Pharmaceutical propellant market leader Mexichem has announced its acquisition of a distribution and sale license for DuPont's pharmaceutical grade Dymel 227ea/P propellant and says that it will market the product under its Zephex brand. Zephex propellants are used in about three quarters of all metered dose inhalers manufactured worldwide. The acquisition of … [Read more...] about Mexichem acquires DuPont’s Dymel 227ea/P propellant
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Novartis announces NDA submissions for QVA149 and NVA237 DPIs
Novartis has announced that it submitted New Drug Applications to the FDA for both the QVA149 indacaterol/glycopyrronium bromide and NVA237 glycopyrronium bromide DPIs in the fourth quarter of 2014. Both inhalers are meant for the treatment of COPD. In early 2012, the company said that it planned to submit marketing applications for the two products in the US by the … [Read more...] about Novartis announces NDA submissions for QVA149 and NVA237 DPIs
Vectura and Janssen to partner on DPI development
Vectura has announced that it will partner with Janssen Biotech to develop inhaled dry powder anti-inflammatory products for the treatment of asthma and COPD. Janssen's drug candidates will be developed using Vectura's DPI delivery technology, with Janssen taking responsibility for clinical development and Vectura having responsibility for pharmaceutical development. … [Read more...] about Vectura and Janssen to partner on DPI development
Dymel pharmaceutical propellants acquired by SRF
Indian conglomerate SRF Limited has acquired DuPont's Dymel pharmaceutical propellants for $20 million in cash, according to reports in the Indian press. SRF, which already has two technical grade HFA-134a plants, plans to build its own cGMP facility to produce pharmaceutical grade propellant. DuPont will supply pharmaceutical grade HFA-134a until the new plant is … [Read more...] about Dymel pharmaceutical propellants acquired by SRF
Plumestars gets orphan drug designation for amikacin DPI
Italian startup Plumestars has announced via Twitter that it has received orphan drug status from the EMA for its amikacin dry powder inhaler for the treatment of P. aeruginosa infections in cystic fibrosis patients. https://twitter.com/PlumeStars/status/546688438003826688 According to the company's website, it is also developing a tobramycin DPI. … [Read more...] about Plumestars gets orphan drug designation for amikacin DPI
FDA approves QNASL for children
Accoding to Teva, the FDA has approved the company's QNASL beclomethasone dipropionate HFA nasal spray for the treatment of allergic rhinitis symptoms in children aged 4-11. The supplemental NDA for the pediatric product was accepted by the FDA in May 2013. The children's version of QNASL is a 40 µg formulation; the adult version, which was approved in 2012, is an … [Read more...] about FDA approves QNASL for children
Verona Pharma appoints Chief Medical Officer, creates US subsidiary
Verona Pharma has announced that Kenneth Newman, a former Acton Pharmaceuticals CMO and former Boehringer Ingelheim VP, Medical Affairs, will become Verona's Chief Medical Officer as of January 1. At Acton, Newman headed up clinical development and regulatory activities for several OINDPs. Acton was acquired by Meda in 2013. The new position will be based in the … [Read more...] about Verona Pharma appoints Chief Medical Officer, creates US subsidiary
Novartis sues Cipla over generic Onbrez
Novartis has reportedly sued Cipla in the Delhi High Court for infringing patents related to Novartis's Onbrez Breezhaler indacaterol DPI (Arcapta Neohaler). Cipla began marketing a generic indacaterol DPI called "Unibrez" in October; after losing a trademark infringement case, Cipla changed the product's name to "Indaflo." Cipla has claimed that there is a … [Read more...] about Novartis sues Cipla over generic Onbrez
Insmed provides update on its pipeline
According to Insmed, the company has filed an MAA for its Arikayce liposomal amikacin for inhalation, and it has been informed by the EMA that the only remaining issue, a review of the Pediatric Investigation Plan (PIP) by the agency's Pediatric Committee, should be finished by the first quarter of 2015. A trial of Arikayce for the treatment of resistant … [Read more...] about Insmed provides update on its pipeline
Hovione announces results of FDA pre-approval inspection
Hovione has announced that the FDA has found its Loures, Portugal manufacturing site to be GMP compliant, although the agency issued a Form 483 citing three inspectional observations. The inspection took place from December 1 to December 5, 2014. In October 2013, the company announced that it had completed a successful FDA inspection of the Loures facility with no … [Read more...] about Hovione announces results of FDA pre-approval inspection