Pharmaceuticals News and Research

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PBI awarded contract to provide essential laboratory data for Phase I cardiovascular trial

Pacific Biomarkers, Inc. has been awarded a contract by a leading multinational pharmaceutical company to provide essential laboratory data for an adaptive Phase I cardiovascular trial. This study is part of a major drug-development program to evaluate an innovative new treatment to reduce recurrent cardiovascular events associated with acute coronary syndrome.

27 May 2010

TESARO secures $60 million in start-up funding to acquire, develop and commercialize cancer therapeutics

TESARO, Inc., an oncology-focused biopharmaceutical company, today announced that it has secured $60 million in start-up funding to acquire, develop and commercialize cancer therapeutics and supportive care products. Participants in a $20 million Series A financing included New Enterprise Associates (NEA) and TESARO management; additionally, NEA has reserved $40 million to support company growth.

27 May 2010

Impax Laboratories, IGI Laboratories announce product development and supply agreement

Impax Laboratories, Inc. today announced that it has entered into a product development and supply agreement with IGI Laboratories, Inc., a formulation and manufacturing company. IGI will be responsible for developing two topical drug products, obtaining FDA marketing approvals, and manufacturing the commercial products.

27 May 2010

Restanza shows greater efficacy against species of Plasmodium that cause malaria

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced positive results from in vitro and in vivo studies assessing the efficacy of Restanza (cethromycin), its novel oral antibiotic, against the species of Plasmodium that cause malaria.

27 May 2010

Logical Therapeutics closes $16.9 million Series C equity financing round

Logical Therapeutics, Inc., a private, clinical stage biopharmaceutical company, announced today it had closed on a $16.9 million Series C equity financing. The round was led by existing investor SV Life Sciences, and included Burrill & Company, Novo A/S and Novitas Capital.

27 May 2010

FDA accepts Horizon Pharma's DUEXA NDA for review

Horizon Pharma, Inc., a late-stage biopharmaceutical company focused on the development and commercialization of innovative medicines for pain-related diseases and inflammation, today announced that its New Drug Application (NDA) for DUEXA®, a proprietary tablet formulation containing a fixed-dose combination of ibuprofen and high-dose famotidine, was accepted by the U.S. Food and Drug Administration (FDA) for review.

27 May 2010

Important milestone in development of ORMD-0801 published in DOM journal

Oramed Pharmaceuticals Inc., a developer of alternative drug delivery systems, announced today that the paper entitled, "Open-label study to assess the safety and pharmacodynamics of five oral insulin formulations in healthy subjects," authored by Dr. Roy Eldor, Dr. Miriam Kidron and Dr. Ehud Arbit, was accepted and published in the Diabetes, Obesity and Metabolism journal.

26 May 2010

Anadys Pharmaceuticals to raise $12.5 million through registered direct offering

Anadys Pharmaceuticals, Inc. announced today that it has entered into definitive agreements with certain institutional investors to raise approximately $12.5 million in gross proceeds in a "registered direct" offering through the sale of a total of 5,813,954 shares of its common stock at an offering price of $2.15 per share. Anadys estimates that net proceeds from the offering will be approximately $11.3 million, after deducting placement agents' fees and estimated offering expenses.

26 May 2010

TASE approves new listing of PROLOR Biotech's common stock

PROLOR Biotech, Inc.,, a company developing next generation biobetter therapeutic proteins, today announced that the Tel Aviv Stock Exchange (TASE) has approved the new listing of PROLOR's common stock on the TASE beginning on Thursday, May 27, 2010. At that time, the company's common stock will be listed on both the NYSE Amex in the United States and the TASE in Israel.

26 May 2010

FDA approves Mylan's ANDA for Valacyclovir Hydrochloride Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Valacyclovir Hydrochloride Tablets, 500 mg (base) and 1000 mg (base), the generic version of GlaxoSmithKline's Valtrex, a treatment for the herpes virus infection.

26 May 2010

Jubilant Organosys announces repayment of FCCBs amounting to $50M and YTM of $19M

Jubilant Organosys Limited, an integrated pharmaceutical industry player and the largest Custom Research and Manufacturing Services Company out of India, today announced the repayment of FCCBs amounting to US$ 50 million along with the YTM of US$ 19 million. The FCCBs were due for redemption on May 24, 2010.

26 May 2010

Gentium first-quarter net loss decreases to EUR 0.03 million

Gentium S.p.A. today reported financial results for the quarter ended March 31, 2010. The Company reports its financial condition and operating results using U.S. Generally Accepted Accounting Principles (GAAP).

