pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. The post FDA fast-tracks Leap’s gastric cancer immunotherapy appeared first on.

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pharmaphorum

OCTOBER 19, 2020

Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results.

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Adverse Reactions FDA Chemotherapy Labelling 59

pharmaphorum

APRIL 23, 2021

The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 While some argued that GSK overpaid for Tesaro in 2018, at least the deal is bringing badly needed new drugs to market for the under-pressure UK pharma and its highly-paid research chief Hal Barron.

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FDA Chemotherapy Labelling 52

pharmaphorum

SEPTEMBER 6, 2022

The Nijmegen, Netherlands-based biotech was founded in 2018 to develop therapies designed to change the balance of protein expression within the tumour ‘microenvironment’, which can defend cancers against the immune system, and is increasingly becoming a source of new targets in oncology. The Series A round includes €3.6

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pharmaphorum

AUGUST 3, 2022

Ipsen and Servier’s hopes of extending the uses for chemotherapy drug Onivyde have been knocked back by a failed phase 3 trial of the drug as a second-line therapy for small cell lung cancer (SCLC). Onivyde is already FDA-approved for metastatic pancreatic cancer previously treated with gemcitabine, and Ipsen reported €83 million ($84.5

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Chemotherapy FDA 52

pharmaphorum

JUNE 13, 2022

Three years after Daiichi Sankyo’s FLR3 inhibitor quizartinib was rejected by the FDA, the drugmaker has reported the results of a new phase 3 trial that is key to getting the drug to the US market and chasing down rival drugs from Astellas and Novartis. Quizartinib plus standard chemotherapy reduced the risk of death by 22.4%

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Chemotherapy FDA 97

pharmaphorum

AUGUST 11, 2022

Pluvicto (lutetium (177Lu) vipivotide tetraxetan) has been cleared for adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor inhibitors and taxane-based chemotherapy or not medically suitable for taxane drugs. After a median follow-up of 20.9

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Chemotherapy FDA 64

Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. The current standard of care for many cancers is cisplatin chemotherapy or platinum therapy.

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FDA Communication Chemotherapy Labelling 52

pharmaphorum

JUNE 23, 2021

Keytruda (pembrolizumab) was given an accelerated approval in 2018 as a second-line therapy for PD-L1-positive cervical cancer, but the new survival data – from the phase 3 KEYNOTE-826 trial – could extend the use of the drug. The post In a class first, Merck’s Keytruda extends survival in cervical cancer appeared first on.

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Chemotherapy FDA Labelling 86

pharmaphorum

MAY 24, 2021

While there are plenty of EGFR-targeting drugs on the market for NSCLC, Rybrevant is the first to be FDA-approved for patients with exon 20 mutations, and also represents Janssen’s first lung cancer therapy. It is in trials as both a first-line and second-line therapy after chemotherapy for tis type of cancer.

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FDA Chemotherapy Immunization 52

pharmaphorum

OCTOBER 14, 2021

The FDA has approved Merck’s Keytruda as a first-line therapy for advanced cervical cancer. Keytruda (pembrolizumab) can be used in combination with chemotherapy, with or without bevacizumab, to treat patients with persistent, recurrent or metastatic cervical cancer where the tumour expresses a certain level of PD-L1.

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Chemotherapy Research Laboratories Immunization FDA 45

pharmaphorum

MARCH 24, 2022

Novartis has been steadily investing in radiopharmaceuticals over the last few years, and one of those deals has just paid off with an FDA approval for Pluvicto, the first targeted radioligand therapy for prostate cancer. After a median follow-up of 20.9 months, patients on Pluvicto had radiographic progression-free survival (PFS) of 8.7

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Chemotherapy Labelling FDA 59

pharmaphorum

NOVEMBER 10, 2022

In June, Clovis suffered another blow when it withdrew Rubraca’s mCRPC approval, after a post-marketing trial showed a higher death rate with the drug compared to chemotherapy when used as a third- or later-line treatment for the cancer.

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Chemotherapy Labelling FDA 59

pharmaphorum

JANUARY 5, 2021

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

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Chemotherapy Immunization FDA Labelling 52

pharmaphorum

AUGUST 4, 2022

The CRPC trial – KEYNOTE-921 – looked at the combination of Keytruda (pembrolizumab) with docetaxel in more than 1,000 patients who had not been treated with chemotherapy before, but who had seen disease progression despite earlier treatment with an anti-hormonal therapy.

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Chemotherapy Labelling FDA 105

pharmaphorum

APRIL 20, 2021

Zytiga is the older of the two drugs and was used in the active control arm of the ACIS study, which tested the combination of Erleada (apalutamide) and Zytiga (abiraterone) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC).

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Chemotherapy FDA 52

pharmaphorum

SEPTEMBER 29, 2020

China’s Junshi Biosciences has said it plans filings for a new cancer immunotherapy after its toripalimab outperformed standard chemotherapy in cancer of the upper throat in a phase 3 trial. Toripalimab was first approved in second line metastatic melanoma in China in December 2018 and launched in February last year.

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Chemotherapy FDA 40

European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies. cited 2023June].

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Chemotherapy Immunization FDA Vaccines 98

pharmaphorum

NOVEMBER 14, 2022

GSK has had another setback in its oncology business, after the FDA asked it to restrict use of its PARP inhibitor Zejula in ovarian, fallopian tube, or primary peritoneal cancer to patients with a specific mutation. That was due last Friday, but cancelled when GSK opted to withdraw the approval. GSK acquired Zejula as part of its $5.1

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Labelling Chemotherapy FDA Vaccines 52

pharmaphorum

FEBRUARY 24, 2021

The main object of the deal is Merck’s MEK 1/2 inhibitor pimasertib, a drug it originally licensed from Santhera Pharmaceuticals more than a decade ago, bringing the drug to phase 2 in melanoma and ovarian cancer and running trials in various other solid tumours and blood cancers before shelving it in 2018.

