Pharmaceutical Manufacturing News and Research

RSS

Momenta, Baxter partner to develop and commercialize biosimilars

Baxter International Inc. and Momenta Pharmaceuticals, Inc. today announced that they have entered into a global collaboration to develop and commercialize follow-on biologic products, also known as biosimilars.

From Baxter International Inc. 23 Dec 2011

Anesthesia drug shortages can have devastating impact on patient care

The United States is facing ongoing shortages of several critical anesthesia medications—shortages with potentially serious effects on patient care and safety, according to a special article in the December issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

24 Nov 2011

Brazilian Ministry of Health, Bristol-Myers Squibb sign technology transfer agreement for Reyataz

Bristol-Myers Squibb Company today announced a technology transfer agreement with the Brazilian Ministry of Health to expand access to Reyataz (atazanavir sulfate) in Brazil.

13 Nov 2011

NeoStem third quarter revenues increase to $17.8 million

NeoStem, Inc., an international biopharmaceutical company with a focus on cell based therapeutics development, today reported third quarter results and recent progress in its business.

11 Nov 2011

Obama takes action to address drug shortages

President Barack Obama issued an executive order Monday directing the Food and Drug Administration to, among other steps, speed up reviews of manufacturers' applications to begin or alter production of a drug in potentially short supply.

2 Nov 2011

Researchers announce new method to build important heparin drug

Robert Linhardt is working to forever change the way some of the most widely used drugs in the world are manufactured. Today, in the journal Science, he and his partner in the research, Jian Liu, have announced an important step toward making this a reality. The discovery appears in the October 28, 2011 edition of the journal Science in a paper titled "chemoenzymatic synthesis of homogeneous ultra-low molecular weight heparins."

28 Oct 2011

NanoViricides President completes stock sales program

NanoViricides, Inc. announced that its President, Dr. Anil Diwan, has completed the programmed sale of the NanoViricides stock that he had obtained as a founder.

18 Oct 2011

Pew Health Group to ensure safety of U.S. drug supply

On Wednesday, September 14, Allan Coukell, a pharmacist and director of medical programs at the Pew Health Group, will testify before the Senate Health Education Labor and Pensions Committee about the need for Congressional action to ensure the safety of the U.S. drug supply.

12 Sep 2011

Drugs produced in offshore manufacturing plants more likely to have quality problems

Drugs produced in offshore manufacturing plants -- even those run by U.S. manufacturers -- pose a greater quality risk than those prepared in the mainland United States, a new study suggests.

7 Sep 2011

Foreign drug manufacturing, testing raise regulatory and ethical concerns

JAMA discusses "a recent report from the Pew Health Group about the growing risks of substandard and counterfeit medications resulting from the increasing overseas production of pharmaceuticals and their ingredients."

25 Aug 2011

Merck receives Oliver Wight Class A certification

Pharmaceutical and chemical giant Merck KGaA has been awarded Class A certification by Oliver Wight after dramatic improvements in service levels and a €15 million reduction in inventory, at its Darmstadt pharmaceutical production facility.

11 Aug 2011

Protox reports net loss of $3.2 million for second quarter 2011

Protox Therapeutics Inc., a developer of innovative products for the treatment of urological diseases, today announced financial results and achievements for the quarter ended June 30, 2011.

10 Aug 2011

Pharmalucence selects Bosch to provide isolated filling line for Billerica production facility

Pharmalucence, Inc. has selected Robert Bosch Packaging Technology, Inc. to provide a state-of-the-art isolated pharmaceutical filling line for the new Pharmalucence production facility being constructed in Billerica, MA.

30 Jul 2011

Pew director issues statement on Prescription Drug User Fee Act hearing

Allan Coukell, director of medical programs for the Pew Health Group, issued the following statement today on a U.S. Senate Health, Education, Labor & Pensions Committee hearing, "FDA User Fees: Advancing Public Health."

29 Jul 2011

Swaziland government, Vantage plan to construct pharmaceutical manufacturing facility

Vantage Health, announced today that it has been invited by the Ministry of Health for the Kingdom of Swaziland to plan the construction of a pharmaceutical manufacturing facility in that country.

25 Jul 2011

EPA to expand Cooperative Research And Development Agreement with NanoLogix

NanoLogix, a biotechnology innovator in the rapid detection and identification of live-cell bacteria and microorganisms, announced today the U.S. Environmental Protection Agency (EPA) intends to expand its Cooperative Research And Development Agreement (CRADA) with NanoLogix to include additional water-borne pathogens.

19 Jul 2011

USANA receives FDA registration to manufacture OTC drugs

USANA Health Sciences, Inc. today announced it has obtained the U.S. Food and Drug Administration's "Drug Establishment Registration," allowing the company to manufacture over-the-counter (OTC) drugs and holding it to a standard well above what is required of a dietary supplement manufacturer.

11 Jul 2011

New technologies could bring innovative sensors, devices for 'lab-on-a-chip' applications

Researchers are developing new technologies that combine a laser and electric fields to manipulate fluids and tiny particles such as bacteria, viruses and DNA for a range of potential applications, from drug manufacturing to food safety.

6 Jul 2011

FDA to beef up monitoring of imports

As Food and Drug Administration (FDA) commissioner, Dr. Margaret A. Hamburg has been trying to correct inadequately controlled imported food and drugs overwhelming her organization’s ability to monitor them.

21 Jun 2011

FDA's new strategy calls for coalitions of international regulators, increased data sharing

The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the "Pathway to Global Product Safety and Quality."

20 Jun 2011