Biotech

ObsEva Submits New Drug Application (NDA) of Linzagolix to the FDA for Treatment of Uterine Fibroids

Women’s health-focused biotech company ObsEva has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for linzagolix for the treatment of uterine fibroids. Uterine fibroids are common benign tumors of the muscular tissue of the uterus. Uterine fibroids affect women of childbearing age and can vary in size from undetectable to large bulky masses.  Few long-term medical…

Field Trip Pursues Postpartum Depression and Treatment Resistant Depression as Lead Indications for FT-104, Its Novel Psychedelic Compound

Field Trip, a leader in the development and delivery of psychedelic therapies, has announced the lead indications for FT-104, its novel psychedelic compound in development, will be Treatment Resistant Depression (TRD) and Postpartum Depression (PPD). Through Field Trip Discovery, its drug development division, Field Trip is developing next-generation psychedelic molecules. Its first molecule in development, FT-104, a prodrug, is a synthetic serotonin-2A…

Visby Medical Receives FDA Clearance and CLIA Waiver at the Point of Care for Click Test, its PCR Sexual Health Test

Visby Medical has received a 510(k) clearance and was granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) from the US Food and Drug Administration (FDA) to market its fast, single-use polymerase chain reaction (PCR) diagnostic test for the multiplexed detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV), using a self-collected vaginal swab.  With the…

OrganiCare Raises a $8.5M Series A to Expand its Natural Feminine Over-the-Counter Healthcare Platform

OrganiCare, the maker of all-natural over the counter healthcare products has announced the closing of an oversubscribed Series A financing of $8.5M after an aggressive 2020 year of growth, which included the launch of a new OTC Genital Herpes product under the FemiClear brand. “We are excited about the growth of OrganiCare,” said Jake Moilanen, General Partner at Seraph Group, and second time investor in…

Gynov Releases Gynositol, A New Supplement Promising Relief for Women with PCOS

Gynov is a company dedicated to pioneering genuine, effective, and targeted solutions to various female health concerns. Beyond the qualitative approach based on robust scientific data, the French company designs products integrated not only into medical care but above all into a holistic vision of human health. Gynov, short for Gynecological Innovation, was founded by Pierre-Yves Mousset MD, in France in 2016. The company’s flagship product…

Organon and ObsEva Enter Global License Agreement for Preterm Labor Treatment

Every year, an estimated 15 million babies are born preterm. Organon, a global women’s health company spun out of Merck and ObsEva, a biopharmaceutical company dedicated to improving women’s reproductive health have now announced that the companies have entered into an agreement whereby Organon will license the global development, manufacturing and commercial rights to ebopiprant (OBE022). Ebopiprant is an investigational, orally active,…

Jeeva Wants to Help Increase Patient Diversity in Clinical Trials

While nearly 40% of Americans belong to a racial or ethnic minority, the base of patients who participate in clinical trials for new drugs skew heavily white—in some cases, 80 to 90 percent. “How,” asks Dr. Harsha Rajasimha, founder and CEO of Jeeva Informatics, “can a drug aimed at the general public be trusted if its effect on other races and ethnicities is…

Evvy Raises a $5M Seed Round for its At-Home Vaginal Microbiome Test Leveraging Metagenomic Sequencing

Evvy, a female-founded startup that aims to build a new understanding of the female body, launches today. Evvy’s first focus is on a critical but often overlooked biomarker: the vaginal microbiome. Evvy is co-founded by Stanford alumni Priyanka Jain and Laine Bruzek and backed by a newly raised seed round of $5 million from General Catalyst, Box Group, Virtue, Human Ventures, G9 Ventures, BBG Ventures, and others. Margo Georgiadis, Executive-in-Residence at General…