CDMO Experic has announced the appointment of Denise Sabaday as vice president of business development. Sabaday was most recently Executive VP of Business Development and Marketing at Transformative Pharmaceutical Solutions and was previously Director of Business Development at inVentiv Health Clinical. In October 2018, Experic announced that it had hired OINDP … [Read more...] about Experic appoints Denise Sabaday as VP of Business Development
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Positive Phase 1 results for Theravance Biopharma’s inhaled JAK inhibitor for lung disease
Theravance Biopharma has announced positive results from a Phase 1 single-ascending dose and multiple-ascending dose trial of its TD-8236 pan-JAK inhibitor DPI for the treatment of inflammatory lung diseases. The company had announced initiation of the study in November 2018. According to Theravance Biopharma, a single dose of up to 4500 μg of TD-8236 was … [Read more...] about Positive Phase 1 results for Theravance Biopharma’s inhaled JAK inhibitor for lung disease
Janssen publishes positive Phase 3 results for Spravato esketamine nasal spray in patients with suicidal intent
Janssen Pharmaceutical Companies has announced that both the ASPIRE I & ASPIRE II Phase 3 clinical studies of esketamine nasal spray in addition to standard of care (SOC) for the treatment of major depressive disorder in adult patients with active suicidal ideation with intent have met their primary endpoints. In both studies, the nasal spray plus SOC demonstrated … [Read more...] about Janssen publishes positive Phase 3 results for Spravato esketamine nasal spray in patients with suicidal intent
HCmed Innovations to build R&D and production facilities in Wuxi International Life Science Innovation Park
Handheld nebulizer manufacturer HCmed Innovations announced that it has accepted an invitation to build an R&D center and production facility in the newly opened Wuxi International Life Science Innovation Park, which is anchored by AstraZeneca. HCMed's Deepro smart vibrating mesh nebulizers can be used for delivery of AstraZeneca's Pulmicort Respules, the company … [Read more...] about HCmed Innovations to build R&D and production facilities in Wuxi International Life Science Innovation Park
Hovione Technology partners with Kiel University on dry powder formulations
Hovione Technology has partnered with Kiel University Institute of Pharmacy on methods of dry powder formulation for delivery of high doses of antibiotics using Hovione Technology TwinMax and 8Shot DPIs, the company said. Areas of exploration will include techniques such as the use of soft pellets and nanocrystals for formulation of drugs such as clarithromycin and … [Read more...] about Hovione Technology partners with Kiel University on dry powder formulations
Meggle signs deal for distribution of pharmaceutical grade lactose in the US
LBB Specialties announced that it has signed a strategic partnership deal with Meggle for distribution of Meggle's pharmaceutical lactose excipients, including lactose for inhalation formulations, in the United States through LBB's Charkit Chemical and American International Chemical (AIC) subsidiaries. Charkit Chemical President Jay Lang said that "representing … [Read more...] about Meggle signs deal for distribution of pharmaceutical grade lactose in the US
Phase 3 trial of Breztri Aerosphere meets primary endpoint
AstraZeneca said that the 52-week Phase 3 ETHOS trial of its Breztri Aerosphere (formerly PT010) budesonide/glycopyrronium/formoterol fumarate MDI in more than 8,500 patients with moderate to very severe COPD and a history of exacerbations within the past year has met its primary endpoint. The trial, which compared Breztri Aerosphere to Bevespi Aerosphere … [Read more...] about Phase 3 trial of Breztri Aerosphere meets primary endpoint
FDA approves Akorn azelastine hydrochloride nasal spray
The FDA has approved Akorn's ANDA for its azelastine hydrochloride nasal spray, 0.15%, for the treatment of allergic and perennial rhinitis in patients 6 years old and older, the company said. In May 2019, the FDA approved Akorn's 0.1% azelastine hydrochloride nasal spray. According to Akorn, the nasal spray is manufactured at the company's facility in Amityville, … [Read more...] about FDA approves Akorn azelastine hydrochloride nasal spray
Satsuma initiates Phase 3 study of intranasal DHE for the treatment of migraine
Satsuma Pharmaceuticals announced that it has initiated the Phase 3 EMERGE trial of STS101 dihydroergotamine (DHE) nasal powder for the acute treatment of migraine. In April 2019, Satsuma announced that it had raised $62 million to fund Phase 3 development of STS101. The study, which is expected to enroll approximately 1,140 migraine patients, will compare two … [Read more...] about Satsuma initiates Phase 3 study of intranasal DHE for the treatment of migraine
Pneuma Respiratory names Jay Morgan as Chairman of the Board
Pneuma Respiratory, which is developing a digital soft mist inhaler, has announced the appointment of Jay Morgan as Chairman of the Board. Morgan, a former Bayer and Merck executive who has been a member of the board since 2017, will replace Walt Robb as chairman. Robb will remain a member of the board. In 2018, Pneuma Respiratory announced that it had raised $8.3 … [Read more...] about Pneuma Respiratory names Jay Morgan as Chairman of the Board