In this week’s news, China and biologics CDMO growth drivers, valsartan impurities probed and more…
China, emerging markets and biologics key CDMO drivers in 2019
CDMOs looking for revenue growth should keep an eye on China and consider investing in biologics capacity according to analysis of topics discussed at the recent JP Morgan Healthcare conference.
GlobalData Healthcare looked at the presentations at the event in January to come up with a list of potential revenue drivers for the contracting sector.
The firm flagged emerging markets as an opportunity, explaining that contractors have started to explore new territories to counter static outsourcing growth in more developed markets.
China, despite the current economic slowdown, is worthy of particular attention according to GlobalData. Regulations introduced in 2016 allowing drug firms lacking capacity to use CDMOs, have kick started the market.
Growing pharmaceutical industry demand for a wider range of biopharmaceutical outsourcing services was also highlighted as an opportunity.
GlobalData said, “As the drug pipeline continues to shift further towards biologics and an increasing number of marketed blockbuster biologics emerge, top CMOs have been seeking ways to expand their related capacity and enhance their capabilities through developing innovative techniques and forging new partnerships.”
Generic valsartan synthesis route may be source of impurities
Carcinogenic Impurities in batches of recalled heart drugs are the result of ‘side reactions’ occurring during production say analysts.
Over the past year, multiple batches of generic valsartan, losartan and irbesartan have been withdrawn after being found to contain the impurities N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA).
The problem, according to Chemical & Engineering News, is the synthesis route used to make the API in the recalled drugs – specifically the use of the intermediate sodium azide rather than tributyltin azide.
Valsartan was developed by Novartis. The original API production method specified that tributyltin azide be used during synthesis steps for the formation of the tetrazole ring.
The EMA, FDA and other regulatory agencies continue to research the issue.
Read more here.
Overseas device trials must be GCP under new FDA rule
Clinical studies for medical devices conducted outside the US must comply with GCP under rules that came into force last week.
The regulation, which applies to all clinical trials enrolling after 21 February 2019, is designed to ensure information submitted in device applications is of consistent quality, irrespective of where the research is carried out.
See RAPS’ coverage here.
Brexit could halt 1,300 clinical trials say German regulators
German regulators say Brexit could halt more than 1,300 clinical trials being conducted in the country by UK registered sponsors.
Last week the Federal Institute for Drugs and Medical Devices (BfArM) said it may suspend the studies, explaining they will no longer meet its requirements when the UK leaves the European Union at the end of March.
“For clinical trials in which there is no sponsor or representative of the sponsor who is domiciled in a Member State of the EU or in the EEA at the time when a so-called hard Brexit becomes effective, revocation or suspension of the con-duct of the trial is mandatory by law. Such clinical trials may then not be continued.”
The regulator advised affected sponsors “to prepare themselves for the case of the so-called hard Brexit and to notify the BfArM immediately of any change of sponsor, representative or registered office.”
Also in the news
Janssen told Pharmaceutical Manufacturing about its approach to external partnerships.
STAT looked at how the biopharmaceutical industry is preparing for the impact of climate change on its manufacturing and business operations.
The Wall Street Journal took a look at the dynamics that are reshaping the pharmacy sector in Europe.
Supplies of the bladder cancer drug called BCG are threatened according to STAT, which resorts that only one firm continues to make the product.
Pharmafield covered a study suggesting multiple sclerosis patients derive long-term benefits from intensive therapy in the early stages of the disease.
HealthPolicy Watch looked at Switzerland’s plans to rejig drug procurement.