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BioWorld - Thursday, January 22, 2026
Home » Topics » Regulatory, BioWorld

Regulatory, BioWorld
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Regulatory front for March 13, 2020

March 13, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Emmaus, Global Blood Therapeutics, Novartis.
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JOBS on-ramp for smaller companies just got longer

March 12, 2020
By Mari Serebrov
The U.S. Securities and Exchange Commission (SEC) Thursday extended the public on-ramp for small companies that take longer than five years to generate $100 million in annual revenue, as well as some of the business development companies that invest in them.
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Regulatory front for March 12, 2020

March 12, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Teva Pharmaceutical Industries.
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Earth infected with pandemic

Officially a pandemic, but COVID-19 fight far from over, says WHO director general

March 11, 2020
By Nuala Moran
LONDON – The World Health Organization (WHO) has officially declared COVID-19 a pandemic, but is pushing back strongly against countries giving up on stringent control measures.
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Regulatory front for March 11, 2020

March 11, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Mallinckrodt, Mylan.
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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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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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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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