Biopharma News

The approval of Nucala (mepolizumab) for treating hypereosinophilic syndrome represents the first drug approved for this group of rare blood disorders in nearly 14 years.

The acquisition will support the accelerated commercialization of Kyslecel (autologous pancreatic islets), Koligo’s personalized cell therapy for treating pancreatitis.

Cellnest will join Fujifilm Irvine Scientific’s PRIME-XV portfolio which consists of xeno-free and chemically defined media for stem cell culture.

Following a recent expansion at its Cambridge, MA, facility, the company now houses a new suite of cellular analysis platforms that enhance its exploratory capabilities into oncology, neuroscience, and rare diseases.

The new personal capillary electrophoresis system, Spectrum Compact CE, performs Sanger sequencing and fragment analysis.

The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.

A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19.

The companies plan to increase the production output of Ligand’s Captisol for the formulation of Gilead’s COVID-19 treatment Veklury (remdesivir).

A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents.

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.

The agreement will Increase global manufacturing capacity for Novavax’s vaccine candidate, NVX-CoV2373, to more than two-billion annualized doses when at full capacity in 2021.

The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.

The funding will help advance the vaccine’s clinical evaluation, potential marketing authorization, development and manufacturing in Germany, and the number of participants in late-stage clinical trials.

The companies will focus on the development and commercialization of Seattle Genetics’ ladiratuzumab vedotin and TUKYSA (tucatinib).

The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.

The companies have signed an agreement for the production of two plasmids needed for the manufacture of CG01, a gene therapy for the treatment of drug-resistant focal epilepsy.

The investment at its Madison, WI, facility will expand MilliporeSigma’s capacity for high-potent active pharmaceutical ingredient production and allow for continuous flow manufacturing of ADCs.

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

The companies have signed a definitive agreement to acquire a majority stake of PCI Pharma Services.

The companies provided an update stating that the biologic did not meet a primary endpoint in a Phase III clinical trial when compared with placebo in the treatment of COVID-19 patients.

The companies will collaborate on the production of a novel anti-SARS-CoV-2 immunoadhesin in iBio’s FastPharming manufacturing system.

Novavax and the Government of Canada will finalize an advanced purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning in the second quarter of 2021.

Negotiations for a final advance purchase agreement where the Government of Canada purchases the vaccine candidate on a not-for-profit basis for emergency pandemic use are underway.

The vaccine will be supplied by Moderna and distributed in Japan by Takeda Pharmaceutical starting in the first half of 2021 if the vaccine candidate receives regulatory approval.

The new facility, located in Lenexa, KS, will rapidly expand production of viral transport media.