2017 Drug Development Labelling 
FDA Law Blog: Biosimilars
APRIL 8, 2025
Leading FDAs implementationof the Drug Competition Action Plan (DCAP). The DCAP was an initiative launched in 2017 to remove barriers to generic drug development, approval, and market entry (see our previous post here ). facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).
pharmaphorum
JANUARY 3, 2023
The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. ” The new data could accelerate partnering efforts of the drug this year.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
pharmaphorum
MARCH 23, 2021
Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by independent experts. . The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis.
Pharma Marketing Network
MARCH 25, 2022
The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. Additional concerns for the caregiver include a strain on physical and mental health. February 2019.
Pharmaceutical Technology
JANUARY 23, 2023
Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients. Mirikizumab has lost significant ground in the anti-IL23 drug class to AbbVie’s Skyrizi, and to a lesser extent Janssen’s Tremfya. Ther Innov Regul Sci.
European Pharmaceutical Review
JULY 4, 2024
In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. The worldwide trend of using botanical drugs and strategies for developing global drugs.
pharmaphorum
OCTOBER 18, 2022
Its aim is for patients to benefit from the treatment of others who came before, by providing data tools to drug developers and healthcare professionals. The two companies have been working together for some time.
Expert insights. Personalized for you.
141 
Let's personalize your content