The Pharma Data

JANUARY 10, 2021

The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. ?. .

Clinical Trials 40

Clinical Trials Clinical Development Trials Small Molecule 40

The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

FDA 40

FDA Production Licensing Licensing 40

The Pharma Data

DECEMBER 5, 2020

The most common adverse events (AEs) were cytokine release syndrome (CRS; 39%; n=19), anemia (37%; n=18), fatigue (35%; n=17), nausea (31%; n=15), pyrexia (31%; n=15) and back pain (27%; n=13). 6 months of follow-up, 83% (10 of 12 patients) have ongoing responses for up to 13 months at the time of analysis.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

NOVEMBER 4, 2020

The 8 mg and 12 mg twice-daily doses continued to be generally well tolerated and adverse events were consistent with those reported in the Phase 2 trials. License and research and development revenue. 2019. Revenue: . .

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Treatment 52

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. This study is planned to start in late 2024 and conclude in late 2025.

FDA 40

FDA Trials Therapies Regulations 40

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

The Pharma Data

APRIL 14, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

Government 52

Government Hospitals Long-Term Care Facilities Treatment 52

The Pharma Data

JANUARY 21, 2021

Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. These events may have been associated with inadvertent (partial) intravenous administration and began to resolve within a few minutes after the injection. Hepatotoxicity: Hepatic adverse events were reported.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. Read 🏘️ Events Send me your events. Ricciardi M.J.

DNA 52

DNA RNA Engineering Licensing 52

New Drug Approvals

SEPTEMBER 29, 2024

The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. The most common treatment-related adverse events were gastrointestinal, occurring in 12 to 15 percent of treated participants. All volunteers with AD had P. gingivalis DNA fragments in their CSF at baseline.

Small Molecule 62

Small Molecule DNA Disease Trials 62

The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Disease 40

Disease FDA Clinical Trials Licensing 40

The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. The most frequent treatment-emergent adverse events were nasopharyngitis and atopic dermatitis. kg (70 mg) and -7.9

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

The Pharma Data

APRIL 16, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

MAY 4, 2021

About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together. Some of these events required hospitalization. It is approved in the U.S.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

MARCH 5, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

The Pharma Data

JANUARY 26, 2021

Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 Serious adverse events were reported at a similar frequency in the bamlanivimab and etesevimab together and placebo groups. INDIANAPOLIS, Jan. See Limitations of Authorized Use.

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

The Pharma Data

MARCH 11, 2021

There were four events in patients taking bamlanivimab with etesevimab and 15 events in patients taking placebo, representing an 87 percent risk reduction (p<0.0001). Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone.

Hospitals 40

Hospitals Trials Long-Term Care Facilities Treatment 40

The Pharma Data

AUGUST 22, 2021

The LAAB was well tolerated and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales. About AstraZeneca. Griffin MP, et al. Antimicrob Agents Chemother. Yu XQ, et al.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

Codon

FEBRUARY 23, 2025

By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. Pharmaceutical developers often avoid fluorine because the element can alter pharmacokinetics, making it hard to predict how a drug will be absorbed, metabolized, and excreted. This has happened before with other drugs.

Clinical Trials 70

Clinical Trials Virus Vaccine DNA 70