BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy for treating chronic myocardial ischemia and refractory angina as it seeks a second indication. The San Carlos, Calif.-based company’s CardiAMP therapy uses autologous cells to treat chronic myocardial ischemia, and is designed to stimulate […]
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Denali inks collab with Takeda to help Alzheimer’s drugs get into the brain
Denali Therapeutics (NSDQ:DNLI) has landed a strategic partnership with Takeda Pharmaceutical (TYO:4502) to develop and commercialize three of its product candidates for neurodegenerative diseases. The deal includes Denali’s preclinical Alzheimer’s projects, among other undisclosed candidates, which make use of the company’s antibody transport vehicles, or ATVs, to penetrate the blood-brain barrier. According to the terms of […]
Swiss biotech Oculis raises $21m for nanoparticle eye-drops
Swiss biotech Oculis has raised $21 million in a Series B round backed by investors including Novartis (NYSE:NVS) and Bay City Capital. The company is developing topical drugs for back-of-the-eye diseases, which are normally treated with painful injections directly into the eye. Oculis reported that its newly-acquired funds will be used to support the clinical development of […]
Drug-delivery tech developer AMW lands $30m from EU bank
Drug-delivery tech developer AMW has landed $30 million from the European Union’s lending institution to help fund the company’s development activities and expand production capacity. The German pharmaceutical company’s newly-acquired funds will specifically support a new R&D facility located in Bavaria. The transaction was supported by the European Fund for Strategic Investments. “Supporting research, development […]
The ‘smart pill’ market could be worth $3B by 2025 – meet the key players
The “smart pill” market is expected to nearly quadruple in value to $3 billion by 2025, according to Grand View Research. Driving this growth is an increasing demand for minimally-invasive procedures, as well as better patient monitoring capabilities. There are a number of players in the pharmaceutical and medtech arenas looking to stake a claim […]
Bellerophon brings inhaled nitric oxide into Ph2 pulmonary hypertension trial
Bellerophon Therapeutics (NSDQ:BLPH) has enrolled the first patient in a Phase IIb study assessing its INOpulse device in patients with pulmonary hypertension due to interstitial lung disease. The company’s placebo-controlled study is slated to evaluate the safety and efficacy of pulsed, inhaled nitric oxide in patients with PH-ILD, including those with idiopathic pulmonary fibrosis, Bellerophon reported. […]
Abbott nabs CMS reimbursement for FreeStyle Libre continuous glucose monitor
Abbott (NYSE:ABT) said today that its FreeStyle Libre continuous glucose monitor is now available to Medicare patients, after the Centers for Medicare & Medicaid Services determined that the device can be classified as a therapeutic CGM. The FreeStyle Libre is designed to read glucose levels through a sensor worn on the back of a person’s upper […]
Mylan, Momenta take aim at Regeneron’s Eylea with biosimilar
Momenta Pharmaceuticals (NSDQ:MNTA) and Mylan (NSDQ:MYL) announced yesterday that they plan to launch a pivotal trial in the first half of 2018 for a proposed biosimilar to Regeneron‘s (NSDQ:REGN) blockbuster drug, Eylea. Eylea, a VEGF-inhibitor designed to treat wet age-related macular degeneration and diabetic macular edema, has little competition on today’s market. The drug brought in […]
Tandem Diabetes Care launches manufacturing ops at new San Diego plant
Tandem Diabetes Care (NSDQ:TNDM) said today that its new San Diego, Calif.-based manufacturing facility is fully operational. The 50,000 square foot plant doubles the company’s previous manufacturing capacity for insulin pumps and cartridges, Tandem reported, and expands its available warehousing for infusion set supplies. Tandem’s new facility has two insulin pump production lines, four cartridge manufacturing […]
Egalet teams up with Valeant division to promote pain-relief nasal spray
Egalet (NSDQ:EGLT) has partnered with a division of Valeant Pharmaceuticals (NYSE:VRX), OraPharma, to co-promote its pain-relief nasal spray to dentists and oral surgeons in the U.S. Sprix nasal spray is a nonsteroidal anti-inflammatory drug designed for the short-term management of moderate to moderately-severe pain. Financial terms of the two-year deal were not disclosed. “Given the need for […]