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Amneal Pharmaceuticals, Inc. (AMRX) announced the FDA has approved the company's Biologics License Application for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the name FYLNETRA. FYLNETRA was developed in collaboration with Kashiv Biosciences. It is used...

Reata Pharmaceuticals Inc. (RETA), a clinical-stage biopharmaceutical company, on Thursday, announced that its New Drug Application for Omaveloxolone has been accepted for priority review by the FDA, with a decision date set for November 30, 2022.

SpringWorks Therapeutics, Inc. (SWTX) reported positive topline results from the DeFi trial, a double-blind, placebo-controlled phase 3 trial evaluating nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors. The trial met its primary endpoint...

Seagen Inc. (SGEN) announced Monday positive topline results from the pivotal phase 2 MOUNTAINEER clinical trial investigating TUKYSA (tucatinib) in combination with trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer (mCRC). The results showed a 38.1% confirmed...

dupixent may23 The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals, Inc.'s Dupixent (dupilumab) to treat eosinophilic esophagitis or EoE, a chronic immune disorder. It is the first FDA approval to treat EoE in adults and pediatric patients 12 years and older weighing at least 40 kilograms.

Italian pharmaceutical company Menarini Group and Radius Health, Inc. (RDUS) announced Friday positive data from the pivotal phase 3 EMERALD clinical trial (NCT03778931) evaluating elacestrant as a monotherapy vs. standard of care for the treatment of ER+/HER2- advanced or metastatic breast cancer. The...

Calliditas Therapeutics AB (CALT) said the CHMP of the European Medicines Agency adopted a positive opinion recommending the granting of a conditional marketing authorisation for Kinpeygo for the treatment of primary immunoglobulin A nephropathy in adults at risk of rapid disease progression with a urine...

doximity may18 Shares of Doximity Inc. (DOCS) are down over 18% at $27.60 in premarket trading Wednesday, following a lackluster revenue forecast for fiscal first quarter.

Ampersand-backed Alliance Pharma Plc (APH.L) said on Tuesday that it has agreed to buy Drug Development Solutions or DDS, a bio-analytical business arm of LGC Group. Financial terms of the deal were not disclosed. KKR & Co. Inc. (KKR) will become an equal shareholder in the combined business alongside...

Bristol Myers Squibb (BMY) said the phase 3 CheckMate -901 trial, comparing Opdivo plus Yervoy to standard-of-care chemotherapy as a first-line treatment for patients with untreated unresectable or metastatic urothelial carcinoma, did not meet the primary endpoint of overall survival in patients whose...

Medtronic plc (MDT) has received FDA approval for the Onyx Frontier drug-eluting stent for the treatment of patients with coronary artery disease, which is caused by plaque buildup on the inside of the coronary arteries. The Onyx Frontier DES is now approved in the U.S. and is pending CE Mark. The...

PolarityTE, Inc. (PTE) announced the FDA granted a Regenerative Medicine Advanced Therapy designation to SkinTE. RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising regenerative medicine products. Richard Hague, CEO, said: "The Agency...

Biopharmaceutical company AbbVie Inc. (ABBV) announced on Wednesday positive topline results from U-ENDURE, its Phase 3 maintenance study evaluating upadacitinib in adult patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to a conventional or biologic therapy. The...

Eli Lilly and Co. (LLY) and Incyte (INCY) announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane...

cara may10 Castle Biosciences Inc. (CSTL) has increased its revenue outlook for 2022, based on the first-quarter results. The company now anticipates total revenue in 2022 in the range of $118 million to $123 million, up from its prior outlook of $115 million to $120 million. Revenue was $94.1 million in 2021.

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