• Merck & Co. Inc., of Whitehouse Station, N.J., said its new drug application for a tablet formulation of antifungal agent Noxafil (posaconazole) was accepted for review by the FDA. Merck currently markets Noxafil oral suspension for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 and older, at high risk of developing those infections due to being severely immunocompromised.

• PeptiDream Inc., of Tokyo, and Ipsen SA, of Paris, entered a research collaboration and license option agreement to discover, evaluate, potentially develop and launch therapeutic peptides to treat serious medical conditions in areas of therapeutic focus for Ipsen. The collaboration will combine PeptiDream's peptide library with Ipsen's expertise in peptide drug discovery and pharmaceutical R&D. Financial terms were not disclosed.

• Pfizer Inc., of New York, said its palbociclib (PD-0332991), an oral and selective inhibitor of cyclin-dependent kinases 4 and 6, received breakthrough therapy designation by the FDA for the potential treatment of patients with breast cancer. The drug is in a Phase III study in combination with letrozole vs. letrozole alone as a first-line treatment in postmenopausal patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer.

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