Manufacturing News and Research

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

SALVAT submits complete response to FDA approvable letter for CETRAXAL

SALVAT announced today the submission of the response to the FDA Approvable Letter for CETRAXAL (Ciprofloxacin 0.2% Otic Solution in Single Dose Containers).

6 Nov 2008

BioLife Solutions submits FDA master file on HypoThermosol preservation and storage media for cells, tissues

BioLife Solutions Inc. has announced that it has submitted a Master File to the United States Food and Drug Administration (FDA) for the Company's HypoThermosol preservation media product.

6 Nov 2008

SurModics acquires drug delivery assets of PR Pharmaceuticals

SurModics, Inc. announced today that it has acquired a portfolio of intellectual property and collaborative drug delivery projects from PR Pharmaceuticals, Inc., a drug delivery company specializing in injectable, biodegradable sustained release formulations.

4 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

FDA grants tentative approval for 75th generic anti-retroviral drug

The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS) has reached the milestone of the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush's Emergency Plan for AIDS Relief (PEPFAR).

29 Oct 2008

HSE launch campaign on asbestos awareness - 20 tradesmen die per week

Figures issued by the Health and Safety Executive revealed that every week 20 tradesmen die from asbestos-related diseases, and this number is set to increase.

23 Oct 2008

Surface analysis exposes counterfeit medicines

CERAM Surface and Materials Analysis has published a white paper highlighting how surface analysis can expose counterfeit medicines. It describes how technologies such as X-ray photoelectron spectroscopy (XPS) and Time-of-Flight Secondary Ion Mass Spectroscopy (ToFSIMS) are being used in novel ways to not only analyse the composition of various pharmaceuticals, but also to determine differences in the manufacturing processes involved.

15 Oct 2008

GE announces battery-free RFID sensor

GE Global Research has announced a battery-free, multi-detection radio-frequency identification (RFID) sensing platform that could enable a wide range of low cost wireless sensing products in healthcare, security, food packaging, water treatment and pollution prevention. GE's unique RFID sensors are built on traditional RFID tags.

14 Oct 2008

FDA licenses for marketing Cinryze for hereditary angioedema

The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States.

12 Oct 2008

Lilly to acquire ImClone Systems for $6.5 billion

Eli Lilly and Company and ImClone Systems Inc. today announced that the boards of directors of both companies have approved a definitive merger agreement under which Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion.

6 Oct 2008

Advanced Life Sciences submits NDA for cethromycin in mild-to-moderate community acquired pneumonia

Advanced Life Sciences Holdings, Inc. has announced the submission of a new drug application (NDA) for cethromycin in mild-to-moderate community acquired pneumonia (CAP). Advanced Life Sciences also entered into debt and equity financing agreements to strengthen its balance sheet and help fund commitments associated with the NDA submission and pre-commercialization activities.

2 Oct 2008

PEPFAR suspends funding for three Ranbaxy AIDS drugs banned by FDA

The President's Emergency Plan for AIDS Relief program has suspended funding for three antiretroviral drugs manufactured by Indian generic drugmaker Ranbaxy that were included in an importation ban imposed by FDA on Sept. 16, Bloomberg reports.

29 Sep 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

House members send letter to Condoleezza Rice requesting information on antiretrovirals supplied to PEPFAR by Ranbaxy

Rep. John Dingell (D-Mich.) and members of the House Committee on Energy and Commerce on Friday sent a letter to Secretary of State Condoleezza Rice requesting information about alleged safety problems with antiretrovirals manufactured by the Indian generic pharmaceutical company Ranbaxy and distributed through the President's Emergency Plan for AIDS Relief, the AP/International Herald Tribune reports (AP/International Herald Tribune, 9/19).

22 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

Bariatric surgery cost-effective for treating obesity

Health insurers can offset the cost of laparoscopic or traditional bariatric surgery as a weight-loss treatment for obese patients within two to four years as a result of savings on other medical costs, according to a study published this month in the American Journal of Managed Care, the Wall Street Journal reports.

9 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

Alte Biosciences files patent for novel inflammatory bowel disease drugs

Alte Bioscience, Inc., a development stage pharmaceutical company, is pleased to announce the filing of a provisional patent for a new class of drugs that may benefit patients with inflammatory bowel disease.

3 Sep 2008

FDA authorizes INDA for recombinant human C1 inhibitor in kidney transplantation

Biotech company Pharming Group NV has announced that the US Food and Drug Administration (FDA) has authorized a clinical study with recombinant human C1 inhibitor (rhC1INH) for the treatment of antibody-mediated rejection (AMR) in kidney transplantation. Dr. Hans Sollinger of the University of Wisconsin, Madison will conduct the clinical trial with rhC1INH under an Investigator IND from the FDA.

3 Sep 2008