Caroline Hroncich

Cancer cell lines could provide viable pathways to determining how tumors respond to specific anti-cancer drugs.

A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

In the wake of Britain’s decision to exit the EU, pharma companies face uncertainty.

Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.

Pharmaceutical Technology sat down with Charles N. Kettler, PhD, director of Natoli Scientific, to discuss the Natoli Institute for Industrial Pharmacy at Long Island University.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

FDA approved Probuphine, the first buprenorphine implant approved in the United States for the treatment of opioid dependence.

The Phase I trials will examine AX-1602’s clinical efficacy for the treatment of psoriasis and eczema.

The updated guidelines detail best practices for conducting research with human embryonic stem cells.

Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.

A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.

AbbVie will acquire Stemcentrx and its lead late-stage asset rovalpituzumab tesirine (Rova-T), a novel biomarker-specific therapy derived from cancer stem cells.

The National Institutes of Health (NIH) released a statement on April 19, 2016 saying that it plans to suspend research in two laboratories after preliminary results found the labs not in compliance with CGMP practices.

PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs.

The IMS Institute for Healthcare Informatics report examines spending on medicine in the US, drivers of growth, major market segments, prescription volume, patient costs, and healthcare delivery changes.

FDA added warning labels to medications containing saxagliptin and alogliptin after clinical trials linked the drugs to increased risk of hospitalization for heart failure.

A report by Reuters found that four of the top 10 most widely used drugs increased 100% since 2011, while the other six increased 60%.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Researchers at the University of Pittsburgh say the compound may be more potent and selective than drugs currently available to treat epilepsy.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

CDER is now prioritizing review of generic drug products for which there is only one approved drug product on the market.

GW Pharmaceuticals released Phase III trial results on Epidiolex, which was shown to decrease monthly convulsive seizures in children by 39%.

The researchers examine the top 20 cancer drugs dosed by body size in the US, and estimate that drug companies will earn $1.8 billion in 2016 in revenue from leftover cancer drugs.

A reformulated version of Rose Bengal, PV-10, may be used to treat melanoma when injected directly into tumors.

Stephen Ostroff published a blog on FDA regarding goals to modernize the generic drug review process in an effort to increase patient access to generics.

Several biopharmaceutical companies announce plans to launch R&D into Zika vaccine candidates.

Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.

More than 80 pharmaceutical, biotechnology, generics, and diagnostics companies draft and sign the Declaration on Combating Antimicrobial Resistance.