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Home » Newsletters » BioWorld

BioWorld

Aug. 16, 2021

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Dermatology-psoriasis-eczema-pic

Lilly’s $1.1B Dermira buy looks like good business as phase III eczema trials hit targets

Eli Lilly and Co.’s $1.1 billion acquisition of Dermira Inc. early last year is looking like a smart move after the company’s atopic dermatitis (AD) drug, lebrikizumab, hit all its targets in two phase III trials. Lebrikizumab is an interleukin-13 antagonist and is part of Lilly’s strategy to build a dermatology portfolio to compete in a market dominated by Sanofi SA and Regeneron Pharmaceutical Inc.’s Dupixent (dupilumab), which was the first injected antibody drug available for AD in 2017. Lilly picked up Dermira, of Menlo Park, Calif., along with lebrikizumab in January last year shortly after the FDA granted lebrikizumab fast track status, paving the way for a potential six-month review. Read More

Pfizer’s Ticovac approved by the FDA as tick-borne encephalitis vaccine

Pfizer Inc.’s Ticovac has been approved by the FDA for immunizing those ages 1 year and older against tick-borne encephalitis, a disease that’s not endemic to the U.S. but increasingly is found in Europe and Asia. Ticovac, developed with a master seed virus, was first approved outside the U.S. 45 years ago. Before the FDA approval, the CDC had recommended that travelers on their way to high-risk areas be vaccinated in Europe though the process could take up to six months. Read More
Kidneys

Travere phase III in IgAN positive, ETA next year for sparsentan filing

Travere Therapeutics Inc. plans to file for accelerated approval in the first half of next year, based on data from the pivotal phase III Protect study of sparsentan, a dual-acting antagonist of the endothelin type A (ETA) and angiotensin II type 1 receptors, for IgA nephropathy (IgAN). Read More

Innovent’s sintilimab combo heads toward sNDA filing in gastric cancer

Following an interim analysis of phase III gastric cancer data, Innovent Biologics Inc. said it’s planning to seek an expanded label the company’s Eli Lilly and Co.-partnered PD-1 inhibitor, Tyvyt (sintilimab), in the indication. According to Innovent, a combination of the drug with chemotherapy met the primary endpoint of overall survival in the study, delivering a statistically significant improvement in the measure vs. placebo, also with chemotherapy. Read More
Psychiatric disorders illustration

Beckley Psytech raises $80M in upsized B round as first psychedelic programs enter the clinic

DUBLIN – Beckley Psytech Ltd. raised $80 million in an oversubscribed series B round to move its early stage pipeline of psychedelic therapies into the clinic and to continue research on novel compounds with enhanced properties. Read More

Inmagene gains rights to Syk inhibitor fostamatinib in Chinese markets

Inmagene Biopharmaceuticals Co. Ltd. has licensed rights from Kissei Pharmaceutical Co. Ltd. to develop and commercialize the spleen tyrosine kinase (Syk) inhibitor fostamatinib for all potential indications in China. Read More

ICMRA advises on AI regulatory challenges

The increasing use of artificial intelligence (AI) technologies across all stages of drug development is presenting challenges for regulators across the world. Read More

FDA sets out 2022 menu of fees

New PDUFA, BsUFA and GDUFA user fees go into effect Oct. 1 in the U.S. Read More
ICYMI illustration

ICYMI: Week in review, Aug. 9-13, 2021

A quick look back at top stories. Read More

Financings for Aug. 16, 2021

Biopharmas raising money in public or private financings, including: Rani, Taysha. Read More

Other news to note for Aug. 16, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 9 Meters, Arctic, Avidity, Basilea, Calidi, Clearside, Curevac, Exelixis, Futuregen, Gracell, HDT, HLS, Invenra, Mannkind, Medivir, Moderna, Oncotelic, Oxurion, Pfizer, Quratis, Tetralogic, United. Read More

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