How the Defend Trade Secrets Act Could Better Protect Manufacturers Who Outsource to CMOs
PharmTech 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.
AMRI Adds Custom API Capabilities
AMRI’s acquisition of Euticals expands its API development and manufacturing business.
The Value of Saving Lives
Policies for patient access to life-saving therapies must keep pace with biomedical innovation.
The Evolving War on Drug Prices
Immuno-oncology drugs are demonstrating patient benefits, but growing resistance to the high cost has implications for patients, market access, and manufacturers.
Futureproofing the Pharmaceutical Industry through Technology
By focusing on laying strong technology foundations, pharmaceutical businesses can make informed decisions, equip themselves with the capabilities to eliminate threats, and future-proof operations.
Who Says the Blockbuster is Dead?
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.
CMC Biologics and IDT Biologika Collaborate on ADC Manufacturing
Collaboration will provide for unified development and manufacture of antibody drug conjugates.
Market Opportunities to be Explored at CPhI Japan
Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.
Wyeth Agrees to $784 Million Medicaid Claim Fine
Wyeth reaches agreement in principle to resolve Medicaid drug rebate claims for 2001-2006 period for Protonix.
Pfizer Announces Organizational Changes for Pending Allergan Merger
Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.
Innovating for Innovation
Suppliers must develop new technologies to drive the bio/pharma innovation engine.
Global Drug Directions
Infrastructure and payer decisions will determine drug choices in emerging and developed regions.
Bio/Pharma Navigates New Routes to Drug Development
Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?
Bio/Pharma’s 2016 Agenda in Europe
Regulatory, corporate restructuring, and manufacturing issues will challenge bio/pharma to meet the needs and expectations of patients around the world.
Role of Drug Compounders Debated in Drug Pricing Probe
The use of drug compounding facilities to produce over-priced generic drugs raises quality and regulatory questions.
The Search for Job Satisfaction
Employers have work to do to improve job satisfaction and retain qualified workers.
Mapping a Career Path Forward in Bio/Pharma
Bio/pharma employee dissatisfaction with pay and progress may direct some to new career pathways.
Litigation and Manufacturing Hurdles Block US Biosimilars Market Success
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.
Facing Crucial Career Choices
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.
Industry Suppliers Honored for Innovative Advances
The CPhI Pharma Awards celebrate innovations in the pharma industry.
Pfizer Receives FTC Clearance for Hospira Acquisition
Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.
Shire Proposes Combination with Baxalta
Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxalta declines to discuss the proposal.
Taking the Pulse of Manufacturing Trends and Equipment Use
The Bottom Line on Pipeline Progress
FDA notes progress in drug development, but cites scientific and funding roadblocks.
A Voice of Their Own
Contract development and manufacturing organizations join forces to address legislative, regulatory, and business concerns in the Pharma & Biopharma Outsourcing Association.
What’s Next for the CMO Industry?
What if the expanding pipeline isn’t enough to fuel CMO growth?
Opening Up Pharma Innovation
Driven by competitive pressures and using models pioneered in other industries, pharmaceutical companies are extending collaboration efforts well beyond their walls.
Industry Viewpoints: Can Sterile Manufacturing Turn the Ship Around?
Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?
Are IPRs Impacting the Pharmaceutical Industry?
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.