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Home » Topics » Regulatory

Regulatory
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India ramps up testing requirements after contaminated cough syrup exports

May 30, 2023
By T.V. Padma
India has revised its policy to make quality tests by government-certified laboratories mandatory for cough syrups to be exported beginning June 1. The decision is the result of numerous safety alerts involving the death of children.
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Cancer cells

Bayer’s PI3K inhibitor cleared in China for follicular lymphoma

May 30, 2023
By Doris Yu
Bayer AG’s copanlisib was approved in China for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. It is the first indication approved in the country for copanlisib, which is entering a market with room to grow but marked by some domestic competition.
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EU flag, pills, syringe

Otsuka’s schizophrenia drug filing U-turn amongst latest CHMP announcements

May 30, 2023
By Caroline Richards
Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.
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Regulatory actions for May 30, 2023

May 30, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biophytis, BMS, Curium, Gilead, Hutchmed, Inventiva, Ipsen, Novavax, Novo Nordisk, Sino, Takeda.
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Regulatory actions for May 26, 2023

May 26, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Vielight.
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Clinical trial virtual display

UK investing £121M to revive clinical trial activity as part of overall life sciences boost

May 26, 2023
By Nuala Moran
The U.K. government has announced £121 million (US$148 million) in funding to reboot the commercial clinical trials system after a sharp decline saw the number of industry-sponsored studies falling by 44% from 2017 to 2021.
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FDA Approved stamp
Biopharma regulatory actions and approvals April 2023

US FDA approvals show modest growth in 2023, while global drug approvals decline

May 26, 2023
By Amanda Lanier
U.S. FDA approvals had a modest increase during the first four months of 2023 compared to last year, but still fall short of the peaks seen in 2019 and 2021.
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Demand for obesity drugs a golden opportunity for counterfeits

May 26, 2023
By Mari Serebrov
Mixing a trendy drug for a global health problem like obesity with a demand that far exceeds the supply cooks up a recipe too good for counterfeiters to ignore. That’s the problem patients are facing with Novo Nordisk A/S’ semaglutide products, Ozempic and Wegovy, which have been in short supply all over the world since early last year due to significant, and unexpected, demand for weight management.
Read More
EU flag, pills, syringe

Otsuka’s schizophrenia drug filing U-turn amongst latest CHMP announcements

May 26, 2023
By Caroline Richards
Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.
Read More

Regulatory actions for May 26, 2023

May 26, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accropeutics, Applied Therapeutics, Celltrion, Dyne, Hibio, Janssen, Legend, Pfizer, Sandoz.
Read More
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