In this week’s news: EC calls for feedback on GMP tweaks; US FDA issues new guidance; UK launches side-effects site; and more…
EC extends GMP revision comment period citing Covid-19
The European Commission has extended the feedback period for proposed revisions to sterile drug manufacturing regulations.
The Commission has been working to revise Annex 1 of the EU GMP Guide to Good Manufacturing Practice for several years. The first draft, released in 2017, prompted a large number of comments according to GMP-Compliance.
The original comment period for the current draft, the second revision, was due to end later this month. However, the Commission gave interested parties more time to provide feedback, citing the Covid-19 pandemic.
It wrote, “Due to the challenges posed by COVID-19, the timeline for the second targeted consultation has been extended until 20 July 2020.
“Those who have already submitted their comments are welcome to revise their contribution if they would like to. Only their latest comments will be considered.”
US FDA finalises cytomegalovirus guidelines
The US FDA has finalized guidelines on the development of drugs to treat cytomegalovirus infection in transplant patients.
The guidance – here – covers products that prevent infection. Cytomegalovirus is usually harmless, however, it causes complications and increases the risk of death in patients with compromised immune systems.
The document defines viremia (DNAemia) as a validated surrogate endpoint for certain trials as part of a composite endpoint. It also makes clear that nonclinical studies for drug combinations are generally not needed.
“Unless data from nonclinical studies of an early-stage entity suggest a potential for serious synergistic toxicity with an approved therapeutic drug, combination toxicology studies are not recommended,” the FDA wrote.
The guidance also includes up-to-date information about preventing cytomegalovirus infection in transplant patients.
MHRA sets up Covid-19 vaccine, drug and tech side effect reporting site
The UK MHRA has set up a site for reports of side effects caused by vaccines, drugs and medical equipment used to treat Covid-19.
The regulator said the idea is to make it makes it quicker and simpler for healthcare professionals, patients and carers to report side-effects or incidents.
June Raine MHRA Chief Executive said, “While our aim is to ensure that potentially lifesaving COVID-19 treatments and medical equipment reach patients as quickly as possible, patient safety is our highest priority.”
Fake coronavirus meds warning
In other news the MHRA has reiterated warnings not to buy drugs claiming they protect against or treat Covid-19 online.
The agency said, “We have been receiving reports of ‘miracle cures’, ‘antiviral misting sprays’, antiviral medicines being sold through websites. Offering to sell unauthorised medicines is against the law.
“Don’t be fooled by online offers for medical products to help prevent or treat COVID-19. One of the risks of buying medicines and medical devices from unregulated sources is that you just don’t know what you will receive.”
It added that “At this time there is no medicine licensed specifically to treat or prevent COVID-19.”
Turkey rejigs rules for devices during pandemic
The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) announced measures to fight the COVID-19 pandemic.
According to a report by Mondaq TİTCK provided detailed explanations on measures concerning readability tests; product certification applications; pharmaceuticals used by patients with chronic diseases; and scientific meetings approvals.
Also in the news
Reuters reports the Trump administration is urging industry – including the drug sector – to remove Chinese firms from supply chains.
US efforts to secure supplies of any SAR-CoV2 vaccine before other countries will slow the process according to Slate.
Gilead is seeking help to boost supplies of its Covid-19 drug remdesivir according to the Wall Street Journal.
Bioprocess Insider reports Biogen will make its candidate Alzhemier’s disease drug aducanumab at a recently completed site in Switzerland.
EPR looks at the role drug packing is playing in maintaining drug supplies during the pandemics.
Some developments of note in the contracting sector:
3M Drug delivery has launched as an independent company called Kindeva.
CytoDyn has hired Ajinomoto Bio-Pharma Services to make a candidate mAb drug being developed to treat COVID-19 patients.
CDMO Avid Bioservices and CRO Aragen Bioscience have formed a co-marketing agreement that will aim to provide an integrated “sequence-to-manufacturing” service.
The Center for International Health Research at Rhode Island Hospital has contracted Tedor Pharma to make the schistosomiasis drug praziquantel for clinical trials.
Univercells shares details of its recently established CDMO business with Bioprocess Insider.
European Pharmaceutical review reported that AMRI has boosted production of the malaria drug hydroxychloroquine sulfate. US President Donald Trump has claimed the drugs is a potential COVID-19 treatment.