridge of the Company's proprietary chemosaturation system.

19 Jun 2012

US Court of Appeals confirms District Court decision in Watson's Sanctura XR patent suit

Watson Pharmaceuticals, Inc. today confirmed that the United States Court of Appeals for the Federal Circuit has affirmed the United States District Court for the District of Delaware's March 31, 2012 decision that the asserted claims of U.S. Patent Nos. 7,410,978; 7,759,359; 7,781,448; 7,781,449 and 7,763,635 relating to Sanctura XR (trospium chloride extended-release capsules) are invalid.

19 Jun 2012

Pfizer receives FDA Complete Response Letter for tafamidis meglumine NDA

Pfizer Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for tafamidis meglumine.

19 Jun 2012