Bio/Pharma Business

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.

Intellectual challenge, job security, and opportunity for advancement contribute to employee happiness, but the ultimate prize may be a satisfactory salary for bio/pharma employees in Europe.

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.

The CPhI Pharma Awards celebrate innovations in the pharma industry.

Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.

Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxalta declines to discuss the proposal.

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

Contract development and manufacturing organizations join forces to address legislative, regulatory, and business concerns in the Pharma & Biopharma Outsourcing Association.

What if the expanding pipeline isn’t enough to fuel CMO growth?

Driven by competitive pressures and using models pioneered in other industries, pharmaceutical companies are extending collaboration efforts well beyond their walls.

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

As more patents make their way through IPRs, the balance of how the pharmaceutical industry selects between IPRs and district court litigation will likely evolve.

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

Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.

The bio/pharma industry enjoys success, but it cannot ignore patient access to medications.

Gil Roth, Founder and President of the Pharma & Biopharma Outsourcing Association speaks with Pharmaceutical Technology.

Gordon Haines, Chief Executive Officer, and Kay Thiele, Head of Product Optimization, at Rottendorf Pharmaceuticals, spoke with Pharmaceutical Technology about the human element in pharmaceutical manufacturing.

EvaluatePharma's report shows upward trends in R&D and drug approvals.

The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.

Pharma can boast of big-picture successes, but needs to work on operational issues.

The company’s new corporate name will be simply Biogen.

AbbVie’s acquisition of Pharmacyclics establishes the combined company as an emerging leader in hematological oncology.

Patheon cites expanded API services with acquisition of IRIX Pharmaceuticals.

Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.

Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, cost of goods, and sustainability from the start.

Shire adds rare-disease portfolio with acquisition of NPS Pharma.

Although competing therapies will continue to be released in the immuno-oncology space, efficacy profiles, combination regimens, and administration setting may influence a drug’s preferred status more than price.

Pharmacy benefit manager Express Scripts offers Viekira Pak at a discount and excludes the drug’s higher-priced competitors from its formulary.

The acquisition will enhance Merck's "superbug" medication portfolio.