Formulation and Drug Delivery

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.

DCPrime and Apceth Biopharma Collaborate on Cancer Vaccines

October 19, 2017

The two companies announced their collaboration for the production and development of cancer vaccines.

Japanese Agency Supports Daiichi Sankyo’s Genetic Vaccine Platform

October 16, 2017

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

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.

Batavia Biosciences Expands Viral Vector Facilities

October 16, 2017

The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.

Dow Highlights Solutions for Formulation Challenges at CPhI Worldwide

October 16, 2017

Dow’s portfolio of solutions for pharmaceutical applications now includes products from Dow Corning’s silicone technology platform.

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.