API Synthesis and Manufacturing, Large Molecule

Therapeutic Vaccines Target Cancer and Other Viral-Induced Diseases

November 15, 2017

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.

WuXi and Pall Establish Continuous MAb Manufacture

November 13, 2017

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

AbbVie and Alector Partner on Alzheimer’s Disease Immunotherapies

October 27, 2017

AbbVie will pay a $205-million upfront payment and have the option to develop and commercialize two antibody targets globally.

FDA Approves Kite’s CAR-T Drug, Second Gene-Therapy in US

October 20, 2017

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

Lilly and CureVac Partner on mRNA Cancer Vaccines in $1.8-Billion Deal

October 20, 2017

The companies aim to use CureVac’s proprietary messenger RNA technology to develop and commercialize up to five potential cancer vaccine products.

FDA Expands Approval for J&J’s Psoriasis Biologic

October 16, 2017

Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.

GSK’s Shingles Vaccine Approved in Canada

October 16, 2017

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

FDA Licenses Second Samsung BioLogics Facility

October 14, 2017

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.

FDA Committee Recommends Approval of Spark’s Eye-Disease Gene Therapy

October 13, 2017

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

Promethera and Shibuya Partner on New Cell-Therapy Manufacturing Platform

October 12, 2017

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.