ALTASCIENCES
Altasciences ’ pharmaceutical contract manufacturing site in Philadelphia, PA, has been chosen by Respira Technologies, Inc. to manufacture proprietary drug products for the world’s first inhaled smoking cessation therapy. This treatment uses RespiRx™, a vibrating mesh nebulizer (VMN) with a maintenance-free disposable cartridge that reduces and potentially eliminates the risk of patient misuse and non-compliance.
Following a successful Pre-Investigational New Drug (IND) meeting with the Food and Drug Administration (FDA) on November 18, Respira is intending to submit their IND application in 2022 under the 505(b)(2) regulatory pathway.
Respira also plans to create a larger platform approach for active pharmaceutical ingredient (API) delivery, taking advantage of the multi-drug capabilities of their proprietary platform drug delivery system. To date, 91 potential APIs have been identified.
“Our team chooses best-in-class partners, and working with Altasciences has been a great experience overall. Altasciences is playing a big role in advancing Respira’s ambition to secure the FDA’s authorization on a potential breakthrough drug product, and through this collaborative environment, we can change the world of drug development. Altasciences is agile, flexible, and quick, while providing the proven expertise and capability required for cGMP pharma drug product manufacturing. We are thankful for their fast response rate, creativity, and ability to take on the needs of nimble start-ups like Respira ,” said Mario Danek, Founder and CEO at Respira Technologies, Inc.
Altasciences leverages deep expertise in formulation, development, and manufacturing, as well as flexible processes and significant investments in state-of-the-art technologies, to support clients in their research and commercial manufacturing requirements.
“We are delighted to be partnering with Respira Technologies, Inc. on this new and exciting technology. Our team has truly enjoyed having the opportunity to work with a world-class organization that quickly makes key decisions to ensure we meet accelerated timelines,” stated Ben Reed, Executive Vice President of Operations at Altasciences.
More information on Respira Technologies, Inc.’s program can be found here .
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services . For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing , clinical pharmacology and proof of concept , bioanalysis , program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211214006040/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Axelspace: Notice of Signing a Service contract for In-Orbit Demonstration with Pale Blue, Inc.22.12.2025 10:00:00 CET | Press release
Axelspace Corporation (“Axelspace”), a leading microsatellite company committed to making “Space within Your Reach,” has entered into a service agreement with Pale Blue Inc. (“Pale Blue”), a company that develops, manufactures, and sells thrusters (engines) for small satellites, for an in-orbit demonstration, as detailed below. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251219321165/en/ Jun Asakawa, Co-founder & CEO of Pale Blue (left in photo) and Yuya Nakamura, President and CEO of Axelspace Axelspace provides AxelLiner Laboratory (AL Lab), a new service originating from the AxelLiner business that is specialized in in-orbit demonstration of space components. Under this contract, an in-orbit demonstration of a fast-start Hall thruster developed by Pale Blue is scheduled to be conducted in 2027. Nonetheless, conducting in-orbit demonstrations in a short period of time is known to be a significant challenge due to the in
Axelspace Signing Agreement on a Multi-Launch Arrangement and the Launch of New Satellites with Exolaunch22.12.2025 10:00:00 CET | Press release
Axelspace Corporation (“Axelspace”), a leading microsatellite company committed to making “Space within Your Reach,” is pleased to announce a multi-launch agreement (MLA) with Exolaunch, a global launch integrator and leader in launch mission management, satellite integration and satellite deployment technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251219038364/en/ The Multi-Launch Agreement will accelerate the growth of Axelspace. In particular, one satellite scheduled for launch under the new Agreement will be used in the AxelLiner business’s in-orbit demonstration service, “AxelLiner Laboratory”. Exolaunch has already secured launches for eight (8) Axelspace’s satellites on the upcoming missions. Axelspace provides AxelLiner Laboratory (AL Lab), a new service originating from the AxelLiner business that is specialized in in-orbit demonstration of space components. Nonetheless, conducting in-orbit demonstration
Zambon Biotech Announces First Patient Dosed in Phase 3b ADIP Clinical Study of IPX203 in Parkinson’s Disease22.12.2025 10:00:00 CET | Press release
Zambon Biotech, a specialized biotech company part of the Zambon group that aims to build a scientifically robust and commercially viable portfolio of innovative patient-oriented drugs through the scouting, acquisition, licensing and development of new molecules, today announced that the first participant with advanced Parkinson’s disease has been enrolled in the European Phase 3b ADIP (IPX203 in Advanced Parkinson’s disease) study, which is planned to evaluate the efficacy and safety of IPX203 versus immediate-release (IR) levodopa/carbidopa (LD/CD) in a regimen which has not yet been the focus of a Phase 3 trial. IPX203 is a novel, oral modified-release formulation of LD/CD designed for the treatment of Parkinson’s disease, the fastest growing neurological condition in the world according to the World Health Organization1. IPX203 contains immediate-release granules and extended-release beads, providing both a rapid onset of action and a longer duration of benefit, sustaining the levo
Pimicotinib Approved as Systemic Treatment in China for Tenosynovial Giant Cell Tumor22.12.2025 09:00:00 CET | Press release
First regulatory approval in the world for pimicotinib based on positive data from global Phase 3 MANEUVER studyIn MANEUVER, pimicotinib significantly improved objective response rate at week 25 (54% vs. 3.2% for placebo), while providing clinically meaningful and statistically significant improvements across all patient-reported outcomesWith longer-term follow-up, 3 out of 4 patients treated with pimicotinib achieved response per RECIST v1.1, and treatment continued to be well-toleratedApproval strengthens Merck’s leadership in rare tumors, with additional ongoing regulatory filings for pimicotinib underway globally Merck, a leading science and technology company, announced today that following Priority Review, the China National Medical Products Administration (NMPA) has approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause functional limitation or relatively severe morbidity.
Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma22.12.2025 08:44:00 CET | Press release
Incyte Biosciences Japan G.K. today announced approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). “Today's approval of Minjuvi in combination with rituximab and lenalidomide marks a significant milestone as the first dual-targeted CD19 and CD20 immunotherapy combination for relapsed or refractory FL in Japan,” said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. “By improving progression-free survival, Minjuvi offers a chemotherapy-free option for eligible patients with relapsed or refractory disease. This approval underscores our commitment to bridging critical treatment gaps to patients and families affected by this challenging disease in Japan.” The approval is based on the pivotal Phase 3 inMIND trial, which enrolled 654 adult patients, including patients based in Japan. The study demonstrated that Minjuvi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom