Pharmaceutical Technology

DECEMBER 20, 2022

Companies are recognizing the importance of working together to advance science, improve solutions, and best serve patients. Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. Free Whitepaper.

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Clarivate

OCTOBER 19, 2023

The most important benefit is that it can deliver efficacious therapeutics to patients awaiting treatment much faster. the FDA offers a period of 3 years of data exclusivity for a new application of a previously approved drug. For example, in the U.S.,

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Clarivate

MAY 24, 2023

A narrow FDA AdComm vote in favor of accelerated approval for Sarepta’s first-in-class gene transfer therapy illustrates challenges faced by regulators, payers and developers as a wave of innovative genetic treatments for rare diseases comes to market. Most patients must use a wheelchair by the time they are in their teens.

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Clarivate

OCTOBER 7, 2021

Clarivate oncology experts share major takeaways from ESMO and their expected impact on the treatment landscape and patients. Introduced earlier in the treatment paradigm, Keytruda could substantially reduce risk of recurrence in high-risk early-stage melanoma patients. Context: In August 2021, Merck & Co. in the placebo group.

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Pharmaceutical Technology

MARCH 21, 2023

FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older. Regulatory decisions by the FDA and EMA for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.

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Pharmaceutical Technology

JANUARY 15, 2023

FDA expands approval labels. The FDA passed several positive supplementary approval decisions involving younger patients. Baxter Biopharma Solutions, Fareva SA, BSP Pharmaceuticals SpA, and Takeda Pharmaceuticals are manufacturing the parenteral portion of the ADC. Source: GlobalData Pharmaceutical Intelligence Center.

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Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. as the secondary endpoints. as the secondary endpoints.

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Pharmaceutical Technology

FEBRUARY 27, 2023

EMA and NICE decisions come through In late January, the EU expanded the approved use of Daiichi Sankyo’s and AstraZeneca’s antibody-drug conjugate (ADC) Enhertu (deruxtecan) as a monotherapy to include the treatment of unresectable or metastatic HER2-low breast cancer adult patients.

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Clarivate

DECEMBER 14, 2023

The weight loss drug conundrum PBMs may rethink their coverage policies for GLP-1 receptor agonists after the November 2023 approval of Eli Lilly’s Zepbound whose active ingredient was already available as diabetes drug Mounjaro ® and which joins Novo Nordisk’s Wegovy ® among the latest class of FDA-approved options.

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