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Quantum Pharma launches Mucodis Rectal Gel Quantum Pharma has launched its Mucodis Rectal Gel for the prevention and treatment of rectal mucositis, a common side effect of chemotherapy and radiotherapy in cancer patients.
Drug Research > Drug Delivery > News
Puma submits NDA for PB272 to FDA for extended adjuvant treatment of HER2-Positive early stage breast cancer Puma Biotechnology has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy.
Drug Research > Drug Delivery > News Citron Pharma launches Rosuvastatin calcium tablets Citron Pharma confirmed that its licensing partner received final approval from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Application (ANDA) for Rosuvastatin Calcium 5, 10, 20 and 40 mg tablets, the generic version of AstraZeneca's CRESTOR (rosuvastatin calcium) tablets.
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West-Ward Pharmaceuticals launches generic Xeloda tablets 150 mg and 500 mg in US
Hikma Pharmaceuticals' wholly owned US affiliate, West-Ward Pharmaceuticals has launched Capecitabine Tablets 150 mg and 500 mg, the generic equivalents to Xeloda1 Tablets.
Drug Research > Drug Delivery > News
ProQR secures FDA fast track designation for QR-010 to treat Cystic Fibrosis
ProQR Therapeutics has received Fast Track designation from the Food and Drug Administration (FDA) for its molecule QR-010 that is in clinical development for the treatment of patients with CF due to the ∆F508 mutation.
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Samsung Bioepis' Humira biosimilar application accepted for review in Europe
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted for review Samsung Bioepis’ marketing authorization application (MAA) for SB5, an adalimumab biosimilar candidate referencing AbbVie’s Humira.
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Advanced Proteome formulates strategic plan featuring novel antibody program
Advanced Proteome Therapeutics has announced plans bearing on its site-specific protein modification technology as it applies to therapeutic antibodies.
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Provectus Biopharmaceuticals establishes Australian subsidiary
Provectus Biopharmaceuticals, a clinical-stage oncology and dermatology biopharmaceutical company, has formed an Australian subsidiary, Provectus Biopharmaceuticals Australia.
Drug Research > Drug Delivery > News
Mylan launches generic Fenoglide tablets in US
Mylan announced the US launch of Fenofibrate Tablets USP, 40 mg and 120 mg, which is a generic version of Santarus's Fenoglide.
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AlliancePharma signs definitive agreements to acquire three companies
AlliancePharma has entered into definitive agreements to acquire three companies and has also entered into a private placement agreement with a healthcare-focused private equity fund.
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FDA grants orphan drug status to Araim’s ARA 290 to treat sarcoidosis
By PBR Staff Writer
Araim Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for ARA 290 to treat sarcoidosis.
Drug Research > Drug Delivery > News
Allergan gets positive opinion from Swedish MPA for Belkyra to treat patients with submental fullness
By PBR Staff Writer
Allergan has received a positive opinion from the Swedish Medical Products Agency (MPA) for Belkyra to treat patients with submental fullness.
Drug Research > Drug Delivery > News
Kitov's KIT-302 drug achieves manufacturing milestone ahead of planned NDA Filing with FDA
Kitov Pharmaceuticals announced that Dexcel Pharma, Kitov's manufacturing partner, has successfully completed an initial stability study for its lead drug candidate KIT-302.
Drug Research > Drug Delivery > News
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