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Biotech

Bio-Techne Collaborates with Luminary to Utilize TcBuster in the Development of CAR-T cell Therapies

Shots: The companies signed a license agreement to deploy TcBuster for the manufacturing of gene-modified cell therapies Luminary gets a non-exclusive license for TcBuster and will use it in the LMY-920 program. Luminary plans to

Clinical Trials

Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan

Shots: Takeda is providing rapid & sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Earlier, Takeda has completed enrollment in the P-I/II study of TAK-919 in Japan The studies are

Regulatory

Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine)

Shots: The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in Aug 2021. If approved, the vaccine may help reduce the

Pharma

Merck KGaA Signs an Exclusive Worldwide License Agreement with Day One for Pimasertib and MSC2015103B

Shots: Merck KGaA to receive up front, additional regulatory, approval, and sales milestone along with royalties on sales of pimasertib and MSC2015103B. The agreement broadens Day One’s clinical-stage pipeline of targeted cancer therapies with the

Regulatory

Sanofi’s Dupixent (dupilumab) Receives Health Canada Approval as the First Biologic to Treat Atopic Dermatitis in Children

Shots: Health Canada has approved Dupixent for the treatment of mod. to sev. AD in children aged 6 to 11yrs. whose disease is not adequately controlled with topical prescription therapies or when those therapies are

Pharma

Graviton Signs an Exclusive Worldwide License Agreement with Beijing Tide for TDI01

Shots: Beijing Tide to receive up to $517.5M including up front, development, regulatory and sales milestone along with royalties and an option for a revenue-sharing arrangement for certain developed products Graviton to get exclusive development

Clinical Trials

MatriSys Report Results of MSB-0221 in P-I study for the Topical Treatment of Atopic Dermatitis

Shots: The P-I trial involves assessing MSB-0221 (ShA9) or vehicle applied topically on forearm skin in 54 adults with staphylococcus aureus-positive AD for 1week The expression of mRNA for psmα was inhibited from S. aureus

Regulatory

Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Shots: The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis The P-III ADVANCE study results: @16wks.,

Clinical Trials

BMS Expands its Collaboration with Compugen to Evaluate the Combination of COM701 + Opdivo

Shots: Under the amended agreement, BMS will supply its Opdivo (nivolumab) for Compugen’s P-Ib cohort expansion study to evaluate COM701 in combination with Opdivo in selected cancer indications. The study is expected to be initiated