Manufacturing News and Research

RSS

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

NDA for Cadence Pharmaceuticals' OFIRMEV injection to be re-submitted to FDA

Cadence Pharmaceuticals, Inc. announced today that, based on feedback received during a meeting with the U.S. Food and Drug Administration on April 16, 2010, it plans to re-submit a New Drug Application for its investigational product candidate, OFIRMEV (acetaminophen) injection, within the next 30 days.

19 Apr 2010

Protein Potential receives Phase II SBIR Grant to develop vaccine for prevention of P. vivax infections

Protein Potential LLC has received support from the National Institute of Allergy and Infectious Diseases of the NIH in the form of a Phase II Small Business Innovation Research Grant. The three-year award totaling approximately $3 million will support translational research to develop a vaccine for the prevention of malaria caused by the parasite Plasmodium vivax.

19 Apr 2010

Organogenesis to showcase study results of Apligraf product at SAWC / WHS 2010

Organogenesis, Inc. will have a substantial presence at the 23rd Annual Symposium on Advanced Wound Care and Wound Healing Society being held April 17-20 in Orlando, FL. Results from several clinical and scientific studies will be presented which will further the understanding of Organogenesis' bilayered living cellular construct technology.

19 Apr 2010

Trans fats back on the agenda in UK

Dariush Mozzaffarian and Meir J Stamper, wrote an article in the British Medical Journal urging the government to ban industrial trans fatty acids or TFAs. This adds to the plea of doctors and medical charities across the country, who want to follow the example of Denmark and New York City where TFAs have been eradicated without affecting the price, taste or availability of products.

19 Apr 2010

Solos Endoscopy reports revenues of $421,882 for 2009

Solos Endoscopy, Inc. announced today that the Company has posted its financial results for the year ending December 31, 2009 on Pink Sheets OTC Markets website.

17 Apr 2010

Akela to terminate lease payment agreement

Akela a leader in the development of therapeutics for the treatment of pain and its wholly owned subsidiary, PharmaForm, a leader in the contract pharmaceutical development and manufacturing business, today announced that it has reached agreement with HEP Davis Spring, L.P. to terminate its lease located at 9825 Spectrum Drive, Austin, Texas, eliminating $14,500,000 in future lease payment obligations to the Company.

17 Apr 2010

Boston Scientific receives FDA clearance to resume distribution of COGNIS CRT-Ds and TELIGEN ICDs

Boston Scientific Corporation today announced that it has received U.S. Food and Drug Administration clearance for the two validated manufacturing changes affecting all of its cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators, and that it will immediately resume distribution of its COGNIS CRT-Ds and TELIGEN ICDs.

16 Apr 2010

FDA approves Akorn's ANDA for generic version of Dilaudid-HP Injection

Akorn, Inc. a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted approval of the Company's Abbreviated New Drug Application for the generic version of Dilaudid-HP® 10mg/ml Injection. The company intends to begin shipping the product next month.

16 Apr 2010

3M Drug Delivery Systems grows its product portfolio in Asia’s pharmaceutical industry

3M Drug Delivery Systems recently advanced its participation in the Asian market with a sponsorship of the Asia Pharma R&D Leaders 2010 event, held March 4 and 5 in Shanghai, China.

16 Apr 2010

Contura submits PMA for Aquamid

Contura Inc. has submitted a Premarket Approval Application for Aquamid to the U.S. Food and Drug Administration requesting marketing approval in the U.S. for the aesthetic treatment of moderate to severe facial wrinkles and folds.

16 Apr 2010

Tengion completes initial 6M common stock public offering

Tengion, Inc., a regenerative medicine company focused on discovering, developing, manufacturing and commercializing neo-organs and neo-tissues, today announced the completion of its initial public offering of 6,000,000 shares of common stock at a price of $5.00 per share. The net proceeds of the offering to Tengion, after deducting underwriting discounts and commissions and estimated offering expenses payable by Tengion, were approximately $26.0 million.

15 Apr 2010

New cardiac CT technology promises low radiation exposure and improved image quality

Cardiovascular disease is the leading cause of death globally and a tremendous burden on the healthcare system. Better detection of hardening or clogging of arteries and other blood vessels before symptoms occur is needed.

15 Apr 2010

FDA approves Sagent Pharmaceuticals' two ANDAs to market granisetron

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced the U.S. Food and Drug Administration has approved the Company's two abbreviated New Drug Applications to market granisetron hydrochloride injection, USP (granisetron), an antiemetic used to prevent nausea and vomiting caused by chemotherapy.

15 Apr 2010

Patheon adds development and manufacturing softgel capability in Cincinnati facility

Patheon, a global provider of drug development and manufacturing services to the international pharmaceutical industry announced today that it is adding development and manufacturing softgel capability in its Cincinnati facility, providing the pharmaceutical industry a new contract provider for this popular drug delivery system.

15 Apr 2010

FDA approves J&JPRD's PANCREAZE NDA

Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for PANCREAZE™ (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Exocrine pancreatic insufficiency is the inability to properly digest and absorb food due to a lack of enzymes made by the pancreas that are important in the digestion of fats, proteins, and sugars.

15 Apr 2010

Neovasc's 2009 revenues up 94%

Neovasc Inc., today announced financial results for the year ended December 31, 2009.

13 Apr 2010

XOMA expands anti-inflammatory antibody intellectual property portfolio

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced that the U.S. Patent and Trademark Office has issued two new patents that significantly expand the company's intellectual property portfolio relating to its anti-inflammatory antibody, XOMA 052, that targets interleukin-1 beta (IL-1 beta).

13 Apr 2010

Tongjitang special committee to evaluate Hanmax Investment and Fosun Industrial buyout proposal

Tongjitang Chinese Medicines Company, a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced that it has established a special committee to evaluate the proposal presented on April 8, 2010 by Hanmax Investment Ltd. and Fosun Industrial Co., Ltd.

13 Apr 2010

Pancreaze Delayed Release Capsules receive FDA approval

The U.S. Food and Drug Administration today approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product. It is the third such product to receive FDA approval.

13 Apr 2010

Diasorin migrates to Orange Business Services' Business VPN solution

Diasorin S.p.A., an international player in the market of in vitro diagnostics based in Saluggia (Vercelli, Italy), has migrated to Business VPN, a fully-managed, secure, global IP infrastructure from Orange Business Services connecting 12 locations in Europe, the Americas and Asia.

12 Apr 2010