Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.
Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more...
The House Committee on Energy and Commerce issued a revised discussion draft to the Food and Drug Administration Globalization Act of 2008.
Bristol-Myers Squibb is seeking to acquire the biopharmaceutical company ImClone Systems (New York) for $4.5 billion or $60 per share. BMS currently holds a 17% stake in ImClone.
Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more...
The pharmaceutical industry?s outsourcing practices receive increased attention as Congress evaluates the role of outsourcing in drug-safety issues.
CMOs expand capacity and capabilities in high-potency manufacturing to meet strong demand for cytotoxic and other potent drugs.
Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.
The high-profile case of contaminated heparin from a Chinese supplier has intensified the debate on the effectiveness of FDA's process for inspecting foreign drug-manufacturing facilities. The article examines proposed legislative and regulatory reforms and actions taken by the agency to improve drug-import safety.
Also, Cobra Biomanufacturing to extend collaboration and form joint venture with ViroMed, Epix Pharmaceuticals CEO resigns, more...
As part of a new strategic direction, GlaxoSmithKline CEO Andrew Witty outlined three priorities that are designed to improve the company's long-term financial performance.
Senator Sherrod Brown sent a letter to Richard T. Clark, president and chief executive officer of Merck (Whitehouse Station, NJ), to ask for information about the company's reliance on global outsourcing for the manufacture of pharmaceutical ingredients and finished products.
Roche plans to acquire the biopharmaceutical company Genentech (South San Francisco, CA) for $43.7 billion. Roche currently holds a 55.9% stake in Genentech and it plans to acquire the remaining publicly held minority interest that it does not own for $89 per share.
Also, Niro changes its name to GEA Process Engineering; Frances K. Heller joins Exelixis as executive vice-president of business development, more...
Also, Roche to end HIV/AIDS research program, WuXi PharmaTech makes appointments, more...
Also, Catalent Pharma Solutions to collaborate with One World Design and Manufacturing Group, Bioheart appoints Howard J. Leonhardt as CEO, more...
The European Pharmacopoeia Commission adopted revised monographs for heparin calcium and heparin sodium to strengthen the level of testing required for quality control.
A recent US government study shows that follow-on biologics are likely to have a favorable economic impact if proposed legislation authorizing a regulatory pathway in the US is approved.
Also, Covance and WuXi PharmaTech to form contract research joint venture in China, Covidien makes appointments to its Pharmaceutical Products and Imaging Solutions businesses, more...
Richard E. Maleczka Jr. and Milton R. Smith III, professors of the Department of Chemistry at Michigan State University, were recognized by the Environmental Protection Agency's Presidential Green Chemistry Challenge Awards, for designing a catalytic reaction to synthesize precursors for the Suzuki-coupling reaction.
Molecular Profiles created a poster that demonstrates the efficacy of its "nanoPASS" (nanoscale predictive analytical screening solution) technique to characterize an active pharmaceutical ingredient's (API) surface energy.
With no economic relief in sight, industry, like all of us, is grappling with high-and new-costs.
The year 2007 was slow for approvals for new molecular entities and overall pharmaceutical industry growth. Big Pharma seeks relief in a growing biologics portfolio.
Nasal drug delivery depends on many factors, including the conditions of use by the patient, the drug formulation, and the spray pump and aerosol characteristics. In recent years, the types of drug administered via the nasal route have expanded from locally acting drugs, such as those for allergic rhinitis, to delicate molecules for systemic activity, such as vaccines, proteins and peptides, which can be difficult to administer noninvasively. While the nasal cavity provides a delivery pathway for these large molecules, the rate of mucociliary clearance in the nasal cavity may hinder the extent of absorption. Therefore, formulators must develop mechanisms that improve absorption for high molecular weight compounds.
The US Pharmacopeia (USP) posted revised monographs for heparin sodium and heparin calcium on its website.
