Top News

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

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.

The Reproducibility Project: Cancer Biology has been working to confirm the results in five prominent cancer biology experiments, and just released the results of its preliminary findings on Jan. 19, 2017. The researchers were only able to validate the findings in two of the five initial studies. The researchers could not replicate the findings in one study, and deemed another two studies “uninterpretable” because the tumor cells under investigation either grew too quickly or too slowly to measure whether the cancer drug had the predicted effect.

A new FDA Q&A document released on Jan. 12, 2016 describes 180-day exclusivity for generic-drug manufacturers and explains the number of conditions under which an abbreviated new drug applicant (ANDA) submitting a paragraph IV certification would forfeit eligibility to be the authorized generic manufacturer of a drug.

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.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

FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).In 2016, 11 of the 12 large-molecule drugs that were approved were biologics. This includes seven monoclonal antibodies (mAbs), one hormone, and three DNA-derived medications. The remaining large-molecule medication was a diagnostic agent.

J&J’s Innovation Global announced the company has entered into 15 new collaborations.

The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.

What’s ahead for the healthcare and pharmaceutical industries?

Teva and IBM expanded their partnership to focus on drug development and chronic disease management.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

Pfizer announced its decision to remain one company after debating the possibility of splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies.

Walmsley will succeed Andrew Witty as CEO of the British drug maker.

The department gave Moderna $8.2 million to accelerate development of an mRNA-based Zika vaccine.

The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.

Pfizer will acquire Medivation for approximately $14 billion.

The debate over who has control over patents for CRISPR gene-editing technology came to a head on August 17, 2016 after an email was released from a former graduate student at the Broad Institute accusing Harvard-MIT of wrongfully securing patents to the technology.

A KPMG survey reveals that approximately 84% of pharma and medical device executives plan to add jobs in next 12 months.

The NIH has launched a Phase I clinical trial in humans of an investigational Zika vaccine.

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.

John C. Lechleiter will step down from his post as CEO of Eli Lilly effective December 31, 2016.

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

Amgen and Allergan’s biosimilar to popular breast cancer drug Herceptin is comparable to the innovator molecule, Amgen recently announced.

A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.

Thirty percent of current Remicade patients could be eligible for a switch to competitors such as Inflectra, according to estimates, although J&J doubts this will occur in the United States in 2016.