Eugene

[email protected]

LATEST

Amneal Pharmaceuticals Names New Co-CEOs and New Chairman
By

By
Amneal Pharmaceuticals, a generic-drug company, has named its co-founders, Chirag Patel and Chintu Patel, as Co-Chief Executive Officers (CEOs), effective immediately with the company’s announcement of August 5, 2019. Chirag…

Biohaven Receives FDA Complete Response Letter After Apotex API Issues
By

By
Biohaven Pharmaceutical, a clinical-stage biopharmaceutical company, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its 505 (b) (2) new drug application (NDA)…

Lonza, Flamma, Regis, Fujifilm Irvine Scientific, and Catalent Expand
By

By
The latest news from CDMOs, CMOs, and suppliers featuring news from Lonza, Flamma, Regis Technologies, Evotec, Fujifilm Irvine Scientific, GenScript Biotech, Catalent, GenScript Biotech, Wasdell and Marken. Chemicals/Chemical API Manufacturing…

Strides Pharma Receives FDA Warning Letter
By

By
Strides Pharma, a Bangalore, India-based pharmaceutical company, has received a Warning Letter from the US Food and Drug Administration (FDA) for violations of current good manufacturing practice (cGMP) regulations for…

Celltrion Partners To Form New Biosimilars JV in China
By

By
Celltrion, an Incheon, Korea-based biopharmaceutical company developing innovator drugs and biosimilars, and Nan Fung Group, a Hong Kong-based conglomerate, have formed a joint-venture company, Vcell Healthcare, to develop biosimilars in…

FDA Approves Generics for Pfizer’s Blockbuster Drug Lyrica
By

By
The US Food and Drug Administration (FDA) has approved multiple applications for first generics of Pfizer’s blockbuster drug, Lyrica (pregabalin), for treating neuropathic pain and epilepsy. The approvals were granted…

Astellas, Frequency Therapeutics in $625-Million Deal for Hearing-Loss Drug
By

By
Astellas Pharma has entered into an exclusive license agreement, worth up to $625 million, with Frequency Therapeutics, a biopharmaceutical company focused on small-molecule drugs, to develop and commercialize Frequency Therapeutics’…

Sanofi Gains OTC Rights in US to Roche’s Flu Drug Tamiflu
By

By
Sanofi has signed an agreement with Roche for the exclusive over-the-counter (OTC) rights in the US to Roche’s Tamiflu (oseltamivir phosphate) for the prevention and treatment of influenza. Tamiflu is…

Bayer Recalls Mislabeled Vials of Hemophilia A Treatment
By

By
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the US at the patient level due to mislabeling of certain vials. Certain vials…

Gilead, Novartis Form Antiviral Drug Pact
By

By
Gilead Sciences has licensed three preclinical antiviral programs from Novartis, including investigational agents with the potential to treat human rhinovirus, influenza and herpes viruses. Novartis will receive an upfront payment and…