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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)

Engage Therapeutics reports positive results from Phase 2 study of Staccato alprazolam for epileptic seizures

Engage Therapeutics said that the Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of Staccato inhaled alprazolam in epilepsy patients has met its primary endpoint, terminating seizure activity within two minutes of dosing with no recurrence in 50 of 76 patients. Engage had announced the initiation of the study in April … [Read more...] about Engage Therapeutics reports positive results from Phase 2 study of Staccato alprazolam for epileptic seizures

Fluidda’s Broncholab FRI platform cleared by FDA for clinical use

Functional respiratory imaging (FRI) company Fluidda announced that the FDA has cleared the company's Broncholab FRI platform for use in clinical settings. According to the company, Broncholab can provide much more accurate information about patient-specific regional lung function than conventional test methods like spirometry, allowing for better diagnosis and … [Read more...] about Fluidda’s Broncholab FRI platform cleared by FDA for clinical use

Senzer obtains IND data package for inhaled dronabinol from Insys Therapeutics

According to Senzer, the company has obtained the IND application and data package for its inhaled dronabinol from its former partner, Insys Therapeutics, and will now move ahead with development for the treatment of side effects from chemotherapy and for neuropathic pain. Insys filed for bankruptcy in June 2019. Senzer partnered with Insys in 2015 to develop … [Read more...] about Senzer obtains IND data package for inhaled dronabinol from Insys Therapeutics

Mark Bridgewater joins Vectura as Chief Commercial Officer

Vectura has announced the appointment of Mark Bridgewater as Chief Commercial Officer, a position the company said it has created as it "continues with its strategy to become a leading inhalation specialist in the pharmaceutical services space." In February 2020, the company announced the appointment of Sharon Johnson as Executive VP for Delivery Management, another … [Read more...] about Mark Bridgewater joins Vectura as Chief Commercial Officer

FDA issues new and revised product specific guidances for a number of generic OINDPs

The FDA has announced the publication of a batch of new and revised product specific guidances for development of generic versions of a number of drugs, including a number of inhaled and nasal drug products, . One of the new guidances is for generic sumatriptan succinate nasal powder. Onzetra Xsail intranasal sumatriptan was approved by the FDA in January 2016 for … [Read more...] about FDA issues new and revised product specific guidances for a number of generic OINDPs

Virpax announces completion of pre-IND meeting for its intranasal enkephalin

Virpax Pharmaceuticals has announced the successful completion of a pre-IND meeting with the FDA regarding the company's NES100 intranasal enkephalin formulation for the management of acute and chronic pain. NES100 is a molecular envelope technology (MET) formulation licensed from Nanomerics and is delivered via a cartridge-based device. In January 2020, Virpax … [Read more...] about Virpax announces completion of pre-IND meeting for its intranasal enkephalin