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NICE recommends first licenced treatment for AL amyloidosis

European Pharmaceutical Review

According to the Janssen Pharmaceutical Companies of Johnson & Johnson and NICE, DVCd is recommended for the rare bone marrow disorder, only if daratumumab is stopped after 24 cycles of treatment, or earlier if the condition progresses.

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The GoCART Coalition: Guidance for pharmacists

Hospital Pharmacy Europe

1,2 CAR T-cell products, such as tisagenlecleucel and axicabtagene ciloleucel, have been available on the European market for clinical use since 2018 3-5 and are used to treat patients who have not responded to other first-line therapies. 11 Many documents and checklists detail every stage of the pathway in preparing CAR T.

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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009. So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness?

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Navigating Life Sciences Construction in California

ISPE

It's no wonder that global pharmaceutical companies are increasingly sourcing innovation through alliances and partnerships with their peers in California. California accounted for 15–18% of patents granted in core life sciences applications between 2018 and 2022.

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External control arms and debunking real-world data myths

pharmaphorum

The US regulator has not only taken a proactive role in exploring the current and future applications of RWD, but also published the framework for its Real-World Evidence Program in 2018, which launched through the 21st Century Cures Act. Furthermore, ECAs are well-documented in the post-approval setting.

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The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

There was bipartisan support for the program at the hearing and support for measures such as requiring pharmaceutical companies to publish their prices in a password protected site on HRSA's website. Four of the five staffers originally involved in the investigation now work for or lobby for the pharmaceutical industry.

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Since the start of 2013, pharmaceutical companies based in the U.S. The Chinese company, Zhejiang HuaHai Pharmaceutical company in Linhai, China, had changed its manufacturing process.

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