来源: Pharmaceutical Technology
J&J made a new EU regulatory submission for its multiple myeloma monoclonal antibody therapy darzalex. Credit: Michael Vi via Shutterstock. Free ReportHow is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success.
来源: Pharmaceutical Technology
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来源: Pharmaceutical Technology
来源: Pharmaceutical Technology
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A type II variation application is submitted when a company is seeking approval for a marketing authorisation that may have a major impact on the safety, quality or efficacy of a medicine, but no change is made to the active pharmaceutical ingredient, the strength of the drug or the route of administration.
In the EU, regulators previously approved the Darzalex combination for patients with newly diagnosed multiple myeloma and light chain (AL) amyloidosis, a blood disease that causes a buildup of amyloids in tissues and organs. Across the EU, it was estimated that over 35,000 individuals were diagnosed with multiple myeloma in 2022, with more than 22,700 patient deaths related to the condition. The latest regulatory submission is based on positive data from the Phase III PERSEUS trial (NCT03710603). The Phase III study, conducted in partnership with the European Myeloma Network, demonstrated a clinically meaningful reduction in the risk of disease progression or death at a median follow-up of 47.5 months, compared to the control group. See Also:Precigen files patent for insect population control using multiple lethal gene expression systems 来源: Pharmaceutical Technology
ContraFect files patent for antibacterial lysin-amp polypeptide constructs and compositions 来源: Pharmaceutical Technology
J&J presented data from the study at the 2023 American Society of Hematology (ASH) Annual Meeting, later publishing it in the New England Journal of Medicine. In a 6 March press release, Dr Craig Tendler, J&J’s vice president of clinical development, diagnostics, and global medical affairs said: “The impressive results from the PERSEUS study highlight the potential of this daratumumab subcutaneous-based regimen to transform patient outcomes and provide an effective therapy option in newly diagnosed, transplant-eligible multiple myeloma.” Free ReportHow is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success.
来源: Pharmaceutical Technology
Antigua & Barbuda (+1268)
Bosnia Herzegovina (+387)
Cape Verde Islands (+238)
Central African Republic (+236)
Dominican Republic (+1809)
Sao Tome & Principe (+239)
Trinidad & Tobago (+1868)
Turks & Caicos Islands (+1649)
United Arab Emirates (+971)
Virgin Islands - British (+1284)
Virgin Islands - US (+1340)
Bonaire, Sint Eustatius and Saba
British Indian Ocean Territory
French Southern Territories
Heard Island and McDonald Islands
Saint Helena, Ascension and Tristan da Cunha
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
South Georgia and The South
US Minor Outlying Islands
-->By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit
Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
Thank you.You will receive an email shortly. Please check for download the Report.