Fluticasone propionate

FDA expands DUPIXENT use for COPD, offering new treatment options for patients. COPD affects 44 million in 7MM, with cases expected to rise. DUPIXENT targets IL-4 and IL-13 pathways, reducing exacerbations and improving lung function.

FDA proposes to ban oral phenylephrine from OTC drugs due to ineffectiveness in treating nasal congestion, despite its common use in cold medications. Public comment period open until May 7, 2025, with no safety concerns cited. Proposal does not affect nasal spray form. Alternatives include nasal sprays, oral pseudoephedrine, and antihistamine nasal sprays.

Viatris (VTRS) to report Q3 results on Nov. 7, 2024; Zacks Consensus Estimate for revenues at $3.68B and earnings at $0.68/share. Developed Markets expected to contribute $2.2B, Emerging Markets $567M, JANZ $396M, and Greater China $562M. Brand business growth in Emerging Markets, JANZ, and Greater China offset by unfavorable dynamics in North America and price regulations in Japan/Australia. Generics business improved due to new product launches and strong performance in Europe. Operating expenses likely increased due to SG&A investments and R&D progress.

Cipla's Goa manufacturing facility, cleared after regulatory hurdles, paves the way for the launch of key oncology drug Abraxane, expected to be a $120 million opportunity. Brokerages upgrade Cipla's outlook, anticipating significant revenue contributions from the Goa unit and future drug launches, driving stock gains.

Cipla faces delays in launching key drugs Advair and Abraxane due to regulatory hurdles, projecting a mid-FY26 launch for Advair and pending clearance for Abraxane's Goa facility. Competitors gaining ground could impact market share and revenue potential.

The global Rx-to-OTC switches market is projected to reach USD 66.5 billion by 2033, driven by consumer convenience, cost-effectiveness, and regulatory support.

Cipla's Q2 earnings on Oct 29 expected to show 5% net profit growth to Rs 1,215 crore and 5% revenue growth to Rs 6,996 crore, with EBITDA margin around 26%. US sales growth forecast at 3% to $235 million, domestic sales likely high single-digit growth. Margin growth expected to remain capped due to lack of high-margin drug launches in the US.

EP-104IAR showed safety and efficacy in reducing knee osteoarthritis pain for up to 14 weeks in a phase 2 trial, with significant pain relief and minimal changes in glucose and cortisol, positioning it as a potential best-in-class therapy.

PBPK modeling simulates drug behavior in the body, crucial for OINDPs and nasal drug delivery. Models like Simhalation™ assess drug response variability, optimizing formulations and reducing clinical trial needs. Validation against clinical data ensures model credibility, aiding regulatory submissions and accelerating drug approval.

GSK removed branded Flovent, a crucial asthma drug for children, from the US market, replacing it with a costly generic lacking insurance coverage. This has left families struggling to afford essential asthma medications, despite some manufacturers capping out-of-pocket costs at $35. The situation endangers children's health, with limited, expensive alternatives available.