26 May 2010

Presidio Pharmaceuticals to advance PPI-1301 inhibitor from HCV NS5A program into clinical development

Presidio Pharmaceuticals, Inc. announced today that they have selected a second clinical candidate, PPI-1301, from their hepatitis C virus (HCV) NS5A program for advancement into clinical development. Presidio's first NS5A inhibitor, PPI-461, is currently undergoing evaluation in a Phase 1a clinical study.

26 May 2010

IMC announces "Commitment to Compliance" initiative in response to FDA's "Bad Ad Program"

Informed Medical Communications (IMC), a leading full-service provider of peer-to-peer medical forums and integrated medical communications for the bio-pharmaceutical industry, today announced its "Commitment to Compliance" initiative, responding to the FDA's new program to minimize misleading drug advertising and promotion.

26 May 2010

Report: 235 new medicines in development to treat diabetes

A record 235 new medicines to treat diabetes, one of the fastest-growing diseases in America, are being developed by America's pharmaceutical research and biotechnology companies, according to a national report unveiled today in Charleston.

26 May 2010

Study demonstrates efficacy of CONCERTA in treating ADHD in presence of comorbid learning disability

Turning in assignments, following instructions and focusing on learning something new are among the daily classroom challenges for children with Attention Deficit Hyperactivity Disorder (ADHD), according to the National Institute of Mental Health (NIMH). New data presented today show efficacy of CONCERTA® (OROS® methylphenidate HCl Extended-Release Tablets CII) on ADHD symptoms in children with the condition who also may face other specific challenges.

26 May 2010

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

POZEN Inc., announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration approval of VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application and New Drug Application for VIMOVO to AstraZeneca over the next few weeks.

26 May 2010

CEVEC, Pevion Biotech sign license option agreement for transient CAP-T cell expression technology

CEVEC Pharmaceuticals, the German developer of a novel human expression system derived from amniocytes, announced today the signing of an exclusive license option agreement with Pevion Biotech, the Swiss vaccine company. The agreement enables Pevion Biotech to exclusively use CEVEC's transient CAP-T™ cell expression technology to manufacture and commercialize a protein antigen for vaccination against a widespread human infectious disease.

26 May 2010

Consequences of secrecy in medicine

No one knows how many mothers' and babies' lives have been saved by the obstetrical forceps. This device has been part of the standard equipment of every maternity room for about 250 years. However, a shadow lies over the success story: after the Chamberlen brothers developed the device at the beginning of the 17th century, the brothers and their descendants used it for 3 generations, but kept it a secret from other obstetricians.

26 May 2010

Positive results from 3 year follow-up of BPH patients treated with NX-1207 in Study NX02-0016

Nymox Pharmaceutical Corporation is pleased to report positive new results from the 30-36 month follow-up study of patients treated with NX-1207 in Study NX02-0016. The initial study, completed in the U.S. in 2007, reached statistical significance in Intent-to-Treat Primary Efficacy outcomes at 90 days and 6 months post-treatment with NX-1207 2.5 mg.

26 May 2010

Pharmaceuticals News and Research

PBI awarded contract to provide essential laboratory data for Phase I cardiovascular trial

TESARO secures $60 million in start-up funding to acquire, develop and commercialize cancer therapeutics

Impax Laboratories, IGI Laboratories announce product development and supply agreement

Restanza shows greater efficacy against species of Plasmodium that cause malaria

Logical Therapeutics closes $16.9 million Series C equity financing round

FDA accepts Horizon Pharma's DUEXA NDA for review

Important milestone in development of ORMD-0801 published in DOM journal

Anadys Pharmaceuticals to raise $12.5 million through registered direct offering

TASE approves new listing of PROLOR Biotech's common stock

FDA approves Mylan's ANDA for Valacyclovir Hydrochloride Tablets

Jubilant Organosys announces repayment of FCCBs amounting to $50M and YTM of $19M

Gentium first-quarter net loss decreases to EUR 0.03 million

Presidio Pharmaceuticals to advance PPI-1301 inhibitor from HCV NS5A program into clinical development

IMC announces "Commitment to Compliance" initiative in response to FDA's "Bad Ad Program"

Report: 235 new medicines in development to treat diabetes

Study demonstrates efficacy of CONCERTA in treating ADHD in presence of comorbid learning disability

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

CEVEC, Pevion Biotech sign license option agreement for transient CAP-T cell expression technology

Consequences of secrecy in medicine

Positive results from 3 year follow-up of BPH patients treated with NX-1207 in Study NX02-0016

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