Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
The New Orleans-based Fifth US Circuit Court of Appeals remained steadfast in a ruling to heavily restrict access to the abortion pill mifepristone on 16 August. 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.
Source: 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
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US Minor Outlying Islands
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The court decision banned telemedicine prescriptions and mail orders of the drug, which will take effect upon Supreme Court review. This could potentially happen in its upcoming term from October 2023 to June 2024.
Source: Pharmaceutical Technology
ReportsLOA and PTSR Model - Zoliflodacin in Uncomplicated Cervical And Urethral Gonorrhea GlobalData Source: Pharmaceutical Technology
ReportsChemotherapy Induced Nausea and Vomiting Drugs in Development by Stages, Target, MoA, RoA, Molecu... GlobalData View allCompanies IntelligenceDanco Laboratories LLCThe White HouseGenbiopro IncView all
The US Food and Drug Administration (FDA) first approved mifepristone in 2000, under its brand name Mifeprex, imposing several conditions to prevent potentially serious medical side effects from the drug. However, in 2016, the organisation lightened these restrictions. The agency followed this with approval of the drug’s generic version in 2019. In 2021, the FDA further reduced restrictions such that therapy did not need to be prescribed solely in person. Finally, earlier this year, the regulator approved mifepristone for over-the-counter use, increasing access to those in need. In the US, mifepristone is sold by Danco Laboratories in its branded version while GenBioPro sells a generic version of the drug. The abortion pill has been the subject of several heated debates in 2023, surrounding its over-the-counter approval, and a Texas appeals court decision amongst other things. The 16 August appeal decision centred around the drug’s 2000 approval, the 2016 removal of prior protections for mifepristone, the generic approval and the 2021 amendment. The Alliance for Hippocratic Medicine, a Christian association of doctors who advocate for ethical medical practices, plus similar organisations and individual doctors, challenged these actions. The group argued that the FDA had taken unlawful action under the Administrative Procedure Act, by “[overlooking] important safety risks in approving mifepristone and amending its restrictions”. The Administrative Procedure Act was instilled in 1946 to govern the way in which federal agencies develop and issue regulations.
The White House’s press secretary Karine Jean-Pierre stated the Biden Administration’s strong disagreement with the ruling in a same-day press release. She said: “If the Fifth Circuit’s ruling stands, it will significantly roll back the ability for women in every state to get the healthcare they need, and undermine FDA’s scientific, evidence-based process for approving safe and effective medications that patients rely on.”
The US Supreme Court will have the opportunity to overturn the Appeals Court decision, following its landmark 2022 overturning of the Roe versus Wade ruling that had legalised abortion nationwide.
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.By GlobalData
Source: 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.Please check your email to download the Report.