News
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Opiant Pharmaceuticals said that it has filed the first part of a 505(b)(2) NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose and that it expects to complete the submission later this year.… Read more . . .
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According to Codagenix, the FDA has cleared the company’s IND for CodaVax-RSV intranasal live-attenuated vaccine (LAIV) for the prevention of respiratory syncytial virus (RSV) infection, and plans are in progress for a Phase 1 study… Read more . . .
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According to Avillion, the FDA has accepted the company’s NDA for AstraZeneca’s PT027 albuterol/budesonide MDI for the treatment of asthma in patients aged 4 and older for review. In March 2018, Avillion announced that it… Read more . . .
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Hailie inhaler monitoring system maker Adherium has announced the appointment of Tara Creaven-Capasso as VP of Quality, Regulatory and Clinical Affairs. Creaven-Capasso has been a long-time regulatory affairs consultant; earlier in her career, she also… Read more . . .
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Gerresheimer has announced that it will manufacture supplies of Iconovo’s IcoOne dry powder inhaler for Phase 3 trials of ISR’s intranasal COVID-19 vaccine and has started the design process for molding and manufacturing the device.… Read more . . .
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Posted on OINDPnews on May 30, 2022Company: ModernaLocation: Norwood, MA, USA The Role:This role is an exciting opportunity to be a critical part of a team enabling delivery of mRNA at an organization that is… Read more . . .
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Posted on OINDPnews on May 25, 2022Company: Recipharm Job Description Recipharm is a leading CDMO (contract development and manufacturing organization) in the pharmaceutical industry employing 9,000 employees with headquarters in Sweden. One of Recipharm’s seven research… Read more . . .
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CDMO Upperton Pharma Solutions, which recently launched a new nasal delivery development platform, has announced that it will invest £15 million in a new 50,000 sq ft facility in Nottingham, UK that will include new… Read more . . .
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United Therapeutics has announced the FDA’s approval of its NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics licensed Treprostinil… Read more . . .
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According to CyanVac subsidiary Blue Lake Biotechnology, the FDA has granted Fast Track designation for the company’s BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) in children under 2 and adults over 60. The vaccine… Read more . . .
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