XTalks

FEBRUARY 7, 2023

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. What does this Approval Mean for Breast Cancer Patients? This approval is significant for the breast cancer community. months vs. 11.2

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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The Pharma Data

JULY 29, 2021

SYNAPSE showed that there was a 57% reduction in the proportion of patients who had surgery in the group treated with mepolizumab vs. placebo, HR=0.43 (95% CI 0.25, 0.76). With 41 clinical trials, mepolizumab has been studied in over 4,000 patients. The mechanism of action for mepolizumab has not been definitively established.

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Drug Discovery World

APRIL 4, 2023

Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. This made Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to be approved in the US.

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The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

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The Pharma Data

NOVEMBER 18, 2021

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’santi-PD-1 remedy, for the adjuvant treatment of cases with renal cell melanoma (RCC) at intermediate-high or high threat of rush following nephrectomy, or following nephrectomy and resection of metastatic lesions. 0.87); p = 0.0010) compared to placebo. About Merck.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial. KENILWORTH, N.J.–(BUSINESS Verquvo (vericiguat) 2.5 0.98; p=0.019).

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XTalks

DECEMBER 19, 2023

billion Company: Pfizer Disease it is FDA-approved to treat: Comirnaty is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. billion Company: Pfizer Diseases it is FDA-approved to treat: COVID-19 Cost: The price of Paxlovid oral tablet is around $10 for a supply of 30 tablets.

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XTalks

MARCH 25, 2021

Since joining Xtalks in 2015, she has written over 1,000 articles on diverse topics from remote clinical trials and rare disease to medical device sterilization and drug pricing. She focuses on news relating to the food industry and writes blogs on recruitment and HR in the life sciences.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e.,

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The Pharma Data

AUGUST 22, 2021

Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status. months [95% Confidence Interval (CI): 16.5 months [95% CI: 8.3 to 13.9]). to 13.9]).

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The Pharma Data

AUGUST 3, 2021

announced today results from an additional cohort of 101 adult patients from the COV-BARRIER trial. Similar mortality benefit was observed by Day 60 (HR [96% CI] = 0.56 [0.33, 0.97]) with a cumulative proportion of death of 45.1 In the COVID-19 clinical trials, adverse drug reactions in the safety population occurring in ?

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The Pharma Data

JULY 29, 2021

Data supporting the initial EUA included the primary endpoint of median time to recovery, which was seven days for baricitinib plus remdesivir compared to eight days for placebo plus remdesivir (HR: 1.15; 95% CI: 1.00, 1.31; p=0.047). In the COVID-19 clinical trials, adverse drug reactions in the safety population occurring in ?

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XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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The Pharma Data

FEBRUARY 8, 2021

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that ERLEADA ® plus ADT provided a statistically significant improvement in OS with a 35 percent reduction in risk of death versus ADT alone (HR 0.65; p<0.0001). ERLEADA ® received U.S. All rights reserved.

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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pharmaphorum

FEBRUARY 14, 2022

Astellas and Seagen’s Padcev is on course to move further up the treatment pathway in bladder cancer, thanks to a positive readout in the EV-103 clinical trial. For that reason, Seagen and Astellas are running phase 3 trials of Padcev in combination with Keytruda, in the hope showing synergy between the two treatments.

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The Pharma Data

MARCH 15, 2021

Trial enrolled patients with advanced cervical cancer regardless of PD-L1 status. The trial will be stopped early based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), and the data will form the basis of regulatory submissions in 2021. This is reflected in the trial where the average age was 51.”.

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Pharmaceutical Technology

MARCH 2, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; months: HR 0.70 [95% CI, 0.60-0.83]). months: HR 0.70 [95% CI, 0.60-0.83]). 0.83]; p<0.0001).

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The Pharma Data

APRIL 14, 2021

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. FOSTER CITY, Calif.–(BUSINESS –(BUSINESS WIRE)– Gilead Sciences, Inc.

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The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. vs. 11.4%) (p < 0.0001).

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The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. “The results add to the extensive clinical evidence supporting the use of single-agent ibrutinib for long-term disease control.” Barr , M.D., 1 Additionally, at 6.5

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The Pharma Data

MAY 4, 2021

The findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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Pharmaceutical Technology

MARCH 21, 2023

The ongoing monthly CMO Moves series is outlining the relationship between pharmaceutical and biotech companies, and CMOs using recent news events and clinical trial catalysts. Clinical trial catalysts announced for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.

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