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. What is the difference between a Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory vs a research laboratory?

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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

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

SEPTEMBER 28, 2021

10) and who haven’t received prior chemotherapy for metastatic disease. 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. Source link: [link].

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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

MARCH 17, 2021

KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88]; We are driven to advance therapies to help improve outcomes for patients with blood cancers, including those with relapsed or refractory classical Hodgkin lymphoma, through our broad clinical program.”. months versus 8.3 months (95% CI, 10.9-19.4)

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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. In the U.S., About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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The Pharma Data

MARCH 13, 2021

Further, prespecified exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in patients affected by Alzheimer’s disease. Lilly’s chief scientific officer and president of Lilly Research Laboratories. Apostolova, M.D.,

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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. We develop solutions and provide services to protect animals from disease and pain.

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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. 0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; KENILWORTH, N.J.–(BUSINESS

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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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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. PAH is a chronic, progressive disease caused by the hardening and narrowing of the pulmonary arteries that can cause right heart failure and eventual death. It was granted Priority Review. Source link.

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The Pharma Data

MARCH 16, 2021

This collaboration with the Lieber Institute further expands our innovative neuropsychiatric research program, a key focus area at Boehringer Ingelheim, with a first-in-class mechanism that may have the potential to address these symptoms,” said Dr. Hugh Marston, Ph.D., Head of Department CNS Diseases Research at Boehringer Ingelheim. “By

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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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Codon

JULY 21, 2024

Of course, AA and P-line rats are not the only research animals bred for the study of disease. The most famous of these is the Oncomouse , engineered in 1984 for the express purpose of developing tumors so that researchers could study cancer in living organisms, rather than in petri dishes. 1 Subscribe to Asimov Press.

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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. 1)] as determined by a U.S.

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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 months).

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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 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

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

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

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. Source link: [link].

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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). It is an aggressive type of breast cancer that has a high risk for disease recurrence. months (95% CI, 7.6-11.3) months (95% CI, 5.3-7.5), 0.80; p=0.0002) and doubled median PFS (16.5

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The Pharma Data

MARCH 23, 2021

0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; We are committed to putting patients first and continuing our research to help advance new approaches to potentially extend the lives of people with cancer. Ninety-one percent had M1 disease, and 9% had M0 disease.

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The Pharma Data

JUNE 1, 2022

Under her leadership, Pfizer advanced into clinical development or approval bacterial vaccine programs directed at the prevention of diseases due to Streptococcus pneumoniae, Group B Streptococcus, Neisseria meningitidis, Staphylococcus aureus, and Clostridium difficile. Dr. Anderson joined Pfizer via Wyeth in 2007.

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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

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. Kenilworth, N.J.,

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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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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. The median OS was 12.4 months (95% CI, 10.5-14.0)

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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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JANUARY 20, 2021

“The approval of Verquvo provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Therapy was initiated at Verquvo 2.5 Kenilworth, N.J.,

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DECEMBER 17, 2020

Most recently, Cadavid served as senior vice president and Head of Clinical Development at Fulcrum Therapeutics where he led the development of multiple small molecules for the treatment of genetically defined rare diseases. Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies.

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APRIL 11, 2021

50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. Initiate or adjust anti-hypertensive therapy as appropriate. Retevmo has not been studied in patients with clinically significant active cardiovascular disease or recent myocardial infarction. Retevmo is an U.S.

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NOVEMBER 9, 2020

. “The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” said Daniel Skovronsky, M.D.,

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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 23, 2021

10) and Who Have Not Received Prior Chemotherapy for Metastatic Disease. 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.

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