The Pharma Data

AUGUST 31, 2021

today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Source link: [link].

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The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.

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The Pharma Data

JUNE 2, 2023

Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. prostate cancer is the second most common cancer in men, and despite an increase in the number of available therapies for patients with mCRPC, five-year survival remains low. 0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59])

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Conversations in Drug Development Trends

DECEMBER 12, 2022

Genetic testing may help confirm a clinical diagnosis, help predict disease prognosis and progression, facilitate early detection of symptoms, allow for family planning and genetic counseling, inform optimal treatments and therapies, and/or promote enrollment in clinical trials.

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The Pharma Data

MARCH 15, 2022

The safety profile of KEYTRUDA in combination with LYNPARZA in this trial was consistent with that observed in previously reported studies for the individual therapies; however, the combination was associated with a higher incidence of grade 3-5 adverse events and drug-related serious adverse events, compared to the control arm.

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The Pharma Data

AUGUST 10, 2021

The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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The Pharma Data

MARCH 23, 2022

Baynes, head of Global Clinical Development (GCD) and Chief Medical Officer, Merck Research Laboratories (MRL), will be retiring from Merck in July. Li, president, Merck Research Laboratories, until his retirement. Dr. Baynes will be succeeded by Dr. Eliav Barr, effective April 1, 2022.

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The Pharma Data

OCTOBER 12, 2021

The winning research receives 5,000 USD and a bronze horse for the research that has the highest translational potential; the investigator is awarded with 1,000 USD and the research laboratory 4,000 USD to continue the great work. This year, Prof. billion euros in 2020 and presence in more than 150 countries.

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The Pharma Data

SEPTEMBER 28, 2021

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. About KEYTRUDA® (pembrolizumab) Injection, 100 mg.

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The Pharma Data

MARCH 17, 2021

The European Commission’s approval of an expanded use of KEYTRUDA provides another option for adult and pediatric patients with classical Hodgkin lymphoma who have disease progression after earlier lines of therapy or relapse after transplantation,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “We

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The Pharma Data

JUNE 7, 2023

Consider the potential for drug interactions prior to and during PREVYMIS therapy; review concomitant medications during PREVYMIS therapy; and monitor for adverse reactions associated with PREVYMIS and concomitant medications. See additional Selected Safety Information below. Source link: [link]

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The Pharma Data

MARCH 5, 2021

Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations. In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition.

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The Pharma Data

MARCH 16, 2021

While peripherally acting COMT inhibitors are currently used as an adjunctive therapy in the treatment of neurological conditions, including Parkinson’s disease, this new collaboration is investigating centrally acting COMT inhibitors in neuropsychiatric disorders. Our mission is to create breakthrough therapies that change lives.

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The Pharma Data

JUNE 29, 2021

KEYTRUDA is First Anti-PD-1 Therapy Approved in Europe in Combination With Chemotherapy for First-Line Treatment of Advanced Esophageal or GEJ Cancer, Regardless of Histology. KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

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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).

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The Pharma Data

JUNE 7, 2023

Patients who experience metastases at distant sites typically have worse survival outcomes and a poor prognosis, thus these results showing a reduction in the risk of distant recurrence underscore the potential of neoantigen therapy,” said Kyle Holen, M.D., Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology.

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The Pharma Data

NOVEMBER 22, 2020

The drug is a once-daily oral precision therapy designed for highly potent and selective targeting of oncogenic RET alterations. The FDA approved it under the brand name Gavreto on September 4. In addition to RET-altered NSCLC, it is being developed for RET-altered thyroid cancer and other solid tumors.

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The Pharma Data

MARCH 30, 2021

KEYTRUDA has become an important treatment option for certain patients with locally advanced or metastatic bladder cancer in the European Union and other countries around the world,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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The Pharma Data

JULY 6, 2021

Food and Drug Administration (FDA)-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy. About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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The Pharma Data

DECEMBER 17, 2020

Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies. Thérin is the president of Advanced Therapies at Siemens Healthineers. Prior to SpringWorks, Smith was the executive vice president of Gene Therapy at Bamboo Therapeutics. Previously he was CFO of Voyager Therapeutics.

