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Home » Topics » Regulatory

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Liver disease

India wins the dash for NASH, as Zydus Cadila’s saroglitazar wins first approval

March 10, 2020
By David Ho and Elise Mak
HONG KONG – Cadila Healthcare Ltd. (Zydus Cadila) has won approval for its saroglitazar to be used as the treatment of non-cirrhotic nonalcoholic steatohepatitis (NASH) in India. The green light from the Drug Controller General of India (DCGI) makes saroglitazar the first drug in the world approved for this indication.
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Hands holding brain

Keystone Heart secures CE mark for Triguard 3

March 10, 2020
By Liz Hollis
Keystone Heart Ltd., of Caesarea, Israel and Tampa, Fla., scored a win in Europe after obtaining the CE mark for the Triguard 3 cerebral embolic protection (CEP) device. It is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation (TAVI) and other transcatheter heart procedures. According to the company, the device is the only product with a CE mark designed to cover and protect all three major cerebral aortic arch vessels.
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Tablet, health professional, EHR/medical icons
Digital health developers, telehealth among the winners

CMS, ONC rules for electronic health records largely mirror both drafts

March 10, 2020
By Mark McCarty
The Office of the National Coordinator (ONC) and CMS both posted their final rules for electronic health records (EHRs), and analysts with Cowen Washington Research Group said both rules essentially replicate the draft versions. The provisions dealing with data blocking and interoperability are expected to benefit developers of HER systems in the near term, and telehealth should also benefit, albeit over a longer scale of time.
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Postponed stamp on calendar

Preparing for COVID-19, FDA shuts down inspections, postpones meetings

March 10, 2020
By Mari Serebrov
Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.
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Regulatory front for March 10, 2020

March 10, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Applied Biosystems, Cardinal Health, Qiagen, Roche.
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FDA approves Ofev for chronic fibrosing interstitial lung diseases with a progressive phenotype

March 10, 2020
FDA Approved stamp with blister pack

Competition aplenty as Novartis’ Isturisa is FDA-approved to treat Cushing’s disease

March 9, 2020
By Lee Landenberger
With the FDA approval of Novartis AG’s Isturisa (osilodrostat), an oral treatment for adults with Cushing’s disease, Recordati SpA, of Milan, is planning its U.S. market launch for the second or third quarter of this year. Recordati, which acquired Isturisa’s worldwide rights from Novartis in October for $390 million, expects sales to peak at $100 million annually.
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Hurdles to robust U.S. biosimilar market in the eye of the beholder

March 9, 2020
By Mari Serebrov
“For those of us who believe in a free market, it is really important that the market works well,” FDA Commissioner Stephen Hahn said March 9 at a public workshop on ensuring a U.S. biologic marketplace that includes sustainable biosimilar and interchangeable competition.
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Regulatory front for March 9, 2020

March 9, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for March 6, 2020

March 6, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Carefusion.
Read More
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