Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arvinas, Astrazeneca, Hemispherian, OS Therapies, Pfizer.
Absent extraordinary circumstances, the Patent Trial and Appeal Board “should never cancel claims it has not determined to be unpatentable as a sanction” for misconduct during a board proceeding, according to the acting director of the U.S. Patent and Trademark Office (USPTO).
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued its first official guidance on how to develop bacteriophages as licensed medicinal products. This covers personalized phage therapies designed for specific patients – at present the only form in which they are available – but also is relevant to the development of off-the-shelf products for treating common infections.
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