GE Capital Healthcare Financial Services has announced today that it is providing $7.5 million in financing to Trimel Pharmaceuticals for Phase 2 and 3 clinical development of several OINDPs. Trimel's pipeline includes asthma and allergic rhinitis therapies based on its Trivair dry powder inhaler technology and male and female sexual dysfunction therapies based on its … [Read more...] about $7.5 million in new financing for Trimel Pharmaceuticals
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Positive Phase 2 results for Lightlake’s naloxone nasal spray
Lightlake Therapeutics has announced what it called "very encouraging preliminary results" from a Phase 2 clinical trial of its naloxone nasal spray for the treatment of binge eating disorder. According to the company, the randomized, double-blind, placebo controlled trial demonstrated a 56% greater reduction in the amount of time that patients who received the spray … [Read more...] about Positive Phase 2 results for Lightlake’s naloxone nasal spray
Chiesi to distribute Kamada’s inhaled AAT
Israeli biopharmaceutical company Kamada will receive milestone payments of $60 million as part of a 12-year distribution agreement with Chiesi Farmaceutici for Kamada's inhaled alpha-1 antitrypsin for the treatment of alpha-1 antitrypsin deficiency (AATD-IH). Chiesi will distribute the inhalation solution in Europe, Turkey and former CIS countries. Kamada expects … [Read more...] about Chiesi to distribute Kamada’s inhaled AAT
Insmed gets additional patent for Arikace
According to Insmed, the US Patent and Trademark Office has issued the company a second composition of matter patent for Arikace liposomal amikacin for inhalation, US Patent No. 8,226,975. Insmed is developing the product for the treatment of cystic fibrosis and non-tuberculous mycobacteria (NTM). The company recently decided to defer a Phase 3 study of Arikace in the … [Read more...] about Insmed gets additional patent for Arikace
Promotions at Alexza
Inhaled drug company Alexza Pharmaceuticals has announced the promotions of four executives. The company has promoted James V. Cassella to Executive VP, Research and Development and Chief Scientific Officer; Darl Moreland to Senior VP, Quality; Mark K. Oki to Senior VP, Finance and Chief Financial Officer; and Edwin S. Kamemoto to VP, Regulatory Affairs. … [Read more...] about Promotions at Alexza
Melbourn Scientific first CRO in Europe to offer cGMP spray pattern and plume geometry
Melbourn Scientific has added a Proveris SprayVIEW system and Vereo actuator, making the contract research organization the first in Europe to offer cGMP spray pattern and plume geometry measurements required for nasal spray and MDI approval for the US. The company provides a number of analytical and formulation services for OINDPs. Proveris Scientific Chief … [Read more...] about Melbourn Scientific first CRO in Europe to offer cGMP spray pattern and plume geometry
Aptar dose indicator on newly-approved nasal aerosol
Aptar Pharma has announced that the Zetonna nasal aerosol device recently launched in the US includes a customized Aptar Landmark dose indicator, the result of a six-year collaboration with Sunovion. Zetonna is delivered by a pressurized metered dose inhaler, and the FDA recommends that all new pMDI products have an integrated dose counter. Aptar Pharma … [Read more...] about Aptar dose indicator on newly-approved nasal aerosol
Health Canada to review calcitonin nasal spray risks
In the wake of the EMA's recent recommendation against use the use of calcitonin nasal sprays due to an increased risk of cancer, Health Canada says that it is also evaluating the risks of calcitonin products. Novartis, its generic division Sandoz, and Apotex market calcitonin nasal sprays in Canada. The agency, which says that it has not received any reports of … [Read more...] about Health Canada to review calcitonin nasal spray risks
Watson gets FDA approval for budesonide, sued over levalbuterol
The FDA has approved Watson Pharmaceuticals' Abbreviated New Drug Application (ANDA) for a generic version of Pulmicort Respules. The budesonide inhalation suspension 0.25mg/2mL and 0.5mg/2mL ampules are the subject of an ongoing patent dispute with AstraZeneca. Watson says that it if it prevails in court, it will launch the budesonide product by the end of this … [Read more...] about Watson gets FDA approval for budesonide, sued over levalbuterol
Lupin to market Onbrez inhalation capsules in India
According to a report in The Business Standard, Novartis India has announced an agreement with Lupin to sell the Onbrez indacaterol inhalation capsules for the treatment of COPD in India. The newspaper cited "an industry source" for the information. The article says that the capsules would be available in two doses, 150 mg and 300 mg. Few other details were … [Read more...] about Lupin to market Onbrez inhalation capsules in India