The FDA has published notice of an online meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to take place on November 8, 2022 for the purpose of discussing Avillion and AstraZeneca's NDA (214070) for PT027 albuterol / budesonide MDI for the treatment of asthma in patients aged 4 and older. The agency accepted the NDA in May 2022. According to the … [Read more...] about PADAC schedules meeting to discuss Avillion’s NDA for PT027 albuterol / budesonide MDI
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Positive Phase 1 results for MannKind’s clofazimine inhalation suspension
MannKind Corporation announced today that a Phase 1 study of MNKD-101 clofazimine demonstrated that the inhalation suspension was well tolerated at doses up to 90 mg/day over 7 days and identified no safety issues. The company is developing MNKD-101 for the treatment of nontuberculous mycobacterial (NTM) lung disease. According to MannKind, the FDA has granted both … [Read more...] about Positive Phase 1 results for MannKind’s clofazimine inhalation suspension
Hoth Therapeutics says that its HT-004 inhaled antisense oligonucleotide reduced lung inflammation in a mouse model
Hoth Therapeutics said that a preclinical study conducted at North Carolina State University demonstrated that the company's HT-004 inhaled antisense oligonucleotide significantly reduced lung inflammation in mice following an ovalalbumin challenge. According to Hoth, HT-004 works "to eliminate cell surface high-affinity IgE receptor (FceRI) expression and function on … [Read more...] about Hoth Therapeutics says that its HT-004 inhaled antisense oligonucleotide reduced lung inflammation in a mouse model
Court rules that Liquidia’s Yutrepia treprostinil DPI would infringe United Therapeutics patents covering Tyvaso
The United States District Court for the District of Delaware has ruled that Liquidia's Yutrepia treprostinil DPI would infringe claims contained in US patents 9,593,066 and 10,716,793, which cover United Therapeutics' Tyvaso inhaled treprostinil; however, the judge found that the claims in the '066 patent that would be infringed are invalid and the sole valid claim … [Read more...] about Court rules that Liquidia’s Yutrepia treprostinil DPI would infringe United Therapeutics patents covering Tyvaso
Orexo gets European patent covering OX640 intranasal dry powder adrenaline
The European Patent Office (EPO) has granted Orexo a patent (EP 3962455B1) covering the company's OX640 intranasal dry powder adrenaline, which is in Phase 1 development for the emergency treatment of anaphylaxis. According to the company, the European patent will protect OX640 until May 2041. OX640 intranasal adrenaline is based on the same technology as the … [Read more...] about Orexo gets European patent covering OX640 intranasal dry powder adrenaline
Aptar Pharma acquires HF specialist Metaphase Design Group
Aptar Pharma said that it has acquired US-based design firm Metaphase Design Group and will integrate the company into its subsidiary Noble, which Aptar acquired in 2019. Noble launched its Human Factors Plus (HF+) services for combination product development in 2021, and Aptar Pharma says that Metaphase's capabilities will complement Noble's offerings. Metaphase … [Read more...] about Aptar Pharma acquires HF specialist Metaphase Design Group
Hikma launches Ryaltris nasal spray in the US
Hikma Pharmaceuticals has launched Ryaltris olopatadine / mometasone nasal spray in the US, the company said. Hikma acquired US rights to Ryaltris in February 2020, and the FDA approved Glenmark's NDA for the nasal spray for the treatment of seasonal allergic rhinitis in January 2022. The company's US catalog includes several other nasal sprays, including … [Read more...] about Hikma launches Ryaltris nasal spray in the US
Lupin’s Lutio tiotropium bromide DPI approved for the treatment of COPD in the UK
According to Lupin, the MHRA has approved company's Lutio tiotropium bromide inhalation powder, a generic version of Boehringer Ingelheim's Spiriva Handihaler. The approval is the second for a Lupin OINDP in the UK; the MHRA approved the company's Luforbec beclometasone / formoterol MDI for the treatment of asthma and COPD, a generic of Chiesi's Fostair, in June 2021, … [Read more...] about Lupin’s Lutio tiotropium bromide DPI approved for the treatment of COPD in the UK
Badrul Chowdhury resigns as Savara’s Chief Medical Officer
Savara has announced the resignation of Badrul Chowdhury as Chief Medical Officer, effective September 9, 2022. Chowdhury, a former Director of the FDA's Division of Pulmonary, Allergy, and Rheumatology Products, joined Savara as CMO in November 2019. The company did not cite any reason why Chowdhury was leaving the company or any indication of what he planned to do … [Read more...] about Badrul Chowdhury resigns as Savara’s Chief Medical Officer
Adherium submits 510(k) for Hailie sensor use with Teva MDIs
Adherium has submitted a 510(k) application for use of its next generation Hailie inhaler monitoring sensor with Teva's ProAir albuterol MDI and its generic albuterol HFA MDI, the company said. Recently, the company filed a 510(k) submission for use of the Hailie sensor with GSK's Ventolin, Advair, and Flovent MDIs, and the FDA cleared the Hailie sensor for use with … [Read more...] about Adherium submits 510(k) for Hailie sensor use with Teva MDIs