Viewpoints

COVID-19 has brought to light the issues of European manufacturing capabilities, leading industry to question whether it is now time to reinvest in domestic medicines supply.

COVID-19’s impact on the global economy is dealing a blow to merger and acquisition activity in the biopharma industry.

COVID-19 vaccines are being developed rapidly, giving rise to a reinvigoration of the sector.

As Brexit talks intensify, bio/pharma companies from both the UK and EU need to consider and aim to prepare for all scenarios.

Achieving herd immunity will require testing, data, a vaccine, and public support.

Pharma’s reputation is being boosted in light of the current COVID-19 pandemic efforts.

A network-based supply chain approach has the potential to improve resilience and performance.

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

Having a better understanding about compliance will be of benefit when looking for a job or for furthering one’s career, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

In light of the hype around chloroquine and hydroxychloroquine as potential COVID-19 treatments, it is important to remember that drug repurposing should never be rushed, irrespective of the urgency of the situation.

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.

As the coronavirus pandemic unfolds, Pharma must practice science over hype.

According to recent figures, Cambridge’s technology sector is booming and the city is emerging as a hub for biotech companies.

Emergency action to protect patients and the drug supply may have long-term implications.

No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Despite increasing R&D budgets by bio/pharma companies, returns on this investment are reducing and the cost of bringing an asset to market is increasing.

Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.

The promise of new therapies is tempered by the need for affordability, safety, and ethics.

As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.

Nearly four decades after the first diagnosis, the fight to treat HIV/AIDs continues.

As the UK heads to the polls for an unusual December general election, industry issues manifestos on medicines while Europe rejoices some movement … finally.

In batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.

FDA report says drug shortages are underappreciated and patients pay a price.

After years of discussions around pricing, UK governmental bodies and Vertex have finally reached an agreement on cystic fibrosis treatments.

Climbing out of a reputation hole starts with adopting a quality culture.

With no plausibly approvable deal on the table in the UK government at the moment, it is possible that Brexit could be extended even further.

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Government statistics show that pharma can be an illustrious career for graduates, which must be taken advantage of by industry to avoid skills shortages.

As a potential ‘no-deal’ Brexit looms, pharma companies and industry bodies are preparing for the worst-case scenario but hoping that the UK won’t end up with a disorderly exit from the EU.