Remove tag efficacy
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Drug Regulatory Affairs Certificate Institutes in India

Pharmatutor

Historical Overview of Pharmaceutical Industries and Regulatory Affairs:During 1950s, multiple tragedies i.e., sulfanilamide elixir, vaccine tragedy and thalidomide tragedy have resulted in substantial increase of legislations for drug products quality, safety and efficacy. Mon, 07/18/2022 - 15:31.

Safety 59
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What is Biogen and can they repair their reputation?

World of DTC Marketing

Then, against the advisory panel’s advice, Aduhelm was approved, but insiders within the industry criticized both the FDA and Biogen weren’t sold on the drug or its price tag. 2wo: The new CEO needs to withdraw Aduhelm from the market until such a time that they have independent data that confirms efficacy.

Insurance 222
Insiders

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CSL doses first patient with haemophilia B gene therapy Hemgenix

Pharmaceutical Technology

The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. Despite the limited market, the price tags of haemophilia make it potentially lucrative. Haemophilia B is a rare condition.

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Can gene therapies for haemophilia defend their high price tags?

Pharmaceutical Technology

A previous October 2020 report concluded that longer-term safety and efficacy were needed to update health-benefit price benchmarks. In August 2020, the agency had rejected an approval application, suggesting the company complete its Phase III Gener8-1 study and include two-year follow-up safety and efficacy data. million price tag.

Safety 111
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Amylyx ALS drug draws criticism over $158,000 price tag

pharmaphorum

Chief medical officer at the independent drug pricing watchdog, Institute for Clinical and Economic Review (ICER), David Rind said Relyvrio should have been priced closer to the cost of production until there is clear proof about its efficacy. The post Amylyx ALS drug draws criticism over $158,000 price tag appeared first on.

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A broad range of unmet needs remains in the immuno-oncology space

Pharmaceutical Technology

Oncolytic viruses, cytokines, and therapeutic vaccines currently play a very minimal role in oncology treatment, with substantial efficacy still to be demonstrated for these classes. Combining data from all markets, efficacy-related needs were identified as the most important unmet needs category.

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Versanis’ bimagrumab, first-in-class obesity therapy, enters Phase IIb of development

Pharmaceutical Technology

On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. Despite its high price tag, bimagrumab’s unique features set it apart from currently marketed therapies.