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PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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The Pharma Data

JANUARY 26, 2021

Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said the emergence of new variants of the virus calls for new strategies even while vaccination is ongoing in many parts of the world.

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The Pharma Data

JULY 22, 2021

Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma That is Not Microsatellite Instability-High or Mismatch Repair Deficient, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. After a median follow-up of 13.4 About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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The Pharma Data

SEPTEMBER 7, 2021

In China, esophageal and gastroesophageal junction cancers are leading causes of death, and there have been few treatment advances for patients over the past several decades,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

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The Pharma Data

AUGUST 30, 2021

today announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). KEYTRUDA Also Approved for the Treatment of Patients With Unresectable, Advanced or Recurrent High Microsatellite Instability (MSI-H) Colorectal Cancer.

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The Pharma Data

JULY 21, 2021

mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. In the EU, VERQUVO (2.5 VERQUVO is being jointly developed by Merck and Bayer AG. mg, 5 mg and 10 mg).

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The Pharma Data

AUGUST 15, 2021

WELIREG Approved for Adult Patients With VHL Disease Who Require Therapy for Associated Renal Cell Carcinoma, Central Nervous System Hemangioblastomas, or Pancreatic Neuroendocrine Tumors, Not Requiring Immediate Surgery. inhibitor therapy approved in the U.S. WELIREG is the first HIF-2? As an inhibitor of HIF-2?,

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Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. Read A one-time gene therapy injection for spinal muscular atrophy. Gene Therapy. Nature Neuroscience. Read You love to see it! Trends in Biotechnology. ” Max Bayer.

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The Pharma Data

OCTOBER 25, 2021

Week 48 Data Met Safety and Efficacy Endpoints in Adults with HIV-1 Infection Currently on Antiretroviral Therapy. Merck Research Laboratories. “

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The Pharma Data

OCTOBER 23, 2021

KEYTRUDA Is the First Anti-PD-1 Therapy in Combination With Chemotherapy to Demonstrate Statistically Significant Overall Survival in These Patients; Based on Results From the Phase 3 KEYNOTE-355 Study. Vicki Goodman, vice chairman, clinical exploration, Merck Research Laboratories. “

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The Pharma Data

JANUARY 26, 2021

percent) in patients taking therapy and 36 events (7.0 Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution. who require oxygen therapy due to COVID-19, OR.

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The Pharma Data

JUNE 1, 2022

Prior to Pfizer, Dr. Anderson worked at Merck Research Laboratories where she founded its prokaryotic bio-combinatorial engineering laboratory and initiated a bacterial vaccine program. She leaves Pfizer’s Vaccine R&D group stronger than ever and poised to continue to deliver innovative science.”.

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The Pharma Data

APRIL 11, 2021

Initiate or adjust anti-hypertensive therapy as appropriate. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Optimize blood pressure prior to initiating Retevmo. SE HCP ISI All_25MAR2021.

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The Pharma Data

MARCH 23, 2021

Because esophageal cancer generally has poor survival rates, new first-line therapies are urgently needed for these patients,” said Dr. Peter Enzinger, Director, Center for Esophageal and Gastric Cancer, Dana-Farber/Brigham and Women’s Cancer Center. For more information, see “Selected Important Safety Information” below.

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The Pharma Data

NOVEMBER 18, 2021

50 copies/mL, demonstrating that antiviral efficacy was comparable between DOR/ISL and different antiretroviral therapy regimens (ILLUMINATE SWITCH A) and between DOR/ISL and bictegravir/emtricitabine/tenofovir (ILLUMINATE SWITCH B). About IMAGINE-DR.

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The Pharma Data

JULY 21, 2021

In the ongoing Phase 2a (NCT04003103) randomized, double-blind, parallel assignment, placebo-controlled, multicenter trial in adults at low-risk for acquiring HIV-1 infection, participants were randomly assigned (2:2:1) to one of three oral once-monthly therapy groups: islatravir 60 mg, islatravir 120 mg or placebo.

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