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. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). log 10 copies/mL for combined doses).

Antibody 52

Antibody Trials Production Clinical Trials 52

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.

FDA Approval 52

FDA Approval Drugs Sales Development 52

The Pharma Data

APRIL 20, 2023

FDA approves Roche’s Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. 0.95; p<0.02). versus 57.5%), serious AEs (34.0% versus 30.6%), Grade 5 AEs (3.0% versus 13.0%).

FDA Approval 40

FDA Approval HR Antibody Drugs 40

XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

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.

FDA Approval 52

FDA Approval HR Trials Drugs 52

The Pharma Data

JULY 29, 2021

First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation Fourth indication for mepolizumab in the US for eosinophil-driven diseases. With 41 clinical trials, mepolizumab has been studied in over 4,000 patients. About mepolizumab.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

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.

Sales 64

Sales FDA Approval Drugs Vaccination 64

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.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pharmaceutical Technology

SEPTEMBER 13, 2022

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. month OS benefit compared to SOC chemotherapy in the DESTINY-Breast04 trial. months) versus physicians’ choice chemotherapy (11.2

HR 162

HR Marketing Hormones FDA Approval 162

The Pharma Data

JANUARY 15, 2021

“This approval represents the first time a HER2 directed medicine has demonstrated a significant improvement in survival compared to chemotherapy for patients following initial treatment in the metastatic setting and it has the potential to become the new standard of care for this patient population.”. Regular approval by the U.S.

Medicine 52

Medicine Trials Antibody HR 52

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 ?

HR 52

HR Licensing Licensing FDA Approval 52

The Pharma Data

AUGUST 3, 2021

today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1?1%,

HR 52

HR Antibody FDA Approval Licensing 52

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 ?

HR 52

HR Licensing Licensing FDA Approval 52

The Pharma Data

MARCH 18, 2022

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab 1. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.1 months (95% CI: 3.4

Antibody 52

Antibody HR Dermatology Trials 52

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.

Trials 59

Trials HR Drugs Sales 59

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.”.

Trials 52

Trials HR Genetics Medicine 52

Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. This work is undertaken once a new variant of concern has been identified by public health authorities. No dosage adjustment is needed in patients with mild renal impairment.

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Research Vaccination Vaccine Drugs 112

The Pharma Data

JULY 15, 2021

The trial investigated neoadjuvant KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy (the KEYTRUDA regimen) compared with neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen) in patients with high-risk early-stage triple-negative breast cancer (TNBC).

HR 52

HR Trials Clinical Development Clinical Research 52

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.

FDA Approval 52

FDA Approval HR Trials Medicine 52

The Pharma Data

DECEMBER 21, 2020

Adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83% in the primary endpoint of DFS in patients with Stage II and IIIA disease (hazard ratio [HR] 0.17; 95% confidence interval [CI] 0.12-0.23; The safety and tolerability of Tagrisso in this trial was consistent with previous trials in the metastatic setting.

Trials 52

Trials Medicine HR Development 52

The Pharma Data

MARCH 23, 2021

The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.

HR 52

HR FDA Approval Containment Genome 52

The Pharma Data

APRIL 7, 2021

The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months vs. 6.9

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

JUNE 26, 2021

Approval based on a Phase 3 trial demonstrating Libtayo significantly improved overall survival compared to chemotherapy in advanced NSCLC that included challenging-to-treat patient populations Libtayo now approved by the European Commission for three advanced cancers. 0.87; p=0.0022).

Trials 52

Trials Genetics Antibody HR 52

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. About Trodelvy.

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

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).

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

JANUARY 4, 2021

Food and Drug Administration (FDA) , in combination with Tecentriq ® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61).

Immune Response 52

Immune Response Medicine Protein Gene 52

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. 1 With up to seven years of follow-up, progression-free survival (PFS) benefit with single-agent IMBRUVICA was sustained (Hazard Ratio [HR] 0.160 [95 percent Confidence Interval (CI): 0.111–0.230]).

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

MAY 4, 2021

and developed Europe following the approvals in 2019 for combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced renal cell carcinoma; as well as. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Vaccination 40

Vaccination Vaccine Production Sales 40

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. Regulatory decisions by the FDA and EMA for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.

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