BioBusiness

Contract service providers debate the pros and cons of consolidation, accelerated drug approvals, regulatory issues, and the impact of new therapies.

New drug approval policies promote industry growth and injectable contract manufacturing opportunities in China.

Biopharmaceutical contractors continue to invest in development, facility upgrades, technological advancement, and mergers and acquisitions.

Insight on the new regulatory framework from the China Food and Drug Administration

BioPharm sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.

Policies for patient access to life-saving therapies must keep pace with biomedical innovation.

Immuno-oncology drugs are demonstrating patient benefits, but growing resistant to the high cost has implications for patients, market access, and manufacturers.

Thought leaders tackle drug shortages and biomanufacturing challenges.

Report: Biologics contribute to rebirth of biopharma innovation.

Infrastructure and payer decisions will determine drug choices in emerging and developed regions.

Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.

Biopharma employees in different market segments note subtle differences in job satisfaction.

Limited career and salary growth complicate a somewhat positive employment picture.

Biopharma and contract providers must tread carefully amid changing market dynamics.

A CPhI report suggests that the pharma industry should be careful not to outsource to lower labor-cost countries rather than investing in manufacturing technology and innovation.

A CPhI report predicts how two potential mega free-trade deals, one among Pacific-Rim countries and the other between the US and EU, could affect pharmaceutical companies.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies. JLL’s 2015 Life Sciences Outlook report highlights global clusters worth watching.

This article examines trends in biopharma post-grant patent review and projects what the future holds in store.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies. JLL’s 2015 Life Sciences Outlook report highlights global clusters worth watching.

How can the industry achieve excellence when its training programs are geared to meeting minimum regulatory guidelines?

In the development of biopharmaceuticals and pharmaceuticals, the line is blurring.

China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.

European Union regulators said Pfizer must divest its infliximab biosimilar candidate and some sterile injectables for the merger with Hospira to be completely approved.

FDA notes progress in drug development, but cites scientific and funding roadblocks.

The 21st Century Cures Act took a giant step forward with a 344-77 approval in the House; the Senate debate is still ahead.