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GSK's COPD treatment Encruse Ellipta gets Japanese approval GlaxoSmithKline (GSK) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Encruse Ellipta (umeclidinium) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (COPD). Drug Research > Drug Delivery > News
Bayer gets Japanese approval for Gadovist injection By PBR Staff Writer
Bayer HealthCare has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Gadovist (gadobutrol) injection for contrast-enhancement magnetic resonance imaging (MRI) in cranial, spinal, the body and extremeties at a dose of 0.1ml/kg body weight.
News Zogenix begins dosing in Phase Ib Relday multi-dose clinical trial to treat schizophrenia By PBR Staff Writer
US-based pharmaceutical firm Zogenix has started dosing patients in its multi-dose Phase Ib clinical trial of Relday, a proprietary, long-acting, subcutaneously injected formulation of risperidone being investigated to treat schizophrenia.
News Takeda's NDA of Zafatek tablets gets approval in Japan to treat type 2 diabetes By PBR Staff Writer
Takeda Pharmaceutical has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the new drug application (NDA) of Zafatek, a once-weekly DPP-4 (dipeptidyl peptidase-IV) inhibitor, for the treatment of people with type 2 diabetes.
News
Gilead secures approval in Japan for Sovaldi to treat genotype 2 chronic HCV By PBR Staff Writer
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Gilead Sciences' Sovaldi (sofosbuvir) for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis.
News Merck, American Diabetes Association partner to educate adults with diabetes By PBR Staff Writer
Merck has entered into collaboration with the American Diabetes Association (ADA) to educate adults with diabetes about their increased risk for potentially serious health problems, including pneumococcal pneumonia, influenza (flu) and hepatitis B.
News Novo Nordisk introduces hemophilia therapy Novoeight in US By PBR Staff Writer
Danish pharmaceutical firm Novo Nordisk has introduced Novoeight (Antihemophilic Factor [Recombinant]) in the US for the treatment of people living with hemophilia A.
News

Latest News and Insight by Sector

Production & Manufacturing

Takeda's NDA of Zafatek tablets gets approval in Japan to treat type 2 diabetes
By PBR Staff Writer
Takeda Pharmaceutical has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the new drug application (NDA) of Zafatek, a once-weekly DPP-4 (dipeptidyl peptidase-IV) inhibitor, for the treatment of people with type 2 diabetes.
News
Novo Nordisk introduces hemophilia therapy Novoeight in US
By PBR Staff Writer
Danish pharmaceutical firm Novo Nordisk has introduced Novoeight (Antihemophilic Factor [Recombinant]) in the US for the treatment of people living with hemophilia A.
News

Drug Research

Bayer gets Japanese approval for Gadovist injection
By PBR Staff Writer
Bayer HealthCare has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Gadovist (gadobutrol) injection for contrast-enhancement magnetic resonance imaging (MRI) in cranial, spinal, the body and extremeties at a dose of 0.1ml/kg body weight.
News
Zogenix begins dosing in Phase Ib Relday multi-dose clinical trial to treat schizophrenia
By PBR Staff Writer
US-based pharmaceutical firm Zogenix has started dosing patients in its multi-dose Phase Ib clinical trial of Relday, a proprietary, long-acting, subcutaneously injected formulation of risperidone being investigated to treat schizophrenia.
News

Inward Investment

PPF Group acquires minority stake in Cytune Pharma
By PBR Staff Writer
PPF Group, in cooperation with SOTIO has completed acquisition of minority stake in French biotechnology firm Cytune Pharma.
News
Merck in talks to acquire Cubist Pharmaceuticals for nearly $8bn
By PBR Staff Writer
New Jersey-based drug giant Merck & Co is, reportedly, in talks over a potential acquisition of antibiotics maker Cubist Pharmaceuticals for more than $8bn.
News

Packaging

MP Global Products introduces foam-free packaging for shipment of temperature sensitive pharmaceuticals
MP Global Thermal Packaging Products insulated protective mailers and box liners are specifically designed for temperature control and protection of mail order shipments of temperature sensitive pharma, pet meds, and natural and organic cosmetics.
News
Bosch expands CPS portfolio for serialization of pharmaceutical packaging
Bosch Packaging Technology, a leading supplier of process and packaging technology, has expanded its portfolio for the serialization of pharmaceutical packaging. In the fight against counterfeit drugs, many countries are about to implement legislation changes for a stricter labelling of pharmaceuticals. Consequently, drug manufacturers require safer and more flexible solutions.
News

Contract Research & Services

Merck, American Diabetes Association partner to educate adults with diabetes
By PBR Staff Writer
Merck has entered into collaboration with the American Diabetes Association (ADA) to educate adults with diabetes about their increased risk for potentially serious health problems, including pneumococcal pneumonia, influenza (flu) and hepatitis B.
News
Signum out-licenses SIG990 to Dermata to develop new topical treatment for rosacea
By PBR Staff Writer
US-based biotechnology firm Signum Dermalogix has out-licensed SIG990, a new anti-inflammatory compound, to Dermata Therapeutics for the development of a topical product to treat patients with rosacea, a chronic skin condition.
News

Automation

GenVec, TheraBiologics to develop new cancer therapeutics
By PBR Staff Writer
US-based biopharmaceutical firm GenVec has entered into a collaboration agreement with TheraBiologics to develop neural stem cell mediated cancer therapies.
News
Takeda, Immunogen sign potential $440m drug development deal
By PBR Staff Writer
Japan-based Takeda Pharmaceutical Company and US-based ImmunoGen have signed a drug development agreement that could be worth more than $440m.
News

Regulatory Affairs

Gilead secures approval in Japan for Sovaldi to treat genotype 2 chronic HCV
By PBR Staff Writer
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Gilead Sciences' Sovaldi (sofosbuvir) for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis.
News
FDA grants orphan drug status for CymaBay's MBX-8025 to treat HoFH
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for CymaBay Therapeutics' MBX-8025, a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, to treat homozygous familial hypercholesterolemia (HoFH), an autosomal genetic disease.
News



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