Regulatory

Australian cannabinoid developer Incannex Healthcare said that its pre-IND meeting with the FDA regarding its IHL-216A inhaled CBD/isoflurane for the treatment of traumatic brain injury was “constructive.” In June 2021, Incannex signed an agreement with… Read more . . .

Harm Reduction Therapeutics announced that it has made an initial filing for a rolling review of its NDA for RiVive naloxone nasal spray, an OTC product for the treatment of opioid overdose. In August 2022,… Read more . . .

According to Bausch Health and Glenmark, Health Canada has approved Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in people aged 6 and older. Bausch Health acquired the Canadian rights… Read more . . .

According to CanSino Biologics, China’s National Medical Products Administration (NMPA) has approved the company’s Convidecia Air nebulized COVID-19 vaccine as a booster dose. In December 2021, CanSino Bio announced a deal with Aerogen for the… Read more . . .

According to Bharat Biotech, Indian regulators have cleared its iNCOVACC (BBV154) intranasal vaccine against COVID-19 for use in adults aged 18 and older under a Restricted Use in Emergency Situation. Following the approval, Bharat Bio… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

According to Savara, the MHRA has granted Promising Innovative Medicine (PIM) designation to the company’s molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The PIM designation… Read more . . .