Deals, Development and Manufacturing

GRAM is expanding fill/finish capacity and is working with Janssen on tech transfer in preparation for production of Janssen’s SARS-CoV-2 vaccine candidate at GRAM’s Grand Rapids, MI facility.

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

Thermo Fisher will handle the technical transfer of the lenzilumab bulk drug substance process, with commercial scale production potentially beginning before the end of 2020.

The companies will work together to produce a wearable device that can subcutaneously deliver ketamine therapy as a non-opioid pain treatment.

Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.

Roche will gain full rights to Inflazome’s portfolio which includes clinical and preclinical orally available small molecule NLRP3 inhibitors.

Catalent will use T-knife´s TCR platform for a T-cell receptor-based cell therapy at its Gosselies, Belgium, site in order to manufacture clinical batches for European trials in 2021.

The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.

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 companies aim to scale up production of Eli Lilly’s potential COVID-19 antibody therapies, pending regulatory approval.

Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.

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).

Vectura will support the product from Phase I through to commercial launch.

The acquisition will give Gilead access to an anti-cancer antibody drug conjugate in clinical development for treating breast and bladder cancers.

Takeda is divesting its portfolio of select, non-core prescription pharmaceutical products sold in Europe and Canada to Cheplapharm, a German pharmaceutical company.

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.

Catalent’s Redwood Bioscience subsidiary will develop antibody-drug conjugates (ADCs) for Exelixis using Catalent’s proprietary SMARTag site-specific bioconjugation technology.

AMRI will provide AstraZeneca with manufacturing capacity and sterile fill/finish services at its drug product manufacturing facility in Albuquerque, NM.

The companies have signed a partnership agreement to provide extractables and leachables testing at the SG US Technology Excellence Center in Boston, MA.

Alcami will provide services for Trevena’s OLINVYK (oliceridine) injection, an opioid approved for the management of acute pain severe enough to require an intravenous opioid analgesic in adults.

Avomeen will offer contract product development laboratory services to support the advancement of Daré’s innovative pipeline of investigational products dedicated to women’s health.

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

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

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 facility offers office, production, sampling, and warehouse space and delivers products to all major global markets.

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.

The Ventofor Combi Fix will be brought into the Turkish market via Bilim’s development program, while the PowdAir Plus DPI is manufactured and commercialized by H&T Presspart under a patent license from Hovione.