Biopharma News

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.

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.

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.

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.

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

The company will begin trials with its CBD chewing gum, CanChew Plus, for the treatment of irritable bowel syndrome.

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.

Luke Miels will replace Abbas Mussain as president of GSK’s Global Pharmaceutical division later this year.

The company agreed to pay Forward Pharma $1.25 billion to settle a patent dispute over the formulation of Tecfidera, the company’s leading multiple sclerosis treatment.

The company announced that it has terminated an agreement made with UMN Pharma for the co-development of influenza vaccine programs in Japan.

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

Takeda will acquire ARIAD Pharmaceuticals for approximately $5.2 billion.

A judge ruled that Regeneron’s mAb be removed from the market after Amgen alleged that the marketing of Praluent hurt its reputation as innovator of this class of drugs.

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

PF-06410293 met primary endpoints during clinical trials and demonstrated similar efficacy to its reference product.

Prokarium in the UK and Probiomed in Mexico hope to demonstrate large-scale production of oral vaccines that will reduce cost compared to injections and improve availability.

Portola signed a $50-million loan agreement with BMS and Pfizer to provide additional funding for the development of andexanet alfa.

Univercells received a grant from the Bill & Melinda Gates Foundation for the development of a vaccine manufacturing platform.

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

GlaxoSmithKline opened a new vaccines R&D center in Rockville, MD creating up to 200 new jobs.

BMS changes its US geographic footprint with R&D investments and closures.

Spark Therapeutics and Selecta entered a license agreement for Selecta’s gene-therapy co-administration technology.

At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.