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 […]
Propeller raises $20m and prepares to extend reach beyond digital inhalers
Digital therapeutics company Propeller Health and drug-delivery device-maker Aptar Pharma are teaming up, yet again, to develop an array of connected drug-delivery devices. The pair has worked together in the past – in 2016, the companies launched the world’s first fully-integrated connected metered dose inhaler. Now, they hope to create a platform of digital therapeutics, […]
Adherium looks to give doctors a window into their patients’ lives
To control an asthma patient’s symptoms, doctors will prescribe an inhaler to stop symptoms from cropping up and a rescue inhaler to be used if patients find themselves in the middle of an asthma attack. “But if your rescue inhaler doesn’t give you the relief that you need, your next recourse is to go to […]
GSK’s Arnuity Ellipta asthma therapy wins FDA nod for use in kids as young as 5 years old
GlaxoSmithKline (NYSE:GSK) won FDA approval for the use of its Arnuity Ellipta inhaler as a once-daily therapy for the maintenance treatment of asthma in children as young as five years old. The pharmaceutical company touted its regulatory win, pointing out that the fluticasone furoate treatment is one of the only once-daily asthma therapies cleared in the […]
GlaxoSmithKline touts long-term study of biologic treatment for severe eosinophilic asthma
GlaxoSmithKline (NYSE:GSK) touted new data today from a long-term study of its biologic treatment for patients with severe eosinophilic asthma. One-third of patients treated with mepolizumab experienced no exacerbations, GSK reported – down from an average of two exacerbations each year at the start of the study. The 347-patient Columba trial gave participants 100-mg of mepolizumab […]
Theravance Biopharma touts expanded FDA nod for GSK’s Trelegy Ellipta inhaler
Theravance Biopharma‘s (NSDQ:TBPH) said today that the FDA granted expanded indications for GlaxoSmithKline‘s (NYSE:GSK) Trelegy Ellipta inhaler, now approved for use to treat a broader population of chronic obstructive pulmonary disease patients. With the expansion, the inhaler is now cleared for COPD patients with airflow limitations and for those who have experienced an acute worsening of […]
AstraZeneca inks outcomes-based contract with Highmark for COPD, asthma drug
Health insurer Highmark inked an outcomes-based contract with AstraZeneca (NYSE:AZN) for Symbicort, the pharmaceutical company’s drug designed to treat asthma and chronic obstructive pulmonary disease. Highmark said its contract with AstraZeneca is one of the first outcomes-based deals involving a respiratory drug and will apply to commercial members of its national and core markets in Pennsylvania, […]
Study: Propeller’s digital asthma tech informs policy, improves health
Results from a large, real-world study of asthma patients found that digital health technology can improve patient outcomes and inform city-planning policy, Propeller Health touted this month. The company teamed up with local government in Louisville, Kentucky and a nonprofit group to assess how environmental conditions can influence asthma symptoms using connected inhalers and a […]
- 1
- 2
- 3
- …
- 18
- Next Page »
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn