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The Swiss drugmaker raised its full-year guidance Tuesday projecting net sales to grow in the high-single to low double-digit range while reporting better-than-expected first-quarter results.
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CEO Hervé Hoppenot said Tuesday on an investor call that Escient Pharmaceuticals’ two lead assets “address large populations with a clear medical need” with a potential multibillion-dollar market opportunity.
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Data from the Phase III LUNA 3 study on Tuesday showed that Sanofi’s BTK inhibitor rilzabrutinib significantly improved durable platelet response in patients with chronic immune thrombocytopenia.
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Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer.
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The U.S. Supreme Court on Monday indicated that it will not hear Vanda Pharmaceuticals’ petition in its patent case against Teva Pharmaceuticals regarding the former’s sleep-wake disorder drug Hetlioz.
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The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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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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Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings.
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Astellas' XTANDI™ (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting
4/23/2024
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
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Medicure Receives US FDA Fast Track Designation for MC-1 for PNPO Deficiency
4/23/2024
Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH)(OTC PINK:MCUJF) announced today that through its subsidiary, Medicure International Inc., the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for MC-1, an investigational product for the prevention or treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase (PNPO) deficiency.
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Curio Digital Therapeutics Inc. Announces the U.S. Food and Drug Administration (FDA) Clearance of MamaLift Plus™, the First Prescription Digital Therapeutic Authorized for the Treatment of Postpartum Depression (PPD)
4/23/2024
Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift PlusTM.
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Curium Enrolls First Prostate Cancer Patients in its Phase 3 SOLAR Trials
4/23/2024
Curium, a world leader in nuclear medicine, announced today that it has successfully enrolled and scanned patients in its SOLAR clinical trials.
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Vanda Pharmaceuticals Reacts to U.S. Supreme Court's Denial of its Petition in HETLIOZ® ANDA Litigation
4/23/2024
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Supreme Court denied Vanda's petition for a writ of certiorari in its HETLIOZ ® Abbreviated New Drug Application litigation against Teva Pharmaceuticals USA , Inc.
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Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1065845 in Adults with Major Depressive Disorder
4/23/2024
Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced positive topline data for its Phase 2 SAVITRI™ study. This randomized, double-blind, placebo-controlled dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive disorder (MDD).
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Egnyte to Host Fourth Annual Life Sciences Summit for Emerging Biotech Companies
4/23/2024
Egnyte, a leader in cloud content security and governance, will host its annual Life Sciences Summit on May 8, 2024. This year’s event will be a hybrid event, with Boston-based guests
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Generic Drugs Market Size to Worth Around USD 779.68 Bn by 2033
4/23/2024
A recent market report published by nova one advisor, the global generic drugs market size was estimated at USD 465.19 billion in 2023 and is expected to be worth around USD 779.68 billion by 2033 with a CAGR of 5.3% from 2024 to 2033.
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Third Generation Sequencing Market 2024-2031 | Increasing Demand for Real-Time Sequencing and Rapid Analysis
4/23/2024
Global Third Generation Sequencing Market in terms of revenue was estimated to be worth $10.07 Bn in 2023 and is poised to reach $27.66 Bn by 2031, growing at a CAGR of 13.73% from 2024 to 2031 according to a new report by InsightAce Analytic.
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Epigenetics Market Size Forested to be Worth over USD 61.04 Bn by 2033
4/23/2024
According to the Vision Research Reports, the global epigenetics market size was estimated at around USD 14.65 billion in 2023 and it is forecasted to be worth over USD 61.04 billion by 2033 with a CAGR of 15.34% from 2024 to 2033
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Direct-to-Consumer Genetic Testing Market Rising Rapidly at CAGR 24.43%
4/23/2024
The direct-to-consumer genetic testing market size is expected to be worth around USD 17.35 billion by 2033 and growing at a CAGR of 24.43% from 2024 to 2033, according to Vision Research Reports.