AMAG Announces Positive Opinion for Approval of Ferumoxytol; Incyte Announces EU Regulatory Milestone for Ruxolitinib Print E-mail
By Staff and Wire Reports   
Friday, 20 April 2012 18:17
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 20, 2012.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of ferumoxytol, an intravenous (IV) iron therapy, for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). In the European Union, ferumoxytol will be marketed as Rienso® by AMAG's partner, Takeda Pharmaceutical Company Limited.


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Incyte Corporation (Nasdaq: INCY) announced a European Union (EU) regulatory milestone from Novartis. The milestone includes a $40 million payment earned based on the recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for approval of ruxolitinib for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. A second payment of $60 million would be earned once Novartis achieves reimbursement and pricing approval in specific EU countries.

Ruxolitinib was approved by the US Food and Drug Administration (FDA) in November 2011 and is the first and only JAK inhibitor to have received regulatory approval. Ruxolitinib is known as Jakafi™ (ruxolitinib) in the US and will be called Jakavi™ in Europe.



Also Friday:



Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of the third patient in its Phase I/II trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

Aetna (NYSE: AET)
announced that it has reached agreement on a three-year contract extension with WakeMed Health & Hospitals.

Allos Therapeutics, Inc. (NASDAQ: ALTH) announced today that following its request for re-examination, the European Medicines Agency’s Committee For Medicinal Products for Human Use (CHMP) confirmed its previous negative opinion on the marketing authorisation application (MAA) for FOLOTYN® (pralatrexate injection) as a treatment for patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today positive results from its Phase I clinical trial of ALN-PCS, an RNAi therapeutic targeting PCSK9 for the treatment of severe hypercholesterolemia. ALN-PCS is a PCSK9 synthesis inhibitor that reduces intracellular and extracellular levels of PCSK9 resulting in lowered plasma levels of low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of ferumoxytol, an intravenous (IV) iron therapy, for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).

Biogen Idec (NASDAQ: BIIB) will highlight its commitment to using novel science to address unmet medical needs in neurology at the upcoming 64th American Academy of Neurology (AAN) Annual Meeting.

BioTime, Inc. (NYSE Amex:BTX) and its wholly owned subsidiary LifeMap Sciences today announced that they have signed a definitive agreement to acquire XenneX, Inc. through a merger of XenneX into LifeMap Sciences.

Cannabis Science, Inc. (OTCBB: CBIS) a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is thrilled to welcome Andrew Pitsicalis as International Brand and Licensing Director.

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that 12 data presentations, including six platform presentations, from the company’s multiple sclerosis (MS) clinical trial programs for alemtuzumab and teriflunomide will be featured at the American Academy of Neurology's (AAN) 64th Annual Meeting in New Orleans, La., April 21-28.

Health Discovery Corporation (OTCBB: HDVY)
, the molecular diagnostics company that launched MelApp, the first SVM-based image analysis iPhone app for melanoma risk assessment is featured in this month's Men's Health Magazine.

Holzer Holzer & Fistel, LLC is investigating potential violations of the federal securities laws by ViroPharma Incorporated (NASDAQ: VPHM).

Human Genome Sciences, Inc. (NASDAQ: HGSI) announced today that it will sponsor a conference call to discuss its financial results for the quarter ended March 31, 2012.

Incyte Corporation (Nasdaq: INCY)
announced today a European Union (EU) regulatory milestone from Novartis.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it will release its first quarter 2012 financial results on Wednesday, May 9, 2012.

Trim Holding Group (PINKSHEETS: TRHG) (OTCQB: TRHG) is pleased to announce that on April 19, 2012, the Company filed a Preliminary Schedule 14C Information Statement with the US Securities and Exchange Commission for the purpose of providing advance notice to its stockholders that it intends to change its corporate name to HPIL Holding.

Recognizing the important role retailers play in corporate responsibility and as stewards of the environment, Walgreens (NYSE, NASDAQ: WAG) today affirmed its commitment to environmental sustainability, innovative technology and renewable energy initiatives during Earth Week 2012.



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