Pharmaceutical Manufacturing News and Research

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Aphios awarded US patent for compositions, methods for treating diseases involving 5-α reductase enzyme

Aphios® Corporation today announced that it was awarded United States Patent No. 7,744,935 B2 for "Compositions and Methods for Inhibiting 5-α Reductase," granted June 29, 2010. This invention is related to compositions and methods for treating diseases involving the 5-alpha (α) reductase enzyme.

28 Jul 2010

Mediomics receives additional $460,000 in STTR Phase II grant for PINCER protein assay development

Mediomics, LLC has received an additional $460,000 in a renewal of its 2nd year STTR Phase II grant (R42GM079891) from the National Institute of General Medical Sciences. Since 2007, Mediomics has received over one million dollars of STTR funding to develop its quick and sensitive homogenous PINCER™ protein assay. The major goal of the second year project is to further increase the sensitivity of the biosensor.

28 Jul 2010

CTI signs agreement with NerPharMa for long-term manufacture of pixantrone

Cell Therapeutics today announced that it has signed a manufacturing agreement with NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences S.r.l. for CTI's drug candidate pixantrone.

14 Jul 2010

EPA honors Merck and Codexis with Presidential Green Chemistry Challenge Award

Merck and Codexis, Inc. today announced that they have jointly been awarded the annual Presidential Green Chemistry Challenge Award from the U.S. Environmental Protection Agency for the development of a novel biocatalytic method for the synthesis of sitagliptin. In addition, a paper co-authored by Merck and Codexis scientists and published online June 17 in the peer-reviewed journal Science, details how an enzyme was systematically customized using Codexis technology to perform the key chemical step in the sitagliptin synthesis process.

22 Jun 2010

Lawmakers want crackdown on drug agreements that keep generics out

Democrats are looking at proposals to crack down on licensing agreements between drug companies that keep generic drugs out of the market, Politico reports. In the agreements, pharmaceutical companies pay generic manufacturers to "delay introduction of generic drugs, which are often cheaper than brand-name drugs.

18 Jun 2010

CTI announces AIFA approval for manufacture of pixantrone at NerPharMa facility

Cell Therapeutics, Inc. today announced that the Italian Medicines Agency ("AIFA"), the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of CTI's drug candidate pixantrone.

14 Jun 2010

Insulin pills to manage diabetes are finally moving ahead in clinical trials

After years of research and anticipation, insulin pills that could make it easier for millions of patients worldwide to manage diabetes are finally moving ahead in clinical trials and a step-closer to the medicine cabinet. That's among the topics highlighted in a two-part cover story on drug manufacturing in the current issue of Chemical & Engineering News, ACS' weekly newsmagazine.

3 Jun 2010

Experts to discuss problem of drug production and trafficking in Afghanistan

The international forum "Drug Production in Afghanistan: A Challenge for the International Community" will be held in Moscow on June 9 and 10, 2010, at Russia's initiative.

25 May 2010

BioPharm Asia first-quarter revenues increase 41.6% to $32.1 million

BioPharm Asia, Inc., a producer, distributor and retailer of medical products in China, today announced its financial results for the first quarter ended March 31, 2010.

18 May 2010

BioPharm Asia revenues increase 36.4% for fiscal 2009

BioPharm Asia, Inc., a producer, distributor and retailer of medical products in China, today reported its financial results for the full year ended December 31, 2009. The finalization of these results was delayed due to the February 2010 appointment of Davis Accounting Group P.C. as the Company's auditor.

13 May 2010

Particle Sciences extends collaboration with Microfluidics to implement MRT system

Particle Sciences and Microfluidics extended their collaboration with the placement of the newly-announced Microfluidics Reaction Technology system at Particle Sciences.

5 May 2010

Symphogen's Sympress II technology demonstrates cost-effective single batch production of rpAb

Symphogen A/S today announced the publication of data in the March 20, 2010 online edition of Molecular Biotechnology by Nielsen LS et al. [epub ahead of print] demonstrating the ability of its Sympress II technology to enable cost-effective production of recombinant polyclonal antibodies (rpAb) and antibody mixtures with batch-to-batch consistency that the Company believes could supply drug product for large indications such as cancer and infectious disease.

26 Apr 2010

Lotus Pharmaceuticals' asthma drug Laevo-Bambutero to receive Chinese SFDA Fast Track Approval

Lotus Pharmaceuticals, Inc., a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China reported that its asthma drug Laevo-Bambutero will receive the China's State Food & Drug Administration's (SFDA) Fast Track Approval to enter clinical trials. The SFDA's Drug Review and Evaluation Center told the Company during recent consultations at the end of the Company's IND that formal approval would be granted by the Beijing office of the SFDA.

21 Apr 2010

Investment report on Radient Pharmaceuticals from StockPreacher.com

StockPreacher.com announces an investment report featuring Radient Pharmaceuticals Corp. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

9 Apr 2010

China Medicine's 2009 revenues up 20.7%

China Medicine Corporation, primarily a manufacturer, leading distributor and developer of Western pharmaceuticals, traditional Chinese medicines, and other nutraceuticals, today announced its fourth quarter and full year 2009 results.

29 Mar 2010

Stemedica files IND for trial using allogeneic mesenchymal bone marrow cells in patients with ischemic stroke

Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it has filed an Investigative New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial. The trial will assess the safety, tolerability and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.

19 Mar 2010

Pew Prescription Project statement: Protect Americans from unsafe drugs made overseas

Two years after dozens of Americans lost their lives to contaminated heparin, we are still not able to protect U.S. consumers from many of the risks of pharmaceuticals manufactured in foreign factories. It is time for Congress to take action to better protect health.

17 Mar 2010

NerPharMa facility receives FDA approval to manufacture CTI's drug pixantrone

Cell Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has completed its inspection of the facility at NerPharMa (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy), which manufactures the CTI's drug pixantrone and has found the site in compliance and acceptable for continued manufacturing of the drug product.

8 Mar 2010

China Pharma Holdings reports 21% increase in 2009 revenue

China Pharma Holdings, Inc., which develops, manufactures, and markets specialty pharmaceutical products in China, today announced financial results for the fiscal year ended December 31, 2009.

5 Mar 2010

KV Pharmaceutical makes agreement with U.S. Department of Justice to resolve investigation on ETHEX

KV Pharmaceutical Company today announced that it has reached an agreement, subject to court approval, with the United States Attorney for the Eastern District of Missouri and the Office of Consumer Litigation of the United States Department of Justice to resolve an investigation regarding certain activities of ETHEX Corporation, its generic pharmaceutical marketing and distribution subsidiary, which occurred in 2008.

26 Feb 2010