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Regulatory

Wockhardt subsidiary Morton Grove Pharmaceuticals ordered to stop manufacturing

A US District Court has ordered Wockhardt subsidiary Morton Grove Pharmaceuticals "to stop manufacturing and distributing drugs alleged to be adulterated." The Morton Grove facility manufactured fluticasone propionate nasal sprays in addition to other products. The company has signed a consent decree agreeing to cease production, to destroy already manufactured drugs, … [Read more...] about Wockhardt subsidiary Morton Grove Pharmaceuticals ordered to stop manufacturing

FDA approves Lupin’s formoterol fumarate inhalation solution

According to Lupin, the FDA has approved the company's ANDA for a generic version of Mylan's Perforomist formoterol fumarate inhalation solution. Teva launched a generic equivalent in the US in June 2021 after expiration of the final patent covering Perforomist, and the agency approved Alembic Pharmaceuticals' ANDA for its Perforomist equivalent in November 2021. … [Read more...] about FDA approves Lupin’s formoterol fumarate inhalation solution

Nuance Pharma gets the go-ahead for clinical trials of nebulized ensifentrine in China

According to Nuance Pharma, the Chinese Center for Drug Evaluation has approved the company's IND, allowing for a Phase 3 trial of nebulized ensifentrine, a PDE3/PDE4 inhibitor for the treatment of COPD, in China. The IND also grants approval for a Phase 1 PK study in healthy volunteers that the company plans to conduct in China. Nuance acquired the Chinese rights to … [Read more...] about Nuance Pharma gets the go-ahead for clinical trials of nebulized ensifentrine in China

Harm Reduction signs supply agreement for RiVive naloxone nasal spray after getting Fast Track designation

Harm Reduction Therapeutics announced that it has signed a commercial supply agreement for its RiVive (HRT001) intranasal naloxone after the FDA granted Fast Track designation to the nasal spray, which is in development as a low cost OTC product for the reversal of opioid overdose. HRT did not name the company it contracted with but said that RiVive would be … [Read more...] about Harm Reduction signs supply agreement for RiVive naloxone nasal spray after getting Fast Track designation

Adherium submits 510(k) application for a Hailie sensor for use with Ventolin, Advair, and Flovent MDIs

Just over a week after receiving 510(k) clearance for a Hailie inhaler sensor for use with Ellipta DPIs, Adherium said that it filed a 510(k) submission to the FDA for a new Hailie sensor to be used with GSK's Ventolin, Advair, and Flovent MDIs. The new Hailie sensor measures various parameters, including respiratory flow rate, and connects to the company's Hailie … [Read more...] about Adherium submits 510(k) application for a Hailie sensor for use with Ventolin, Advair, and Flovent MDIs

Renovion announces planned Phase 3 trial of ARINA-1 inhaled mucolytic in bilateral lung transplant patients

Renovion announced that the company has gotten the go-ahead from the FDA to initiate a Phase 3 clinical trial of its ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the prevention of bronchiolitis obliterans in bilateral lung transplant patients who have recently had a reduction in lung function. ARINA-1, which is delivered via the PARI eFlow nebulizer … [Read more...] about Renovion announces planned Phase 3 trial of ARINA-1 inhaled mucolytic in bilateral lung transplant patients

Adherium announces 510(k) clearance for Hailie sensor for use with Ellipta DPIs and new distribution deal

Hailie inhaler monitoring system maker Adherium announced that the FDA has cleared the company's new version of the Hailie sensor for use with Ellipta dry powder inhalers. Adherium submitted the 510(k) application to the FDA in March 2022. The company said that the new clearance means that Hailie is now eligible for reimbursement on 18 of the top 20 branded inhalers … [Read more...] about Adherium announces 510(k) clearance for Hailie sensor for use with Ellipta DPIs and new distribution deal

PTAB rules in Liquidia’s favor, finds another Tyvaso patent’s claims are not patentable

According to Liquidia, the US Patent Trial and Appeal Board (PTAB) has found that none of the claims included in US Patent No. 10,716,793, covering Tyvaso inhaled treprostinil, are valid. The company said that the PTAB ruling would have to be upheld on appeal before it can affect a court ruling holding up final approval of Liquidia's NDA for … [Read more...] about PTAB rules in Liquidia’s favor, finds another Tyvaso patent’s claims are not patentable

FDA approves Beyond Air’s LungFit PH inhaled NO system for PPHN

According to Beyond Air, the FDA has approved the company's LungFit PH inhaled nitric oxide (iNO) generation and delivery system for the treatment of babies with persistent pulmonary hypertension of the newborn (PPHN). The approval is the first for the company, which is also developing LungFit iNO systems for the treatment of COVID-19 pneumonia, bronchiolitis, and … [Read more...] about FDA approves Beyond Air’s LungFit PH inhaled NO system for PPHN

Altamira’s Bentrio nasal spray gets 510(k) clearance

Altamira Therapeutics (formerly Auris Medical) announced that the company has received 510(k) clearance to sell its Bentrio Allergy Blocker nasal spray over the counter for the treatment of allergic rhinitis in the US. The company said that it is in talks with "established OTC consumer health companies" regarding distribution of Bentrio in the US and elsewhere and … [Read more...] about Altamira’s Bentrio nasal spray gets 510(k) clearance

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