Biopharma News

The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.

FDA approved avelumab for the treatment of patients with Merkel cell carcinoma.

The company said it plans to expand diabetes manufacturing facilities in the United States.

Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.

The companies will be expanding their collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.

The company said that it has successfully completed its first in-orbit experiment using its miniature end-to-end space laboratory.

Under the agreement, Allergan will receive exclusive access to five of Editas’ ocular programs.

Senator Chuck Grassley sent a letter to the Kaléo CEO questioning the drugs high listing price.

The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.

BeiGene and the Guangzhou Development District have established a joint venture to build a biologics manufacturing facility in China.

The companies have entered into an agreement to develop and commercialize a mAb for the prevention of lower respiratory tract illness in young children.

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.

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

Sarepta sold the priority review voucher for Exondys 51, a controversial treatment for Duchenne Muscular Dystrophy, to Gilead.

FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.

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

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.

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.

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.

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

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.

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

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.