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SEC recommends approval for MSN Laboratories’ sleep disorder drug

AuroBlog - Aurous Healthcare Clinical Trials blog

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.

Drugs 189
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Lilly market value soars on higher sales, obesity drug potential

Bio Pharma Dive

The Indianapolis drugmaker is now worth more than $500 billion, higher than any other pharmaceutical company, as analysts project lucrative markets for its obesity and Alzheimer's drugs.

Marketing 246
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Pfizer to pull sickle cell drug from market, shut down trials

Bio Pharma Dive

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S.

Trials 280
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Osteoporosis market expected to reach $17.9bn across 7MM by 2033

Pharmaceutical Technology

The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% The osteoporosis market is expected to grow at a compound annual growth rate of 5.4%

Marketing 264
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The Future of Generic Drug Development for Emerging Markets: Opportunities and Challenges

Drug Patent Watch

The Future of Generic Drug Development: Opportunities and Challenges for Emerging Markets As the global healthcare landscape continues to evolve, emerging markets are playing an increasingly important role in shaping the future of generic drug development. Share your thoughts in the comments below!

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog

As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA. Leading FDAs implementationof the Drug Competition Action Plan (DCAP). And DPD was a significant piece of that puzzle. facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).

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Current and future players in the lupus market

Pharmaceutical Technology

As such, the SLE and LN marketplace is dominated by generics, and GSK’s Benlysta and AstraZeneca’s Saphnelo are the only drugs that have gained marketing approval specifically for SLE in more than 50 years. In previous years, Benlysta has managed to grow the lupus market in terms of value, having generated approximately $492.9m

Marketing 278