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. […]
Pharmaceuticals
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 […]
Enteris touts Ph2 trial data for oral endometriosis therapy
Privately-held biotech Enteris BioPharma touted data today from a Phase IIa trial of its oral leuprolide formulation, Ovarest. The Boonton, N.J.-based company reported that its product triggered significant suppression of estradiol, which is correlated with efficacy in treating endometriosis. “The positive results from the Phase IIa clinical trial of Ovarest are a significant advancement towards Enteris’ […]
Infusion catheter developer Ablative Solutions raises $4m
Delaware-based Ablative Solutions has raised $4 million as part of a $10 million round, according to regulatory filings. The company is developing the Peregrine System, an infusion catheter that delivers diagnostic and therapeutic agents to the perivascular space surrounding blood vessels. The 510(k)-cleared device includes three microneedles that remain within radiopaque guide tubes prior to […]
FDA wants Fresenius to hire a consultant to fix long-standing CGMP woes
The FDA issued a warning letter to one of Fresenius‘ (NYSE:FMS) drug manufacturing plants in India last week, citing concerns that the company has not adequately addressed a sterility problem noted during previous inspections. It’s not the first time that the Kalyani, India-based manufacturing firm has been hit with a warning. In its letter to […]
Frequency touts first-in-human safety study for hearing loss therapy
Frequency Therapeutics has finished a first-in-human study of its progenitor cell activation therapy, FX-322, in nine adults with severe to profound sensorineural hearing loss. The company’s candidate is a combination of small molecules that are designed to activate progenitor cells and trigger the formation of new hair cells in the inner ear. The patients enrolled in […]
Pear Therapeutics raises $50m for digital substance use disorder therapies
Pear Therapeutics said today that it closed a $50 million Series B round to help commercialize its prescription digital substance abuse therapies. Temasek led the round and was joined by 5AM Ventures, Jazz Venture Partners, Novartis (NYSE:NVS) and others. In September, the company’s reSET therapy became the first prescription digital therapeutic approved by the FDA. One […]
Inovio lands $23m in collab with ApolloBio for HPV immunotherapy
Inovio Pharmaceuticals (NSDQ:INO) has inked an amended collaboration and licensing deal with ApolloBio for its DNA immunotherapy product designed to treat the pre-cancers caused by human papillomavirus. The exclusive partnership is limited to China, Hong Kong, Macao and Taiwan, but it could also include the Republic of Korea over the next three years, Inovio reported. In […]