ALTASCIENCES
14.12.2021 18:00:10 CET | Business Wire | Press release
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
Alphatax Makes Two Acquisitions to Strengthen Transfer Pricing Capabilities4.8.2026 10:00:00 CEST | Press release
Acquisitions Expand Transfer Pricing Offering and Support Long-Term Platform Strategy Alphatax, the global tax compliance software provider, has today announced the acquisitions of TP Accurate and Intra Pricing Solutions, expanding its transfer pricing capabilities and reinforcing its ambition to build the world's first tax operating system. The acquisitions strengthen Alphatax's transfer pricing portfolio with complementary capabilities across financial transactions and documentation. TP Accurate provides specialist software for intra-group financing arrangements, while Intra Pricing Solutions' flagship product, TPGenie, enables multinational organisations and advisors to produce transfer pricing documentation using intelligent automation and AI. Together, they expand Alphatax's ability to support the full transfer pricing lifecycle, helping customers manage compliance more efficiently while improving governance and reducing audit risk. They also represent another step towards Alphata
LabPMM® Launches Global KMT2A MRD Testing Service to Support Menin Inhibitor Development and Acute Leukemia Care4.8.2026 09:10:00 CEST | Press release
LabPMM®, an Invivoscribe® subsidiary, today announced the global availability of its new KMT2A measurable residual disease (MRD) testing service. The highly sensitive digital PCR service is available to healthcare providers, clinical researchers, and biopharmaceutical partners through LabPMM’s global laboratory network, with CAP/CLIA-accredited testing available in the U.S. The service addresses a growing need for accurate molecular monitoring in acute leukemias.1,2,3 KMT2A rearrangements (KMT2Ar) are oncogenic drivers in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).4 These rearrangements are present in about 80% of infant cases and 5-15% of childhood and adult leukemia cases.5 KMT2Ar leukemias are associated with chemotherapy resistance, high relapse rates, and poor clinical outcomes.5 The emergence of menin inhibitors is transforming the therapeutic landscape for patients with AML and ALL, particularly those with KMT2A-rearranged and NPM1-mutated disease.6 The
“HATSUNE MIKU LIGHTS TOKYO” Debuts on July 254.8.2026 09:00:00 CEST | Press release
Giant Hatsune Miku Returns to Light Up Tokyo’s Night! The Tokyo Metropolitan Government has been presenting year-round projection mapping displays on the Tokyo Metropolitan Government Building, using light and sound to showcase a wide range of artistic expressions as part of its efforts to create new nighttime tourism attractions in Tokyo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260802298570/en/ © Crypton Future Media, INC. On Saturday, July 25, "HATSUNE MIKU LIGHTS TOKYO", featuring the globally beloved virtual singer Hatsune Miku, held its first screening. The work brings the world of the popular song “M@GICAL☆CURE! LOVE ♥ SHOT!” to life across the entire façade of the Tokyo Metropolitan Government Building. Since its launch in February 2024, “TOKYO Night & Light” has welcomed visitors from Japan and around the world, with total attendance surpassing 1.55 million. As one of Tokyo’s emerging landmark attractions, the
Mosaic Therapeutics appoints Dr Allison Jeynes as Chair of the Board4.8.2026 09:00:00 CEST | Press release
Accomplished life sciences leader with a proven track record of driving successful development of novel therapeutics, joins Mosaic to guide its next phase of growthAllison brings three decades of drug development, board and executive leadership experience to support Mosaic’s transition towards a clinical-stage company Mosaic Therapeutics, Ltd, (‘Mosaic’, or ‘the Company’) an oncology therapeutics company developing novel, targeted drug combinations across a range of haematological and solid cancers, today announced the appointment of Dr Allison Jeynes as Chair of the Board to support its next phase of growth and advancement towards clinical development. Allison succeeds Dr Edward Hodgkin, who remains a Non-Executive Director of the Board. Allison is a UK-trained oncologist and highly-experienced life sciences leader, and brings over three decades of drug development and executive experience to Mosaic Therapeutics. As CEO of Avillion, a clinical development company, for the last 13 year
TOHKnet and Adtran conduct Japan’s first 50G PON trial on a live network4.8.2026 09:00:00 CEST | Press release
News summary: TOHKnet is exploring next-generation PON to meet enterprise demand while maintaining continuity across its regional fiber network Using Adtran technology, the trial validated 50G PON, XGS-PON and EPON operating together on a single fiber network Results show a practical path to evolve networks, enabling phased upgrades while maximizing fiber assets and avoiding service disruption Adtran today announced that TOHKnet has completed Japan’s first live network trial demonstrating the coexistence of 50G PON, XGS-PON and EPON on a single fiber. Conducted in Sendai using Adtran’s SDX 6400 Series OLT, the demo showed how the platform enables three generations of PON technology to operate together in a live service environment. The results highlight a realistic path for operators to introduce 50G PON capacity while maintaining continuity for existing services, maximizing the value of deployed fiber assets and reducing the complexity and disruption typically associated with network
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