The American Academy of Allergy, Asthma & Immunology (AAAAI) has published results of three Phase 1 studies of ARS Pharmaceuticals' ARS-1 (Neffy) intranasal epinephrine that had been scheduled for presentation at the AAAAI annual meeting. The FDA granted Fast Track designation to the ARS-1 for the treatment of anaphylaxis in February 2019. The studies, EPI … [Read more...] about AAAAI publishes new data showing bioequivalence of ARS Pharmaceuticals’ ARS-1 epinephrine nasal spray to injected epinephrine
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Hovione names Jean-Luc Herbeaux as Chief Operating Officer
Hovione has announced the appointment of former Evonik executive Jean-Luc Herbeaux as the company's new Chief Operating Officer. Herbeaux was most recently Senior VP and General Manager of Evonik's Health Care Business Line. He will be based at Hovione's headquarters in Lisbon, Portugal. Over the past few years, Hovione has been expanding production capacity at … [Read more...] about Hovione names Jean-Luc Herbeaux as Chief Operating Officer
Nanoform gets GMP certification
The Finnish Medicines Agency has granted GMP certification to nanonization specialist Nanoform Finland, the company said. In December 2019, Nanoform announced that it had applied for the certification. The company's CESS (controlled expansion of supercritical solutions) nanoparticle engineering platform will now be available for manufacturing of clinical trial … [Read more...] about Nanoform gets GMP certification
Alnylam and Vir select candidate for development as inhaled COVID-19 vaccine
Alnylam Pharmaceuticals and Vir Biotechnology have announced that they intend to meet with the FDA soon regarding an IND for VIR-2703 (ALN-COV), an inhaled siRNA in development for prevention and/or treatment of COVID-19. The companies said that VIR-2703 may also have activity against other coronaviruses. The collaboration agreement between Vir and Alnylam includes … [Read more...] about Alnylam and Vir select candidate for development as inhaled COVID-19 vaccine
3M Drug Delivery Systems becomes Kindeva Drug Delivery
3M announced that it has completed the sale of "substantially all" of 3M Drug Delivery Systems to Altaris Capital Partners, and the new company is now known as Kindeva Drug Delivery. The initial announcement of the sale was made in December 2019. Kindeva issued a separate press release announcing its launch as "a leading global contract development and … [Read more...] about 3M Drug Delivery Systems becomes Kindeva Drug Delivery
CHMP recommends approval of Enerzair Breezhaler for the treatment of asthma
At its April 2020 meeting, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for Enerzair Breezhaler (QVM149) indacaterol / glycopyrronium / mometasone for the treatment of uncontrolled asthma as well as for a duplicate inhaler, Zimbus Breezhaler. Novartis partners Vectura and Sosei announced in May 2019 that … [Read more...] about CHMP recommends approval of Enerzair Breezhaler for the treatment of asthma
Fluidda study suggests that inhaled vasodilators may be helpful in COVID-19
Functional respiratory imaging (FRI) company Fluidda has announced that an FRI study of COVID-19 patients has shown that the virus is resulting in narrowing of small capillaries in the lung, resulting in higher flow pressures that in turn causes higher pressure in the main blood vessels and suggests that vasodilators delivered to the lung may be a useful therapy. … [Read more...] about Fluidda study suggests that inhaled vasodilators may be helpful in COVID-19
Monaghan Medical will market Adherium’s Hailie inhaler monitoring platform in the US
Following the signing of a letter of intent for a sales agreement with Adherium, Monaghan Medical said that it will launch Adherium’s Hailie digital inhaler monitoring platform in the US. The Hailie sensor was approved by the FDA for US over the counter sales in July 2018, and Adherium launched the sensor in August of that year. Monaghan's parent company, Trudell … [Read more...] about Monaghan Medical will market Adherium’s Hailie inhaler monitoring platform in the US
FDA tentatively approves Lupin’s generic arformoterol tartrate inhalation solution
According to Lupin, the FDA has tentatively approved the company's arformoterol tartrate inhalation solution, a generic version of Sunovion's Brovana, for the treatment of COPD. Sunovion's final patent covering Brovana expires in November 2021. Brovana was originally approved by the FDA for the treatment of COPD in 2006. A post-marketing study commitment required … [Read more...] about FDA tentatively approves Lupin’s generic arformoterol tartrate inhalation solution
MedPharm adds respiratory tissue culture models to aid in development of coronavirus therapies
CDMO MedPharm announced that it has added human epithelial cell models for screening of drugs intended for the treatment of coronaviruses at its facility in Durham, North Carolina, US. The company says that use of the nasal, bronchial, and alveolar models "will help to de-risk development programs and screen drugs for therapeutic effectiveness to accelerate … [Read more...] about MedPharm adds respiratory tissue culture models to aid in development of coronavirus therapies