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BioWorld - Thursday, June 12, 2025
Home » Topics » Regulatory

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New Indian medical device policy aims to boost local manufacturing

June 27, 2023
By T.V. Padma
With a new medical device policy, India is laying the groundwork for a spurt in domestic manufacturing and to emerge as an innovative and globally competitive in the space, which is currently heavily reliant on imports. The new National Medical Devices Policy 2023, approved by the government at the end of April and notified in May, aims to place the Indian medical devices sector on an accelerated growth path.
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Regulatory actions for June 27, 2023

June 27, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alx, Invivyd, Pharvaris.
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Industry not placated by changes to US negotiations guidance

June 26, 2023
By Mari Serebrov
In releasing a revised guidance June 30 detailing the requirements of the new Medicare Drug Price Negotiation Program, the U.S. Centers for Medicare & Medicaid Services addressed some of the issues raised in recent constitutional challenges to the guidance and the underlying negotiation provision in the Inflation Reduction Act.
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Hair loss illustration

Another win for Pfizer as FDA approves JAK inhibitor for teen hair loss

June 26, 2023
By Caroline Richards
The U.S. FDA is on a roll with new drug approvals for Pfizer Inc., clearing severe alopecia areata treatment Litfulo (ritlecitinib) just under a month after giving the go-ahead for the firm’s oral COVID-19 antiviral, Paxlovid (nirmatelvir/ritonavir).
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Gavel and FTC logo

US FTC no longer alone in trying to stop Amgen-Horizon deal

June 26, 2023
By Mari Serebrov
The U.S. FTC picked up six allies in its unprecedented effort to stop Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc, as the attorneys general for California, Illinois, Minnesota, New York, Washington and Wisconsin joined the agency in signing onto an amended complaint filed under seal June 22 in the U.S. District Court for the Northern District of Illinois.
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Regulatory actions for June 26, 2023

June 26, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medical IP.
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Regulatory actions for June 26, 2023

June 26, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amylyx, Astrazeneca, Boehringer Ingelheim, Erasca, Gilead, Intercept, Janssen, Leo, Lianbio, Moderna, Molecure, Pfizer, Sarepta, Zealand.
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Regulatory actions for June 23, 2023

June 23, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atyr, Cidara, GSK, Kite, Kymera, Mindset.
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Healios, Sumitomo begin phase I/II trial of allogeneic iPS cells in retinal pigment epithelium tears

June 23, 2023
By Tamra Sami
Japan’s Pharmaceutical and Medical Devices Agency has cleared Healios K.K. and Sumitomo Pharma Co. Ltd. to begin a phase I/II study of HLCR-011, which is composed of retinal pigment epithelial (RPE) cells derived from allogeneic induced pluripotent stem cells (iPS) in patients with RPE tear.
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Intercept quits NASH on second CRL

June 23, 2023
By Jennifer Boggs
Intercept Pharmaceuticals Inc.’s second attempt to score an expanded U.S. FDA approval of its farnesoid X receptor agonist, obeticholic acid, in patients with non-alcoholic steatohepatitis (NASH) went the way of the first, with the agency issuing another complete response letter (CRL), prompting the company to drop all NASH-related investment and cut a third of its workforce.
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