In this week’s news, raft of new FDA guidance on withdrawals, EC reviews orphan drug and child drug rules and more…
US FDA gives advice on drug-drug interaction assessment
The US FDA has issued guidelines on drug-drug interaction studies.
The document suggests developers use a “systematic, risk-based” approach to determine if their therapeutic protein candidates require drug-drug- interaction studies.
The agency advises firms to consider a range of potential interactions, pointing out – for example – that proteins which effect cytochrome P450 enzymes can amplify or damp down the impact of other medicines
In other news, the FDA issued final guidance on what drug firms need to do when they stop marketing products.
Current regulations require NDA and ANDA holders to notify the Agency of the marketing status of drug products approved under NDAs and ANDAs. In 2017 the FDA Reauthorization Act added additional reporting requirements.
The new guidance addresses these additional requirements.
EC: Orphan and pediatric regs working but access action needed
The European Commission published its review of regulations covering the development and trial of medicines intended for people with rare diseases or those for children.
According to the commission while current legislation supports industry development of such products, further work is needed to improve access.
“Regulations have not adequately managed to support development in all areas of rare and paediatric diseases where the need for medicines is greatest. The evaluation has also shown that authorised medicines for patients with rare diseases and for children are not equally accessible by patients across the EU.
The Commission said it plans to examine the impacts of possible future policy options to update the legal framework.
“The evaluation found that both Regulations fostered the development and availability of medicines for patients with rare diseases and for children which have increased in recent years,” the commission
Calculated risk is key to rapid COVID-19 vaccine development says CEPI
The Coalition for Epidemic Preparedness Innovations (CEPI) has suggested SARS-CoV-2 vaccine and COVID-19 therapy developers may need to invest in manufacturing capacity early to help combat the pandemic.
Traditional development models take years, followed by clinical development and manufacturing. The COVID-19 pandemic calls for a different approach through according to Ingrid Kromann, CEPI’s head of CMC. “We have to be able to scale-up our products at risk” Kromann said, explaining the CEPI’s approach to start process-scale up before it had clinical data.
Read more at Bioprocess Insider.
The COVID-19 vaccine decision will be “deliberative” says US FDA commissioner Hahn
US FDA commissioner Stephen Hahn says approval of any SARS-CoV-2 vaccine will be based on data and good science amid concerns the agency will come under political pressure to clear a jab quickly.
Hahn recently delivered a presentation along with American Medical Association president Patrice Harris, MD. Hahn wanted to make it very clear that despite the time limitations and the speed at which things are progressing, the FDA was proceeding with caution. “Let me assure you that we will not cut corners… All of our decisions will continue to be based on good science and the same careful, deliberative processes which we have always used when reviewing medical products”, he stated.
Read RAPS’ coverage here.
Also in the news
Russia has approved a Covid-19 vaccine according to Reuters.
Politico reports a US Government loan offered to Kodak to set up an API CDMO has been delayed.
The Indian Government has lifted restrictions on the exportation of ventilators and related equipment. See the official statement here.
India has also has created a regulatory pathway for fixed-dose combinations (FDCs) that include vitamins, minerals and micronutrients. See the CDSCO announcement here.
Some developments of note in the contracting space:
Iovance has hired Avid to make a developmental Il 2 receptor antagonist being development for the treatment of cancer. Read the full report at Bioprocess Insider.
Swiss firm Lonza plans to add a mid-scale microbial manufacturing facility to service its contract with Servier. The deal will see the CDMO make APIs for blood cancer therapies. Read more at Reuters.