Manufacturing News and Research

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

Gilead submits cobicistat NDA with FDA for treatment of HIV

Gilead Sciences, Inc. announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing.

29 Jun 2012

Powerful new technique can manipulate the building-block molecules of organic chemistry

Scientists at The Scripps Research Institute have developed a powerful new technique for manipulating the building-block molecules of organic chemistry. The technique enables chemists to add new functional molecules to previously hard-to-reach positions on existing compounds-making it easier for them to generate new drugs and other organic chemicals.

28 Jun 2012

Anthera announces results from blisibimod Phase 2b study on SLE

Anthera Pharmaceuticals, Inc., a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus.

28 Jun 2012

Seahorse Bioscience launches XF Palmitate-BSA FAO Reagent for FAO assays

Seahorse Bioscience, the world leader in manufacturing instrumentation and assay kits for measuring cellular metabolism, has announced the launch of its newest product, the XF Palmitate-BSA FAO Reagent, eliminating the need for radioactivity in fatty acid oxidation (FAO) assays.

27 Jun 2012

Dow announces Omega-9 Oils as first Breakthrough to World Challenges

The Dow Chemical Company today announced Omega-9 Oils as its first Breakthrough to World Challenges, addressing one of the Company's 2015 Sustainability Goals in the area of health.

26 Jun 2012

Sinovac provides update on EV71 vaccine Phase III trial on HFMD

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today provided an update on its Phase III clinical trial progress and commercialization preparation for its proprietary inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD).

26 Jun 2012

FDA approves Daiichi Sankyo's US-based Bethlehem packaging facility

Today, Daiichi Sankyo, Inc. received U.S. Food and Drug Administration (FDA) approval to package product at its first United States-based packaging facility located in Bethlehem, PA. With this approval, the Company expands its global supply chain capability, helping to ensure the supply of medicine to U.S. physicians and their patients.

25 Jun 2012

China SFDA approves China Biologic's Human Coagulation Factor VIII

China Biologic Products, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, today announced that its indirectly owned subsidiary, Shandong Taibang Biological Products Co., Ltd. has received a manufacturing approval certificate from the China State Food and Drug Administration for Human Coagulation Factor VIII ("FVIII").

25 Jun 2012

MAP Pharmaceuticals completes End-of-Review meeting with FDA for LEVADEX NDA

MAP Pharmaceuticals, Inc. today announced that the Company completed an End-of-Review meeting with the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for LEVADEX (dihydroergotamine) inhalation aerosol.

25 Jun 2012

BV treatment: full enrolment for phase 2 and first phase 3 trial

Starpharma Holdings Ltd (ASX:SPL; OTCQX: SPHRY) is pleased to report that recruitment is now 100% complete for its Phase 2 clinical trial to investigate the ability of VivaGel® to prevent the recurrence of BV, and also for the first of two pivotal Phase 3 studies of VivaGel® for the treatment of BV.

25 Jun 2012

U.S. District Court rules in favor of Teva in COPAXONE patent infringement case

Teva Pharmaceutical Industries Ltd. announced today the U.S. District Court for the Southern District of New York has found in favor of Teva in the Company's patent infringement lawsuit against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals regarding Teva's relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE.

23 Jun 2012

FDA issues CRL to Repligen's RG1068 NDA for treatment of pancreatitis

Repligen Corporation today announced that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for RG1068.

23 Jun 2012

Alexza resubmits ADASUVE NDA to U.S. FDA

Alexza Pharmaceuticals, Inc. announced today that it has resubmitted its ADASUVE New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2012.

22 Jun 2012

Southern Implants, Keystone announce merger agreement

Keystone Dental, Inc., a leading oral healthcare company dedicated to the delivery of breakthrough implant technology, and Southern Implants, Inc., a producer of unique and innovative dental implant technologies aimed to simplify clinical challenges for implant surgeons and restorative dentists, today announced the companies have merged.

From Danaher 22 Jun 2012

Nouveau Life launches Azul Instant supplement for erectile dysfunction

Nouveau Life Pharmaceuticals Inc., a provider of quality all-natural dietary supplements, announced today the release of its Azul Instant supplement.

21 Jun 2012

DSM XD high cell density process technology granted patents in several countries

DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM N.V., announced today that several countries have granted patents or have given statements of patent allowance to its proprietary XD® high cell density process technology.

19 Jun 2012

Vetter prepares new filling line for syringes at Ravensburg location

The demand for prefilled syringes is on the rise and Vetter is prepared. The company, a leading contract development and manufacturing organization is building a state-of-the-art, high-performance filling line for syringes at its Ravensburg Vetter South location.

19 Jun 2012

FDA grants Cook Pharmica first commercial manufacturing approval

In a decision that paves the way for greater pharmaceutical industry use of the company's contract manufacturing services, Cook Pharmica LLC has received its first approval from the U.S. Food and Drug Administration (FDA) to manufacture commercial product.

18 Jun 2012

Mallinckrodt, Horizon enter co-promotion agreement for DUEXIS

Mallinckrodt, the Pharmaceuticals business of Covidien, today announced that it has entered into a co-promotion agreement with Horizon Pharma, Inc. to promote DUEXIS (ibuprofen and famotidine).

18 Jun 2012

Wellcome Trust awards University of Maryland $4M to accelerate development of conjugate NTS vaccine

The University of Maryland School of Medicine's Center for Vaccine Development (CVD) has received a $4 million Strategic Translation Award from the prestigious Wellcome Trust to support a collaboration with Bharat Biotech for clinical development of a new conjugate vaccine to prevent the potentially lethal infectious disease caused by invasive non-typhoidal Salmonella.

18 Jun 2012