Small Molecules

05 May 2020 TG Therapeutics Announces Positive Topline Results from the UNITY-CLL Phase 3 Study Evaluating the Combination of Umbralisib and Ublituximab (U2) for the Treatment of Patients with Chronic Lymphocytic Leukemia
04 May 2020 Lupin Announces Positive Topline Results From its Phase 3 Study of Single-Dose Solosec® (secnidazole) for the Treatment of Trichomoniasis
04 May 2020 Newron Reports Top-Line Results from its STARS Study Evaluating Sarizotan in Patients with Rett Syndrome
02 May 2020 Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19
01 May 2020 Akari Therapeutics Announces Positive Topline Results from Fully Recruited Phase II Study of Nomacopan in Bullous Pemphigoid Patients
01 May 2020 ESSA Pharma Announces FDA Allowance of the Clinical Investigation of EPI-7386 in Prostate Cancer
01 May 2020 Sosei Heptares Notes That Enerzair® Breezhaler® (QVM149) has been Recommended for Approval in the European Union for Treating Uncontrolled Asthma
01 May 2020 Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) for Children and Adolescents With Cystic Fibrosis Between the Ages 6 Months and 18 Years With the R117H Mutation in the CFTR Gene
01 May 2020 Pierre Fabre receives positive CHMP opinion for BRAFTOVI® (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer
01 May 2020 U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia
30 Apr 2020 Soligenix Announces Positive Phase 3 FLASH Study Demonstrates Increased Efficacy with Continued Treatment in Patients with Cutaneous T-Cell Lymphoma
30 Apr 2020 FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status
29 Apr 2020 Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19
29 Apr 2020 Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19
29 Apr 2020 Vicore Pharma gets regulatory approval to start phase II clinical trial with VP01 (C21) in patients with COVID-19, SARS CoV-2 infection
29 Apr 2020 Syndax Pharmaceuticals Announces Preclinical Profile and Initial Phase 1 Data Demonstrating Clinical Activity of Menin Inhibitor SNDX-5613 in Adults with Relapsed/Refractory Acute Leukemias
29 Apr 2020 Chimerix Receives FDA Clearance for Rolling Submission of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
28 Apr 2020 Onvansertib Trial in KRAS-Mutated Colorectal Cancer Demonstrates Consistent Tumor Regression Across KRAS Mutation Subtypes and Durable Response
28 Apr 2020 ORIC Pharmaceuticals Presents Preclinical Data on CD73 Inhibitor at the American Association for Cancer Research (AACR) Virtual Annual Meeting
28 Apr 2020 Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS® (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes
28 Apr 2020 BioXcel Therapeutics Announces Initiation of a Phase 2 Study of BXCL701 in Combination with a PD-1 Inhibitor for Treatment Emergent Neuroendocrine Prostate Cancer
28 Apr 2020 Sovateltide significantly (p=0.0157) improved clinical outcome (modified Rankin Scale) in patients with acute cerebral ischemic stroke when compared to standard of care
28 Apr 2020 Blueprint Medicines Announces Top-line Results from Phase 3 VOYAGER Trial of Avapritinib versus Regorafenib in Patients with Advanced Gastrointestinal Stromal Tumor
28 Apr 2020 Tarveda Therapeutics Presents Pharmacokinetic and Tumor Biopsy Data from First in Human Study of PEN-866 at the 2020 AACR Virtual Annual Meeting
28 Apr 2020 Shionogi Receives European Commission Marketing Authorisation for FETCROJA® (cefiderocol) for the Treatment of Infections Due to Aerobic Gram-negative Bacteria in Adults With Limited Treatment Options

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