In this week’s news, Dr Reddy’s turns to Chinese CDMOs, FDA launches anti-infectives app and Ireland has drug fee rethink and more…
Dr Reddy’s looks to local CDMOs to tap Chinese market
Dr Reddy’s plans to use local contract manufacturers to build its presence in the Chinese pharmaceutical market.
The Indian drug company recently told the Economic Times it will launch 70 or so products in China, some of which will be made by local contractors.
Most of the medicines will be made by KunshanRotam Reddy Pharmaceutical, a JV the firm set up in the Kunshan Economic and Technology Development Zone with Canada’s Rotam Group in 2000.
However, Dr Reddy’s told the newspaper it will outsource production to Chinese contractors.
The comments are in keeping with the strategy outlined by CEO Erez Israeli last month. He told analysts, “We have a plant that is making product for China, primarily for the KRRP products, and we took a decision and we are implementing an expansion for that plant. So this will take some of the growth.
“On top of it, we are moving few products to a contractor, to make in China. There are certain advantages for example, exemptions from certain tests when you do a bio study and make products in China, and we will exploit that.”
Ireland’s HPRA cuts fee hike after industry feedback
Ireland’s Health Products Regulatory Authority (HPRA) has bowed to industry feedback – particularly concerns about Brexit – and decided on a smaller fee increase.
The drug regulator announced its decision last week, explaining it will now only increase fees 2% rather than the 3% announced in October.
It wrote, “The HPRA acknowledges that it is a difficult year for the pharmaceutical industry with Brexit and the additional responsibilities and costs arising out of the falsified medicines directive. In light of these considerations, we revisited the fee proposal and consequently we have reduced the general increase from 3% to 2%.
“In addition, we will apply no increase to the maintenance fee for products that are not marketed. In relation to essential medicines with very small markets the HPRA will be very happy to engage with companies over the level of fees charged. In addition, the HPRA is committed to considering any issues including fees, arising from Brexit which may prevent market access, and we would encourage companies with any Brexit related issue to engage with the HPRA.”
Read the full letter here.
US FDA hopes anti-infectives crowdsourcing app will guide drug development
The US FDA shared details of an app that lets clinicians record when they use anti-infective medicines to cure hard-to-treat diseases.
The application – called CURE ID – is designed to enable the crowdsourcing of medical information to guide potentially life-saving interventions and facilitate the development of new drugs for neglected diseases.
Amy Abernethy, FDA Principal Deputy Commissioner. “Our hope is that this app will serve as a connector among major treatment centres, academics, private practitioners, government facilities and other health care professionals from around the world and ultimately get treatments to patients faster.”
The app was developed by the FDA and the National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences (NCATS) and was trialled in India and South Africa.
Also in the news
Several reports on alleged price fixing in the US generic drug sector this week. STAT reported a second firm has admitted to colluding to keep prices high.
Meanwhile, Reuters looked at Teva’s discussions with the US Justice Department.
Novartis has called on Amazon to use its digital architecture to help streamline its distribution and sourcing network. Read more in the press release.
Reuters reported on the current wave of major investments in gene therapy development and production by innovative pharmaceutical companies.
Regulators at agencies worldwide are struggling to alleviate drug shortages and recalls according to a report by Pharmaintelligence.
Some developments of note in the CDMO sector.
Thermo Fisher Scientific is expanding viral vector and gene therapy production capacity in the US according to a report by Bioprocess Insider.
Wuxi Vaccines is to build a $240m manufacturing facility in Ireland. See press statement.
Ethicann has called on Catalent to help it develop a fast dissolve cannabinoid-based treatment for multiple sclerosis spasticity.
Dinaqor has formed a partnership with Lonza in which the CDMO will help develop gene therapies for cardiomyopathies.