Upsher-Smith Laboratories, LLC announced the recent launch of Difluprednate Ophthalmic Emulsion 0.05%. According to IQVIA, the Difluprednate Ophthalmic Emulsion market had U.S. sales of approximately $18 million*. The Therapeutic Equivalence (TE)...
Alteogen Inc. announced today that the European Commission (EC) has granted marketing authorization for EYLUXVI® (code name: ALT-L9), an Eylea® biosimilar co-developed by its subsidiary, Alteogen Biologics. EYLUXVI® is Alteogen's second approved...
Sanguine Biosciences, a leading provider of healthy and disease-state human biospecimens and data for research, today announced the expansion of its oncology sample offerings through new partnerships with oncology clinics nationwide. These...
Acadia Pharmaceuticals Inc. announced that the journal Developmental Medicine and Child Neurology published interim results from the caregiver-reported observational online, open-label, ongoing LOTUS study evaluating effectiveness and tolerability...
to a median OS of 10.8 months (95% CI, 8.3 to 17.6 months) in patients treated with a PD-1/PD-L1 inhibitor alone (n=71), which was a statistically significant extension in median OS of more than 8.0 months (P=0.02). Patients randomized to receive...
FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today presented new plixorafenib results from the previously completed Phase 1/2a clinical trial that...
Corsair Pharma, Inc., a clinical-stage biopharmaceutical company focused on advancing innovative transdermal therapies for pulmonary arterial hypertension (PAH), today announced it will present new data on the TRX-248 Transdermal System at the...
Medicines Discovery Catapult (MDC) and Crown Bioscience have formed a strategic global collaboration to deliver an integrated translational biology platform for innovators developing radiopharmaceuticals. Radiopharmaceuticals are a growing class...
Marius Pharmaceuticals, Inc. announced a collaboration with Hims & Hers™, one of the largest digital health platforms for men, to make KYZATREX®, an FDA-approved oral testosterone replacement therapy for adult men with low or no testosterone...
Waldencast plc a global multi-brand beauty and wellness platform, announced that the U.S. Food and Drug Administration (“FDA”) has approved Obagi® saypha® MagIQ™ injectable hyaluronic acid (“HA”) gel, the first product in the Obagi® saypha®...
at World Sleep 2025 include: Updated and new results from an interim descriptive analysis of data from REFRESH (n=51), a prospective multicenter, real-world study in patients with narcolepsy, including those who switched to LUMRYZ from...
Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, which enrolled 173 patients, and TRUST-II (NCT04919811), a global study, which enrolled 189 patients. The primary endpoint of these registrational studies is confirmed objective...
7.2 months (95% CI: 3.6–NE) and a DCR of 96.9% (95% CI: 83.8–99.9) were observed. Median PFS of 5.6 months (95% CI: 3.9–8.1) and median OS of 12.0 months (95% CI: 7.3–19.1) were seen. In a subset of patients (n=105) receiving ifinatamab deruxtecan...
Precision BioSciences, Inc. a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet need, announced that it will be issued U.S. Patent No....
Launching now in the U.S., INGELVAC CIRCOFLEX® AD is the first vaccine to combine both PCV2a and PCV2d antigens in a single dose designed for optimized herd health. Built on the industry-leading vaccine INGELVAC CIRCOFLEX® from Boehringer...
Experic, a contract development and manufacturing organization (CDMO) and clinical trial supply services company serving the biopharmaceutical industry, today announced the appointment of Jeffrey Shane as its Chief Commercial Officer. Mr. Shane...
Mytos, a biotechnology company automating cell manufacturing, announced new manufacturing collaborations with three innovative biotech companies - StemSight, Rinri Therapeutics, and Novadip. Each company intends to integrate Mytos’ iDEM automated...
Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®)...
and Manufacturing Organization (CRDMO), today announced the completion of Phase II of its new Production Block (PB-11) at the company’s flagship API manufacturing facility in Bidar, India (Unit IV). The Phase I of PB-11, with a capacity of 110 KL,...
Reponex Pharmaceuticals A/S (Reponex), et datterselskab af Pharma Equity Group A/S har i dag meddelt, at selskabet har modtaget myndighedsgodkendelse til at igangsætte et afgørende fase 2-studie med lægemiddelkandidaten RNX-011. Studiet skal...
