Kind Consumer has announced the UK launch of its breath activated Voke 0.45mg nicotine inhaler, which will be available to consumers by direct online purchase at a price of £11.99. The Voke inhaler was approved by the MHRA for general sale for the relief or prevention of nicotine cravings and withdrawal symptoms in September 2014. In January 2017, British American … [Read more...] about Kind Consumer launches Voke nicotine inhaler in the UK
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MannKind gets 2nd development milestone payment for dry powder treprostinil
MannKind Corporation said that it has reached the second milestone in its development of Treprostinil Technosphere (“TreT”), a dry powder formulation of treprostinil for inhalation that the company is developing for the treatment of pulmonary arterial hypertension in partnership with United Therapeutics. In April 2019, MannKind announced that United Therapeutics had … [Read more...] about MannKind gets 2nd development milestone payment for dry powder treprostinil
Insmed appoints Martina Flammer as Chief Medical Officer, provides update on Arikayce
Insmed has announced the appointment of Martina Flammer as Chief Medical Officer, effective mid-December 2019. Flammer was most recently Senior VP Customer Value at Boehringer Ingelheim and her previous positions include VP Medicine, Regulatory Affairs & Pharmacovigilance at BI Canada; VP Clinical Development & Medical Affairs of BI's Specialty Care Business … [Read more...] about Insmed appoints Martina Flammer as Chief Medical Officer, provides update on Arikayce
Bryn Pharma raises $17.5 million to fund regulatory and commercial activities for its epinephrine nasal spray
Bryn Pharma, which recently announced that it would use Aptar's Bidose nasal device for delivery of its BRYN-NDS1C intranasal epinephrine, said that it has raised $17.5 million that it will use to prepare for US regulatory approval and commercialization of the nasal spray. BRYN-NDS1C has received Fast Track designation from the FDA, and the company plans to pursue … [Read more...] about Bryn Pharma raises $17.5 million to fund regulatory and commercial activities for its epinephrine nasal spray
TFF Pharmaceuticals announces IPO
TFF Pharmaceuticals, which is developing DPI formulations based on its thin film freezing (TFF) technology, has announced an initial public offering of 4,400,000 shares of common stock at $5.00 per share. Earlier this year TFF announced that it had raised $8.17 million through a Series A preferred stock offering. The company said that it expects to use the net … [Read more...] about TFF Pharmaceuticals announces IPO
Studies show Penthrox is superior to standard of care for acute trauma pain
Medical Developments International (MDI) has announced data from multiple European studies demonstrating the benefits of MDI's Penthrox methoxyflurane inhaler for the treatment of pain from acute trauma. Among the findings announced, Penthrox was shown to be superior to intravenous morphine, NSAIDS, paracetamol (acetaminophen), and ketoprofen in trauma settings; … [Read more...] about Studies show Penthrox is superior to standard of care for acute trauma pain
FDA clears BlueWillow IND for intranasal anthrax vaccine
The FDA has cleared BlueWillow Biologics' IND for its BW-1010 intranasal anthrax vaccine, and a Phase 1 trial of the vaccine is planned for later this year, the company said. Earlier this year, BlueWillow (formerly NanoBio) announced that it had received a patent for the anthrax vaccine, which is formulated with the company's NanoVax adjuvant. BW-1010 is in … [Read more...] about FDA clears BlueWillow IND for intranasal anthrax vaccine
Seelos Therapeutics says it has amended agreement for development of its intranasal ketamine
Seelos Therapeutics has announced an amendment of its agreement with Vyera Pharmaceuticals regarding development of SLS-002 intranasal ketamine. According to Seelos, the company will now not be required to conduct a Phase 3 trial and will make cash and stock payments to Vyera instead of a milestone that would be due on initiation of a Phase 3 trial. Seelos said … [Read more...] about Seelos Therapeutics says it has amended agreement for development of its intranasal ketamine
Bryn Pharma to use Aptar’s Bidose nasal device for epinephrine delivery
Bryn Pharma (formerly Epi-Now) announced that it has signed a deal with Aptar Pharma for worldwide exclusive rights to use Aptar's Bidose nasal delivery device for its BRYN-NDS1C intranasal epinephrine for the treatment of anaphylaxis. The company said that it has recently completed dosing in a pivotal clinical trial using the device. According to Bryn's website, … [Read more...] about Bryn Pharma to use Aptar’s Bidose nasal device for epinephrine delivery
Circassia announces US launch of Duaklir Pressair for the treatment of COPD
Circassia Pharmaceuticals has announced the US launch of Duaklir aclidinium bromide/formoterol fumarate DPI for the treatment of COPD. The FDA approved Duaklir Pressair in April 2019. Circassia acquired the US rights to Duaklir and Tudorza Pressair from AstraZeneca in 2017. Circassia Chief Executive Steve Harris commented, “The US launch of Duaklir represents a … [Read more...] about Circassia announces US launch of Duaklir Pressair for the treatment of COPD