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Review of 505(b)(2) Drug Products Approved by USFDA from 2010 to 2020: A Focus on Intellectual Property and Regulatory Considerations

Drug Patent Watch

A review article in the Journal of Pharmaceutical Sciences analyzes the trends in drug repurposing through the 505(b)(2) pathway, as approved by the USFDA from 2010 to 2020.

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US states seek $26.4 billion from major pharmaceutical manufacturers and distributors to settle opioid litigation

The Pharma Data

Multiple Attorney Generals from across the US are seeking billions of dollars in damages to settle opioid cases against major pharmaceutical manufacturers and distributors. . Photo by Adam. This amounts to the states seeking a collective $21.14 billion from opioid distributors including Cardinal Health, McKesson Corp and AmerisourceBergen.

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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Afimetoran

New Drug Approvals

US10071079, Example 15 Ref WO2018005586 [link] The invention further pertains to pharmaceutical compositions containing at least one compound according to the invention that are useful for the treatment of conditions related to TLR modulation, such as inflammatory and autoimmune diseases, and methods of inhibiting the activity of TLRs in a mammal.

RNA 62
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Cardiovascular Disease Still Leading Cause of Death Worldwide

The Pharma Data

percent from 2010. percent increase compared with 2010. ” Several authors disclosed financial ties to the pharmaceutical and other industries. According to the report, in 2019, about 18.6 million deaths were attributed to CVD globally, representing an increase of 17.1 The crude prevalence of CVD was 523.2 © 2021 HealthDay.

Disease 52
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The evolution of cell therapy to address unmet medical needs

Drug Target Review

Also, many companies never reached the point where they received validation from big pharmaceutical companies. MSTX), from 2010, and was also a member of its board of directors from 2011, until Mast’s merger with Savara, Inc. Mr Culley served on the Board of Orphagen Pharmaceuticals, Inc. SVRA) in April 2017.

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How the AI revolution can accelerate early drug discovery

Drug Target Review

Training AI/ML tools to predict results of otherwise complex and time-consuming calculations is gaining traction in pharmaceutical R&D. To really benefit from AI, the pharmaceutical industry must be more open to data sharing. Rob joined Cresset as CEO in 2010 and now also serves as Chairman of Cresset.

Drugs 105