PharmTech Talk

QbD represents a breakthrough in thinking, but does it go far enough to address today's business challenges? NeoStem has expanded it to include business and market issues, in "Development by Design." Could this be (or is it becoming) a new model for pharma?

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

The industry reacts to the departure of Commissioner Margaret Hamburg.

President Obama unveils his “Precision Medicine Initiative”.

The pharmaceutical supply chain continues to be a challenge for the industry despite advances in QbD and PAT.

CPhI experts make predictions on pharma trends for 2015.

Industry voices concerns over draft legislation that seeks to get much needed treatments to patients.

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

A global framework of standards enabling collaboration among industry stakeholders is needed to battle the increasing threat of counterfeit medicines.

Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress, as seen in new policies to spur R&D and added funding for these efforts.

The author looks at how life-science research has evolved in Europe and the United Kingdom, and discusses the current funding opportunities for SMEs.

Sponsor response to FDA's breakthrough program has exceeded FDA expectations, but puts pressure on manufacturers to address formulation, stability and quality production issues very early in development.

The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House, a clear blow to Obama administration policies, including the president’s landmark health reform initiative.

Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers.

Many factors can contribute to tablet manufacturing problems. Tablet tooling failures are generally the result of one, or a combination of issues.

Leading US senators are proposing legislation to add Ebola to the list of diseases eligible for priority review vouchers from FDA as an incentive for biopharmaceutical companies to invest in treatments for this deadly disease.

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), has administration approval for organizational changes to bolster programs and policies to ensure drug quality.

After almost two years of discussion and analysis, FDA is finalizing a proposal for collecting data from manufacturers to help measure the performance of manufacturing operations and the quality of resulting drugs and biologics.

To encourage adoption of advanced manufacturing technologies that can help industry meet high quality standards consistently, and avoid drug recalls and shortages, FDA’s Center for Drug Evaluation and Research is establishing an Emerging Technology Team (ETT) to assist innovative manufacturers in navigating the regulatory process and overcome roadblocks.

The significant contribution that generic drugs make to health services across Europe cannot be denied.

Increasing concerns are being expressed by industry observers and top-tier pharmaceutical manufacturers that contract manufacturing organizations (CMOs) will not be ready to comply with emerging track-and-trace requirements.

The development of new treatments and preventives to combat the lethal Ebola virus has been slow, marked by caution at public health agencies to approve testing of high-risk compounds, and reluctance of biopharmaceutical companies to invest in a field with limited market potential. All that has changed now, as thousands of people have been sickened by the virus, and the death rate has escalated.

In Part 1 of this blog, Richard Freeman looked at some of the challenges faced by pharma firms today as a result of growing competition, regulation and globalization, and argued that more effective communication and collaboration was key to their continued success.

For an industry that saves millions of lives, pharma is sometimes unfairly perceived by the public as being aloof, unresponsive, or occasionally worse.

After months of speculation about prospects for biosimilar development in the United States, Novartis announced on July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim).

A potential treatment for sickle cell disease has come through the “valley of death” of early-stage development due to support from a collaborative partnership established by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).

Life sciences and biotech research clusters across the UK, including those linked to university research departments are benefiting from an improved funding climate and ongoing consolidation in the pharmaceutical sector.