Windtree Therapeutics (formerly Discovery Laboratories) said that it has received an additional $1 million from a Phase 2 Small Business Innovation Research (SBIR) grant initially announced in October 2014. The grant, with a total potential value of $3 million, supports development of the company's aerosolized KL4 surfactant as a treatment for radiation-induced lung … [Read more...] about Windtree Therapeutics gets $1 million for aerosolized KL4 surfactant development
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FDA approves nasal spray dental anesthetic
The FDA has approved St. Renatus's Kovanaze tetracaine HCl and oxymetazoline HCl nasal spray, the company announced. The product is approved for regional anesthesia for adults and children weighing 40 kg or more who are having work done on the upper incisors, canines, or premolars. The company announced positive results from a Phase 3 study of the nasal spray in … [Read more...] about FDA approves nasal spray dental anesthetic
H&T Presspart opens Latin American sales office
Inhaler component manufacturer H&T Presspart has announced the opening of a new sales office in Montevideo, Uruguay to serve customers in the South and Central American region. In addition, Jesus Polanco, formerly Business Development Manager at H&T Presspart Tarragona has been appointed Sales and Business Development Manager Latin America, effective immediately, … [Read more...] about H&T Presspart opens Latin American sales office
Health Canada allows temporary importation of naloxone nasal spray from the US
While Health Canada conducts an expedited review of a new drug submission (NDS) for naloxone nasal spray, Minister of Health Jane Philpott has signed an Interim Order temporarily allowing naloxone nasal spray imported from the US to be sold in Canada. Currently, the only form of naloxone available in Canada is injectable. Adapt Pharma submitted the NDS to Health … [Read more...] about Health Canada allows temporary importation of naloxone nasal spray from the US
Therapix Biosciences licenses intranasal cannabinoid formulation from Hebrew University
Therapix Biosciences has entered into an agreement with the Hebrew University's technology transfer company Yissum to obtain an exclusive worldwide license for an intranasal formulation of cannabinoids developed by Elka Touitou of the university's Institute of Drug Research, the company said. The news comes one week after the company, which is developing cannabinoids … [Read more...] about Therapix Biosciences licenses intranasal cannabinoid formulation from Hebrew University
US subsidiary of MedPharm now open
UK-based formulation development company MedPharm has announced the opening of its new US subsidiary, MP Pharma Services, located in Durham, NC. MedPharm offers services for transdermal and topical, including inhaled and intranasal, formulations. MP Pharma Services is led by former Stiefel Director of Topical Delivery Jon Lenn. MedPharm CEO Andrew Muddle … [Read more...] about US subsidiary of MedPharm now open
Approval packages for Stiolto Respimat and Spiriva Respimat now available
The FDA has made the approval packages for Boehringer Ingelheim's Stiolto Respimat and Spiriva Respimat available on its website. The Stiolto Respimat tiotropium bromide/olodaterol SMI, which is marketed as Spiolto Respimat in Europe, was approved for the treatment of COPD by the FDA in May 2015. Spiriva Respimat tiotropium bromide SMI was approved for the treatment … [Read more...] about Approval packages for Stiolto Respimat and Spiriva Respimat now available
FDA accepts Teva NDAs for fluticasone propionate/salmeterol and FP monotherapy DPIs
Teva has announced the FDA's acceptance of the company’s NDAs for fluticasone propionate (FP)/salmeterol and FP monotherapy DPIs for the treatment of asthma. Both products are delivered using the breath-activated RespiClick inhaler. In late 2015, Teva announced positive data from Phase 3 studies of both products. The FDA is expected to take action on both … [Read more...] about FDA accepts Teva NDAs for fluticasone propionate/salmeterol and FP monotherapy DPIs
US Centers for Disease Control (CDC) advises against using FluMist for 2016-17
The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) has recommended against the use of MedImmune's FluMist Quadrivalent Live Attenuated Influenza Vaccine (FluMist Quadrivalent) for the 2016-2017 influenza season because the intranasal vaccine has failed to demonstrate significant effectiveness in children … [Read more...] about US Centers for Disease Control (CDC) advises against using FluMist for 2016-17
Savara Pharmaceuticals acquires Serendex, inhaled molgramostim
AeroVanc developer Savara Pharmaceuticals has acquired Serendex Pharmaceuticals, which is developing Molgradex inhaled granulocyte-macrophage colony-stimulating factor (molgramostim) for the treatment of autoimmune pulmonary alveolar proteinosis (PAP). Serendex announced in September 2015 that it was initiating a Phase 2 clinical trial of Molgradex, which is delivered … [Read more...] about Savara Pharmaceuticals acquires Serendex, inhaled molgramostim