The Pharma Data

MARCH 13, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. “Tau has become increasingly validated as a predictive biomarker for Alzheimer’s disease progression, as shown again in this trial,” said Liana G. Patients with treatment discontinuations were allowed to continue in the trial.

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The Pharma Data

NOVEMBER 9, 2020

and Canada, announced along with Eisai today that it has new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307). The trial looked at a combination of Keytruda from Merck and Lenvima from Eisai for the treatment of advanced renal cell carcinoma (RCC).

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The Pharma Data

SEPTEMBER 21, 2020

This came after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave the recommendation based on a positive opinion of the PAOLA-1 Phase 3 trial which was published in The New England Journal of Medicine. .

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. About Molnupiravir.

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The Pharma Data

JANUARY 26, 2021

In what looks like a breakthrough for COVID-19 treatments, Regeneron’s monoclonal antibody cocktail REGEN-COV (casirivimab and imdevimab) cut infection rates in half and provided full protection against symptomatic COVID-19, according to interim results from a phase 3 trial evaluating the treatment as a passive vaccine.

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The Pharma Data

SEPTEMBER 1, 2021

Study Now Enrolling Participants Who Live in the Same Household as Someone With Symptomatic, Laboratory-Confirmed COVID-19. The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms.

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The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial, also published in NEJM Evidence. The Committee voted 11 to 1, with 1 abstaining, that the indication should be limited to patients whose tumours have a BRCA mutation. 0.81; p<0.001).

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AUGUST 31, 2021

Continued approval was contingent upon verification and description of clinical benefit in confirmatory trials. This indication was approved under accelerated approval based on tumor response rate and duration of response.

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The Pharma Data

SEPTEMBER 28, 2021

Recommendation supported Data From Phase 3 KEYNOTE-355 Trial. Triple-negative carcinoma grows and spreads faster than other sorts of carcinoma and consequently features a worse prognosis,” said Dr. Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories.

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The Pharma Data

APRIL 8, 2021

The trial will continue to evaluate overall survival (OS), a key secondary endpoint. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Merck has the industry’s largest immuno-oncology clinical research program. KENILWORTH, N.J.–(BUSINESS About KEYNOTE-564.

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The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence. AstraZeneca and Merck will continue to work with the FDA as the agency completes its review of the application.

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The Pharma Data

JUNE 7, 2023

Rubin, senior vice president, global clinical development, Merck Research Laboratories. Patients with stage III and IV melanoma can be at high risk of having their cancer recur or metastasize to other sites,” said Dr. Eric H. The safety profile of KEYTRUDA was consistent with findings from previous studies.

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The Pharma Data

MARCH 16, 2021

This NDA is based on data from the Phase 2 Study-004 trial, in which belzutifan showed a confirmed overall response rate of 36.1% (n=22/61) (95% CI: 24.2-49.4) In fact, up to 70% of patients with VHL develop renal cell carcinoma during their lifetime,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

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Drug Target Review

NOVEMBER 1, 2023

I work in the Centre for Cancer Drug Discovery (CCDD) at The Institute of Cancer Research in London, which is an academic drug discovery centre. The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials.

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The Pharma Data

NOVEMBER 11, 2021

Reclamation for the VICTOR trial has begun. Like the VICTORIA trial, Merck and Bayer AG will serve asco-sponsors for the VICTOR trial. VICTOR is anticipated to take 39 months to complete, and the trial will include cases from 34 countries at roughly 500 spots around the world. The study will be executed by Merck.

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The Pharma Data

FEBRUARY 12, 2022

Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. ” The data supporting this EUA are primarily based on analyses from the Phase 2 BLAZE-4 trial (NCT04634409), treatment arms 9-14. “With the emergence of variants such as Omicron, treatment options remain limited.

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The Pharma Data

NOVEMBER 22, 2020

Patent Trial and Appeal Board (PTAB) had instituted inter partes review (IPR) against U.S. DAXI was evaluated in three Phase III trials, with the median time to loss of none or mild wrinkle severity was 24 weeks and the median time to return to baseline wrinkle severity was about 28 weeks. On October 14, Liquidia announced the U.S.

