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MediStem, Inc. Submits Response to FDA Clinical Hold PDF Print E-mail
Tuesday, 30 August 2011 00:26
Medistem Inc. (Pinksheets: MEDS.PK - News) announced today filing with the FDA a response to clinical hold regarding the company's FDA Phase I clinical trial application, BB-IND 13898, entitled "Allogeneic-Unrelated, Menstrual Derived, Mesenchymal Stem Cell-Like Endometrial Cells Administered Intramuscular."
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Sigma-Tau Said to Study a Possible Sale of Stake After Founder’s Death PDF Print E-mail
Monday, 29 August 2011 00:15

Sigma-Tau SpA, the Italian drugmaker that’s developing rare-disease medicines, is considering selling a stake in the company after the death of founder Claudio Cavazza, said two people with knowledge of the situation.

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Longtime Roche Exec to Lead EMD Millipore PDF Print E-mail
Monday, 29 August 2011 00:01
EMD Millipore, the Life Science division of Merck KGaA of Germany, today announced that Robert Yates will become President of the EMD Millipore division as of September 1, 2011.
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GSK and Unilever Among Early Adopters of BioLeap’s Technology for Creating New Molecules PDF Print E-mail
Saturday, 27 August 2011 00:42

Last year, consumer-products giant Unilever had a problem. The company wanted to make a meaningful impact in the ultra-crowded category of anti-aging cosmetics, but to do so, it had to come up with entirely new methods for fighting wrinkles.

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Top-Line Results from Pivotal Trial of Shire plc's Dermagraft(R) for Venous Leg Ulcers PDF Print E-mail
Friday, 26 August 2011 00:33
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that Advanced BioHealing (ABH), its regenerative medicine business, has concluded its phase three pivotal trial of Dermagraft® in subjects with venous leg ulcers.
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United Therapeutics Corporation Oral Lung Drug Fails Trial PDF Print E-mail
Friday, 26 August 2011 00:27
United Therapeutics Corporation (NASDAQ: UTHR) announced today the completion of its FREEDOM-C(2) Phase 3 trial of treprostinil diethanolamine (oral treprostinil), an investigational sustained release oral formulation of treprostinil, a stable synthetic form of prostacyclin, in patients with pulmonary arterial hypertension (PAH).
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Amgen Creates 100 Jobs at Plant in Ireland PDF Print E-mail
Thursday, 25 August 2011 00:30

US drug firm, Amgen, is to create 100 jobs at its factory in Dublin.

The announcement comes just months after the firm saved 280 jobs when it took over the Pfizer plant.

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Data May Prove Bristol-Myers Squibb Company, Pfizer Inc. Drug a Winner PDF Print E-mail
Wednesday, 24 August 2011 00:23
Despite being third to market, a new bloodthinner from Bristol-Myers Squibb (NYSE:BMY - News) and Pfizer (NYSE:PFE - News) may become the biggest seller in an emerging multibillion-dollar class of drugs for preventing strokes in heart patients.
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FDA Approves Seattle Genetics, Inc. Cancer Drug Adcetris to Treat Two Types of Lymphoma PDF Print E-mail
Wednesday, 24 August 2011 00:16
The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).
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Alexza Pharmaceuticals, Inc. Announces Adasuve (Staccato(R) Loxapine) PDUFA Goal Date of February 4, 2012 PDF Print E-mail
Tuesday, 23 August 2011 00:09
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the U.S. Food & Drug Administration (FDA) has accepted the ADASUVE New Drug Application (NDA) as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012. On August 4, 2011, Alexza resubmitted the ADASUVE NDA, which seeks marketing approval for the rapid treatment of agitation in adults with schizophrenia or bipolar disorder.
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HPV Vaccine Rates Trail Other Teen Vaccines PDF Print E-mail
Tuesday, 30 August 2011 00:23
Despite strong endorsements from public health officials, teenage vaccination rates for the HPV vaccine are trailing the other two vaccines recommended for teens and pre-teens, according to the Centers for Disease Control and Prevention.
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Johnson & Johnson Gets FDA Approval For Extended-Release Pain Drug Nucynta ER PDF Print E-mail
Monday, 29 August 2011 00:08
Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved NUCYNTA® ER, an oral analgesic taken twice daily, for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
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Lightlake Therapeutics Inc. Set to Begin Phase II Clinical Trials of Binge Eating Disorder Treatment PDF Print E-mail
Saturday, 27 August 2011 00:44
Lightlake Therapeutics Inc. (OTCBB: LLTP) (“Lightlake” or “the “Company”), an early stage biopharmaceutical company currently developing a nasal spray for the treatment of overweight and obese patients with Binge Eating Disorder, today announced that its patient testing stage of the Phase II clinical trials will start August 26th, 2011
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Pharmasset, Inc. Receives Fast Track Designation for Hep C Drug PDF Print E-mail
Saturday, 27 August 2011 00:37
Pharmasset, Inc. (Nasdaq: VRUS) has received fast track designation from the U.S. Food and Drug Administration (FDA) for PSI-938 for the treatment of chronic hepatitis C virus (HCV) infection. PSI-938 is an oral guanosine nucleotide analog polymerase inhibitor of HCV.
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Takeda Pharmaceutical Co. Ltd. in Talks to Buy Cipla Ltd., Lupin Ltd. (LUPN.BO) Drug Business; Companies Deny Rumor PDF Print E-mail
Friday, 26 August 2011 00:29
Takeda Pharmaceutical Co , Japan's largest drugmaker, is in talks with Indian generic drugmakers Cipla and Lupin about buying one of the companies' pharmaceutical businesses, the Economic Times reported on Wednesday.
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Biotech Investment Firm, ESI Florida Plans 150 Jobs for Jupiter PDF Print E-mail
Thursday, 25 August 2011 00:34
The town of Jupiter on Wednesday approved a $300,000 loan guarantee for ESI Florida, a biotechnology investment company that plans to create 150 jobs.

 

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BioCon Limited Arm Inks Pact for Clinical Research with US Firm PDF Print E-mail
Thursday, 25 August 2011 00:28
Clinigene International Limited, an India-based Central and Bioanalytical Laboratory and Phase I-IV Clinical Research Organization, and Spaulding Clinical Research, LLC, US-based leading-edge Clinical Pharmacology, Cardiac Core Lab, and Medical Device Manufacturer, announce a strategic partnership agreement
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Boehringer Ingelheim Corporation Unit Will Exit Contract Manufacturing PDF Print E-mail
Wednesday, 24 August 2011 00:20

A Boehringer Ingelheim GmbH plant that has caused shortages in drug supplies will exit the pharmaceutical contract-manufacturing business as it faces a Canadian ban on the importation of some of its drugs.

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Warnex Inc. Completes its Debenture Restructuring PDF Print E-mail
Tuesday, 23 August 2011 00:20
Warnex Inc. (TSX: WNX.TO - News)("Warnex") is pleased to announce that it has closed its previously announced debenture restructuring which has resulted in the extension of the maturity date and the modification of various other terms of its outstanding debentures.
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Amgen , Cytokinetics, Inc. Heart Failure Class Shows Promise in Phase II PDF Print E-mail
Tuesday, 23 August 2011 00:07
Cytokinetics, Incorporated (NASDAQ: CYTK) announced today the publication of results from two clinical trials of omecamtiv mecarbil, a novel cardiac myosin activator, in the August 20, 2011 issue of the journal Lancet.
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