Biohaven Pharmaceutical has announced that it met with the FDA following completion of Phase 2 clinical trials of its intranasal vazegepant (BHV-3500) for the treatment of migraine and is ready to advance the 10 mg dose of the nasal spray into a Phase 3 trial. In December 2019, Biohaven reported topline data from a Phase 2/3 dose finding trial in which both 10 and 20 … [Read more...] about Biohaven’s intranasal vazegepant for migraine to advance into Phase 3 trials
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Digital RDD 2020 announces meeting details
Following up on the announcement that RDD 2020 would be replaced by a digital version of the meeting due to the COVID-19 pandemic, meeting organizers have now provided details on registration and on how the digital meeting will work. RDD 2020 was originally scheduled to take place April 26-30 in Palm Desert, California and was to be followed immediately by an IPAC-RS … [Read more...] about Digital RDD 2020 announces meeting details
Nephron Pharmaceuticals looking to increase inhalation solution and suspension production capacity
Nephron Pharmaceuticals CEO Lou Kennedy spoke to local reporters in the company's home state of South Carolina on March 17, 2020, describing the company's efforts to increase production of its inhalation solutions and suspensions to meet demand during the COVID-19 pandemic. Nephron produces its own inhalation products; including albuterol, ipratroprium bromide, … [Read more...] about Nephron Pharmaceuticals looking to increase inhalation solution and suspension production capacity
Synairgen announces trial of SNG001 inhaled interferon-beta-1a for COVID-19
The UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) have expedited approvals for a Phase 2 trial of Synairgen's SNG001 nebulized interferon-beta-1a for the treatment of COVID-19, the company said. According to the company, coronaviruses like SARS-CoV-2 have the ability to interfere with production of endogenous … [Read more...] about Synairgen announces trial of SNG001 inhaled interferon-beta-1a for COVID-19
Pharmascience launches its generic fluticasone propionate/salmeterol DPI in Canada
Montreal-based Pharmascience has announced the launch of its pms-fluticasone propionate/salmeterol DPI in Canada for the treatment of asthma and COPD. The company says that the DPI uses the same device as Advair Diskus. According to the Health Canada Drug Product Database, three strengths of pms-fluticasone propionate/salmeterol DPI (100mcg/50mcg, 250mcg/50mcg, and … [Read more...] about Pharmascience launches its generic fluticasone propionate/salmeterol DPI in Canada
MannKind to focus R&D on potential COVID-19 therapies, collaboration with Immix
Inhaled drug developer MannKind Corporation has announced that it "is committed to joining the global effort to overcome the COVID-19 crisis" and as a result "that it is adjusting research and development resources that were reserved for its pipeline of investigational products for treating serious lung diseases, with the goal of prioritizing work on new compounds … [Read more...] about MannKind to focus R&D on potential COVID-19 therapies, collaboration with Immix
Insmed submits NDA for Arikayce in Japan, announces COVID-19 measures
Insmed has announced its submission of a new drug application to Japan's Ministry of Health, Labour and Welfare (MHLW) for Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who have not responded to other therapies sufficiently. Arikayce was approved by the … [Read more...] about Insmed submits NDA for Arikayce in Japan, announces COVID-19 measures
Beyond Air submits IDE for use of its inhaled NO delivery system for COVID-19
Beyond Air said that it has submitted an investigational device exemption (IDE) to the FDA seeking to use its cylinder-free LungFit BRO inhaled nitric oxide (iNO) delivery system for the treatment of COVID-19. Beyond Air has been developing the LungFit BRO system for the treatment of bronchiolitis. The company said that if the FDA approves the IDE, it will conduct … [Read more...] about Beyond Air submits IDE for use of its inhaled NO delivery system for COVID-19
RDD 2020 switches to digital format
Due to public gathering and travel restrictions imposed in response to the COVID-19 pandemic, the organizers of RDD 2020 have made the decision to cancel the RDD 2020 conference that was scheduled to take place April 26-May 1, 2020 in Palm Desert, California; however, RDD 2020 will go ahead in a digital format of some sort. The associated IPAC-RS symposium that was … [Read more...] about RDD 2020 switches to digital format
FDA lists Arcapta, Seebri, and Utibron Neohalers as discontinued (updated)
According to the FDA, three DPIs marketed by Sunovion in the US have been discontinued as of March 10, 2020. Sunovion acquired the US rights to Utibron (indacaterol/glycopyrrolate) Neohaler, Seebri (glycopyrrolate) Neohaler, and Arcapta (indacaterol) Neohaler from Novartis in December 2016. The inhalers are marketed elsewhere as Ultibro Breezhaler, Seebri Breezhaler, … [Read more...] about FDA lists Arcapta, Seebri, and Utibron Neohalers as discontinued (updated)