pharmaphorum

JANUARY 26, 2022

At the moment the only other BiTE to reach the US market is Amgen’s CD19-targeting Blincyto (blinatumomab), which has been approved for various types of leukaemia and made $340 million in sales in the first nine months of 2021.

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pharmaphorum

JUNE 6, 2022

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. Another research note from SVB Securities predicted that repotrectinib could eventually become a $1.5

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Chemotherapy FDA Labelling 98

pharmaphorum

FEBRUARY 21, 2022

In the study, Enhertu was given to patients with HER2-low, unresectable and/or metastatic breast cancer previously treated with one to two prior lines of chemotherapy. AZ and Daiichi said the new data will be shared with global health authorities with a view to expanding its use even further.

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Chemotherapy Labelling 132

European Pharmaceutical Review

JULY 12, 2022

AstraZeneca’s blood-cancer treatment portfolio already includes Calquence (acalabrutinib), a chemotherapy-free monotherapy for patients with chronic lymphocytic leukaemia (CLL). . The transaction is expected to close in the third quarter of 2022, subject to customary closing conditions and regulatory clearances.

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Immunization Chemotherapy 98

pharmaphorum

MAY 29, 2022

The pair of new approvals are based on the results of the CheckMate-648 trial, and are for Opdivo (nivolumab) paired with chemotherapy or BMS’ CTLA4 inhibitor Yervoy (ipilimumab) as first-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCC) that can’t be treated with surgery.

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FDA Chemotherapy 59

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.

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Chemotherapy Compounding FDA 59

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. billion in 2028.

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Chemotherapy Packaging FDA Documentation 52

IDStewardship

DECEMBER 26, 2022

As someone who enjoys the simplicity of Sesame Street and the complexity of Antimicrobial Chemotherapy, this one was near and dear to my heart as well as a long time coming. December 2021 – First @IDstewardship TikTok. Active memberships at end of 2021: 409. EDITOR’S CHOICE: BEST ARTICLE OF 2022. CONTRIBUTORS SHOUT-OUT.

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European Pharmaceutical Review

AUGUST 10, 2022

” T-Dxd was approved by the European Medicines Agency (EMA) in 2021 for the treatment of unresectable or metastatic HER2-positive breast cancer. It is a chemical conjugate of an antibody against HER2 (trastuzumab) and a chemotherapy drug (deruxtecan).

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Chemotherapy Labelling Hospitals 98

pharmaphorum

NOVEMBER 26, 2020

Y-mAbs said last month it is expecting to resubmit omburtamab for approval to the FDA in late 2020 or early 2021, and will also start clinical trials of a next-generation version of the drug before year-end in neuroblastoma as well as B7-H3-positive leptomeningeal tumours. And combination trials with chemotherapy are also planned.

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FDA Chemotherapy Labelling 105

STAT

NOVEMBER 12, 2024

billion when it went public in 2021, is now just $111 million.  The medicine, Dato-DXd, is a type of next-generation chemotherapy called an antibody-drug conjugate that AstraZeneca and other companies are investing in heavily. Over the course of this year, its stock has plummeted 72% and its market capitalization, which was $3.5

Chemotherapy 83

Chemotherapy Insurance 83

pharmaphorum

FEBRUARY 8, 2021

— Bristol Myers Squibb (@bmsnews) February 5, 2021. At the moment there are limited fallback options for patients whose lymphoma progresses despite first line chemotherapy and anti-CD20 treatment. Our first #CARTcelltherapy is now approved by the #FDA.

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FDA Chemotherapy Labelling 111

pharmaphorum

APRIL 7, 2022

Previously, urothelial carcinoma patients were eligible only to receive supportive care until their cancer progressed, after which they could get second-line treatment with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab), chemotherapy with docetaxel or paclitaxel, or continued supportive care.

Chemotherapy 52

Chemotherapy 52

European Pharmaceutical Review

DECEMBER 12, 2022

Without the experimental CD7 CAR-T cell therapy, having previously undergone unsuccessful conventional treatments including chemotherapy and a bone marrow transplant, the patient’s only other option was palliative care. Six months later, the patient is doing well and is recovering at home.

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Chemotherapy Hospitals 124

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.

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Chemotherapy FDA Labelling 64

European Pharmaceutical Review

OCTOBER 19, 2023

How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy? There is great hope of this class of drug specifically to work in conjunction with immunotherapeutics, given the lack of toxicity of radiopharmaceuticals in general compared to most chemotherapies.

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Chemotherapy Compounding Immunization FDA 105

The Checkup by Singlecare

MARCH 7, 2024

In cases of chronic nausea—like the kind that comes from gastroesophageal reflux disease (GERD) , ulcers, or chemotherapy—prescription medications might be necessary. According to a recent study , breathing exercises reduced chemotherapy-induced nausea, vomiting, and retching in cancer patients.

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Chemotherapy 96

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. These patients face a poorer prognosis and shorter survival rates compared with lung cancer driven by more common EGFR mutations. 2012; 23(8): 6 – 9. Personalized medicine at FDA.

