New Drug Application News and Research

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FDA approves Horizon Pharma's RAYOS to treat key IL-6 mediated diseases

Horizon Pharma, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved RAYOS (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).

26 Jul 2012

Takeda, Sucampo file AMITIZA sNDA with FDA for treatment of opioid-induced constipation

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A. Inc. today announced the filing of a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for a new indication for AMITIZA (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

26 Jul 2012

Gilead Sciences second quarter total revenues increase 13% to $2.41 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2012.

26 Jul 2012

Insomnia: an interview with Dr Darryle Schoepp

Insomnia is a very common disorder. In medical terms it can affect a third of people. It affects elderly as well as non-elderly people, and is more common in women.

26 Jul 2012

Multi-center clinical trial results demonstrate safety and efficacy of carfilzomib for multiple myeloma

Researchers from John Theurer Cancer Center at HackensackUMC, one of the nation's 50 best hospitals for cancer, played leading roles in three separate multi-center studies with the new proteasome inhibitor carfilzomib published in Blood, a major peer-reviewed scientific journal.

26 Jul 2012

FDA grants priority review to GSK’s Promacta sNDA for treatment of thrombocytopenia

Ligand Pharmaceuticals Incorporated today announced that its partner GlaxoSmithKline has been granted priority review from the US Food and Drug Administration for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus (HCV) infection.

26 Jul 2012

Aeterna Zentaris files request with FDA for Fast Track designation for AEZS-130

Aeterna Zentaris Inc. today announced that it has filed a request with the United States Food and Drug Administration (FDA) for Fast Track designation for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD).

25 Jul 2012

New investment to fund Chiasma's Octreolin Phase 3 pivotal program for acromegaly

Chiasma, Inc., a privately held biopharma company, announced that it closed a $38.5 million equity financing co-led by new investor Abingworth and current investor MPM Capital that also included investments from existing shareholders 7 Med Health Ventures, ARCH Venture Partners, F3 Ventures and Fredric Price, Chiasma's Chairman & CEO.

23 Jul 2012

Alexza obtains $20 million flexible financing facility from Azimuth Opportunity

Alexza Pharmaceuticals, Inc. announced today that it has obtained a committed equity financing facility under which it may sell up to $20 million of its registered common stock to Azimuth Opportunity, L.P., over an approximately 24-month period.

23 Jul 2012

Silymarin does not offer significant improvements for patients with HCV

Silymarin, an extract of milk thistle commonly used to treat chronic liver disease by millions of people around the World, does not offer significant improvements for patients, according to a new study conducted by a nationwide group of researchers including faculty at the Perelman School of Medicine at the University of Pennsylvania.

20 Jul 2012

Cubist second quarter total net revenues increase 30% to $230.6M

Cubist Pharmaceuticals, Inc. today announced results for the second quarter ended June 30, 2012.

20 Jul 2012

Positive preliminary results from Feraheme phase III study on iron deficiency anemia

AMAG Pharmaceuticals, Inc. today reported preliminary results from the second phase III study from its global registrational program for Feraheme (ferumoxytol) in patients with iron deficiency anemia (IDA) regardless of the underlying cause.

19 Jul 2012

Johnson & Johnson second quarter sales decrease 0.7% to $16.5B

Johnson & Johnson today announced sales of $16.5 billion for the second quarter of 2012, a decrease of 0.7% as compared to the second quarter of 2011. Operational results increased 3.5% and the negative impact of currency was 4.2%.

17 Jul 2012

Positive results from Alnylam’s ALN-TTR02 Phase I trial on TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today the achievement of positive clinical results from its Phase I trial with ALN-TTR02, an RNAi therapeutic targeting the transthyretin (TTR) gene for the treatment of TTR-mediated amyloidosis.

16 Jul 2012

FDA approves Watson's ANDA for Next Choice ONE DOSE emergency contraceptive

Watson Pharmaceuticals, Inc. today announced that its subsidiary Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5 mg), the generic equivalent to Teva Women's Health's Plan B One-Step. Watson plans to launch the product immediately.

13 Jul 2012

FDA approves Watson’s ANDA for generic ARTHROTEC

Watson Pharmaceuticals, Inc. today announced that its subsidiary Watson Laboratories, Inc - Florida has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium and Misoprostol Delayed-Release Tablets, the generic equivalent to G.D. Searle's ARTHROTEC.

12 Jul 2012

Enrollment complete in Lux Biosciences Luveniq Phase 3 study for non-infectious uveitis

Lux Biosciences, Inc. today announced the completion of patient enrollment in its Phase 3 clinical study of Luveniq (oral voclosporin) for the treatment of non-infectious uveitis. Lux Biosciences anticipates that data from the Phase 3 study will be available early in the first quarter of 2013.

9 Jul 2012

Onyx commences ENDEAVOR Kyprolis Phase 3 trial for relapsed multiple myeloma

Onyx Pharmaceuticals, Inc. announced today that the company has begun enrollment in the ENDEAVOR trial, a Phase 3 trial evaluating Kyprolis in combination with dexamethasone, versus bortezomib with dexamethasone in patients with relapsed multiple myeloma.

2 Jul 2012

Rexahn submits RX-5902 IND to FDA for treatment of advanced or metastatic solid tumors

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted an investigational new drug application (IND) to the Food and Drug Administration for a first-in-human study of RX-5902 to treat advanced or metastatic solid tumors.

2 Jul 2012

Janssen seeks accelerated FDA approval for bedaquiline to treat MDR-TB

Janssen Research & Development, LLC today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for the use of the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults.

2 Jul 2012

New Drug Application News and Research

FDA approves Horizon Pharma's RAYOS to treat key IL-6 mediated diseases

Takeda, Sucampo file AMITIZA sNDA with FDA for treatment of opioid-induced constipation

Gilead Sciences second quarter total revenues increase 13% to $2.41 billion

Insomnia: an interview with Dr Darryle Schoepp

Multi-center clinical trial results demonstrate safety and efficacy of carfilzomib for multiple myeloma

FDA grants priority review to GSK’s Promacta sNDA for treatment of thrombocytopenia

Aeterna Zentaris files request with FDA for Fast Track designation for AEZS-130

New investment to fund Chiasma's Octreolin Phase 3 pivotal program for acromegaly

Alexza obtains $20 million flexible financing facility from Azimuth Opportunity

Silymarin does not offer significant improvements for patients with HCV

Cubist second quarter total net revenues increase 30% to $230.6M

Positive preliminary results from Feraheme phase III study on iron deficiency anemia

Johnson & Johnson second quarter sales decrease 0.7% to $16.5B

Positive results from Alnylam’s ALN-TTR02 Phase I trial on TTR-mediated amyloidosis

FDA approves Watson's ANDA for Next Choice ONE DOSE emergency contraceptive

FDA approves Watson’s ANDA for generic ARTHROTEC

Enrollment complete in Lux Biosciences Luveniq Phase 3 study for non-infectious uveitis

Onyx commences ENDEAVOR Kyprolis Phase 3 trial for relapsed multiple myeloma

Rexahn submits RX-5902 IND to FDA for treatment of advanced or metastatic solid tumors

Janssen seeks accelerated FDA approval for bedaquiline to treat MDR-TB

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