Manufacturing News and Research

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

Adult human stem cells shown not to pose a cancer risk when implanted into different organs

A new study by UC Davis researchers provides evidence that methods using human bone marrow-derived stem cells to deliver gene therapy to cure diseases of the blood, bone marrow and certain types of cancer do not cause the development of tumors or leukemia.

6 May 2008

Nuclear radiation-blocking, anti-chemical, biological-protection fabric granted Australian patent

Ronald DeMeo, MD, MBA, president and chief executive officer with Radiation Shield Technologies (RST), today announced the company has been granted a new Australian patent for Demron, the world's first nuclear radiation-blocking, anti-chemical and biological-protection material.

6 May 2008

Biosimilar protein cooperation

A biosimilar protein that can be used to treat neutropenia (a side effect of cancer chemotherapy) is to be developed by Apotex Inc. of Canada in collaboration with Intas Biopharmaceuticals Limited (IBPL).

6 May 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

Results of St. Jude Medical deep brain stimulation study presented at APA meeting

St. Jude Medical, Inc. today announced pilot study results from the first multi-center study investigating deep brain stimulation (DBS) of Brodmann Area 25 for major depressive disorder.

5 May 2008

Novavax opens new U.S. vaccine plant in Rockville, Maryland

Officials from Novavax, Inc., the State of Maryland and Montgomery County today celebrated the opening of Novavax's new state-of-the-art vaccine production facility at the company's headquarters in Rockville, Maryland.

1 May 2008

3M Drug Delivery System collaborates on vaccine adjuvants

3M Drug Delivery Systems announces the signing of a non-exclusive license agreement with the Infectious Disease Research Institute (IDRI) in support of vaccine research for humanitarian efforts in developing countries. Under the agreement, 3M will donate its patented toll-like receptor (TLR) immune response modifier compounds.

1 May 2008

FDA needs additional $225 million, new authority to inspect foreign facilities to protect U.S. residents from unsafe prescription drug imports, agency officials say

FDA officials on Tuesday said the agency would need at least $225 million in additional funding annually, along with other authoritative powers, to adequately inspect the safety of imported drug products, the Baltimore Sun reports.

30 Apr 2008

Turning on cell-cell communication wipes out staph biofilms

University of Iowa researchers have succeeded in wiping out established biofilms of Staphylococcus aureus (staph) by hijacking one of the bacteria's own regulatory systems.

30 Apr 2008

AstraZeneca submits sNDA for SYMBICORT in chronic obstructive pulmonary disease

AstraZeneca today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.

30 Apr 2008

FDA official says agency cannot ensure safety of all medications sold in U.S.

Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, on Thursday at a Senate hearing said that the number of medication ingredients manufactured abroad limits the ability of the agency to ensure the safety of all treatments sold in the U.S., CQ HealthBeat reports (Carey, CQ HealthBeat, 4/24).

26 Apr 2008

Amneal Pharmaceuticals to acquire assets of Interpharm Holdings

Amneal Pharmaceuticals, LLC has announced the execution of an Asset Purchase Agreement for Amneal's wholly-owned subsidiary, Amneal Pharmaceuticals of New York, LLC, to acquire the assets, facilities and business of Interpharm. The acquisition includes Interpharm's facilities on Long Island, New York as well as the intellectual property including ANDA's, technology and processes.

24 Apr 2008

Self-referring physicians behind increase in diagnostic imaging

Physicians who refer patients to their own facilities or machines for scans account for much of the increase in diagnostic imaging ordered for privately insured patients said a Baylor College of Medicine expert in a commentary that appears in the current issue of the journal Medical Care.

24 Apr 2008

Beta arrestins found to generate new proteins

Duke University Medical Center researchers have recently discovered that a crucial communications pathway in cells not only stops cells from making proteins, it also makes them go. The team was able to define the way in which proteins called beta arrestins (for their role in stopping signals) also turn on pathways that ultimately lead to the production of new proteins in virtually all tissues in the body.

24 Apr 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

Researchers unravel heparin death mystery

An international team of researchers led by MIT has explained how contaminated batches of the blood-thinner heparin were able to slip past traditional safety screens and kill dozens of patients recently in the United States and Germany.

23 Apr 2008

Taro Pharmaceutical receives final FDA approval for Cetirizine Hydrochloride oral solution

Taro Pharmaceutical Industries Ltd. reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for cetirizine hydrochloride oral solution, 1 mg / 1 mL ("Cetirizine Oral Solution").

22 Apr 2008