Randi Hernandez

As cost pressures mount as a result of multiple biologics being developed for the same indication, manufacturers can harness process efficiencies to maintain the value of legacy products.

Richard D. Braatz, PhD, will discuss using mathematical models to design a continuous drug manufacturing plant and the differences between batch and continuous operations for biologics.

A blog posted on Health Affairs on March 7, 2017 presents a study that tested PhRMA’s long-standing argument that high prices for drugs fund research and development in the pharmaceutical industry.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

The regulatory agency rejected the medication, citing various issues related to device use.

Momenta’s fill/finish contract manufacturer, Pfizer, was cited in the letter.

PhRMA submits comments to the The Office of the United States Trade Representative encouraging protection of US innovation in foreign markets.

Evaluate and BioPharm International highlight the antibody-based therapeutics that may have 2017 launch dates in the United States.

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

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.

A change in the tax code could help the company create more jobs in the United States, while fewer FDA regulations could help reduce drug prices, according to Pfizer CEO Ian Read.

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.

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.

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.

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

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 agreements for ten years.

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

A new report says that failure to account for rebates, discounts, and price concessions leads to an “overstatement of payments realized by manufacturers” in most annual industry drug spend reports.

Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

Industry experts identify the future focus of the biopharma industry in a new survey.

The locations will feature end-to-end bioprocessing centers and will be in Shanghai, China and Boston, MA.

The membrane-based Protein A purification tool was unveiled at the 2017 PepTalk Conference in San Diego, California.

Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?

The companies will combine expertise on T-cell therapies with two or more binding domains to create novel oncology medications.

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.