Fierce Pharma

JANUARY 26, 2024

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. | Merck’s unique approval for Keytruda as a postsurgerical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 (..)

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Patients 326

Fierce Pharma

APRIL 8, 2024

Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found. One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials.

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FDA Medicine 278

Fierce Pharma

FEBRUARY 7, 2024

Despite reaching new heights in breast cancer, Eli Lilly’s Verzenio has been sent packing in prostate cancer. | Despite reaching new heights in breast cancer, Eli Lilly’s Verzenio has been sent packing in prostate cancer. Meanwhile, the Indianapolis pharma has another phase 3 prostate cancer program in the works.

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Pharma 212

Fierce Pharma

JANUARY 19, 2024

More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnose | More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its (..)

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FDA Patients 293

Fierce Pharma

APRIL 4, 2024

After two delays spanning more than a year, Novartis is finally gearing up for a high-stakes FDA application to expand the radiotherapy Pluvicto into earlier treatment of prostate cancer. But will the FDA bite?

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FDA Patients 220

Fierce Pharma

JANUARY 16, 2024

After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type.

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FDA 248

World of DTC Marketing

FEBRUARY 17, 2022

The mortality rate from lung cancer has dropped in recent decades—by 56% in men from 1990 to 2019 and by 32% in women from 2002 to 2019. In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. cost approximately $156.2

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Insurance Medicine Leads Medical 271

Fierce Pharma

DECEMBER 22, 2023

As the FDA investigates a safety signal for approved CAR-T therapies, the agency has upgraded a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carv | As the FDA investigates a safety signal for approved CAR-T therapies, the agency has elevated a warning about secondary cancers resulting from use of (..)

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FDA Safety 291

Fierce Pharma

OCTOBER 16, 2023

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer.

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FDA Patients 344

Fierce Pharma

MARCH 18, 2024

After a quick FDA approval in a subset of endometrial cancer, GSK is back with more data for two Jemperli regimens in hopes of reaching a broader patient population.

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FDA Patients 224

Fierce Pharma

JANUARY 18, 2024

Six months after England’s National Institute for Health and Care Excellence (NICE) spurned Pfizer’s breast cancer treatment Talzenna (talazoparib) because it was not cost effective, the agency has | Six months after England’s National Institute for Health and Care Excellence spurned Pfizer’s breast cancer treatment Talzenna because it was not cost (..)

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Fierce Pharma

NOVEMBER 16, 2023

Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Watch out, Pfizer and Roche. Watch out, Pfizer and Roche.

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FDA Marketing 293

Fierce Pharma

JANUARY 8, 2024

San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis.

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Fierce Pharma

JUNE 16, 2023

Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study.

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Patients 298

Fierce Pharma

APRIL 23, 2024

Novartis has increased its full-year sales guidance after pulling off a strong first quarter, even though three cancer drugs missed analysts’ expectations ahead of their key expansion opportunities.

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Sales 180

Fierce Pharma

MARCH 21, 2024

Merck’s attempt to use Lynparza to boost Keytruda in metastatic non-small cell lung cancer has come up short with a second pivotal trial failure. Merck’s attempt to use Lynparza to boost Keytruda in metastatic non-small cell lung cancer has come up short with a second pivotal trial failure.

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Fierce Pharma

DECEMBER 18, 2023

On a mission to grow in oncology, GSK has more positive data to report in endometrial cancer. | GSK has more positive data to report in endometrial cancer as the company's PD-1/PARP combination turned in a trial win. The combination could represent a threat to a rival therapy at AstraZeneca.

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Fierce Pharma

JANUARY 22, 2024

. | The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer. The trial outcome marks a setback in Gilead's ambition to grow its presence in the oncology sector.

Patients 290

Patients 290

MedCity News

APRIL 23, 2024

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News. The novel immunotherapy works by sparking activity from three types of immune cells.

