This week in pharma… 11th March

11th March, 2022

In this week’s news, calls for FDA to disclose details of overseas drug, FDA backs biosimilar regulatory science research and more.

US FDA should share details of overseas plants supplying APIs, drugs and devices

The US FDA should disclose the location of all manufacturing facilities that supply ingredients, drugs and devices approved in the US, according the National Academies of Science, Engineering and Medicine (NASEM).

The suggestion was made in a report published this week, in which the NASEM sought to investigate US reliance on medicines and medical devices made outside the country.

Wallace Hopp of the University of Michigan, who chaired the committee that wrote the report, said “This report offers a vital framework to help stakeholders determine which products are medically essential and vulnerable to shortages, the level of protection they need, and the right measures to take if a disruptive event does occur.

The report makes recommendations to improve the resilience and security of US supply chains, splitting them into categories such as awareness, mitigation, preparedness and response.

US FDA to back biosimilar regulatory science research

The US FDA will fund biosimilar-focused regulatory science projects under the upcoming Biosimilar User Fee Amendments (BsUFA III) program.

The agency announced the funding availability this week, explaining that the aim of the project is to advance the development of interchangeable products and to make biosimilar development more efficient. 

US FDA gives industry more time for DSCSA verification requests 

The US FDA has given drug manufacturers and re-packagers more time to respond to verification requests from trading partners for suspect products.

The agency issued new draft guidance this week, explaining that the aim is to give more flexibility to firms when it comes to the verification systems they are required to have in place under the 2013 Drug Supply Security Act (DSCSA).


Also in the news

RAPS covered the release of the EMA’s review of the PRIME scheme, which is designed to encourage the development of drugs for unmet medical needs.

Contract Pharma looked at Bristol Myers Squibb’s decision to execute a long-term lease for the development of an R&D facility at Alexandria Point in San Diego.

Charles River is expanding its plasmid DNA and viral vector development capabilities, according to a report by Outsourcing Pharma.

Reuters reported that non-profit drug manufacturer, Civica, expects to launch lower-cost versions of insulin in the US by 2024.

The Spanish drug industry calls for a dedicated orphan drug reimbursement route, according to the Pink Sheet.

Drug and device companies say Vladimir Putin’s war against Ukraine, and the sanctions imposed on Russia as a result, may impact the delivery of medical supplies to those who need them. Read the full article here.

Pharma Manufacturing published an article discussing the trends shaping pharma as the industry adjusts to a changed world.


CDMO trends

Some developments of note in the contracting sector: 

Cambrex announced plans to expand its existing biopharmaceutical testing business. The expansion will include 11 additional cGMP laboratories at its Durham, NC, facility. 

Alcami has set up a non-GMP formulation development lab at the same facility as its parenteral manufacturing operation in North Carolina.

TFF Pharmaceuticals and Catalent have teamed up to work on dry powder formulations. Catalent will provide manufacturing capabilities and will be able to offer customers access to TFF (thin film freezing) technology.

Emergent Biosolutions has begun a $100 million project to retrofit its facility in Bayview, Baltimore, according to Fierce Pharma.

Ray Therapeutics and CDMO Forge Biologics have established a manufacturing partnership that will advance the former’s lead gene therapy program, Ray-001, into clinical trials.