article thumbnail

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Genital Warts (Condylomata Acuminata): Likelihood of Approval

Pharmaceutical Technology

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

article thumbnail

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Cervical Intraepithelial Neoplasia (CIN): Likelihood of Approval

Pharmaceutical Technology

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA hands Cassiopea its first approval, for acne drug Winlevi

pharmaphorum

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria.

article thumbnail

Sanofi snaps up acne vaccine developer Origimm Bio

pharmaphorum

Sanofi said it would also apply its mRNA vaccine platform – acquired along with Translate Bio earlier this year – to find other acne vaccine candidates that could start clinical trials in 2023. Origimm’s expertise in the skin microbiome and antigen discovery will be central to that effort, it added.

article thumbnail

It’s been a long time coming for long-term topical psoriasis treatments

pharmaphorum

Vtama and Zoryve work in different pathways, but there is no clear superior option and there have been no head-to-head trials. This may lead to cuts and bruises or suppression of the hypothalamic-pituitary-adrenal axis, which is a systemic condition that results in a decrease in cortisol, a natural stress hormone found in humans.

article thumbnail

GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours

The Pharma Data

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). As we saw in the GARNET trial, of those patients who respond to treatment with dostarlimab, nearly all continued to respond for six months or longer.”. by blinded independent central review.

article thumbnail

LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

The Pharma Data

The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84];

HR 52