Manufacturing News and Research

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

FindPharma.com website for pharma professionals

Advanstar Communications announced today that it has launched FindPharma.com, a digital vertical search destination that will enable pharma professionals to find and filter relevant industry information, high quality suppliers and career assistance.

16 Sep 2009

Matrix Laboratories receives tentative FDA approval for its NDA

Mylan Inc. today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.

16 Sep 2009

CEL-SCI to commence its LEAPS-H1N1 clinical trial following FDA approval

CEL-SCI Corporation (NYSE Amex: CVM), a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases and a late-stage oncology company, announced today that the U.S. Food and Drug Administration (FDA) has indicated that the Company can proceed with its first clinical trial to evaluate the effect of its investigational LEAPS-H1N1 treatment on the white blood cells of hospitalized H1N1 patients.

16 Sep 2009

Savient updates on its Biologics License Application with the FDA for KRYSTEXXA

Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that on September 14, 2009, the Company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) received by Savient on July 31, 2009 regarding the Company's Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy.

16 Sep 2009

RXi Pharmaceuticals to present in vivo data of rxRNA compounds

RXi Pharmaceuticals Corporation, a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that it will be presenting new in vivo data on its self-delivering rxRNA compounds at a number of upcoming scientific conferences, detailed below.

16 Sep 2009

Standardization of recycling policies can extend the life of electronic products

Processes and policies governing the reuse and recycling of electronic products need to be standardized worldwide to stem and reverse the growing problem of illegal and harmful e-waste processing practices in developing countries, according to experts behind the world's first international e-waste academy

16 Sep 2009

Laser technology lowers manufacturing cost of artificial joints and arterial stents

Researchers are developing technologies that use lasers to create arterial stents and longer-lasting medical implants that could be manufactured 10 times faster and also less expensively than is now possible.

16 Sep 2009

AMRI files two new patent infringement lawsuits

AMRI announced today that it has filed two new patent infringement lawsuits in U.S. District Court in New Jersey against Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc. and Sandoz, Inc. (“the defendants”) for infringement of AMRI’s U.S. Patent Number 7,390,906. The recently issued patent relates to the manufacturing process for the active ingredient in sanofi-aventis’s Allegra and AllegraD drug products.

16 Sep 2009

Ganeden Biotech unveils the first quick dissolving, thin strip probiotic product

Ganeden Biotech Inc., makers of the patented probiotic strain GanedenBC30(R), today announced the launch of the first quick dissolving, thin strip probiotic product. The new thin strip product is the latest in a number of innovative probiotic-enhanced products introduced by Ganeden Biotech over the past year.

16 Sep 2009

NIAID awards Sanaria an SBIR Grant for expediting its malaria vaccine manufacturing process

Sanaria Inc. has received additional support from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health in the form of a Phase II Small Business Innovation Research (SBIR) Grant. The award for two years is $1.99 million. Subject to satisfactory progress by Sanaria, continued funding for a third year will bring the total to nearly $3 million.

16 Sep 2009

WHO says 3b people worldwide could receive H1N1 vaccine

Recent findings that a single dose of an H1N1 (swine) flu vaccine offers protection against the virus and anticipation of vaccination programs starting earlier than predicted will increase the number of people worldwide with access to the vaccine and the likelihood health officials may be able to control the spread of the virus, Bloomberg reports.

16 Sep 2009

Four H1N1 vaccines approved by FDA

The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

16 Sep 2009

Stevens receives training grant from LWD

Stevens Institute of Technology has again been awarded a $563,600 High-Growth Workforce Development training grant from the New Jersey Department of Labor and Workforce Development (LWD).

15 Sep 2009

Genova gains access to Big Pharma's distribution channels

GENova Biotherapeutics Inc. ("GENova"), a cancer drug acquisition and development company, is pleased to announce it has gained access to distribution channels for its promising drug targets through a recently-signed deal with Bridge BioResearch Plc. ("Bridge BioResearch").

15 Sep 2009

NSF International certification for COLD-FX(R)

Afexa Life Sciences Inc. ("Afexa") (TSX:FXA) today announced that COLD-FX(R) has received the highest sports certification in North America from the leading product safety and banned substances testing body for elite athletes.

15 Sep 2009

Sage Products and EngagementHealth partner to launch health promotion programs

Sage Products, Inc. an established innovator in the manufacture of healthcare products and EngagementHealth, LLC, announced today the successful launch of comprehensive disease prevention and health promotion programs. All employees and spouses at Sage Products were invited to participate in the EngagementHealth's biometric screenings, health counseling calls, and individualized targeted risk programs.

15 Sep 2009

Phase II clinical study results of Kamada's inhaled-AAT for cystic fibrosis presented at the ERS Congress

Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced that data on its next-generation alpha-1 antitrypsin (Inhaled-AAT) in cystic fibrosis patients was presented today, at the Annual Congress of the European Respiratory Society (ERS) 2009, Vienna. As previously reported, the study showed that inhaled-AAT was safe and biologically effective.

15 Sep 2009

Pall Corporation announces financial results for the fourth quarter and fiscal year ended July 31, 2009

Pall Corporation (NYSE:PLL) today reported financial results for the fourth quarter and fiscal year ended July 31, 2009. Sales and net earnings for the year were $2.3 billion and $195.6 million, respectively. Diluted earnings per share (EPS) were $1.64, compared to $1.76 a year earlier. Pro forma EPS were $1.77 versus last year's $1.97.

From Pall Corporation 15 Sep 2009

AzaSite production increased to combat erythromycin ophthalmic ointment shortage

InSite Vision Incorporated today announced that Inspire Pharmaceuticals, its commercial partner for AzaSite (azithromycin ophthalmic solution) 1% in the U.S and Canada, has committed to increasing production of AzaSite in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%).

15 Sep 2009

Protalix Biotherapeutics reports completion of its Phase III trial of prGCD

Protalix Biotherapeutics, Inc. (NYSE-Amex: PLX), announced the completion of its pivotal Phase III trial for prGCD, the Company’s proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. The trial enrolled a total of 31 patients across Europe, North America, South America, Israel and South Africa. No serious adverse events were reported in this trial.

14 Sep 2009

Manufacturing News and Research

Further Reading

FindPharma.com website for pharma professionals

Matrix Laboratories receives tentative FDA approval for its NDA

CEL-SCI to commence its LEAPS-H1N1 clinical trial following FDA approval

Savient updates on its Biologics License Application with the FDA for KRYSTEXXA

RXi Pharmaceuticals to present in vivo data of rxRNA compounds

Standardization of recycling policies can extend the life of electronic products

Laser technology lowers manufacturing cost of artificial joints and arterial stents

AMRI files two new patent infringement lawsuits

Ganeden Biotech unveils the first quick dissolving, thin strip probiotic product

NIAID awards Sanaria an SBIR Grant for expediting its malaria vaccine manufacturing process

WHO says 3b people worldwide could receive H1N1 vaccine

Four H1N1 vaccines approved by FDA

Stevens receives training grant from LWD

Genova gains access to Big Pharma's distribution channels

NSF International certification for COLD-FX(R)

Sage Products and EngagementHealth partner to launch health promotion programs

Phase II clinical study results of Kamada's inhaled-AAT for cystic fibrosis presented at the ERS Congress

Pall Corporation announces financial results for the fourth quarter and fiscal year ended July 31, 2009

AzaSite production increased to combat erythromycin ophthalmic ointment shortage

Protalix Biotherapeutics reports completion of its Phase III trial of prGCD

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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