Clinical Trials
520
9 active
Approvals
4
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
Active, not recruiting
8
1.5%
Completed
448
86.2%
Not yet recruiting
1
0.2%
Recruiting
1
0.2%
Terminated
45
8.7%
Unknown
4
0.8%
Withdrawn
13
2.5%
- Joaquin Duato, CEO since 2022 and Chairman since 2023, oversaw the landmark separation of J&J's consumer health segment into the independent publicly traded company Kenvue. - Jennifer Taubert, Worldwide Chairman of Innovative Medicine, previously doubled the pharmaceuticals business in the Americas, making J&J the number one pharma company in the U.S. and Canada. - CFO Joseph Wolk played a key role in executing the consumer health business separation, bringing extensive financial leadership across both Innovative Medicine and MedTech divisions. - Tim Schmid leads the MedTech organization with over 75,000 employees and approximately $30 billion in revenue, focusing on innovative medical technologies.
- Amneal Pharmaceuticals announced the launch of bimatoprost ophthalmic solution 0.01%, a generic equivalent to Allergan's LUMIGAN for treating open-angle glaucoma and ocular hypertension. - The prostaglandin analog is available in three vial sizes (2.5 mL, 5 mL, and 7.5 mL) and targets a market with approximately $719 million in annual U.S. sales. - The launch expands Amneal's Affordable Medicines portfolio and addresses the growing prevalence of glaucoma, particularly among aging populations. - The most common adverse reaction associated with the treatment is conjunctival hyperemia, according to prescribing information.
- Tarsus Pharmaceuticals has appointed David E. I. Pyott, former Chairman and CEO of Allergan, to its Board of Directors to support the company's growth strategy. - Pyott transformed Allergan from a $1 billion eye care business into a global specialty pharmaceutical leader generating over $7 billion in revenue during his 17-year tenure. - The appointment comes as Tarsus advances its eye care portfolio, including FDA-approved XDEMVY for Demodex blepharitis and Phase 2 programs for ocular rosacea and Lyme disease prevention. - Pyott's extensive experience in eye care innovation and global commercial execution is expected to support Tarsus's pipeline development and market expansion efforts.
- Shanghai Henlius Biotech announced that the FDA has accepted its Biologics License Application for HLX04, a bevacizumab biosimilar targeting multiple solid tumor indications including colorectal, lung, and ovarian cancers. - The submission marks Henlius' fifth product filed for US marketing approval, following successful approvals of trastuzumab, denosumab, and pertuzumab biosimilars that demonstrate the company's regulatory capabilities. - HLX04 joins a competitive bevacizumab biosimilar market where existing products capture approximately 92% market share, with comprehensive clinical data supporting similarity to the reference product. - The company is advancing combination trials with its anti-PD-1 antibody serplulimab and developing an ophthalmic formulation HLX04-O for wet age-related macular degeneration treatment.
- The FDA has approved Amneal Pharmaceuticals' cyclosporine ophthalmic emulsion 0.05%, a generic equivalent to Allergan's Restasis for treating dry eye disease. - The topical immunomodulator increases tear production in patients with reduced tear production due to ocular inflammation associated with dry eye syndrome. - This marks Amneal's third ophthalmic generic approval in 2025, following prednisolone acetate and bimatoprost approvals earlier this year. - The generic formulation offers the same therapeutic effectiveness as the brand-name drug but at a lower cost for patients.
- Bausch & Lomb's prescription dry eye drug Miebo costs over $800 monthly in the U.S., while the identical drug EvoTears sells over-the-counter in Europe for approximately $20. - The company achieved $172 million in 2024 sales by securing FDA approval as a prescription medication rather than pursuing over-the-counter status like in Europe. - This pricing strategy exemplifies how pharmaceutical companies exploit regulatory loopholes, with U.S. drug prices averaging 2.5 times higher than other developed nations. - Proposed FDA reforms could require international over-the-counter drugs to be evaluated for U.S. OTC status before prescription approval, potentially closing this pricing gap.
- FDC Limited has received FDA approval for its abbreviated new drug application (ANDA) for pilocarpine hydrochloride ophthalmic solution in three concentrations (1%, 2%, and 4%). - The generic ophthalmic solution is indicated for multiple conditions including reduction of elevated intraocular pressure in glaucoma patients, management of acute angle-closure glaucoma, and induction of miosis for presbyopia. - This approval allows the India-based pharmaceutical company to market the generic version in the United States, potentially expanding access to this established glaucoma and presbyopia treatment. - The approval follows recent launches of brand-name pilocarpine products including Vuity from Allergan/AbbVie and QLOSI from Orasis Pharmaceuticals for presbyopia treatment.
- MannKind Corporation has appointed Dr. Ajay Ahuja as Chief Medical Officer, bringing over two decades of biopharmaceutical leadership experience to advance the company's inhaled therapeutics pipeline. - Dr. Ahuja's expertise in cardiometabolic diseases and clinical development will support MannKind's mission to address endocrine and orphan lung diseases through innovative dry-powder formulations and inhalation devices. - The appointment strengthens MannKind's executive leadership as the company focuses on developing treatments for diabetes, nontuberculous mycobacterial lung disease, pulmonary fibrosis, and pulmonary hypertension.
- Amneal Pharmaceuticals received FDA approval for its generic version of bimatoprost ophthalmic solution 0.01%, a prostaglandin analog used to reduce elevated intraocular pressure in glaucoma patients. - The generic equivalent of LUMIGAN is available in three sizes (2.5 mL, 5 mL, and 7.5 mL) and addresses the growing need for affordable glaucoma treatments as prevalence rises among aging populations. - According to IQVIA data, the brand-name bimatoprost ophthalmic solution generated approximately $685 million in U.S. annual sales for the 12 months ended July 2025. - The approval represents a key growth driver for Amneal's Affordable Medicines segment, which focuses on complex generic products including injectables and biosimilars.
- Uniquity Bio has appointed Will Kane as President and CEO to advance solrikitug, a monoclonal antibody targeting TSLP, through completion of three Phase II trials and preparation for Phase III development. - Kane brings over three decades of biopharmaceutical leadership experience from companies including Anthos Therapeutics, Karuna Therapeutics, and Pfizer, succeeding co-founder Brian Lortie who stepped down in June 2025. - Solrikitug is currently being evaluated in separate Phase II trials for asthma, chronic obstructive pulmonary disease, and eosinophilic esophagitis, with the company pursuing best-in-class efficacy and convenient dosing optimization. - The company is also developing bispecific candidates that combine solrikitug with other inflammatory targets to enhance efficacy and broaden patient populations across immunology and inflammation indications.
