|Acura Announces Paragraph IV ANDA Filing for OXECTA(R); FDA Approves New Indication For Prolia® (Denosumab)|
|By Staff and Wire Reports|
|Thursday, 20 September 2012 18:49|
Acura Pharmaceuticals (NASDAQ: ACUR), a specialty pharmaceutical company developing products intended to address medication abuse and misuse, announced it has received notification from a generic sponsor of the filing of an Abbreviated New Drug Application (ANDA) for a generic drug listing Pfizer Inc.'s OXECTA (oxycodone HCl) Tablets CII as the reference listed drug. OXECTA is covered by U.S. patents issued to Acura and licensed to Pfizer.
The notification includes a Paragraph IV certification indicating the generic sponsor believes Acura's patents are invalid, unenforceable or not infringed. Acura intends to take appropriate action to enforce its intellectual property.
Amgen (NASDAQ:AMGN) announced the U.S. FDA approved a new indication for Prolia® (denosumab) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture. Prolia, the first FDA-approved RANK Ligand inhibitor, is a subcutaneous injection administered by a health care professional every six months.
"While osteoporosis and osteoporosis-related fractures are more commonly associated with postmenopausal women, osteoporosis in men is a significant issue that is increasing in prevalence as life expectancies rise," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Fractures can be a life-changing event, so we are pleased that we can offer a new treatment option for the growing number of men with osteoporosis at high risk for fracture."
According to the National Osteoporosis Foundation, two million men in the U.S. have osteoporosis and another 12 million are at risk.1 Osteoporosis and osteoporotic fractures in men remain under diagnosed and under treated.2
The new indication for Prolia is based on results from the ADAMO trial3 (A multicenter, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of DenosumAb 60 mg every six months versus placebo in Males with Osteoporosis), the pivotal Phase 3 study involving 242 men with low bone mineral density (BMD). In the study, treatment with Prolia resulted in significantly greater gains at the lumbar spine when compared to placebo (5.7 percent vs. 0.9 percent). Effects of Prolia on BMD were independent of age, baseline testosterone levels, BMD status and estimated fracture risk.
Additional results showed that patients in the study who received treatment with Prolia experienced BMD increases at all other skeletal sites assessed compared to placebo, including at the total hip (2.4 percent vs. 0.3 percent) and at the femoral neck (2.1 percent vs. 0.0 percent). Safety findings were consistent with what have been observed in other studies of Prolia in postmenopausal women with osteoporosis. The most common adverse reactions reported (per patient incidence > 5 percent) were back pain, arthralgia and nasopharyngitis.
Air Products (NYSE: APD) will exhibit its portfolio of medical and industrial grade gases for pharmaceutical, biotechnology, and life science applications at the 2012 Mid-Atlantic Bio conference in Bethesda, Md. from September 27-28.
Alexandria Real Estate Equities, Inc. (NYSE: ARE), the leading owner, operator, and developer of high-quality, sustainable real estate for the broad and diverse life science industry, is honored to announce that Roche Holding Ltd will establish its new Translational Clinical Research Center (TCRC) at the Alexandria Center for Life Science – New York City.
Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) approved a new indication for Prolia® (denosumab) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture.
AspenBio Pharma, Inc. (Nasdaq: APPY), an in vitro diagnostic company, today announced that it will present at the 2012 Aegis Healthcare Conference to be held September 27 – 29, 2012, at The Wynn in Las Vegas, NV.
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced several business updates.
China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP) ("China Botanic" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and Traditional Chinese Medicines ("TCM") in China, today announced that due to a system error on the Company's part the conference call scheduled for today, September 20, 2012 was mistakenly cancelled.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Greg S. Lea, SVP and Chief Financial Officer, is scheduled to present at the Craig-Hallum 3rd Annual Alpha Select Conference on Thursday, September 27, 2012 at 12:50 pm Eastern Time, at Sentry Centers, New York, NY.
HP (NYSE: HPQ) Enterprise Services today announced it has been awarded a $43 million task order from the U.S. Centers for Medicare & Medicaid Services (CMS) to continue providing information management, maintenance and integration to assist the electronic health records (EHR) incentive programs.
