Manufacturing News and Research

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

Laureate Pharma secures $20 million financing to enhance business

Laureate Pharma, Inc., a full-service contract development and manufacturing organization today announced that it has secured $20 million in debt and equity financing to enhance and grow its business.

7 Oct 2010

American Cancer Society awards 94 national research, training grants to 70 institutions nationwide

The American Cancer Society, the largest non-government, not-for-profit funding source of cancer research in the United States, has awarded 94 national research and training grants totaling $46,633,000 to 70 institutions nationwide in the first of two grants cycles for 2011.

7 Oct 2010

Synergetics anticipates $13 million net sales for fourth quarter 2010

Synergetics USA, Inc., a medical device company that designs, manufactures, and markets innovative microsurgical instruments for ophthalmic and neurosurgical applications, today announced that it expects to report net sales of approximately $13 million and net income of approximately $1 million for its fourth quarter ended July 31, 2010.

6 Oct 2010

Research to focus on effective use of artemisinin stocks for malaria

The frontline malaria treatment artemisinin could soon be treating more people for less cost, thanks to a research collaboration between Bradford and Shanghai.

6 Oct 2010

Johnson & Johnson to acquire all outstanding equity of Crucell for euro 1.75 billion

Johnson & Johnson and Crucell N.V. today announced an agreement whereby Johnson & Johnson, through an affiliate, would acquire all outstanding equity of Crucell that it does not already own for approximately euro 1.75 billion in a recommended cash tender offer.

6 Oct 2010

New Wipro Rapid Trials platform launched to accelerate drug development

Wipro Technologies, the global Consulting, System Integration and Outsourcing business of Wipro Limited, today announced the launch of Wipro Rapid Trials platform to accelerate drug development across the globe.

6 Oct 2010

Nonin Medical announces name change of capnography manufacturing center

Nonin Medical, Inc. today announced that its Hudiksvall-based capnography manufacturing center, formerly MedAir AB, has changed its name to Nonin Medical AB and expanded its operations to better serve Nonin Medical's European customers and distributors.

6 Oct 2010

SAFC expands fermentation capabilities in Israel facility

SAFC, a member of the Sigma-Aldrich® Group (Nasdaq: SIAL), today announced the completion of its state-of-the-art expansion of its Jerusalem, Israel facility. The additional capacity expands SAFC's contract manufacturing capabilities in large molecule recombinant proteins and small molecule Active Pharmaceutical Ingredients (APIs) through fermentation, including High Potent APIs (HPAPIs) and secondary metabolites.

6 Oct 2010

Liquidia commences dosing in LIQ-001 Phase 1 trial for seasonal influenza

Liquidia Technologies, a privately held nanotechnology company developing particle-based vaccines and therapeutics, today announced the initiation of human dosing of its lead vaccine product candidate, LIQ-001, in a Phase 1 clinical trial. LIQ-001, the first in a pipeline of PRINT® vaccines, is being developed as a seasonal influenza vaccine for enhanced protection in the elderly and represents the company's migration from proof of concept to the clinical application of PRINT technology.

5 Oct 2010

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Mylan Inc. today announced that its 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 Abbreviated New Drug Application (ANDA) for Atazanavir Sulfate Capsules, 150 mg and 300 mg. This product will be eligible for purchase outside the U.S. in certain developing countries.

5 Oct 2010

Novo Nordisk announces $73M expansion of Clayton insulin delivery systems manufacturing facility

Novo Nordisk, a global healthcare company and leader in diabetes care, today announced a $73 million expansion of its Clayton, NC manufacturing facility to accommodate increased production capacity for the Company's insulin delivery devices.

5 Oct 2010

FDA announces dates for public hearing on Biologics Price Competition and Innovation Act of 2009

The U.S. Food and Drug Administration has scheduled a two-day public hearing on Nov. 2-3, 2010, on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009. The hearing will be held from 8:30 a.m. to 4:30 p.m. at the FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31, room 1503, in Silver Spring, Md.

