article
Five of the most recent developments in anti-cancer therapeutics
European Pharmaceutical Review investigates five of the latest cancer drug approvals and clinical trial results.
List view / Grid view
US Food and Drug Administration (FDA)
news
Novartis launches review of Beovu after safety concerns, says report
An external review of the medicine Beovu has been announced by Novartis, which produces the drug, according to a new report.
news
FDA accepts Zejula sNDA application as a maintenance treatment for ovarian cancer
The developers of Zejula (niraparib) have announced the FDA will assess the sNDA application under the Real-Time Oncology Review (RTOR) pilot programme.
article
How will the rise of biosimilars impact biologics?
Once patents expire for biologic medicines, a market opportunity opens up for biosimilars, a cheaper alternative. With more patents due to expire soon, what will the future look like for biologic medicines?
news
FDA approves first generic of ProAir HFA inhalation aerosol
The generic of ProAir HFA (albuterol sulfate) inhalation aerosol has been approved by the FDA to advance patient access to lower-cost medicines.
news
COVID-19 update: therapeutic and regulatory developments
European Pharmaceutical Review rounds up the latest news surrounding COVID-19, including a vaccine moving to clinical trials and the FDA's update on Chinese import inspections.
news
FDA centres collaborate to evaluate conclusions of pharmacogenetic testing
The FDA has released a statement that two of its centres will collaborate to provide information on gene-drug interactions they believe have sufficient supporting evidence.
news
US pharma industry leaders support blockchain tech to aid track and trace systems
A report released by pharmaceutical industry leaders in the US demonstrates how blockchain helps to track and trace prescription medicines.
article
Trends in the CDMO industry for 2020
Over the past decade, the pharmaceutical industry has witnessed rapid growth in outsourcing services, driven by various factors including the growth of small molecules, increasing API complexities and the need to optimise costs. Here, Peter DeYoung shares his thoughts on the key trends he expects to see in the contract…
article
Regulating heavy metals in cannabis: what can be learned from the pharmaceutical industry?
The ever-increasing demand for cannabis-based products requires US state regulators to set guidelines that ensure products are safe for human use. However, as medicinal cannabis moves forward at a rapidly increasing pace, regulations are falling behind. Here, Robert Thomas discusses the many inconsistencies across US states for monitoring levels of…
news
Biotech company Promedior merges with Roche
Roche has successfully completed its purchase of Promedior, Inc. along with its entire portfolio of fibrotic disease therapeutics.
news
FDA and India prevented 500 unapproved drug shipments entering US in January
A collaborative effort between the FDA and Government of India stopped shipments of illegal drugs from reaching patients in the US in Operation Broadsword.
news
Voltaren approved for arthritis pain over-the-counter in the US
Voltaren Arthritis Pain has been approved by the FDA as an over-the-counter product for the temporary relief of arthritis pain.
news
FDA requests market withdrawal of weight-loss drug Belviq
After clinical trials showed an increased risk of cancer in patients taking Belviq, the FDA has recommended the withdrawal of the drug from the US market.
article
The importance of labelling compliance for pharma
Bart Vansteenkiste explains why it is important to validate pharmaceutical labelling compliance to ensure good manufacturing practice.