Ingen Technologies, Inc. (PINKSHEETS: IGNT), an emerging medical device manufacturer with proprietary medical products for the growing $4 billion respiratory markets, is pleased to announce that Richard Campbell (President of RC Product Development & Engineering), David Holland (CEO of SomaLife Consulting LLC) and Michael Cooper (Executive Vice President of SomaLife Consulting LLC) have joined its Board of Directors as referenced in the 8-K filing on September 12, 2012.
MetaStat, Inc. (OTCBB: MTST), a life science company focused on the development and commercialization of proprietary clinical diagnostic and prognostic tests that predict the probability of systemic hematogenous (blood borne) cancer metastasis, as well as companion therapeutics to prevent this deadly spread, today announced a National Cancer Institute research grant for the Company's technology licensed from Albert Einstein College of Medicine.
MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane announced today that it will present at the Craig-Hallum 3rd Annual Alpha Select Conference in New York City.
MYOS Corporation (OTCBB: MYOS), a company focused on the discovery, development and commercialization of muscle health and performance therapeutic products, today announced that it has initiated a broad human clinical research study designed to confirm the unique myostatin modulating activities of its first product, MYO-T12™.
Northwest Biotherapeutics (OTC.BB: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for cancer, announced today that it is in late stage discussions with medical centers in the U.S. and Europe to proceed with a Phase I/II clinical trial with the Company's third major product line, DCVax®-Direct, for all types of solid tumor cancers (i.e., cancers in any tissues).
OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced that Punit Dhillon, President and CEO, will present at the following healthcare and investor conferences in upcoming weeks: Noble Financial BioXposition (BIOX), University of Connecticut, Stamford Campus,Stamford, CT, September 24 at 4:00 PM ET.
Progressive Care Inc. (OTCBB: RXMD), and its wholly-owned subsidiary PharmCo, LLC (collectively, "Progressive Care"), a provider of prescription pharmaceuticals, specializing in anti-retroviral patient management, long-term care and durable medical equipment, announced today that it has retained Consulting for Strategic Growth 1 ("CFSG1") as its U.S. investor and public relations representative.
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced that Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics, will present a corporate update at the 2012 Aegis Healthcare Conference taking place from September 27-29, 2012 at The Wynn in Las Vegas, Nevada.
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that several abstracts related to KRYSTEXXA® (pegloticase) in the treatment of patients with Refractory Chronic Gout (RCG) will be presented at the 2012 ACR/ARHP Annual Meeting taking place in Washington D.C., from November 9-14, 2012.
TelVue® Corporation (OTCQB: TEVE), the innovation leader in Television and Internet Broadcasting for communities, cable operators, and media companies announces a significant upgrade to one of its most widely-used broadcast servers, the B100 HyperCaster™.
TheDirectory.com, Inc. (PINKSHEETS: SEEK), an emerging leader in the Vertical and Local search space, today announced that it has launched the third version of www.TheDirectory.com, its Local business search engine.
Tempur-Pedic International Inc. (NYSE: TPX), the leading manufacturer, marketer and distributor of premium mattresses and pillows worldwide, has provided over a million nights of rest and rejuvenation to more than 64,000 families served by Ronald McDonald House Charities® (RMHC®) through their partnership with the Ronald McDonald House® program throughout the United States.
Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that its Chief Scientific Officer, Nozer Mehta, Ph.D., will present an update on UGP281, Unigene's novel anorexigenic peptide, at the 2012 Obesity Society's Annual Scientific Meeting in San Antonio.
United Therapeutics Corporation (NASDAQ: UTHR) announced today that it has signed an exclusive agreement with Ascendis Pharma A/S to apply Ascendis Pharma's proprietary TransCon technology platform to United Therapeutics' treprostinil molecule, the active ingredient in Remodulin® (treprostinil) injection.
VIVUS, Inc. (Nasdaq: VVUS) today announced that multiple scientific abstracts will be presented at Obesity 2012, the 30th Annual Scientific Meeting of The Obesity Society, to be held September 20th to September 24th in San Antonio, Texas.