Pharmaceutical Manufacturing News and Research

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Synco Bio to manufacture Versartis type 2 diabetes drug candidate

SynCo Bio Partners, a Netherlands based biopharmaceutical contract manufacturer, and Versartis, Inc. today announced a strategic partnership to produce Versartis' lead drug candidate VRS-859, a novel GLP-1 analog for monthly dosing to treat type 2 diabetes Under the agreement, SynCo will further develop the Versartis existing production process for VRS-859 and optimize the manufacturing process to increase yields for the forthcoming cGMP production.

18 Aug 2009

Aryx Therapeutics reports Q2 2009 financials

ARYx Therapeutics, Inc. (NASDAQ:ARYX) today reported results of operations and provided a general business update for the second quarter ended June 30, 2009.

13 Aug 2009

Schering-Plough announces agreement with Orchid Chemicals & Pharmaceuticals on generic forms of CLARINEX

Schering-Plough Corporation (NYSE: SGP) today announced an agreement with Orchid Chemicals & Pharmaceuticals Ltd. and Orgenus Pharma, Inc. ("Orchid"), related to the generic manufacturing of certain formulations of CLARINEX(R) (desloratadine).

12 Aug 2009

Mylan receives FDA approval for generic Imitrex

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sumatriptan Succinate Tablets, 25 mg (base), 50 mg (base) and 100 mg (base). This product is manufactured in Mylan's Morgantown, W.Va. facility.

10 Aug 2009

Swine Flu - getting drugs to the market more rapidly

The pharmaceutical industry has been up in arms this year. Giants such as Pfizer, GSK and AstraZeneca are looking for deals in the downturn whilst competing against increasing generic competition as some of the best selling medicines are coming off patent. In addition to the sectors ever-changing landscape companies are under tremendous pressure from governments to combat the Swine flu pandemic that has gripped the world.

29 Jul 2009

Antisense Therapeutics trial of ATL1101 in prostate cancer shows promise

Antisense Therapeutics Ltd. (ASX: ANP) has reported further positive results from its collaborative preclinical research studies on the therapeutic potential of ATL1101 in prostate cancer. In experimental models, ATL1101 treatment significantly enhanced the tumor-suppressive effect of the cancer drug Paclitaxel. Paclitaxel is one of a class of drugs known as taxanes.

18 Jun 2009

Using combinatorial libraries to engineer genetic circuits advances synthetic biology

Streamlining the construction of synthetic gene networks has led a team of Boston University researchers to develop a technique that couples libraries of diversified components with computer modeling to guide predictable gene network construction without the back and forth tweaking.

22 Apr 2009

Experts discuss disease-fight dollars for developing world

The debate over how to spend the hundreds of millions of dollars earmarked to fight AIDS and other killer diseases in developing countries will come under the spotlight at a meeting of international experts.

5 Apr 2009

EPA seeks public comment on proposal to add hazardous pharmaceutical waste to universal waste rule

To help provide a streamlined system for disposing of hazardous pharmaceutical waste that is protective of public health and the environment, the U.S. Environmental Protection Agency is proposing to add hazardous pharmaceutical waste to the Universal Waste Rule.

20 Nov 2008

Simple, inexpensive method for detecting contaminants in heparin

The blood-thinning drug heparin is highly effective when used to prevent and treat blood clots in veins, arteries and lungs, but earlier this year its reputation as a lifesaver was sullied when contaminated heparin products caused serious allergic reactions that led to a large number of deaths.

17 Nov 2008

Pulsed ultrasound used to remote control brain circuits

In a twist on nontraditional uses of ultrasound, a group of neuroscientists at Arizona State University has developed pulsed ultrasound techniques that can remotely stimulate brain circuit activity.

29 Oct 2008

New tool for 'right first time' drug manufacture

A technology which provides high quality images of the crystallisation process marks the next step towards a 'right first time' approach to drug manufacture, according to engineers at the University of Leeds.

From Malvern Panalytical 23 Sep 2008

Advisers to Presidential candidates discuss positions on reimportation, generics, biotechnology medications

Democratic presidential nominee Sen. Barack Obama (Ill.) and Republican presidential nominee Sen. John McCain (Ariz.) have begun "reviewing their support" for prescription drug reimportation in response to recent cases of contaminated medications and other products from other nations, advisers to the candidates said on Thursday during the annual conference of the Generic Pharmaceutical Association in Washington, D.C., Reuters/Boston Globe reports.

22 Sep 2008

FDA warns Ranbaxy Labs and issues import alert

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.

16 Sep 2008

Simple hardness test detects fake medicines

The fight against fake medicines could soon be aided by a small, portable device that quickly measures the hardness of a tablet, revealing whether it is counterfeit, according to research presented at the British Pharmaceutical Conference (BPC) in Manchester.

7 Sep 2008

Researchers create synthetic heparin

Robert Linhardt has spent years stitching together minuscule carbohydrates to build a more pure and safer alternative to the commonly used and controversial blood thinner heparin. At the national conference of the American Chemical Society on August 17, 2008, Linhardt announced that his research team may have accomplished this task by building the first fully synthetic heparin. Their creation is the largest dose of heparin ever created in the lab.

17 Aug 2008

New technique measures formation of clumps of proteins in protein-based pharmaceuticals

Scientists at the National Institute of Standards and Technology (NIST) have developed a technique to measure the formation of clumps of proteins in protein-based pharmaceuticals.

23 Jul 2008

Journal of Pharmaceutical Innovation publishes groundbreaking scientific papers

The first scientific papers outlining the progress made on the Product Quality Lifecycle Implementation (PQLI) initiative are being published in the June 2008 issue of the Journal of Pharmaceutical Innovation (JPI).

2 Jun 2008

Drug candidate to treat smallpox scaled up by new partnership

Two American companies are teaming up for second-round test-phase production of a FDA-designated "fast track" drug candidate to treat smallpox, a deadly virus that is feared to be able to reach people through acts of bio-warfare or bio-terrorism.

5 May 2008

FDA cannot properly inspect foreign companies that manufacture medications, medication ingredients, report finds

FDA does not have adequate resources to inspect foreign companies that manufacture medications or medication ingredients, and current funding levels for the agency will not address the issue, according to a Government Accountability Office report presented on Tuesday at a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee, the Newark Star-Ledger reports.

23 Apr 2008