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Regeneron second-quarter total revenues increase to $115.9 million

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2010. The Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for the second quarter of 2010 compared with a net loss of $14.9 million, or $0.19 per share (basic and diluted), for the second quarter of 2009.

28 Jul 2010

LLS collaborates with Shape Pharmaceuticals to advance treatment for CTCL

The Leukemia & Lymphoma Society (LLS) and Shape Pharmaceuticals announced today that they have entered into a partnership to advance Shape's novel, topical treatment for cutaneous T-Cell lymphoma (CTCL) into clinical development. The compound, SHP-141, is a first-in-class topical histone deacetylase inhibitor with the potential to treat both early- and late-stage CTCL.

28 Jul 2010

Antares Pharma reports positive results from Anturol Gel Phase 3 study in overactive bladder patients

Antares Pharma, Inc. announced today positive results from its Phase 3 study of Anturol Gel in patients with overactive bladder. The study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied.

28 Jul 2010

InterMune second-quarter total revenue decreases to $5.9 million

InterMune, Inc. today announced results from operations for the second quarter and six months ended June 30, 2010. InterMune also highlighted its recent clinical development and business activities, and provided forward-looking financial guidance for 2010.

28 Jul 2010

Momenta Pharmaceuticals provides update on generic Lovenox ANDA litigation

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today provided an update regarding a lawsuit that Sanofi-Aventis U.S. LLC filed in the United States District Court for the District of Columbia against the U.S. Food and Drug Administration (FDA), Margaret A. Hamburg, Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services.

27 Jul 2010

Alcon second-quarter global sales increase 12.5% to $1.89 billion

Alcon, Inc. reported that global sales rose 12.5 percent to $1.89 billion for the second quarter of 2010, or 11.3 percent excluding the impact of foreign exchange fluctuations and acquisitions. Revenue from acquisitions added 40 basis points to sales growth in the quarter, while foreign currency fluctuations added 80 basis points of growth.

27 Jul 2010

Alexza second-quarter net loss decreases to $12.9 million

Alexza Pharmaceuticals, Inc. today reported financial results for the quarter ended June 30, 2010 and provided a business update. The net loss for the three and six months ended June 30, 2010, as reported in accordance with accounting principles generally accepted in the United States (GAAP), was $12.9 million and $26.3 million, respectively, compared to a net loss of $17.0 million and $23.9 million in the respective comparable periods in 2009. Alexza had consolidated cash, cash equivalents and marketable securities at June 30, 2010 of $41.7 million.

27 Jul 2010

QRxPharma reports positive outcome of European Scientific Advice meetings on MoxDuo IR pain therapy

QRxPharmareported today positive outcomes of its European Scientific Advice meetings on the development and registration of MoxDuo IR, an immediate release Dual-Opioid™ pain therapy. The Company is currently completing pivotal Phase 3 trials required for filing a New Drug Application (NDA) for MoxDuo IR with the United States Food and Drug Administration (FDA).

26 Jul 2010

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.

26 Jul 2010

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Onyx Pharmaceuticals, Inc. today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

26 Jul 2010

Teva comments on FDA's approval of generic Lovenox injection

Teva Pharmaceutical Industries Ltd. commented today on the U.S. Food and Drug Administration's response to a citizen petition questioning the approval criteria for a generic Lovenox (enoxaparin sodium) injection and its subsequent approval of another generic filer's Abbreviated New Drug Application.

26 Jul 2010

FDA grants marketing approval of ANDA for enoxaparin sodium for injection

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration has granted marketing approval of the Abbreviated New Drug Application for enoxaparin sodium for injection filed by Sandoz. Developed under a collaboration agreement between Momenta and Sandoz, this product has been designated therapeutically equivalent to the reference-listed drug, Lovenox, which is marketed by Sanofi-Aventis.

26 Jul 2010

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.

23 Jul 2010

Expert to speak on challenges, issues in development, implementation of REMS

At two Food and Drug Administration meetings, Sidney H. Schnoll, MD, PhD, Vice President, Pharmaceutical Risk Management Services of PinneyAssociates, will discuss the need for predictability, feasibility and transparency to ensure that Risk Evaluation and Mitigation Strategies benefit patient safety and public health.

23 Jul 2010

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of patient randomization in its Phase 3 registration study of GATTEX® (teduglutide). The double-blind, placebo-controlled safety and efficacy study, which is known as STEPS, is being conducted in patients with parenteral nutrition (PN) dependent short bowel syndrome (SBS) and is now fully randomized with 86 patients.

23 Jul 2010

FDA approves Mylan's ANDA for generic Solodyn ER tablets for acne treatment

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited received final approval on July 20 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn® ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis). Mylan Pharmaceuticals Inc. commenced immediate shipment of the product after approval.

23 Jul 2010

FDA approves Impax's ANDA for generic OPANA ER 30mg tablet

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of OPANA® ER (oxymorphone hydrochloride) Extended Release 30mg tablet. In June 2010, the Company was granted final approval for the 5mg, 10mg, 20mg, and 40mg tablets.

23 Jul 2010

Alexion second-quarter non-GAAP net income increases 56% to $36.9 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three and six months ended June 30, 2010.

22 Jul 2010

Somaxon's Silenor Phase 3 clinical data accepted for publication in Sleep, Sleep Medicine journals

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that detailed results from two Phase 3 clinical trials of the company's product Silenor® (doxepin) have been accepted for publication in peer-reviewed scientific journals.

22 Jul 2010

Onconase, Amphinase 2 show positive results for SARS virus: Tamir Biotechnology

Tamir Biotechnology, Inc. announced today that scientists supported by the National Institute of Allergy and Infectious Diseases confirmed that testing of two (2) of the company's compounds Onconase (Ranpirnase), and recombinant Amphinase 2 showed positive in vitro results for Severe Acute Respiratory Syndrome, also known as (SARS) virus.

22 Jul 2010