Manufacturing News and Research

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Manufacturing is the production of products across all industries, on a large-scale, using machinery.

Synthetic biology extends anti-malaria drug artemisinin's effectiveness

In addition to providing a simple and much less expensive means of making artemisinin, the most powerful anti-malaria drug in use today, synthetic biology can also help to extend the effectiveness of this drug.

8 Mar 2009

FDA shuts down a flour tortilla manufacturer for repeated violations

The U.S. Food and Drug Administration (FDA) has announced that Del Rey Tortilleria Inc., Chicago, Ill., its president, and two general managers have entered into a consent decree of permanent injunction that prevents Del Rey Tortilleria from manufacturing and distributing soft-shell flour tortillas until the company obtains FDA approval.

8 Mar 2009

Ranbaxy secures FDA approval for quinapril hydrochloride + hydrochlorothiazide tablets

Ranbaxy Pharmaceuticals has announced approval from the U.S. Food and Drug Administration to manufacture and market Quinapril Hydrochloride & Hydrochlorothiazide (Quinapril + HCTZ) Tablets, 10mg/12.5mg, 20mg/12.5mg and 20mg/25mg.

5 Mar 2009

Generic biologics face 'tough, long road to realization'

The development of new generic versions of expensive biologic drugs "faces a long, tough road to realization" because the complex generics "will likely face tough regulatory scrutiny, as well as high development and marketing costs," the Wall Street Journal reports.

4 Mar 2009

FDA warning letter to Genzyme related to Allston manufacturing facility

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced today that the FDA warning letter issued to Genzyme addressing deficiencies related to Genzyme's Allston Landing manufacturing facility during an inspection performed in September and October 2008 has no foreseeable impact on the supply of Aldurazyme.

3 Mar 2009

FDA provides positive review of InNexus' lead preclinical drug candidate

InNexus Biotechnology Inc. has announced the United States Food & Drug Administration (FDA) has completed its comprehensive review of the development plans for InNexus' lead preclinical candidate, DXL625 (CD20) for the prospective treatment of Non-Hodgkin's Lymphoma (NHL) and/or Chronic Lymphocytic Leukemia (CLL).

3 Mar 2009

FDA takes action against KV Pharmaceutical Company

The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs.

2 Mar 2009

Mylan's Matrix receives WHO approval for generic Lopinavir/Ritonavir tablets

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received the first and only World Health Organization (WHO) approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.

25 Feb 2009

Bone Biologics issued U.S. patent for recombinant protein process

Bone Biologics Inc. has announced that it has received a US Patent Office Notice of Allowance of patent claims which protect a method of production for the UCB-1 (NELL-1) recombinant protein that Bone Biologics uses in the bone repair/regeneration technology in its lead product.

24 Feb 2009

CERAM offer medical device manufacturers key highlights to materials

CERAM, a global expert in medical device materials analysis, testing and consultancy, has published a white paper that highlights how critical a knowledge of materials and their characteristics is to the medical device manufacturer.

23 Feb 2009

Neuralstem's ALS trial on hold

Neuralstem, Inc. has announced its spinal cord stem cell trial to treat Amyotrophic Lateral Sclerosis (ALS) is on clinical hold and that the Federal Drug Administration (FDA) has provided the Company with specific comments, questions and recommendations for modifications to its protocol.

22 Feb 2009

New technology could save vision of millions

In the blink of an eye, people at risk of becoming blind can now be screened for eye diseases such as diabetic retinopathy and age-related macular degeneration.

18 Feb 2009

Tobacco marketing causes kids to smoke

Several scientific studies released today provide powerful new evidence that tobacco marketing causes kids to smoke, while anti-tobacco advertising campaigns prevent smoking.

17 Feb 2009

Researcher develops method to combat congenital heart disease in children

Congenital heart defects account for five times more deaths annually than all childhood cancers combined.

9 Feb 2009

Alarming increase in prevalence of chronic low-back pain

The proportion of people suffering from long term, impairing low back pain has more than doubled in North Carolina since the early 1990s, according to a new study.

9 Feb 2009

Medicines sold in Sweden cause serious environmental harm in India

Many of the substances in our most common medicines are manufactured in India and China.

8 Feb 2009

FDA grants priority review of Cinryze C1 inhibitor as treatment for acute attacks of hereditary angioedema

ViroPharma Incorporated has announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Cinryze C1 Inhibitor (human) as a treatment for acute attacks of Hereditary Angioedema (HAE).

5 Feb 2009

Link found between Parkinson's disease genes and manganese poisoning

A connection between genetic and environmental causes of Parkinson's disease has been discovered by a research team led by Aaron D. Gitler, PhD, Assistant Professor in the Department of Cell and Developmental Biology at the University of Pennsylvania School of Medicine.

2 Feb 2009

Discounted prescription drugs online becoming more attractive to many

Healthcare consumers, benefits managers, and even government officials are using the internet to buy unapproved prescription drugs illegally, according to a report to be published in the International Journal of Electronic Healthcare.

29 Jan 2009

SAFC Pharma augments assay development capabilities

SAFC Pharma, a business segment of SAFC, a member of the Sigma-Aldrich group, today announced that it has commenced operations at its 7,000 sq. ft. state-of-the-art laboratory complex in Carlsbad, CA.

29 Jan 2009