New warnings about the risk of addiction associated with over-the-counter medicines containing codeine and dihydrocodeine (DHC) have been brought in by the UK regulator, the MHRA, in a bid to halt overuse.
New warnings about the risk of addiction associated with over-the-counter medicines containing codeine and dihydrocodeine (DHC) have been brought in by the UK regulator, the MHRA, in a bid to halt overuse.
The agency is limiting the number of OTC indications allowed for the products containing these ingredients and, updating patient information...
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The biotech announced positive topline results from its pivotal study in Alexander disease, which has an estimated population of about 300 in the US.
Sanofi’s MS hopeful tolebrutinib hits a regulatory hurdle in the US, renewing pressure on the firm’s pipeline. Analysts hope the delay won’t prove material.
The privately owned biotech said it would pause its Phase I/II study of CAP-002 in STXBP1-related disorders after the first patient in the study died.
Charl van Zyl tells Scrip that pipeline is the priority as the company discontinues commercial operations in 27 markets.
The Phase III trial of the SERD has shown a significant benefit in the intent-to-treat and ESR1-mutated populations in post-CDK ER+/HER2- metastatic breast cancer but whether the data will be enough to support an equally broad approval remains to be seen.
Sanofi’s MS hopeful tolebrutinib hits a regulatory hurdle in the US, renewing pressure on the firm’s pipeline. Analysts hope the delay won’t prove material.
India revokes Novartis's patent pertaining to Entresto, upholding the objections of opponents including the Indian Pharmaceutical Alliance on lack of novelty and prior claiming, among others. Novartis decided against participating in the hearings.
