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Bristol-Myers Squibb’s (BMS) highly anticipated rheumatoid arthritis candidate Orencia will be reviewed by the FDA’s Arthritis Advisory Committee in September.
The European Medicines Agency (EMEA) has released draft guidelines outlining specific parameters for nonclinical and clinical studies for four biosimilar products.
Roughly half of the products large drugmakers receive approval for today are generated from in-licensed molecules, according to an industry expert, who said drugmakers can find particularly high value in acquisitions of large-molecule biologic products.
Roughly half of the products large drugmakers receive approval for today are generated from in-licensed molecules, according to an industry expert, who said drugmakers can find particularly high value in acquisitions of large-molecule biologic products.
Merck has signed a multimillion-dollar drug development deal that will give it exclusive rights to a sepsis product candidate owned by Italian biotechnology firm BioXell.
A House appropriations panel has voted to fund the FDA at $1.48 billion in fiscal 2006, a $30 million increase over the previous year, but $20 million below President Bush’s budget request.
A new monograph from the U.S. Pharmacopeia (USP) describing a human growth hormone (HGH) proves the science is sound for follow-on biologics and that such products can be accurately characterized, according to the Generic Pharmaceutical Association (GPhA).
Barr Laboratories CEO Bruce Downey remains confident that the FDA will eventually establish a pathway for biogenerics, but he concedes that follow-on biologics are still at least three years away from becoming a reality in the U.S.
Science can show quantitatively that the protein structure of a branded biologic molecule is equivalent to the protein structure of a follow-on biologic product, a scientific expert told a recent industry conference.
Venture capitalist (VC) spending in the biotechnology industry dropped sharply during the first quarter, as venture firms looked to bring more balance to their funding initiatives, according to a new survey.