Archive | Regulatory

Chinese authorities approve Sino Pharma’s lenalidomide for multiple melanoma

Source: Pharmaceutical Technology, February 2019 Chinese Sino Pharmaceutical has announced that China’s National Medical Products Administration has approved its subsidiary Chia-Tai Tianqing Pharmaceutical’s anti-tumour drug lenalidomide for multiple melanoma. The approval is due to the convenience of oral administration, proven efficacy and good safety profile, and allows the drug to be taken in conjunction with […]

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Posted in Melanoma News, Regulatory, Publications

NICE clears Pierre Fabre’s targeted melanoma combo to take on Novartis, Roche drugs

Source: Fierce Pharma, February 2019 Thanks to new guidance from England’s drug cost watchdog, Novartis and Roche will be getting some fresh targeted melanoma competition from French pharma lab Pierre Fabre. In guidance published Friday, England’s National Institute for Health and Care Excellence signed off on Pierre Fabre’s combo of Braftovi and Mektovi to treat adult patients with unresectable or metastatic BRAF […]

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Posted in Melanoma News, Regulatory, Publications

Provectus ocular melanoma treatment gets orphan drug designation

Source: Healio, February 2019 The FDA has granted an orphan drug designation to PV-10, Provectus BioPharmaceuticals’ ocular melanoma treatment candidate, according to a press release. Rose bengal disodium, also called PV-10, is a small molecule oncolytic immunotherapy delivered via intratumoral injection, which can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in […]

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Posted in Melanoma News, Regulatory, Publications

Merck’s KEYTRUDA ® (pembrolizumab) Receives Five New Approvals in Japan, Including in Advanced Non-Small Cell Lung Cancer (NSCLC), as Adjuvant Therapy for Melanoma, and in Advanced Microsatellite Instability-High (MSI-H) Tumors

Source: Business Wire, January 2019 KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that KEYTRUDA, Merck’s anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA), including three expanded uses in advanced non-small lung cancer (NSCLC), one in melanoma, as […]

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Posted in Melanoma News, Regulatory, Publications