Search Results for “cancer” – Page 28 – media

EirGenix’s Breast Cancer Biosimilar Receives Marketing Authorization by EC

TAIPEI, Nov. 22, 2023 /PRNewswire/ — EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission (EC). The marketing authorization in the EU will cover the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, which are the same indications approved by the EC for the reference biologic, Herceptin®. Sandoz AG and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix Inc. will remain responsible for the development and manufacturing of trastuzumab while Sandoz will hold the rights to commercialize the medicine upon approval in the global market (excluding Taiwan, China, Russia, and some Asian countries). Breast and gastric cancers are among the most frequently occurring in Europe, and combined, are responsible for nearly 200,000 deaths ...
- Source: drugdu
- 108
- November 28, 2023
White Bagging Policies Endanger the Lives of Cancer Patients

Insurers and PBMs are increasingly implementing white-bagging policies, which require oncology practices to obtain physician-administered infusions and other medications from designated specialty pharmacies often owned by or affiliated with insurers and their PBMs. By DR. JAMAL MISLEH Earlier this year, a young man in his mid-thirties with non-Hodgkin’s Lymphoma came to my oncology clinic for a chemotherapy infusion while waiting on the development of his CAR-T treatment. Under normal circumstances, our practice can move quickly when scheduling patients for their treatments since our in-office infusion clinic maintains an inventory of necessary medications that we prepare ourselves onsite. But, unbeknownst to me, my patient’s health insurance plan included a policy called “white bagging,”- a policy which we soon discovered when they denied one of the chemotherapy drugs I prescribed. Our clinical team repeatedly appealed the denial; however, the plan refused to cover the drug unless it was fulfilled through an unspecified ...
- Source: drugdu
- 95
- November 27, 2023
White Bagging Policies Endanger the Lives of Cancer Patients

Earlier this year, a young man in his mid-thirties with non-Hodgkin’s Lymphoma came to my oncology clinic for a chemotherapy infusion while waiting on the development of his CAR-T treatment. Under normal circumstances, our practice can move quickly when scheduling patients for their treatments since our in-office infusion clinic maintains an inventory of necessary medications that we prepare ourselves onsite. But, unbeknownst to me, my patient’s health insurance plan included a policy called “white bagging,”- a policy which we soon discovered when they denied one of the chemotherapy drugs I prescribed. Our clinical team repeatedly appealed the denial; however, the plan refused to cover the drug unless it was fulfilled through an unspecified designated specialty pharmacy associated with the patient’s pharmacy benefit manager. Eventually, we were able to negotiate coverage through our practice’s internal inventory, but by the time the patient was able to receive the drug four weeks had ...
- Source: drugdu
- 148
- November 25, 2023
EC approves pharmaand’s Rubraca as advanced ovarian cancer maintenance treatment

The European Commission (EC) has approved pharmaand’s (pharma&) Rubraca (rucaparib) as a first-line maintenance treatment for advanced ovarian cancer in patients who have responded to first-line platinum-based chemotherapy. The PARP inhibitor, which has been authorised for use in all advanced ovarian cancer patients regardless of their BRCA mutation status, was previously approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The EC’s latest decision on the drug follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage ATHENAMONO trial. Results showed that, as a first-line maintenance treatment, Rubraca significantly improved investigator- assessed progression-free survival compared with placebo in advanced ovarian cancer patients, regardless of BRCA mutation status. The safety profile observed in the ATHENAMONO trial was also consistent with ...
- Source: drugdu
- 100
- November 24, 2023
Q&A With William Ho, CEO of IN8bio

Mike Hollan Ho discusses how gamma-delta T cells can improve cancer treatments. Pharmaceutical Executive: Can you provide some background on gamma-delta T-Cells? William Ho: I’ve been in the biotech industry for over 22 years, and much of that was spent on the Wall Street side (investor banking, equity research, and as an investor). I co-founded the company together in 2016, and today we’re one of the leading companies developing gamma-delta T-Cells in oncology as a cellular therapy. Much of our work is based on Dr. Lamb’s lifetime of research on these t-cells. He was the first to describe them as being associated with better survival outcomes back in the 1990s. They were first identified in the mid 1980s. Dr. Lamb spent the better part of 25 years or so trying to figure out how to make that observation into a therapeutic. He needed to figure out how to manufacture, scale, ...
- Source: drugdu
- 100
- November 22, 2023
AstraZeneca’s AKT Inhibitor Wins FDA Approval for Combo Breast Cancer Treatment

