pharmaphorum

MAY 26, 2022

billion takeover of Agios Pharma’s oncology business after getting a key FDA approval for Tibsovo, the main asset in the deal. It can be used in in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Servier is on course to get a return on its $1.8

FDA 52

FDA Chemotherapy Labelling 52

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.

FDA 52

FDA Chemotherapy 52

pharmaphorum

NOVEMBER 23, 2020

ADC Therapeutics could claim its first product approval in the US next May, after the FDA started a priority review of lead drug Lonca for diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma. The post FDA sets May date for verdict on ADC’s lymphoma drug Lonca appeared first on.

FDA 52

FDA Chemotherapy Immunization 52

Pharmaceutical Technology

MARCH 30, 2023

On March 27, MSD announced that the combined use of Keytruda with chemotherapy significantly improved progression-free survival versus the chemotherapy alone, as a first-line therapy for advanced or recurrent endometrial carcinoma. This announcement is not the only recent development for Keytruda.

Chemotherapy 52

Chemotherapy Packaging FDA Documentation 52

pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. The FDA approval is conditional on a positive outcome from a phase 3 confirmatory trial – KRYSTAL-12 – which is scheduled to complete next year.

FDA 52

FDA Chemotherapy Labelling 52

pharmaphorum

AUGUST 31, 2022

The 345-subject CodeBreaK 200 trial of once-daily Lumakras (sotorasib) met its primary objective of improving progression-free survival (PFS) compared to chemotherapy with intravenous docetaxel in KRAS G12C-mutated NSCLC patients previously treated with platinum-based doublet chemotherapy and checkpoint inhibitor therapy.

Chemotherapy 64

Chemotherapy FDA Labelling 64

Pharmaceutical Technology

MARCH 23, 2023

The drug is currently licensed in combination with chemotherapy for patients with classical Hodgkin lymphoma, both as frontline therapy and for those at risk of progressing or having progressed following stem cell transplantation. Tivdak, a tissue-factor targeting ADC that was developed in collaboration with Genmab, was approved in 2021.

Chemotherapy 59

Chemotherapy Compounding FDA 59

European Pharmaceutical Review

OCTOBER 19, 2023

How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy? This has been demonstrated recently with PLUVICTO ® , which was the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer.

Chemotherapy 105

Chemotherapy Compounding Immunization FDA 105

European Pharmaceutical Review

MAY 4, 2023

Amivantamab was the first bispecific monoclonal antibody (BsMAb) approved in the EU to treat advanced NSCLC with EGFR exon 20 insertion mutations post chemotherapy. They are not US Food and Drug Administration (FDA)-approved for these patients due to the lack of benefit. Personalized medicine at FDA. 2012; 23(8): 6 – 9.

Immunization 98

Immunization Chemotherapy FDA 98

pharmaphorum

AUGUST 19, 2022

The endorsement of the drug’s efficacy and safety comes at a good time for the Swedish biotech, just a month before the drug, known as Pepaxto in the US, will have its safety reviewed by an FDA advisory committee after being withdrawn from sale there last year.

FDA 52

FDA Chemotherapy 52

pharmaphorum

JANUARY 25, 2023

9,273,135 and 9,320,811, which cover the use of a CTLA4 inhibitor in combination with a PD-1 inhibitor and chemotherapy drug gemcitabine, respectively. BMS’s Yervoy is an immunotherapy treatment, approved by the FDA in 2011 to treat melanoma, having since been approved by the agency to treat kidney, lung, colorectal, and other cancers.

Chemotherapy 52

Chemotherapy FDA 52

pharmaphorum

JULY 19, 2022

China’s Simcere Pharmaceutical has been granted approval in its home market for Cosela, a drug designed to limit the side effects of cancer chemotherapy, partnered with US biotech G1 Therapeutics. Simcere said that the number of new cancer patients requiring chemotherapy in China is expected to reach 4.2

Chemotherapy 59

Chemotherapy FDA 59

pharmaphorum

FEBRUARY 7, 2022

The drug was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for this type of cancer in June 2021 based on results from the GARNET trial , which included women who progressed on or after platinum-based chemotherapy.

Chemotherapy 52

Chemotherapy Labelling FDA 52

Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. Promising results were observed, with outcomes of 19.0% ORR, 81.0%

FDA 52

FDA Chemotherapy Labelling Pharmaceutical Companies 52

pharmaphorum

JANUARY 26, 2023

BTC study positive In the BTC trial – codenamed KEYNOTE-966 – a combination of Keytruda with chemotherapy showed a “statistically significant and clinically meaningful” improvement in overall survival versus chemo alone in newly diagnosed patients, and will form the basis of regulatory filings.

Chemotherapy 59

Chemotherapy Immunization FDA 59

pharmaphorum

APRIL 6, 2022

The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the drug due in July. The Swiss pharma giant licensed ex-China rights to tislelizumab from BeiGene in February 2021 for $650 million upfront and up to $1.55

FDA 52

FDA Chemotherapy 52

pharmaphorum

OCTOBER 3, 2022

Indeed, in the US, the FDA has recently declined approval of Lilly’s sintilimab (Tyvyt), driven in part by a vote 14-1 against approval by the Oncologic Drugs Advisory Committee, owing to the availability of China-only data1. Single Technology Appraisal: Sugemalimab with chemotherapy for untreated metastatic non-small-cell lung cancer ID4001.

