Bio/Pharma Business

At DCAT 2016, IMS Health economist Graham Lewis noted that pharma is reliving trends last seen in the 1980s. Despite value-based medicine, he said, the blockbuster model is alive and well.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.

Wyeth reaches agreement in principle to resolve Medicaid drug rebate claims for 2001-2006 period for Protonix.

Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.

Suppliers must develop new technologies to drive the bio/pharma innovation engine.

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

Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?

Regulatory, corporate restructuring, and manufacturing issues will challenge bio/pharma to meet the needs and expectations of patients around the world.

The use of drug compounding facilities to produce over-priced generic drugs raises quality and regulatory questions.

Employers have work to do to improve job satisfaction and retain qualified workers.

Bio/pharma employee dissatisfaction with pay and progress may direct some to new career pathways.

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.