Phase 3 PREVAIL Trial Named Clinical Advance of the Year by SCRIP; Teva Announces Launch of First Generic Celebrex® Capsules Print E-mail
By Marilyn Mullen   
Wednesday, 10 December 2014 19:47

Below is a look at some of the headlines for companies that made news in the healthcare sector on December 10, 2014.
Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) announced PREVAIL, the global Phase 3 trial of enzalutamide in metastatic castration-resistant prostate cancer (CRPC), was named the Clinical Advance of the Year by SCRIP, a leading pharmaceutical industry publication.

XTANDI® (enzalutamide) capsules is approved in the United States and Europe for the treatment of patients with metastatic CRPC and in Japan for the treatment of patients with CRPC. The companies are also conducting investigational studies of enzalutamide in prostate cancer and advanced breast cancer.

"The PREVAIL trial results have supported successful applications to extend the label of XTANDI to metastatic CRPC patients who are chemotherapy-naïve, marking a significant step forward in the treatment of this common cancer," SCRIP noted.

The annual SCRIP Awards acknowledge the biopharmaceutical industry's most noteworthy achievements and milestones. This year's winners were announced at the SCRIP 10th Anniversary Awards celebration in London.


Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
announces the launch of the first FDA-approved generic equivalent to Celebrex® (Celecoxib) Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules.

“Teva is pleased to be the first to launch generic Celebrex®. The addition of Celecoxib Capsules to our US generics portfolio is further evidence of Teva’s commitment to bring affordable treatment solutions to patients,” said Siggi Olafsson, President and CEO of Global Generic Medicines at Teva.

Celebrex® (Celecoxib) Capsules, marketed by Pfizer, had annual sales of approximately $2.56 billion in the United States, according to IMS data as of October 2014.


Also Wednesday:

Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L),
a leading designer and manufacturer of rapid diagnostic screening and testing products, announces the receipt of an initial purchase order valued at US$1,000,000 from NovoTek Therapeutics Inc. to supply PIFA Heparin PF4/Rapid Assay products in Mainland China.

Allscripts (Nasdaq:MDRX)
and Express Scripts (Nasdaq:ESRX) have announced the deployment of Allscripts eAuth, a new electronic prior authorization (ePA) solution that transacts an electronic prior authorization for Express Scripts patients, replacing the costly, time-consuming, and labor-intensive process of manual prior authorization.

Amedisys, Inc. (Nasdaq:AMED)
, one of America's leading healthcare at home companies, today announced that Dale E. Redman, Interim Chief Financial Officer, will present at the 25th Annual Oppenheimer Healthcare Conference in New York, NY on Thursday, December 11, 2014.

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company primarily focused on the development of oncology therapeutics, today announced that it has dosed the first patient in the Phase II component of a modified Phase I/II clinical study evaluating its lead compound onapristone in women with progesterone receptor expressing tumors.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services and mobile tools for medical groups and health systems, today reaffirmed financial guidance for fiscal year 2014 and announced financial guidance for fiscal year 2015.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
today announced that the Agência Nacional de Vigilancia Sanitaria (ANVISA), or the National Health Surveillance Agency Brazil, has approved VIMIZIM® (elosulfase alfa) for the treatment of patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
announced today that the Food and Drug Administration (FDA) has granted orphan drug designation for BMN 250, a novel fusion of alpha-N-acetyglucosaminidase (NAGLU) with a peptide derived from insulin-like growth factor 2 (IGF2), for the treatment of Sanfilippo Syndrome Type B or Mucopolysaccharidosis IIIB (MPS IIIB). BioMarin expects to initiate clinical studies with BMN 250 in mid-2015.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, announced today that Rob Fannon has joined the company as vice president of operations in the Raleigh/Research Triangle Park (RTP), North Carolina location.

CNS Response, Inc. (OTCQB:CNSO)
, CEO George Carpenter and CFO Paul Buck are hosting a webinar and live question and answer session for investors this Thursday, December 11, 2014, at 4:10 p.m. ET.

Calithera Biosciences, Inc. (Nasdaq:CALA)
, a clinical stage biotechnology company focused on the development of novel cancer agents, today announced results of studies with primary human breast tumors that support glutaminase as a potential target in triple negative breast cancer (TNBC).

Dehaier Medical Systems Ltd. (Nasdaq:DHRM)
, which develops, assembles, markets and sells medical devices and wearable sleep respiratory products in China, today announced that it attended the inaugural Western Sleep Conference (the "WSC") which took place December 5-6, 2014 in Chengdu, Sichuan Province.

FutureWorld Corp. (OTCQB; FWDG)
, a leading provider of advanced technologies and solutions to the global cannabis industry, announces today that the Company has received its first major shipment of organic, high quality, CBD oil, for the purpose of distributing CBD-based Pharmaceuticals & Nutraceutical products.

Health Insurance Innovations, Inc., (Nasdaq:HIIQ)
, a leading developer and virtual administrator of affordable health insurance plans, ancillary products, and research-driven consumer health insurance plan shopping tools, today announced the launch of ACA Supplement Deductible and Gap Protection Plans to help customers with accident expenses their ACA metal plans may not cover until full deductibles are met, as well as healthcare services not included in ACA coverage.

Intersect ENT, Inc. (Nasdaq:XENT)
, a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced the resignations of Rick Anderson, PTV Healthcare Capital, and Mark Fletcher, Medtronic, from the Intersect ENT board of directors, effective December 15, 2014.

MedAssets (Nasdaq:MDAS) today announced that Mike Nolte, who currently serves as executive vice president and chief operating officer (COO), was promoted to president and COO and has been appointed to the company's board of directors, effective immediately.

Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has received 501(k) clearance for three products: the ReSolve® Biliary Locking Drainage Catheter, the ONE Snare® Endovascular Microsnare System and the AEROmini™ Tracheobronchial Stent System.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, is pleased to provide an update on the significance of its partner, Austrianova, opening a new, state-of-the-art current Good Manufacturing Practices (cGMP)-compliant live-cell encapsulation facility inside the Thailand Science Park (TSP).

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN)
today announced that on December 9, 2014 the Company received a Paragraph IV Notice Letter from TWi Pharmaceuticals, Inc. ("TWi") advising Supernus of the filing by TWi of an Abbreviated New Drug Application seeking approval for oxcarbazepine extended-release tablets. Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights relating to Oxtellar XR.

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