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Source: Thailand Medical News Dec 10, 2019 5 years ago
Pharma News
The American Regulator, the Food and Drug Administration (FDA) has approved the first generic versions of Novartis multiple sclerosis drug Gilenya (fingolimod).
Applications for the generic fingolimod by HEC Pharm, Biocon and Sun Pharmaceutical Industries secured the FDA authorisation to treat adults with relapsing forms of multiple sclerosis.
Multiple sclerosis ...
Source: Thailand Medical News Dec 10, 2019 5 years ago
Pharma News
The global HIV specialists pharma company, ViiV Healthcare, majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, has filed a New Drug Application in the US for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection.
Fostemsavir, the drug is being developed for use in combination with other antiretroviral agents ...
Source: Thailand Medical News Dec 02, 2019 5 years ago
Many big pharma and biotech conglomerates are going through a tough time. As businesses struggles, significant debt and legal liabilities put some industry players at particularly high risk of declaring bankruptcy in the near future, including large drugmakers like Teva Pharmaceutical and Bausch Health as well as small biotechs including Clovis Oncology and Puma Biotechnology.
A pharma industry...
Source: Thailand Medical News Dec 02, 2019 5 years ago
Biopharmaceutical company Incyte has announced that the US Food and Drug Administration (FDA) accepted for priority review its New Drug Application (NDA) for pemigatinib as a treatment for patients with cholangiocarcinoma.
Typically, Cholangiocarcinoma is cancer that forms in the bile duct, with patients often diagnosed at a late or advanced stage.
The drug Pemigatinib is a selecti...
Source: Thailand Medical News Nov 27, 2019 5 years ago
Bempedoic acid is an oral, once-daily ATP citrate lyase (ACL) inhibitor that reduces cholesterol synthesis in the liver and is currently undergoing regulatory review
Bempedoic acid lowered LDL-Cholesterol by 17% on top of maximally-tolerated statin therapy at 12 weeks, and the effect was durable through 52 weeks1
Overall adverse events in the bempedoic acid treatment arm were comparable to pla...
Source: Thailand Medical News Nov 26, 2019 5 years ago
Thailand Pharma News
Patients with multiple sclerosis often pay, on average, nearly US$7,000 out of pocket to treat their condition each year. And, even though drug companies have provided no new treatment breakthroughs, the price of these disease-modifying medications is rising by 10% to 15% each year for the past decade.
A team of researchers at Oregon Health & Science University and the...
Source: Thailand Medical News Nov 17, 2019 5 years ago
A panel of specialists from the US Food and Drug Administration has approved allowing Amarin Corp Plc's fish-oil derived drug, Vascepa to be used as an add-on therapy for reducing the chance of heart attack and stroke in high-risk patients with cardiovascular disease.
Everyone of the 16 panelists voted that the drug should be sold as a medicine to reduce the risk of cardiovascular eve...
Source: Thailand Medical News Nov 07, 2019 5 years ago
Pharma giant, Biogen has signed a commercialisation agreement with Samsung Bioepis for biosimilar candidates SB11 (ranibizumab) and SB15 (aflibercept).
SB11, referencing Lucentis, is in Phase III clinical trial and SB15, referencing Eylea, is a pre-clinical candidate. The deal will allow Biogen to commercialise the biosimilars in the US, Canada, Europe, Japan and Australia. Lucentis ...