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FDA Patients Biopharma Pharma 127

Fierce Pharma

JANUARY 26, 2024

Now, Merck can claim another positive readout for Keytruda in bladder cancer, although this one is short of a home run.

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MedCity News

APRIL 19, 2024

The FDA expanded the approval of Roche’s Alecensa to include adjuvant treatment of non-small cell lung cancer. The targeted therapy addresses cancers driven by the ALK genetic mutation. The post Roche Drug Scores Label Expansion for Earlier Use in Lung Cancer appeared first on MedCity News.

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Fierce Pharma

FEBRUARY 28, 2023

Merck ends last Keytruda trial in aggressive prostate cancer campaign, takes separate hit in lung cancer aliu Tue, 02/28/2023 - 09:40

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MedCity News

APRIL 24, 2024

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer.

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FDA Patients Biopharma Pharma 101

MedCity News

APRIL 30, 2024

With cancer as its initial focus, the startup contends its approach could offer safety and efficacy advantages compared to currently available targeted therapies. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer appeared first on MedCity News. The post J.P.

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Leads Safety Biopharma Pharma 96

Pharmaceutical Technology

MARCH 25, 2024

Cancer Research UK and the CRIS Cancer Foundation have awarded a £1.7m ($2.1m) grant for developing the lung cancer vaccine LungVax.

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Fierce Pharma

SEPTEMBER 27, 2023

NICE poised to reject AstraZeneca, Daiichi’s Enhertu in HER2-low breast cancer aliu Wed, 09/27/2023 - 10:40

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MedCity News

APRIL 8, 2024

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.

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PharmaTimes

APRIL 19, 2024

Both will develop cancer vaccine candidates in selected haematological and solid tumour indications

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MedCity News

NOVEMBER 28, 2023

CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.

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FDA Patients Biopharma Pharma 126

MedCity News

APRIL 11, 2024

Novartis gains global rights to an Arvinas protein degrading drug that targets the androgen receptor to treat prostate cancer. The post Novartis Pays $150M to Nab a Phase 3-Ready Protein Degrader for Prostate Cancer appeared first on MedCity News. The deal also includes a preclinical molecule addressing an androgen receptor variant.

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Biopharma Pharma 119

MedCity News

JANUARY 30, 2024

Even just a year ago, we couldn’t fathom a cure for cancer. Cancer treatment is one area that could benefit significantly from AI, as it can aid in early detection, precise diagnosis, and personalized treatment plans. AI algorithms can analyze medical images and identify any abnormalities that may indicate cancer. Now, we can.

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Side effects Ethics Medical Patients 128

MedCity News

FEBRUARY 29, 2024

While the past several decades have seen progress in early detection, recent innovations in metastatic breast cancer—or cancer that has spread to distant parts of the body, including the bone, brain, or lungs—continues to cause excitement.

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Biopharma 113

PharmaTimes

APRIL 12, 2024

NSCLC is the most common type of lung cancer and is responsible for up to 85% of all cases

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MedCity News

FEBRUARY 6, 2024

acquisition of MorphoSys brings two cancer drug candidates, one of which would give the pharmaceutical giant a way to stand apart from other myelofibrosis treatments. In a separate deal, MorphoSys sold to Incyte its rights to a partnered blood cancer drug. Novartis’s €2.7B

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MedCity News

MARCH 15, 2024

Tubulis’s next-generation ADC cancer drugs are designed to overcome limitations of currently available therapies in this drug class. The new financing will support clinical trial plans, but first, preclinical proof-of-concept data will be presented during the American Association for Cancer Research annual meeting.

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Biopharma Pharma 117

MedCity News

APRIL 16, 2024

The post Guidance and Education For Employees Facing a Cancer Journey appeared first on MedCity News. In vulnerable moments when employees need it most, virtual specialty care delivers a human connection that offers empathy, support, and guidance.

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Pharmaceutical Technology

APRIL 22, 2024

Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.

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Patients 103