In this week’s news, Italy still wants EMA, the US FDA hosts DISCO, a green chemistry breakthrough for drug firms and more…
Italy still wants Milan to be EMA’s new home
Italian politicians still want the EU to choose Milan as the new home for the EMA after Brexit.
Milan lost its bid to host the EMA on the toss of a coin – actually it was lots drawn from a bowl – last November after earning the same number of votes as the winning city Amsterdam.
While it may be packing, the EMA has continued to develop guidelines.
Earlier this month the agency asked for feedback on draft guidelines covering how the safety and efficacy of advanced therapy medicinal products – such as gene therapies – should be monitored.
How green was my Valium? New API production method shows promise
Green chemistry researchers claim a new method of making drug ingredients is cheaper and more efficient than traditional metal catalyst based production.
Palladium catalysts are used to make around 70% of chemicals used in drugs. Unfortunately, the reactions they drive are either fast but inefficient – when the metal is in solution – or slow – when it is attached to a substrate.
Now scientists at North Carolina State University claim to have come up with a ‘green’ way of using the catalysts that enables fast reactions but means that very little of the palladium is lost.
Read more at Science Daily.
US FDA hosts drug-fuelled DISCO; Biologics Q11 Q&A
Developers gained a valuable insight into the US FDA’s thinking on the safety and efficacy of cell therapies in an agency podcast this week.
The FDA Drug Information Soundcast in Clinical Oncology – or DISCO – covered Kymriah, which is the first CAR-T cell immunotherapy approved in the US.
Agency oncologists who took part covered everything from how the agency defines CAR-T therapies to what it expects of developers in terms of post-approval safety monitoring.
The FDA also outlined how biologics developers should try to stick to ICH Q11 manufacturing guidelines.
TGA says G’day again to biosimilars
Australia’s Therapeutic Goods Administration (TGA) has published a revised version of its guidelines on biosimilars.
The document updates advice around drug ingredient naming.
Generics and biologics boost for CMOs
Generics and biologics will fuel expansion of the pharmaceutical contracting sector according research unveiled this week.
Mordor Intelligence predicted the contracting market will be worth $146.41bn by 2023, up from $92.3bn last year.
The researchers suggested that profit –focused drug firms will hand over production to CMOs with the know-how to make generics and biologics.
In other news
Investment bank Alantra picked its 50 fastest growing privately-owned UK pharmaceutical companies. Read more at PharmaTimes.
Industry group ACRO has elected John Ratliff, CEO of Covance drug development, as its chairman for 2018.
It has also named Cynthia Verst, president of clinical operations at IQVIA, as vice chairman.
ramarketing has confirmed it is setting up shop in Manchester and will expand its team by 25% with the creation of several new jobs in the North East and North West.