Chemotherapy 98

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies FDA 98

Roots Analysis

DECEMBER 9, 2021

These therapies can be used as a monotherapy or in combination with other therapeutic modalities, such as chemotherapy, surgery or radiation therapy. HER2 Targeting Therapies Market, 2021-2031. The HER2 mutation results in oncogenic transformation of the breast epithelial cells. The Evolving landscape of HER2 Targeting Therapies.

Chemotherapy 52

Chemotherapy FDA 52

pharmaphorum

FEBRUARY 14, 2022

Padcev (enfortumab vedotin) is already approved as a second-line therapy for urothelial carcinoma (UC) after cisplatin chemotherapy and immunotherapy with checkpoint inhibitors, but Seagen and Astellas are working towards earlier use of the drug.

Chemotherapy 59

Chemotherapy FDA 59

Pharmaceutical Technology

JULY 8, 2022

In December 2014, Amgen’s landmark FDA approval saw Blincyto (blinatumomab) approved for relapsed/refractory (R/R) B-cell progenitor acute lymphoblastic leukaemia (B-ALL), at the time being the only marketed BiTE. months vs. 4.0

Chemotherapy 59

Chemotherapy Immunization FDA 59

Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Several CRISPR-based gene therapies are in development , with one for sickle cell disease and transfusion-dependent beta thalassemia (TDT), being examined by the FDA for an approval.

Chemotherapy 98

Chemotherapy FDA Communication Immunization 98

pharmaphorum

NOVEMBER 11, 2021

months in patients treated with chemotherapy. — Gilead Sciences (@GileadSciences) November 11, 2021. Gilead said the results were consistent with ORR data from its phase 3 ASCENT study, which also showed that the ADC significantly improved overall survival with a median of 12.1 months, compared with 6.7 Learn more.

Chemotherapy 52

Chemotherapy FDA 52

The Checkup by Singlecare

SEPTEMBER 12, 2023

According to the FDA, Guillain-Barré syndrome has been reported very rarely after Shingrix. In a 2021 study , there were three GBS cases per 1 million doses of Shingrix administered, and they always appeared within the first 42 days after getting the first dose of the vaccine. What medications should I avoid after the shingles vaccine?

Vaccines 105

Vaccines Immunization Pharmacy Program Director Chemotherapy 105

Pharmaceutical Technology

JUNE 16, 2023

In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum.

Chemotherapy 52

Chemotherapy Labelling FDA Communication 52

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 97

Hospitals FDA Chemotherapy 97

The Checkup by Singlecare

DECEMBER 29, 2023

Safety measures while using CoQ10 What are the FDA warnings about CoQ10? The Food and Drug Administration (FDA) has not issued any warnings about CoQ10. It is available over the counter, so the FDA has determined that it’s safe to use without medical supervision. Who should never take CoQ10? Who should use caution with CoQ10?

FDA 52

FDA Chemotherapy Mayo Clinic Dosage 52

European Pharmaceutical Review

DECEMBER 27, 2023

Bridging therapy has been shown to correlate with an inferior response to CAR T-cell therapy due to both progression of the chemotherapy-refractory malignant disease during the manufacturing period and increased toxicity. FDA; 2022 [cited 2023 Mar]. 2021;3(S1):6–10. Center for Biologics Evaluation and Research. 2022;40(9):945–55.

Adverse Reactions 104

Adverse Reactions Immunization Medical Schools Chemotherapy 104

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.

Dosage 97

Dosage Labelling Chemotherapy Immunization 97

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.

Chemotherapy 40

Chemotherapy Immunization FDA 40

The Thyroid Pharmacist

SEPTEMBER 20, 2024

Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. [45] As the intestines are made of smooth muscles, a reduction in the action of these muscles can slow down digestion and cause constipation. J Am Coll Nutr.

Health and Personal Care Stores 77

Health and Personal Care Stores Chemotherapy Immunization Compounding 77

ISPE

MAY 10, 2023

Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” Big Data Research 24 (15 May 2021): 100172. 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.

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

FDA 135

FDA Chemotherapy Immunization Vaccines 135

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.

Chemotherapy 105

Chemotherapy Immunization FDA Vaccines 105

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.

FDA 96

FDA Chemotherapy Compounding Vaccines 96

European Pharmaceutical Review

NOVEMBER 4, 2022

Despite advances with targeted and immuno-oncology therapies, chemotherapies remain a cornerstone of cancer treatment for many tumour types – a reflection of their significant anti?tumour While highly effective, taxanes also exhibit several of the typical limitations associated with systemic chemotherapies. tumour effects.

Chemotherapy 98

Chemotherapy FDA Hospitals Packaging 98

pharmaphorum

JULY 25, 2022

AstraZeneca and Daiichi Sankyo will hear back from the FDA before the end of 2022 on their license application for Enhertu in HER2-low breast cancer – an indication which could drive the drug into multibillion-dollar sales territory. The post FDA verdict on Enhertu in HER2-low breast cancer due before year-end appeared first on.

FDA 59

FDA Chemotherapy 59

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

FDA 98

FDA Vaccines Chemotherapy Communication 98