News

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.

Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.

EvaluatePharma and BioPharm International highlight the antibody-based therapeutics that may gain United States Regulatory approval in 2017.

The company announced results from a Phase II trial with its THC:CBD drug for the treatment of glioblastoma multiforme.

The companies entered into a license agreement for Immunomedic’s antibody-drug conjugate sacituzumab govitecan.

EMA announces that the European Union’s PAS Register has received its 1000th upload.

A total of 166 biotech executives penned an open letter expressing concern over President Donald Trump’s executive order on immigration.

The company is voluntarily recalling product due to particulate matter.

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

On a recent call, Catalent revealed that it has reached more than 90% of its current capacity and discussed how tax policy changes could affect the outsourcing industry.

Aggressive petitioning by ViroPharma kept a generic equivalent to Vancocin off the market for more than two years.

According to results from the FOURIER trial, Repatha significantly reduced the risk of cardiovascular events and death in patients with atherosclerotic cardiovascular disease.

Companies were recognized for their innovative packaging technologies.

Patients with relapsing-remitting multiple sclerosis (MS) who are treated with currently available disease-modifying drugs (DMARDs) usually experience disease reactivation within the first five years of treatment follow-up. Many of the available treatments for MS only confer complete control of disease activity in a small percentage of patients.

Pfizer executives were not among the pharma representatives who met with Trump yesterday to discuss various issues affecting the industry, a circumstance that Pfizer attributed to a schedule conflict with its quarterly earnings call. Despite the company’s absence from the meeting, Pfizer’s CEO Ian C. Read commented on some of Trump’s policy suggestions, and also discussed sales trends and projections for Pfizer’s R&D pipeline.

In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.

The company announced an investment in a new facility in Dundalk, County Louth, Ireland.

FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of cGMP for finished pharmaceuticals.

Novo Nordisk entered a research collaboration with the University of Oxford focused on Type 2 diabetes.

The £14-million research project aims to better understand adverse drug reactions through a variety of modeling approaches.

Local manufacturing, regulatory strategies, market entry, and harmonization to be featured at CPhI Istanbul.

Lek, a Sandoz company, adds capacity to its plant in Prevalje, Slovenia.

Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.

Operational improvements at Pall contributed to the overall growth in the Danaher life-sciences sector.

Despite the threat of competition, both from biosimilars to Humira and new therapies that work through other mechanisms of action, AbbVie says Humira is still number one.

Alexandre Juillerat, PhD, innovation senior scientist at Cellectis, discusses novel construct UCART123, an investigational agent that is on deck to be the first gene-edited T-cell product in the United States.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

ADMA will acquire BPC’s plasma-based fractionation and purification plant in Boca Raton, FL and plans to resolve issues at the facility noted in an FDA warning letter.