KemPharm (NSDQ:KMPH) touted top-line data from a pivotal efficacy and safety trial of its KP415 pediatric ADHD product. The company reported that KP415, which consists of serdexmethylphenidate and d-methylphenidate, met the primary efficacy endpoint in people with attention-deficit/hyperactivity disorder between the ages of 6 and 12 years. KemPharm’s KP415 capsule makes use of d-MPH hydrochloride as […]
Vaccine maker PaxVax tackles the unmet need posed by chikungunya virus
Transmitted by the same mosquitoes that spread Zika virus and dengue fever, the chikungunya virus is named for an African word meaning “to become contorted.” People infected with the alphavirus are afflicted with lasting joint pain that causes their backs to hunch over, according to the World Health Organization. The virus, which has cropped up […]
Drug-coated balloon developer Urotronic raises $6m
Urotronic has raised $6.1 million in an equity offering involving 21 investors, according to a document filed with the SEC this week. The Minnesota-based company has not publicly stated how it plans to spend its newly-acquired funds. Urotronic is developing a drug-coated balloon catheter designed to treat urethral strictures in men. Last month, Urotronic got […]
Siga Technologies touts pivotal data for oral smallpox therapy
Siga Technologies (NSDQ:SIGA) said today that data from a pivotal human safety study and animal efficacy studies of its oral smallpox therapy were published in the New England Journal of Medicine. Data from the studies support the efficacy and favorable safety profile of Tpoxx, an oral formulation of tecovirimat. “Smallpox is both highly contagious and highly […]
Catalent expands early-phase development skills with $139m Juniper buyout
Catalent (NYSE:CTLT) said today that it inked a $139 million deal to acquire Juniper Pharmaceuticals (NSDQ:JNP) and its early-stage product development services. The company noted that its Juniper acquisition, set at $11.50 per share, will complement Catalent’s formulation development offerings, bioavailability solutions and clinical-scale oral dose manufacturing capabilities. “Juniper’s proven solutions and capabilities will further support […]
Insulet’s Omnipod nabs preferred insulin pump status in British Columbia
Insulet (NSDQ:PODD) said today that its Omnipod device was selected as the preferred insulin pump in British Columbia, Canada under the province’s expanded PharmaCare insulin pump program. According to the terms of the program, any eligible individual who requests an initial or replacement insulin pump will receive coverage for the Billerica, Mass.-based company’s device. There are […]
Insulet assumes direct commercial operations in Europe
Insulet (NSDQ:PODD) said today that it has assumed direct commercial operations in Europe for its Omnipod tubeless insulin pump. The Billerica, Mass.-based company first announced it would part ways with its former European distributor, Ypsomed, in July last year. Insulet has since established a team of more than 100 employees to take care of distributing and […]
Novartis steps in to compete with Mylan’s Epipen
Adamis Pharmaceuticals (NSDQ:ADMP) said this week that it inked an exclusive deal with Novartis‘ (NYSE:NVS) Sandoz unit to distribute and commercialize its Symjepi emergency allergy treatment. The agreement puts Novartis in the position to compete directly with Mylan‘s (NSDQ:MYL) EpiPen auto-injector. The pharma giant has been under pressure in recent months thanks to manufacturing delays that have […]
Ocugen launches Ph3 trial for eye disease nanoemulsion
Ocugen said today that it launched the first of two pivotal Phase III trials for its OCU300 nanoemulsion designed to treat the symptoms of ocular graft versus host disease. The Malvern, Penn.-based company’s drug is a nanoemulsion formulation of brimonidine tartrate made using Ocugen’s OcuNanoE technology. Ocugen touted that it’s the first company to bring […]
Ocular Therapeutix resubmits NDA for ocular pain relief implant
Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a new drug application for its Dextenza ocular pain relief implant to the FDA. The Bedford, Mass.-based company noted that the resubmitted application aims to address manufacturing deficiencies highlighted by the FDA last year when the agency rejected Dextenza for the second time. Ocular Therapeutix’s Dextenza device is designed to […]
