Tiziana Life Sciences has announced that a Phase 1 clinical trial of its intranasal Foralumab human anti-CD3 monoclonal antibody was well tolerated at doses of 10, 50 and 250 µg per day and demonstrated "significant positive immune effects." The company is developing intranasal Foralumab, which it licensed from Novimmune in 2014, for the treatment of neurodegenerative … [Read more...] about Tiziana announces Phase 1 results for intranasal Foralumab
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Milestone Pharmaceuticals announces appointment of Amit Hasija as CFO and Executive VP of Corporate Development
Milestone Pharmaceuticals has announced the appointment of former Sanofi executive Amit Hasija as Chief Financial Officer and Executive VP of Corporate Development. Milestone's etripamil, an intranasal calcium channel antagonist, is in Phase 3 development for the treatment of paroxysmal supraventricular tachycardia (PSVT). Hasija was most recently Chief Business … [Read more...] about Milestone Pharmaceuticals announces appointment of Amit Hasija as CFO and Executive VP of Corporate Development
Experic appoints Denise Sabaday as VP of Business Development
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
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