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Immunization Chemotherapy FDA 98

The Checkup by Singlecare

DECEMBER 14, 2023

Sources Community-acquired urinary tract Infection by Escherichia coli in the era of antibiotic resistance , BioMed Research International (2018) Urinary tract infection , Centers for Disease Control and Prevention (2021) Amoxicillin , StatPearls (2022) Uncomplicated urinary tract infections , StatPearls (2023) Beta-lactam antibiotics , StatPearls (..)

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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.

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Chemotherapy Labelling FDA 52

Pharmaceutical Technology

MAY 12, 2023

The agent is a human epidermal growth factor receptor 2 (HER2)-targeting ADC that utilises Eisai’s chemotherapy Halaven (eribulin) as its payload. The drug became a blockbuster last year, with sales reaching $1.9bn, up from $599m in 2021. The company generated almost $2bn in revenue in 2022, a close to 25% increase from 2021.

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Chemotherapy Compounding 64

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. In 2021, BMS sold over $2bn worth of Yervoy, according to a report by the company.

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

JANUARY 10, 2022

The EU approval is based on the phase 2 CodeBreak 100 study in 733 subjects, which found that treatment with Lumykras was associated with a 37% objective response rate (ORR), defined as a 30% or greater reduction in tumour volume, when used as a second-line therapy for KRAS G12C-mutated NSCLC after chemotherapy and/or immunotherapy.

Chemotherapy 59

Chemotherapy Labelling 59

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.

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Chemotherapy Immunization FDA 59

pharmaphorum

MAY 26, 2022

The US regulator has approved Tibsovo (ivosidenib) in combination with Bristol-Myers Squibb’s chemotherapy Vidaza (azacitidine) as a first-line therapy for IDH1-mutated acute myeloid leukaemia (AML), expanding the eligible patient population for the drug.

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FDA Chemotherapy Labelling 52

pharmaphorum

OCTOBER 3, 2022

It is therefore an interesting development that sugemalimab was given an Innovation Passport in NICE’s Innovative Licensing and Access Pathway (ILAP) in October 2021. Single Technology Appraisal: Sugemalimab with chemotherapy for untreated metastatic non-small-cell lung cancer ID4001. National Institute for Clinical Excellence.

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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.

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Chemotherapy FDA 52

pharmaphorum

AUGUST 19, 2022

The peptide-drug conjugate got accelerated approval from the FDA in February 2021 as a fifth-line therapy for multiple myeloma based on data from the phase 2 HORIZON study, but Oncopeptides voluntarily withdrew the drug from sale a few months later.

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FDA Chemotherapy 52

Druggist

MARCH 11, 2021

Treatment, for example, chemotherapy and radiotherapy. 2018.06.003 Available at: [link] Accessed on 10/03/2021. Available at: [link] Accessed on 11/03/2021. Available at: [link] Accessed on 10/03/2021. Available at: [link] Accessed on 09/03/2021. Available at: [link] Accessed on 09/03/2021.

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Packaging Chemotherapy 97

Pharmaceutical Technology

FEBRUARY 17, 2023

In 2021, the FDA granted Amgen’s (NASDAQ:AMGN) non-small cell lung cancer (NSCLC) drug Lumakras (sotorasib) an expedited approval, making it the first FDA-approved KRAS inhibitor. In 2021, Amgen agreed to conduct a Phase II study (NCT04933695), which is supposed to complete in May 2024, according to Clinicaltrials.gov.

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Dosage FDA Pharmaceutical Companies Pharmaceutical Companies 115

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.

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Chemotherapy FDA 59

pharmaphorum

DECEMBER 2, 2020

Aside from Gazyvaro, CLL can be treated with older chemotherapy agents, or Roche/AbbVie’s Venclexta (venetoclax) in some instances, and the fast track tag showed the FDA considered the combination to be a promising new contender on the market. TG said it expects the data submission to be complete in the first half of 2021.

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FDA Chemotherapy 52

pharmaphorum

NOVEMBER 23, 2020

The FDA has started a six-month review of Lonca for the treatment of relapsed or refractory DLBCL, with an action date of 21 May next year, and ADC says it hopes to have the drug on the market before the end of 2021.

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FDA Chemotherapy Immunization 52

Pharmaceutical Technology

JULY 8, 2022

Blincyto has provided a strong positive signal to demonstrate the clinical and commercial viability of BiTEs, with 2021 company-reported global sales of $542 million and GlobalData’s analyst consensus forecast projecting peak annual sales of $771 million by 2029, thereby sparking further industry interest in this field. months vs. 4.0

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Chemotherapy Immunization FDA 59

pharmaphorum

MARCH 9, 2021

Now, people living with particular types of lymphoma have individualised options beyond chemotherapy for the first time.”. Last accessed March 2021. Available at: [link] Last Accessed March 2021. Last accessed March 2021. Last accessed March 2021. Last accessed March 2021. Available at: [link]. 2018, page 3.

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Chemotherapy Communication Immunization 52

The Checkup by Singlecare

NOVEMBER 28, 2023

Causes of neuropathy can also include autoimmune diseases like rheumatoid arthritis, nutrient deficiencies, medication toxicity (such as chemotherapy), genetics, and age-related changes, says Dr. Machemehl.

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Chemotherapy Communication Immunization 119