Patricia Van Arnum

The Alliance for Fair Trade with India is seeking action to resolve discriminatory trade practices and improved protection of intellectual property rights.

The move follows rejection of Elan shareholders of certain key deals and withdrawal of Royalty Pharma bid.

Quality is of utmost importance in drug development and manufacturing.

Risk and reward. It is a balance that has to be achieved in any business endeavor and is of utmost importance for pharmaceutical and biopharmaceutical companies managing their growth and manufacturing in emerging markets.

Elan urges its shareholders to reject bid in an upcoming meeting on June 17.

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

Emerging markets remain strong as established markets fare less well.

The upcoming DCAT Sharp Sourcing 2013 conference addresses the challenges and opportunities in pharmaceutical sourcing and procurement.

The CMO Aesica has used a combination of organic growth and acquisitions to build its business and is seeking to expand its geographic footprint.

Highlights from the 66th World Health Assembly and the pharmaceutical industry?s role in addressing noncommunicable diseases, mental and neurological disorders, R&D for diseases of the developing world, counterfeit medicines, the global vaccine action plan, and neglected tropical diseases.

International markets play an important role in pharmaceutical and biopharmaceutical companies’ growth strategies, and it is crucial that companies meet the challenge of global regulatory compliance.

Researchers at the Scripps Research Institute advance heteorcylic chemistry trhough new reagents and reaction-tracking techniques.

A recent study of computer-created and natural proteins suggests the number of sites where small-molecule drugs can bind to proteins is limited, thereby narrowing how to mitigate side effects through drug design.

A multifaceted approach is needed to resolve the myriad of challenges in developing oral formulations of poorly soluble drugs.

Microwave spectroscopy overcomes some of the limitations of circular dichroism and vibrational circular dichroism in analyzing enantiomers.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

FDA’s quality-by-design (QbD) initiative is a systematic approach to designing and developing pharmaceutical formulations and manufacturing processes to ensure predefined product quality.

As pharmaceutical and biopharmaceutical companies intensify product development in biologics, they are tasked with meeting the challenges of biologic-based drug development and manufacturing.

The Global Vaccine Action plan maps out a strategy to increase access and R&D for vaccines.

Bristol-Myers Squibb, Novartis, GlaxoSmithKline, Sanofi, and Roche are among the companies expanding biologic-based manufacturing capacity.

Financing to biotech companies in North American and Europe declined in 2012 as debt funding decreased and the IPO market remained weak.

The rejection by India's Supreme Court on Novartis' Glivec/Gleevec (imatinib mesylate) and other recent case law raise important issues on patent strategies for solid forms.

Solid-state chemistry is an important part of drug development, and public research is advancing the field.

Cocrystals are used to improve the performance of APIs that have non-ideal physiochemical properties by cocrystallizing the API with a second compound that modulates the API to provide a way to improve a drug's bioavailability, stability, and processability.

Parenteral drug delivery offers a variety of challenges but also opportunities. The author examines recent developments in nanotechnology-based drug delivery and other advances in injection-based drug delivery.

Despite overall manufacturing rationalization in the pharmaceutical/biopharmaceutical industry, the large pharmaceutical companies continue to invest in biologic-based manufacturing. The author provides an update in recent investment activity among the pharmaceutical majors in biologic-drug substance, vaccine, and parenteral drug manufacturing.

Quality by Design (QbD) is changing drug development and manufacturing. The science- and risk-based approach inherent in a QbD paradigm increases process understanding and leads to better drug development and manufacturing.

The company expands to add process-development and clinical-manufacturing capabilities at its large-scale bulk biologics facility.

Company is notified of GMP violations at facility in Catania, Italy.