By Tyler Patchen Pictured: AstraZeneca office in Gothenburg, Sweden AstraZeneca announced Friday that its adenosine triphosphate (ATP)-competitive inhibitor Truqap (capivasertib), in combination with its endocrine therapy Faslodex (fulvestrant), has been approved by the FDA to treat adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. According to AstraZeneca, the first-in-class inhibitor of all three AKT isoforms (AKT1/2/3) “has potential to reshape treatment for breast cancer patients” with specific biomarker alterations (PIK3CA, AKT1 or PTEN). The company also announced that the FDA has approved a “companion” diagnostic test meant to detect the “relevant” alterations. The FDA approval was based on the CAPItello-291 Phase III trial, which showed that the combination of Faslodex and Truqap reduced the risk of disease progression or death by 50%, compared to Faslodex alone, in patients with tumors having PI3K/AKT pathway biomarker alterations. “The combination of capivasertib and fulvestrant, a first-of-its-kind combination, provides a much-needed ...
- Source: drugdu
- 121
- November 21, 2023
Merck Expands Keytruda’s Label as a First-Line Option for Gastric Cancer

By Tristan Manalac Pictured: Merck Research Laboratories building in California The FDA on Thursday approved Merck’s anti-PD-1 blockbuster Keytruda (pembrolizumab) for the first-line treatment of adult patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Thursday’s label expansion is Keytruda’s seventh approval in gastrointestinal cancer and its 38th indication overall in the U.S., according to Merck’s announcement. This latest approval covers patients with HER2-negative cancers and authorizes the use of the PD-1 blocker in combination with fluoropyrimidine- and platinum-containing chemotherapy. Previously, Keytruda was indicated for gastric cancer only in patients who had progressed after at least two prior lines of systemic therapy, including fluoropyrimidine- and platinum-containing chemotherapy. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, in a statement called Keytruda’s label expansion an “important milestone” in the care of gastric or gastroesophageal junction adenocarcinoma. Data from the Phase ...
- Source: drugdu
- 97
- November 21, 2023
AstraZeneca’s Truqap plus Faslodex receives FDA approval for advanced breast cancer

AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) in combination with its endocrine therapy Faslodex (fulvestrant) has been approved by the US Food and Drug Administration (FDA) to treat a subset of advanced breast cancer patients. The FDA’s decision specifically applies to adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with at least one of three biomarker alterations: PIK3CA, AKT1 or PTEN. The US regulator has also approved the use of a companion diagnostic test to detect the relevant alterations. Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. Breast cancer is the most common cancer worldwide and more than 290,000 people in the US are expected to be diagnosed with breast cancer in 2023. HR-positive breast cancer is the most common subtype, with over 65% of tumours considered HR-positive and HER2-low ...
- Source: drugdu
- 112
- November 21, 2023
AstraZeneca Cancer Drug Is First in Class, But FDA Nod Is Narrower Than Expected

The most common type of breast cancer now has a new targeted treatment: an AstraZeneca drug that’s first in a new class of therapies addressing a certain genetic signature. But the new approval is narrower than expected, which limits the total addressable market for the therapy. The FDA approved the new drug, capivastertib, for use in combination with fulvestrant, an older AstraZeneca breast cancer therapy. The new drug will be marketed under the brand name Truqap. Approval of Truqap covers the treatment of adults with advanced cases of breast cancer classified as HR positive and HER2 negative. Those patients must also have disease that has either progressed after treatment with a hormone therapy or has come back after adjuvant therapy. Truqap joins a group of therapies already available for HR positive, HER2 negative breast cancer, including products from AstraZeneca. Truqap stands apart from them as the first AKT inhibitor. AKT ...
- Source: drugdu
- 110
- November 20, 2023
AstraZeneca shares positive phase 3 results for Imfinzi combination in liver cancer

AstraZeneca (AZ) has shared positive results from a late-stage study of its immunotherapy Imfinzi (durvalumab) when used as part of a combination treatment in a subset of patients with hepatocellular carcinoma (HCC), the most common type of liver cancer. The phase 3 EMERALD-1 trial has been evaluating Imfinzi plus transarterial chemoembolisation (TACE) followed by Imfinzi with or without Genentech’s Avastin (bevacizumab) until progression versus TACE alone in more than 600 patients with unresectable HCC eligible for embolisation. Approximately 75% of all primary liver cancers in adults are HCC and up to 30% of patients are eligible for embolisation, a procedure that blocks the blood supply to the tumour and can deliver chemotherapy or radiation therapy directly to the liver. Despite being the standard of care in this setting, most of those who receive embolisation experience rapid disease progression or recurrence. “Patients with liver cancer eligible for embolisation experience high rates ...
- Source: drugdu
- 207
- November 18, 2023

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