Bio/Pharma Business

Managers of FDA-regulated firms must be proactive in how they manage their company?s compliance with good manufacturing practices regulations.

Achieving the promised benefits of offshore sourcing to India and China is more complicated than it seems.

Innovators and generics makers are staking out positions on follow-on proteins and other manufacturing issues.

Managers of FDA-regulated firms must be proactive in how they manage their company's compliance with good manufacturing practices regulations.

Shortages of Key Drugs

After a five-year downturn, cautious optimism is taking hold among API manufacturers.

This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.

Novartis to Expand Generics Hold

GlaxoSmithKline Rebrands AIDS Drugs

Too many players and threats to the main customer base challenge European dose manufacturers.

Laser-Marking Technique Improves Tablet Branding

Committees make prudent decisions and avoid mistakes, but they're afraid of the new.

Patheon is betting the whole is worth more than the sum of the parts in its acquisition of Puerto Rico contract manufacturer Mova.

Pat Survey

The blockage in the new product pipeline may be breaking. CROs report increased demand for late-stage development services in their latest round of earnings reports.

More than 1500 pharmaceutical industry employees worldwide provide a personal view into the issues that matter most in the workforce, including salary and benefits, skills and education, and perspectives on the current job market.

What should pharmaceutical companies make of recent corporate developments at several high-profile service providers?

Pharmaceutical science and technology news

Beyond the inevitable debate over profit margins, the increasing range and effectiveness of modern medicine leave us with one core issue: the high price of success.

Big Pharma is ramping up capital spending in parenteral manufacturing at the same time that contract manufacturers are completing their own major investment programs.

Early development services continue to be a sweet spot for contract R&D services. The big question is how soon the impact of early-development candidates will be felt in late development and commercialization.

The use of stable isotopic analyses to characterize drug products before they leave the manufacturer is explored as a means to identify counterfeit products.

The contract services industry is fertile ground for the investment banking community this summer.

Data from the 2004 Outsourcing Survey indicate that pharmaceutical companies are spending more on outsourced drug development, but with fewer suppliers.

Despite investors' strong interest in the chemical industry overall, pharmaceutical chemical businesses have not experienced much attention from investors thus far.

It's not clear whether contract service providers can deliver the performance improvements and costs savings that drug companies expect from large, long-term, semi-exclusive contracts.

Sponsors who have been lax in performing financial due diligence on their contractors have been given a wake-up call by the recent developments at aaiPharma.

Despite global economic problems during the last 2 years and continued industry-wide lay-offs in the manufacturing sector, the pharmaceutical industry workforce continues at a slow and steady pace. Employees, however, seem ever more wary of their job security.

Despite continued industry-wide layoffs in manufacturing jobs during the past year, the pharmaceutical industry workforce continues a slow and steady pace.

Outsourcing is part of the public debate as politicians seek to explain the lag in job growth despite a recovering economy, and as the Bush administration presses its initiative to "competitively source" more agency activities.