A group of investors led by Vatera Healthcare Partners has added $69 million to Pearl Therapeutics's funding, bringing the total to more than $102 million since 2007. Pearl's lead candidate, PT003, a glycopyrrolate/formoterol MDI for the treatment of COPD is in Phase 2B studies, and Pearl plans to begin Phase 3 trials by the end of 2012. Vatera was founded by … [Read more...] about Pearl raises $69 million
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Alexza receives complete response letter for Staccato loxapine
Alexza Pharmaceuticals announced that it has received a complete response letter from the US FDA in regards to its application for Staccato loxapine inhalation aerosol for the treatment of agitation in schizophrenic and bi-polar patients. The FDA cited concerns about safety based on reductions in FEV 1 seen during Phase I studies and about stability studies … [Read more...] about Alexza receives complete response letter for Staccato loxapine
US FDA approves Aridol
The FDA has approved Pharmaxis's Aridol mannitol inhalation powder bronchial challenge test kit. According to Pharmaxis, the Aridol test takes less than half the time of a methacholine challenge test. Aridol has already been approved in 19 countries. Read the company's press release … [Read more...] about US FDA approves Aridol
Positive results for VTX-1463 nasal spray
According to VentiRx Pharmaceuticals, a Phase I clinical trial of its VTX-1463 nasal spray for the treatment of allergic rhinitis demonstrated that once-weekly administration of the drug produced a significantly greater reduction in total nasal symptom scores than did a placebo. VTX-1463 is a selective toll-like receptor 8 (TLR8) agonist. Read the … [Read more...] about Positive results for VTX-1463 nasal spray
Pfizer considers divesting Capsugel
Pfizer says that it is "reviewing strategic alternatives" for its Capsugel business and that divestiture is an option. Capsugel manufactures capsules, including Vcaps hypromellose capsules for inhalation applications, and the Xcelodose powder dispensing system. 2009 revenue for Capsugel was approximately $740 million. Pfizer expects to make a decision … [Read more...] about Pfizer considers divesting Capsugel
ISTA plans to file IND for nasal spray by end of year
US eye care company ISTA Pharmaceuticals announced plans to file an investigational new drug (IND) application with the FDA for its bepotastine besilate nasal spray for the treatment of seasonal allergic rhinitis by the end of 2010. The company also released results from a Phase I/II study of the nasal spray showing that the drug was well tolerated and said that … [Read more...] about ISTA plans to file IND for nasal spray by end of year
Generex gets Canadian patent for delivery system
US biotech company Generex has announced that the Canadian Intellectual Property Office has granted its patent titled "Pharmaceutical Compositions for Buccal and Pulmonary Application." Generex develops formulations for buccal delivery using its RapidMist metered dose device, which is essentially an MDI designed to deliver aerosol to the oral cavity … [Read more...] about Generex gets Canadian patent for delivery system
Biovail and Valeant merge
Shareholders of pharma companies Biovail and Valeant voted to approve their merger, and the new company is now called Valeant Pharmaceuticals International. Valeant markets Migranal dihydroergotamine nasal spray in the US, and Biovail had been partnered with Alexza on the development of Staccato loxapine since February 2010. FDA action on the Staccato … [Read more...] about Biovail and Valeant merge
Stirling talking to potential partners for HDA device
According to Stirling Products, the company is in discussions with several major pharmaceutical companies about partnerships on products using its patented high density aerosol (HDA) device. The company says that its ultrasound-based HDA technology produces a concentration level three times higher than that of other ultrasonic devices. One version of the device … [Read more...] about Stirling talking to potential partners for HDA device
EU approval recommendation for TOBI Podhaler
The European Commission's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Novartis's TOBI Podhaler tobramycin inhalation powder for the treatment of P. aeruginosa infections in cystic fibrosis patients. Novartis submitted the product for EU approval in December 2009. Read the company's press release. … [Read more...] about EU approval recommendation for TOBI Podhaler