Pharmaceuticals News and Research

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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

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, today announced the results of a study evaluating the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder in adolescents aged 13 to 17 years.

26 May 2010

Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

Trigemina, Inc., a Mountain View based privately-held biopharmaceutical company, reports positive results from a time-based interim analysis of its Phase IIa clinical trial in Chronic Daily Headache. The trial is a collaborative effort between Trigemina and Dr. Egilius Spierings of MedVadis Research Corporation located outside of Boston. The study compares intranasal oxytocin with placebo in patients suffering from CDH.

26 May 2010

Academic researchers say tour yielded 23 percent increase in patients who got best, cheapest drugs

Reuters reports that 150 academic researchers touring the U.S. to make recommendations on diuretics and best and cheapest practices for blood pressure medicine have reported a 23 percent increase in patients who get the recommended drugs, "twice the increase in the U.S. over the same period."

26 May 2010

Vertex reports 75% patients with HCV achieve viral cure with 12-week telaprevir-based combination regimen

Vertex Pharmaceuticals Incorporated today announced that 75% of people chronically infected with genotype 1 hepatitis C virus (HCV) who had not previously been treated achieved a sustained viral response (SVR or viral cure) after receiving a 12-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone, in the Phase 3 ADVANCE trial.

26 May 2010

AMRI to reduce US workforce by 10%

AMRI today announced that it is repositioning itself to meet a continued shift in demand from customers for services in Asia and Europe. Overall for 2009 and 2010, the company anticipates investing in excess of $30 million on international facility and capability expansions and estimates its non-US workforce will increase by approximately 180 positions in order to meet known and anticipated customer demand.

26 May 2010

Immunomedics announces receipt of $5M from Nycomed for reaching clinical milestone

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced the receipt of $5 million from Nycomed for reaching a clinical milestone under the license and collaboration agreement, entered into on July 11, 2008.

26 May 2010

Genzyme's suit stays final FDA approval of Watson's generic Renvela ANDA

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market sevelamer carbonate 800mg tablets. Watson's sevelamer carbonate tablet is the generic version of Genzyme's Renvela®. Renvela ® is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis.

26 May 2010

Mylan Pharmaceuticals introduces Temazepam Capsules USP, 7.5 mg

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Temazepam Capsules USP, 7.5 mg.

25 May 2010

Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that Phase IIb data for its lead drug candidate Soluble Ferric Pyrophosphate (SFP) have been accepted for presentation at the XLVII European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress, organized in collaboration with the Deutsche Gesellschaft fur Nephrologie (DGfN) in Munich, Germany, June 25-28, 2010.

25 May 2010

La Jolla Pharmaceutical announces $16.3 million private placement

La Jolla Pharmaceutical Company announced today that the Company has entered into definitive agreements with institutional investors and affiliates for a private placement of common stock, convertible preferred stock and warrants to purchase convertible preferred stock totaling up to $16.3 million in gross proceeds.

25 May 2010

Pharmaceuticals News and Research

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

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

Academic researchers say tour yielded 23 percent increase in patients who got best, cheapest drugs

Vertex reports 75% patients with HCV achieve viral cure with 12-week telaprevir-based combination regimen

AMRI to reduce US workforce by 10%

Immunomedics announces receipt of $5M from Nycomed for reaching clinical milestone

Genzyme's suit stays final FDA approval of Watson's generic Renvela ANDA

Mylan Pharmaceuticals introduces Temazepam Capsules USP, 7.5 mg

Rockwell Medical's SFP Phase IIb data accepted for presentation at XLVII ERA-EDTA Congress

La Jolla Pharmaceutical announces $16.3 million private placement

Drug Discovery - Second Edition eBook

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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