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If a company’s final sales end up falling short of the consensus analyst estimate, then they have missed their number. Johnson & Johnson was close in the first quarter of 2024 but ultimately no cigar.
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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Structural Biology Market Experiencing Rapid Growth
4/15/2024
The global structural biology market is expanding rapidly worldwide, and between 2023 and 2032, hundreds of millions of dollars are expected to be generated in revenue altogether.
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The FDA on Thursday approved the label expansion of AstraZeneca’s Fasenra as an add-on maintenance treatment for severe eosinophilic asthma in patients six to 11 years of age.
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Data analytics firm GlobalData expects potential FDA approvals this year of Sanofi and Regeneron’s Dupixent and Verona’s ensifentrine to transform the treatment of chronic obstructive pulmonary disease.
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Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
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Apogee Therapeutics Announces First Participants Dosed in Phase 1 Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) and Other Inflammatory Diseases
3/25/2024
Apogee Therapeutics, Inc. today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-4Rα, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases.
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Immunotherapy Drugs Industry is Rapidly Growing with CAGR of 18.03%
3/22/2024
According to Vision Research Reports, the global immunotherapy drugs market size was valued at USD 239.21 billion in 2023 and it is projected to hit around USD 1,063.44 billion by 2032, growing at a CAGR of 18.03% from 2023 to 2032.
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Incyte’s povorcitinib met both primary and secondary endpoints to relieve itching and improve skin clearance by 16 weeks, suggesting efficacy that is competitive with Sanofi and Regeneron’s blockbuster Dupixent.
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Praluent® (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol
3/11/2024
Regeneron Pharmaceuticals, Inc. announced the U.S. Food & Drug Administration has extended the approval of Praluent® as an adjunct to diet and other low-density lipoprotein cholesterol lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia.
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Apogee Therapeutics Provides Pipeline Progress and Reports Fourth Quarter and Full Year 2023 Financial Results
3/5/2024
Apogee Therapeutics, Inc., a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, asthma and other inflammatory and immunology indications, reported pipeline highlights and fourth quarter and full year 2023 financial results.
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The FDA’s target decision date is June 27, 2024, the companies announced Friday. Sanofi and Regeneron are looking to expand blockbuster Dupixent into chronic obstructive pulmonary disease.
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Biopharma’s latest earnings season was, in a word, predictable. Companies are consistently beating Wall Street earnings and revenue estimates as they set low expectations for investors.
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Regeneron Reports Fourth Quarter and Full Year 2023 Financial and Operating Results
2/2/2024
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2023 and provided a business update.
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Despite strong sales of its blockbuster drug Dupixent, Sanofi on Thursday reported that its fourth-quarter 2023 operating income dropped 5% due to a weaker U.S. dollar, high expenses and generic competition.
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Press Release: Sanofi Delivers Solid Sales and Business EPS Growth at CER Amidst Successful Product Launches and Advancements in Immunology Pipeline
2/1/2024
Strong pipeline including record 12 blockbuster opportunities under clinical evaluation detailed at recent R&D Day.
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With the FDA’s approval on Thursday, Dupixent can now be used for the treatment of children aged 1 to 11 years who have eosinophilic esophagitis, a chronic disease that can severely impact their ability to eat.
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Press Release: Dupixent® FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic esophagitis (EoE)
1/25/2024
The U.S. Food and Drug Administration has approved Dupixent® for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis.
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Dupixent® (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE)
1/25/2024
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
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Dupixent® (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement
1/16/2024
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has updated the label for Dupixent® in atopic dermatitis, adding efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement.