Manufacturing News and Research

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

Protein Sciences receives FDA approval for Flublok vaccine

The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.

16 Jan 2013

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

GE Healthcare today announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility.

16 Jan 2013

Pfizer’s Quillivant XR now available in the U.S. for treatment of ADHD

Pfizer Inc. today announced that Quillivant XR (methylphenidate hydrochloride) CII for extended-release oral suspension is now available in the U.S. for the treatment of attention deficit hyperactivity disorder (ADHD).

16 Jan 2013

Leveraging public-private partnerships to improve global health

"Although global health was historically dominated by U.N. agencies and bilateral organizations, new partnerships with the private sector have emerged since the 1990s," Jeffrey Sturchio, senior partner at Rabin Martin, and Adel Mahmoud, a professor at Princeton University, write in the Huffington Post's "Impact" blog.

11 Jan 2013

Mussels may provide highly adhesive wound closure and more effective healing from surgery

Mussels can be a mouthwatering meal, but the chemistry that lets mussels stick to underwater surfaces may also provide a highly adhesive wound closure and more effective healing from surgery.

10 Jan 2013

Researchers develop new materials to support stem cell growth

Stem cell manufacturing for drug screening and treatments for diseases such as Huntington's and Parkinson's could be boosted by a new method of generating stem cells, a study suggests.

9 Jan 2013

Wockhardt receives final FDA approval for Lamotrigine to treat epilepsy

Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 25mg, 50mg, 100mg, 200mg and 300mg extended release tablets of Lamotrigine, which is used in treatment of epilepsy.

9 Jan 2013

Researchers use electrokinetic patterning to separate particles and microbes by size

Researchers have demonstrated a new technology that combines a laser and electric fields to create tiny centrifuge-like whirlpools to separate particles and microbes by size, a potential lab-on-a-chip system for medicine and research.

9 Jan 2013

ISCT selects Elsevier to publish Cytotherapy

Elsevier, a world-leading provider of scientific, technical and medical information products and services, is pleased to announce that the International Society for Cellular Therapy (ISCT) has selected Elsevier to publish Cytotherapy: The Journal of Cell Therapy effective January 2013.

8 Jan 2013

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA). Merck expects the FDA’s review to be completed in the first half of 2013.

7 Jan 2013

ReadSoft reaches agreement with global healthcare manufacturing company

ReadSoft North America has reached an agreement with a global manufacturing company in the healthcare sector.

4 Jan 2013

Regenerative medicine: an interview with Christophe Dardel, President of DSM Biomedical

Regenerative medicine is a new, exciting field that is based upon the belief that the human body has the inherent power to heal itself, but in some instances it just needs a little help.

3 Jan 2013

EPIRUS’ BOW-015 achieves bioequivalence to Remicade in a single dose comparator trial

EPIRUS Biopharmaceuticals, Inc., formerly known as fourteen22 Inc, announced that its lead asset, BOW-015, achieved bioequivalence to Remicade in a single dose comparator trial.

3 Jan 2013

Protein in human blood platelets points to a new weapon against malaria

One of the world's most devastating diseases is malaria, responsible for at least a million deaths annually, despite global efforts to combat it. Researchers from the Perelman School of Medicine at the University of Pennsylvania, working with collaborators from Drexel University, The Children's Hospital of Philadelphia, and Johns Hopkins University, have identified a protein in human blood platelets that points to a powerful new weapon against the disease. Their work was published in this months' issue of Cell Host and Microbe.

28 Dec 2012

Venaxis seeks CE Mark approval for blood-based appendicitis test

Venaxis, Inc., an in vitro diagnostic company, today announced it has filed for CE Mark approval in Europe for APPY1, the Company's blood-based appendicitis test.

21 Dec 2012

Acorda Therapeutics acquires Neuronex

Acorda Therapeutics, Inc. today announced that the Company has completed the acquisition of Neuronex, Inc., a privately held company developing a nasal spray formulation of diazepam. Under the terms of the agreement, Acorda paid $6.8 million to Neuronex to complete the acquisition.

21 Dec 2012

Patheon acquires Banner Pharmacaps

Patheon Inc., a leading provider of contract development and manufacturing services to the global pharmaceutical industry, today announced that it has completed its acquisition of Banner Pharmacaps, a specialty pharmaceutical business dedicated to the research, development and manufacturing of unique gelatin-based dosage forms.

15 Dec 2012

Manufacturing News and Research

Further Reading

Protein Sciences receives FDA approval for Flublok vaccine

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

Pfizer’s Quillivant XR now available in the U.S. for treatment of ADHD

Leveraging public-private partnerships to improve global health

Mussels may provide highly adhesive wound closure and more effective healing from surgery

Researchers develop new materials to support stem cell growth

Wockhardt receives final FDA approval for Lamotrigine to treat epilepsy

Researchers use electrokinetic patterning to separate particles and microbes by size

ISCT selects Elsevier to publish Cytotherapy

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

ReadSoft reaches agreement with global healthcare manufacturing company

Regenerative medicine: an interview with Christophe Dardel, President of DSM Biomedical

EPIRUS’ BOW-015 achieves bioequivalence to Remicade in a single dose comparator trial

Protein in human blood platelets points to a new weapon against malaria

Venaxis seeks CE Mark approval for blood-based appendicitis test

Acorda Therapeutics acquires Neuronex

Patheon acquires Banner Pharmacaps

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