The Pharma Data

APRIL 8, 2021

The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. .

Hospitals 52

Hospitals FDA Approval Laboratories Treatment 52

Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. Why Clinical Trials Stop: The Role of Genetics. Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. Are drug targets with genetic support twice as likely to be approved?

Disease 111

Disease Clinical Trials Therapies Science 111

The Pharma Data

OCTOBER 21, 2020

The pooled analysis examined 1,744 participants across 16 countries currently taking long-acting cabotegravir and rilpivirine as part of the regimen’s ongoing global clinical development programme of six studies, which includes the phase IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE clinical trials. About ViiV Healthcare.

Clinical Development 52

Clinical Development Therapies Clinical Trials Treatment 52

The Pharma Data

NOVEMBER 9, 2021

”As one of the longest safety trials for a JAK asset in this complaint, these data can help healthcare providers and people living with rheumatoid arthritis in better understanding OLUMIANT when considering treatment options that can be used for dragged ages of time.” Taylor,M.D.,Ph.D., See the full Prescribing Information then.

Treatment 52

Treatment FDA Approval Licensing Licensing 52

The Pharma Data

AUGUST 3, 2021

announced today results from an additional cohort of 101 adult patients from the COV-BARRIER trial. See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib. Serious Side Effects.

Hospitals 52

Hospitals FDA FDA Approval Licensing 52

The Pharma Data

JULY 29, 2021

baricitinib has not been approved by the FDA to treat COVID-19, and the efficacy, safety and optimal duration of treatment of baricitinib for COVID-19 has not been established. Evaluation of baricitinib’s efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials. In the U.S., Serious Side Effects.

Hospitals 52

Hospitals FDA Laboratories Treatment 52

The Pharma Data

APRIL 6, 2021

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm 3 were reported in Olumiant clinical trials. Increases of ALT ?5x

Treatment 52

Treatment Drugs Clinical Trials Therapies 52

The Pharma Data

OCTOBER 29, 2020

Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo. 10x ULN were observed in patients in Olumiant clinical trials.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

Codon

MARCH 28, 2023

In 2009, the USC professor received millions from the Defense Advanced Research Projects Agency, or DARPA, to build a device that plugs into the brain and enhances memory recall. There was nothing left over for human trials, until an opportune call came from Elon Musk’s secretary. The first project, REMIND, began in 2009.

Engineering 52

Engineering Research Science FDA Approval 52

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Olumiant was recently approved in Japan for the treatment of pneumonia associated with COVID-19 in hospitalized adult patients.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm 3 were reported in Olumiant clinical trials. Increases of ALT ?5x

Licensing 40

Licensing Licensing Therapies Laboratories 40

Codon

JANUARY 26, 2025

They ran extensive trials and experiments to inoculate people against this perennial killer. The 2009 H1N1 “swine flu,” for example, emerged when human, avian, and swine strains mixed inside pigs. It’s still in preclinical development, but the hope is to move into clinical trials soon.

Vaccine 101

Vaccine Immune Response Virus Clinical Trials 101

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. million new infections that occur globally each year. percent.

Clinical Trials 70

Clinical Trials Virus Vaccine DNA 70

Drug & Device Law

FEBRUARY 22, 2024

In particular, plaintiffs trying to force clinical trial sponsors to continue providing free drug after the end of the trial—something clinical trial participants are told is not a guaranty—have floundered. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

FDA Approval 52

FDA Approval Clinical Trials Trials FDA 52

Drug & Device Law

JULY 24, 2023

at *6 (plaintiff “has documents and formularies reaching back to only 2009”). Thus, “[o]ne supposed ‘nightmare’ trial is preferable to many hundreds of shorter ones.” First, the class plaintiff got away with destruction of evidence. It preserved no records for nine of the eleven years of the class period. 2023 WL 4191651, at *8.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JANUARY 30, 2023

555 (2009), and rated only a “ cf. 555 (2009), concurring in the 6-3 no-preemption result. 2019), or Mutual Pharmaceutical Co. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. citation in PLIVA, Inc. Mensing , 564 U.S. Dow Agrosciences LLC , 544 U.S. Levine , 555 U.S.

FDA 72

FDA Regulations Production Government 72

Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. Changing tack after the fact did not work.

FDA 59

FDA Regulations FDA Approval Production 59

Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp. Genzyme Corp. ,

Production 72

Production FDA Approval Packaging Doctors 72

Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? 555 (2009). 2021), which was our top-ranked trial court-level decision of 2021. femur fractures.

FDA 52

FDA Regulations Science Drugs 52