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The Pharma Data

OCTOBER 23, 2021

The blessing is grounded on final analysis from the Phase 3 KEYNOTE-355 trial, in which KEYTRUDA in combination with chemotherapy ( nab-paclitaxel, paclitaxel or gemcitabine/ carboplatin) significantly bettered overall survival ( Zilches), reducing the threat of death by 27 (HR = 0.73 (95 CI,0.55-0.95); Data Supporting the European Blessing.

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The Pharma Data

MARCH 17, 2021

This approval is based on results from the pivotal Phase 3 KEYNOTE-204 trial, in which KEYTRUDA monotherapy demonstrated a significant improvement in progression-free survival (PFS) compared with brentuximab vedotin (BV), a commonly used treatment. In this trial, the median duration of exposure to KEYTRUDA was 10 months (range, 1 day to 2.2

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PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required.

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The Pharma Data

JUNE 25, 2021

As previously announced , the trial will continue to evaluate OS, a key secondary endpoint. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

SEPTEMBER 7, 2021

This new indication was granted approval based on overall survival (OS) findings from the pivotal Phase 3 KEYNOTE-590 trial. KEYTRUDA Is Now Approved for Eight Indications Across Five Different Types of Cancer in China. KEYTRUDA is now approved for eight indications across five different types of cancer in China. “In About KEYNOTE-590.

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The Pharma Data

JUNE 7, 2022

Li, president, Merck Research Laboratories. The analyses add to our understanding of the clinical profile of LAGEVRIO and help to reinforce the importance of LAGEVRIO as part of the response to the COVID-19 pandemic,” said Dr. Dean Y.

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The Pharma Data

JUNE 29, 2021

This approval is based on results from the Phase 3 KEYNOTE-590 trial, in which KEYTRUDA plus 5-fluorouracil (5-FU) and cisplatin demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared with 5-FU and cisplatin alone in all pre-specified study populations.

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The Pharma Data

NOVEMBER 5, 2021

Li, administrative vice chairman and chairman, Merck Research Laboratories. “ We’re veritably thankful to the investigators, cases and their families for their critical benefactions to the MOVe- OUT study that made this authorization possible.”. heart complaint, diabetes).

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The Pharma Data

JANUARY 24, 2021

We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We Molnupiravir is currently being evaluated in Phase 2/3 clinical trials in both the hospital and out-patient settings.

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The Pharma Data

JULY 18, 2021

Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted. After sequential administration with PNEUMOVAX 23, OPA GMTs were numerically similar between the two vaccination groups for all 15 serotypes contained in VAXNEUVANCE.

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The Pharma Data

JULY 22, 2021

The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84]; Data Supporting the Approval.

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The Pharma Data

APRIL 11, 2021

” In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020 (with follow-up through March 19, 2021). Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR.

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The Pharma Data

JANUARY 20, 2021

The approval of Verquvo by the FDA, which is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase 3 VICTORIA trial and follows a priority regulatory review. Verquvo (vericiguat) 2.5

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AUGUST 15, 2021

The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC. The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptance toxicity. WELIREG is the first HIF-2? of patients.

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Conversations in Drug Development Trends

DECEMBER 12, 2022

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?

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The Pharma Data

JULY 21, 2021

“This announcement reflects another important regulatory milestone in the development of this medicine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Obtain a pregnancy test before the start of treatment.

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The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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The Pharma Data

NOVEMBER 18, 2021

At the recommendation of the eDMC, Merck is stopping dosing in the trial, with continued monitoring of study participants. In light of the findings from the MK-8507-013 study, Merck conducted a review of trends in total lymphocyte and CD4+ T-cell counts in company-sponsored clinical trials of ISL across all indications and dosing regimens.

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JULY 21, 2021

An overview of the islatravir treatment and prevention development program is available here , which includes our two Phase 3 IMPOWER trials evaluating islatravir as once-monthly oral PrEP across diverse populations of people who may benefit from additional HIV-1 prevention options. KENILWORTH, N.J.–(BUSINESS

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SEPTEMBER 17, 2020

Lilly ‘s chief scientific officer and president of Lilly Research Laboratories. . “Based on our initial clinical studies, we believe that virus neutralizing antibodies, including LY-CoV-555, could play an important role in the fight against COVID-19,” said Daniel Skovronsky , M.D.,

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