News

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.

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.

The company will gain the rights to a mutein that is believed to help maintain immune system homeostasis.

PAT, quality by design, process controls, and analytical advances for small- and large-molecule drugs are on agenda for IFPAC 2017.

The SCIEX PA 800 Plus Pharmaceutical Analysis system is used to identify and quantify glycans to ensure therapeutic efficacy.

The companies will split Actellion’s drug discovery and early-stage clinical development assets into a new Swiss biopharmaceutical company.

After a positive Phase II trial, the company said its C. difficile vaccine candidate will advance to Phase III trials during the first half of 2017.

The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.

FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

Researchers from Cellectis investigate how external signals in the tumor microenvironment could control the cell-surface expression and specificity of engineered CARs.

In a recent deal with the Federal Trade Commission, Endo agreed to refrain from entering into future pay-for-delay patent settlements for ten years.