OINDPnews


Proveris Scientific

Regulatory

FDA reopens comment period for draft guidance on MDI and DPI quality considerations

The FDA has issued a notice that it has reopened the comment period for the “Metered Dose Inhaler and Dry Powder Inhaler Drug Products—Quality Considerations; Draft Guidance for Industry,” which was published in April, 2018. The FDA originally gave interested parties until June 18, 2018 to submit input; the comment period has now been extended until September 18, … [Read more...] about FDA reopens comment period for draft guidance on MDI and DPI quality considerations

3M DDS highlights addition of dose indicator on Proventil inhaler

3M Drug Delivery Systems has announced that its Proventil HFA albuterol MDI, which is marketed and distributed by Merck, now includes a top-mounted dose indicator. The FDA approved an sNDA for Proventil HFA with the dose indicator in September 2017, and Merck launched the new version of Proventil HFA in March 2018, according to 3M DDS. 3M Inhalation Drug … [Read more...] about 3M DDS highlights addition of dose indicator on Proventil inhaler

FDA clears IND for Oyster Point’s OC-01 nasal spray for dry eye disease

Oyster Point Pharma has announced that its investigational new drug application for OC-01, a nicotine acetylcholine receptor (nAChR) agonist nasal spray, has been cleared by the FDA. OC-01 and another nAChR nasal spray, OC-02, are both in Phase 2 development for the treatment of dry eye disease. The company said that an IND for OC-02 was cleared in October 2017, … [Read more...] about FDA clears IND for Oyster Point’s OC-01 nasal spray for dry eye disease

Impel plans for Phase 3 study of intranasal DHE for migraine

According to Impel NeuroPharma, the FDA has given the company a notice to proceed with clinical study of INP101 intranasal dihydroergotamine (DHE) for the treatment of acute migraine. A Phase 3 study is expected to begin enrolling patients in the second half of this year. The company said that it had recently submitted an investigational new drug application to the … [Read more...] about Impel plans for Phase 3 study of intranasal DHE for migraine

Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA

Canadian biotech Arch Biopartners has announced that it will put an ongoing Phase 1 safety study of its AB569 ethylenediaminetetraacetic acid (EDTA)/sodium nitrite bactericidal inhalation solution on hold and will ask the FDA for a pre-IND meeting for AB569. The study began recruiting volunteers in February 2018. Arch Biopartners CEO Richard Muruve said, “We have … [Read more...] about Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA

Novus Therapeutics gets FDA guidance on development of nasal MDI for otitis media

Novus Therapeutics said that it recently had a Type C meeting with the FDA regarding its OP-02 intranasal dipalmitoylphosphatidylcholine (DPPC)/cholesteryl palmitate (CP) suspension for the treatment of otitis media and has received confirmation of its development plans. The company explains that OP-2, which is delivered via a metered dose inhaler, "is intended to … [Read more...] about Novus Therapeutics gets FDA guidance on development of nasal MDI for otitis media

Date set for FDA advisory committee to review Insmed’s NDA for Alis

Insmed has announced that the FDA's Division of Antimicrobial Products has set an advisory committee meeting for August 7, 2018 for review of the company's NDA for ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). Insmed submitted the NDA in March 2018 and … [Read more...] about Date set for FDA advisory committee to review Insmed’s NDA for Alis

Mylan says it expects CRL for its generic version of Advair Diskus

Mylan has announced that it was informed by the FDA on June 13, 2018 that the agency will issue a complete response letter regarding Mylan's ANDA for its generic Advair Diskus fluticasone/salmeterol DPI on June 27, 2018. According to Mylan, the reason for the CRL is that the FDA "has identified minor deficiencies." Mylan received a previous CRL for its generic … [Read more...] about Mylan says it expects CRL for its generic version of Advair Diskus

Phase 1 study MannKind’s Treprostinil Technosphere for PAH achieves primary endpoint

MannKind Corporation has announced that a previously announced Phase 1 study of its Treprostinil Technosphere (TreT) DPI in healthy volunteers has met its primary endpoint of safety and tolerability, and the company is now preparing for a study in patients with pulmonary arterial hypertension (PAH). According to the company, data from the study, which … [Read more...] about Phase 1 study MannKind’s Treprostinil Technosphere for PAH achieves primary endpoint