pharmaphorum

FEBRUARY 8, 2021

Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of large B-cell lymphoma. DLBCL is the most common type of NHL in adults, accounting for around a third of the 77,000 new cases diagnosed in the US, according to the FDA.

FDA

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

Dosage

pharmaphorum

MAY 29, 2022

The FDA has cleared two combination drug regimens based on Bristol-Myers Squibb’s PD-1 inhibitor Opdivo for previously-untreated advanced oesophageal cancer, encroaching on territory held by Merck & Co’s rival Keytruda. The post BMS’ Opdivo gets late-stage oesophageal cancer nod from FDA appeared first on.

FDA

pharmaphorum

JUNE 6, 2022

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

Chemotherapy

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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