AstraZeneca (NYSE:AZN) today touted results from a Phase III extension trial evaluating the long-term safety and efficacy of benralizumab as an add-on maintenance therapy for patients with severe eosinophilic asthma. Benralizumab, or Fasenra, is approved as an add-on maintenance treatment for severe eosinophilic asthma in an array of countries, including the U.S., the E.U., and Japan. […]
Kaleo partners with Walgreens to offer epinephrine auto-injector
Kaleo said this week that its epinephrine auto-injector, Auvi-Q, is available at Walgreens locations across the U.S. The partnership comes as the country is dealing with a shortage of the emergency allergy therapies – a number of epinephrine auto-injector manufacturers have reported supply issues to the FDA. In August, Kaleo confirmed that despite ongoing manufacturing delays […]
In midst of Epipen shortage, Kaleo confirms ‘sufficient supply’ of Auvi-Q auto-injectors
Kaleo said today that despite ongoing manufacturing delays reported by epinephrine auto-injector manufacturers, Kaleo’s Auvi-Q device is available via prescription and that the privately-held company has ‘sufficient supply to meet any anticipated demand.’ Kaleo’s epinephrine auto-injector features voice instructions that guide users through the drug-delivery process and an auto-retractable needle system, according to the company. […]
Adherium launches over-the-counter inhaler sensor in US
Adherium (ASK:ADR) today launched over-the-counter sales of its Hailie digital inhaler add-on in the U.S. The sensor is designed to integrate directly with prescription inhaler medications, sending adherence reminders and relevant data to a user’s smartphone to assist in managing chronic respiratory conditions like asthma and COPD. “We’re extremely excited to announce the availability of the […]
Acorda’s CEO on failure, perseverance and the profound risks of drug development
Dr. Ron Cohen isn’t easily deterred. The physician-turned-executive has spent decades in the biotech industry and weathered a number of setbacks – he learned in his early years at the now-defunct Advanced Tissue Sciences that to succeed, he needed resilience. “I learned that it took hundreds of millions of dollars if not billions to develop […]
Pulmatrix touts data from first-in-human trial of inhaled anti-fungal therapy
Pulmatrix (NSDQ:PULM) said today that all dosing and follow-up visits have finished for its first-in-human study of an inhaled formulation of itraconazole as a treatment of allergic bronchopulmonary aspergillosis in people with asthma. The inhaled iSperse formulation, called Pulmazole, was well-tolerated, according to the Lexington, Mass.-based company. Pulmatrix plans to launch a Phase II trial of […]
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 […]
FDA rejects Mylan’s Advair generic in win for GSK
Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug. Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects […]
Pulmatrix touts Ph1 data for inhaled COPD therapy
Pulmatrix (NSDQ:PULM) touted data today from a dose-ranging Phase I trial of its once-daily inhaled therapy designed for people with chronic obstructive pulmonary disease. The company’s product is a reformulation of tiotropium bromide, the active component in Boehringer Ingelheim’s blockbuster drug, Spiriva. Pulmatrix used salt-based excipients and spray-drying techniques as part of its iSperse drug-delivery platform to […]
Apotex recalls allergy nasal spray due to glass particles
Apotex yesterday issued a voluntary recall of one lot of fluticasone propionate allergy nasal spray devices, noting that they may contain small glass particles. The company first discovered the issue thanks to a customer complaint. The glass particles could block the device’s actuator, according to Apotex, and impact the pump’s functionality. The company’s sprays are used […]
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