4 Oct 2010

VIVUS announces divestiture of MUSE to Meda

VIVUS, Inc. today announced that it has entered into an asset purchase agreement with Meda - an international specialty pharma company - for MUSE®, transurethral alprostadil, for the treatment of erectile dysfunction (ED). Under the agreement, Meda will acquire the MUSE assets including the United States and foreign MUSE patents, existing inventory and the manufacturing facility located in Lakewood, New Jersey.

4 Oct 2010

Emdeon acquires Chamberlin Edmonds

Emdeon Inc., a leading provider of healthcare revenue and payment cycle management solutions, today announced it has completed the acquisition of Chamberlin Edmonds & Associates, Inc., a leading provider of government program eligibility and enrollment services to over 200 acute care facilities in 31 states. Chamberlin Edmonds' technology-enabled services assist hospitals in lowering the incidence of uncompensated care, reducing bad-debt expense and increasing overall cash flow.

4 Oct 2010

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Celsion Corporation, a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.

4 Oct 2010

Pharmatek adds roller compaction to GMP manufacturing facilities

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has added roller compaction to its solid oral dosage form manufacturing capabilities. The company has purchased two roller compactors, a pilot-scale Vector TFC-220 roller compactor with a rate of 20 kg/hour, and a Vector TFC-LAB Micro lab-scale roller compactor with a rate of 1 kg/hour. Both machines have been integrated into Pharmatek's GMP facility and are ready for GMP manufacturing.

4 Oct 2010

Sanofi-aventis commences tender offer for Genzyme acquisition

Sanofi-aventis announced today it has commenced a tender offer for all outstanding shares of common stock of Genzyme Corporation for $69 per share, net to the seller in cash, without interest and less any required withholding taxes. The transaction is valued at approximately $18.5 billion.

4 Oct 2010

Bionovo enters definitive agreement to raise $3.0 million in registered direct offering

Bionovo, Inc., a drug discovery and development company focused on unmet needs in women's health and oncology, today announced that it has entered into definitive agreements to raise approximately $3.0 million in gross proceeds in a registered direct offering through the sale of common stock and warrants.

4 Oct 2010

Medicago announces official groundbreaking ceremony for U.S. plant-based commercial grade vaccine facility

Medicago U.S.A. Inc., a wholly owned subsidiary of Medicago Inc., a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that company executives, along with U.S. Senator Kay Hagan (D-NC) and U.S. Congressman David Price (D-NC), are holding an official groundbreaking ceremony this morning for its U.S. plant-based commercial grade vaccine facility in Research Triangle Park, North Carolina.

1 Oct 2010

FDA takes action against unapproved single-ingredient oral colchicine

The U.S. Food and Drug Administration took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

1 Oct 2010

Manufacturing News and Research

Further Reading

Laureate Pharma secures $20 million financing to enhance business

American Cancer Society awards 94 national research, training grants to 70 institutions nationwide

Synergetics anticipates $13 million net sales for fourth quarter 2010

Research to focus on effective use of artemisinin stocks for malaria

Johnson & Johnson to acquire all outstanding equity of Crucell for euro 1.75 billion

New Wipro Rapid Trials platform launched to accelerate drug development

Nonin Medical announces name change of capnography manufacturing center

SAFC expands fermentation capabilities in Israel facility

Liquidia commences dosing in LIQ-001 Phase 1 trial for seasonal influenza

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Novo Nordisk announces $73M expansion of Clayton insulin delivery systems manufacturing facility

FDA announces dates for public hearing on Biologics Price Competition and Innovation Act of 2009

VIVUS announces divestiture of MUSE to Meda

Emdeon acquires Chamberlin Edmonds

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Pharmatek adds roller compaction to GMP manufacturing facilities

Sanofi-aventis commences tender offer for Genzyme acquisition

Bionovo enters definitive agreement to raise $3.0 million in registered direct offering

Medicago announces official groundbreaking ceremony for U.S. plant-based commercial grade vaccine facility

FDA takes action against unapproved single-ingredient oral colchicine

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