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Chemotherapy Compounding FDA 83

pharmaphorum

DECEMBER 23, 2020

The FDA has gone on to grant a fast review of the results ahead of a regulatory decision on the new lung cancer indication next year. While Trodelvy is already conditionally approved in the US, the data showing the drug improved overall survival compared with chemotherapy could be enough for it to clinch a permanent licence in the US.

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FDA Chemotherapy Compounding Vaccines 97

pharmaphorum

NOVEMBER 11, 2021

months in patients treated with chemotherapy. China’s pharma market was worth $137 billion in 2018 and is predicted to reach $140 to $170 billion by 2023, according to data from IQVIA. months, compared with 6.7 Learn more. link] #TNBC pic.twitter.com/as7B9X7p5T. — Gilead Sciences (@GileadSciences) November 11, 2021.

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Chemotherapy FDA 52

Roots Analysis

OCTOBER 4, 2023

During the research, I noticed a significant increase in the number of FDA approvals for bispecific antibodies in recent years. One area of interest is in oncology , where bispecific antibodies can be used to target two different antigens at the same time, leading to improved efficacy and reduced toxicity compared to traditional chemotherapy.

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Chemotherapy Immunization FDA 40

The Checkup by Singlecare

MARCH 23, 2023

The United States Congress legalized CBD derived from hemp in 2018 when the Agricultural Improvement Act was signed into law, removing hemp from the Federal Controlled Substances Act. The main difference is their legal status: CBD is considered legal if it comes from hemp , according to the Agriculture Improvement Act in 2018.

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Controlled Substances Medical Records Chemotherapy Compounding 52

pharmaphorum

DECEMBER 21, 2020

Trodelvy (sacituzumab govitecan) is a first-in-class TROP2 antibody-drug conjugate drug that was granted accelerated approval by the FDA in April for adults with metastatic triple-negative breast cancer (TNBC), who have received at least two previous therapies for metastatic disease. months in patients treated with chemotherapy.

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Chemotherapy Immunization FDA 126

PharmaShots

MARCH 29, 2023

Lupin has earned the US FDA approval for the generic version of Banzel as Rufinamide Oral Suspension. It is the only drug in its class of chemotherapy and is developed from the natural substance found in a sea sponge. The exact mechanism of action is uncertain. Glenmark has also released its generic drug version in the US market.

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FDA Chemotherapy Immunization Dosage 49

European Pharmaceutical Review

AUGUST 31, 2023

By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed. FDA approves new treatment for certain digestive tract cancers [Internet]. Pluvicto [Internet].

Hospitals 78

Hospitals FDA Chemotherapy 78

The Checkup by Singlecare

DECEMBER 13, 2023

Antiemetics may also reduce radiation-associated or chemotherapy-induced nausea resulting from cancer treatment. Kaopectate tablet and liquid suspension Bismuth subsalicylate is FDA-approved for treating nausea and vomiting. These medications can help with motion sickness, vertigo, postoperative nausea, and morning sickness.

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Dosage Labelling Chemotherapy Immunization 97

pharmaphorum

SEPTEMBER 8, 2020

In England for instance, the introduction of a biosimilar to prevent neutropenia in patients undergoing chemotherapy, resulted in a number of Strategic Health Authorities reassessing their guidance relating to this medicine. Published 17 September 2018. Unpleasant truth: let’s embrace it and take action. Published 8 March 2019.

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Chemotherapy Patient Care Vaccines FDA 99

The Checkup by Singlecare

NOVEMBER 13, 2023

According to the CDC , treatment includes surgery, chemotherapy, radiation therapy, targeted therapy, or a combination of these treatments. To help decrease the risk of shingles, Shingrix vaccine is FDA-approved for adults 50 and older. Antiviral medications such as Acyclovir ( zovirax ) and famciclovir are often prescribed.

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Mayo Clinic Vaccines Chemotherapy Communication 52

European Pharmaceutical Review

OCTOBER 19, 2023

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy?

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Chemotherapy Compounding Immunization FDA 88

Pharmaceutical Technology

SEPTEMBER 14, 2022

In 2018, the World Health Organisation (WHO) reported that 570,000 women were diagnosed with cervical cancer, of which 311,000 died of the disease. Early-stage cervical cancer patients achieve good recovery through surgery and concurrent chemotherapy, but treatment options are scarce for those with recurrent metastatic cervical cancer.

Vaccines 59

Vaccines Chemotherapy Dosage FDA 59

pharmaphorum

DECEMBER 2, 2020

US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche. The FDA had already granted fast-track designation to the combination therapy, allowing extra help during the development process on the basis of earlier clinical data.

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FDA Chemotherapy 52

PharmaShots

FEBRUARY 13, 2023

Traditional therapies have included multi-kinase inhibitors, chemotherapy, and symptom-directed treatments. There is a need for new therapies that selectively target the underlying mutation, KIT D816V, to improve outcomes and quality of life for people living with SM.

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Chemotherapy Immunization FDA 40

PharmaShots

FEBRUARY 13, 2023

Traditional therapies have included multi-kinase inhibitors, chemotherapy, and symptom-directed treatments. There is a need for new therapies that selectively target the underlying mutation, KIT D816V, to improve outcomes and quality of life for people living with SM.

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Chemotherapy Immunization FDA 40

ISPE

MAY 10, 2023

Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” 10 April 2018. Published 5 April 2018. SPuMoNI is particularly timely because blockchain has been proposed to become “a new digital service infrastructure” for Europe. 30 June 2016. link] 6 BBC News. Published 19 January 2017. link] 7 He, J., Cai, and X.

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Dosage Chemotherapy Documentation Labelling 52