Biogen Announces US and EU Authorities Accept Oral BG-12 Marketing Applications; Watson Confirms Lialda Patent Challenge Print E-mail
By Staff and Wire Reports   
Wednesday, 09 May 2012 18:26
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 9, 2012.

Biogen Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory authorities have accepted the company's marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS).

The U.S. FDA has accepted Biogen Idec's New Drug Application (NDA) for marketing approval of BG-12 in the United States and granted the company a standard review timeline. In addition, the European Medicines Agency (EMA) has validated Biogen Idec's Marketing Authorisation Application (MAA) for review of BG-12 in the European Union.


Watson Pharmaceuticals, Inc. (NYSE: WPI)
confirmed 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 Mesalamine Delayed-release Tablets, 1.2g. Watson's ANDA product is a generic version of Shire Development LLC's Lialda®.

Also Wednesday:

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, today announced that management will present a company overview at the 11th Annual JMP Securities Research Conference on Tuesday, May 15 at 2:30 p.m. PT at the Ritz-Carlton in San Francisco.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
today announced the appointment of William K. Heiden as president and chief executive officer, effective May 14, 2012.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today reported financial results for the first quarter ended March 31, 2012 and provided an update on corporate developments.

Arrowhead Research Corporation (NASDAQ:ARWR)
today announced that David Lewis, Ph.D., Vice President Biology and Site Head of its Madison, WI research and development facility presented data at the European Foundation for Clinical Medicine Conference in Basel, Switzerland. Dr. Lewis’ presentation, “DPC Technology for Safe and Effective siRNA Delivery” described the development and capabilities of Arrowhead’s Dynamic Polyconjugate (DPC) siRNA delivery platform, as well as the system’s deployment in the development of a new treatment for chronic Hepatitis B.

BioClinica®, Inc. (NASDAQ: BIOC)
, a leading global provider of clinical trial management solutions, today announced its financial results for the first quarter ended March 31, 2012.

Biogen Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory authorities have accepted the company’s marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS).

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI)
today reported its corporate highlights and financial results as of and for the three months ended March 31, 2012.

BioScrip, Inc. (Nasdaq: BIOS)
today announced 2012 first quarter financial results. First quarter revenue was $155.6 million and net loss was $2.7 million, or $0.05 per share.

HospiScript Services, a wholly owned subsidiary of Catalyst Health Solutions, Inc., (NASDAQ: CHSI) recently announced that HospiScript has been selected as the exclusive provider of pharmacy benefit management (PBM) services to all of Harden’s home and facility-based hospice patients.

Covidien (NYSE: COV)
, a leading global provider of healthcare products, will present at the Bank of America Merrill Lynch 2012 Health Care Conference in Las Vegas, NV, on Wednesday, May 16, 2012.

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA)
today reported financial results for the quarter ended March 31, 2012.

Human Genome Sciences, Inc. (Nasdaq: HGSI)
today confirmed that GlaxoSmithKline plc (GSK) has announced its intention to commence an unsolicited tender offer to acquire all the outstanding common shares of HGS at a price of $13.00 per share in cash.

MannKind Corporation (Nasdaq: MNKD)
today reported financial results for the first quarter ended March 31, 2012.

INC Research, LLC has broadened its services around Medidata Solutions’ (NASDAQ: MDSO) clinical cloud platform by attaining three new accreditations.

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today reported that its wholly owned subsidiary, Medgenics Medical Israel Ltd. (MMI) was awarded a government grant of up to NIS 8.1 million (approximately USD 2.2 million), net, from the Office of the Chief Scientist (“OCS”) at the Ministry of Industry, Trade and Labor of Israel.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, reported today that it will be an exhibitor and sponsor at the 14th Malvern Diabetic Foot Conference on May 9-11, 2012 in Malvern, United Kingdom, at the Abbey Hotel.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB)
, a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its Phase 3 clinical studies investigating Lymphoseek® (Kit for the Preparation of Technetium Tc 99m Tilmanocept for Injection) in head and neck cancer, breast cancer, and melanoma and from Phase 1/Phase 2 clinical trials of its Alzheimer’s Disease candidate, AZD4694, were accepted for presentation at several upcoming scientific and medical meetings in May.

Neutra Corp. (OTCBB:NTRR)
, an emerging nutraceuticals provider, announced today that it has begun formulating its next groundbreaking product: an all-natural supplement designed to restore the body’s natural pH balance.

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX)
today announced consolidated financial results for the quarter ended March 31, 2012 and reviewed recent accomplishments, including the commercial launch in the United States of EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical pain and the successful completion of an equity financing.

Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX)
, a specialty pharmaceutical company, today announced that Cooper Collins, President and Chief Executive Officer, will present at the Bank of America Merrill Lynch 2012 Health Care Conference on Thursday, May 17, 2012 at 11:20 a.m. PDT.

Pfizer Inc. (NYSE:PFE)
announced today that the Arthritis Advisory Committee to the U.S. Food and Drug Administration (FDA) voted 8-2 to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT)
, a development-stage oncology and dermatology biopharmaceutical company, announces that Phase 2 final data on PV-10 for metastatic melanoma will be presented at the 2nd European PostASCO Melanoma Meeting 2012, Interdisciplinary Global Conference on Developing New Treatments for Melanoma, on June 22, 2012, in Munich, Germany.

Puma Biotechnology, Inc. (OTCBB: PBYI), a development stage biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will present an overview of the Company at 3:00 p.m. PDT on Wednesday, May 16, at the Bank of America Merrill Lynch 2012 Health Care Conference.

Sucampo Pharmaceuticals, Inc. (“Sucampo” or the “Company”), (NASDAQ: SCMP)
, a global pharmaceutical company, today reported its consolidated financial results for the first quarter ended March 31, 2012.

Syneron Medical Ltd. (NASDAQ: ELOS)
, the leading global aesthetic device company, today announced first quarter 2012 financial results for the three month period ended March 31, 2012.

Synageva BioPharma Corp. (“Synageva”) (NASDAQ:GEVA)
, a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, today reported first quarter 2012 financial results, and provided data from a natural history study of infants with early onset LAL Deficiency that were recently presented at the 3rd International Congress for Lysosomal Diseases held in North Cyprus, Turkey.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA)
today issued updated dial-in information regarding the conference call to be held today, May 9, 2012 at 8:30 a.m. ET to discuss its first quarter 2012 results.

As an integral part of its transformation to become America’s first choice for health and daily living, Walgreens (NYSE: WAG)(NASDAQ: WAG) today announced it has selected GSD&M to be its new brand and creative agency of record.

Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases announced that Zalicus management will provide an overview of the Company at two upcoming investor conferences.

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