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FDA Grants Fast Track Designation to Sumitomo Pharma’s Novel Treatment for Patients with Relapsed or Refractory Acute Myeloid Leukemia

By Don Tracy, Associate Editor DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability. Image Credit: Adobe Stock Images/Pichitchai The FDA has granted Fast Track Designation to Sumitomo Pharma America’s DSP-5336, an investigational small molecule inhibitor for the treatment of relapsed or refractory acute myeloid leukemia (AML) with KMT2A rearrangement (MLLr) or nucleophosmin mutation (NPM1m). According to the company, DSP-5336 targets the menin and mixed-lineage leukemia (MLL) protein interaction, which is considered vital in a variety of biological processes, including cell growth and genomic stability.1 “For patients and families facing a diagnosis of relapsed or refractory acute myeloid leukemia, significant unmet medical needs remain—and we share in their urgency to identify and advance new treatment pathways,” said Tsutomu Nakagawa, PhD, president, CEO, SMPA, in a press release. “We are encouraged by FDA’s decision and look forward to working closely ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 160
- July 17, 2024
Positive Data in Pancreatic Cancer Pave Way for Pivotal Test of Revolution Medicines Drug

Revolution Medicines drug RMC-6236 increased progression-free survival in patients with advanced cases of pancreatic ductal adenocarcinoma. With these results, the biotech is preparing for a Phase 3 clinical trial in this indication, the most common type of pancreatic cancer. By Frank Vinluan Pancreatic cancer remains one of the toughest cancers to treat, but Revolution Medicines has data from an early-stage study showing its experimental treatment helped patients live longer without their disease worsening. With these encouraging results, Revolution said Monday it is preparing to proceed to a pivotal clinical trial enrolling patients with advanced cases of the most common type of pancreatic cancer. Revolution develops therapies that target the RAS family of proteins, validated but elusive targets for cancer drug research. Mutations to these proteins lead to the uncontrolled cell growth that happens in a variety of cancers. The most advanced program from Redwood City, California-based Revolution is RMC-6236. This small molecule is ...
- Source: https://medcitynews.com/author/fvinluan/
- 152
- July 17, 2024
Urine Test to Revolutionize Lyme Disease Testing

Lyme disease is the most common animal-to-human transmitted disease in the United States, with around 476,000 people diagnosed and treated annually, and its incidence has been increasing. If not addressed promptly and effectively, those affected may experience persistent symptoms known as Post-Treatment Lyme Disease Syndrome, which include issues with concentration and memory, dizziness, fatigue, body aches, depression, and sleep disturbances. Currently, the standard diagnostic approach involves an antibody blood test that detects the immune system’s response to the bacteria responsible for Lyme disease. Now, urine testing could revolutionize Lyme disease detection and diagnosis thanks to its many advantages over existing techniques. Researchers at George Mason University (Fairfax, VA, USA) have developed a urine test for Lyme disease that detects the Borrelia bacteria, which causes Lyme disease. This advancement allows for the confirmation of an infection shortly after a tick bite, leading to timely treatment and helping to avoid the ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801060/urine-test-to-revolutionize-lyme-disease-testing.html
- 125
- May 4, 2024
AstraZeneca’s Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027

In 2014, the FDA approved the first (adenosine diphosphate-ribose) polymerase (PARP) inhibitor AstraZeneca/Merck’s Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who have received three or more prior lines of chemotherapy. Since then, the PARP inhibitors market has made significant strides, but Lynparza maintains its dominance with projected global sales of $4 billion by 2027, according to an analyst consensus forecast by GlobalData. GlobalData’s analyst consensus reveals that high sales projections underscore Lynparza’s role in treating multiple cancer types, including ovarian, pancreatic, prostate, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Expected revenues in these indications will reach over 68 per cent of the global PARP inhibitors market by 2027. GlaxoSmithKline’s (GSK) Zejula (niraparib) holds the second position with over $1.6 billion in sales and 28 per cent of the market share. Most of Lynparza’s sales come from ovarian and HER2-negative breast cancer treatment. Biswajit Podder, ...
- Source: https://www.expresspharma.in/astrazenecas-lynparza-to-dominate-parp-inhibitors-market-with-4-bn-in-sales-by-2027-globaldata/
- 199
- May 4, 2024
Lupin receives EIR from USFDA for its Aurangabad manufacturing facility

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI) Lupin has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Aurangabad manufacturing facility. The inspection was conducted from March 6 to March 15, 2024. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). Nilesh Gupta, Managing Director, Lupin said, “We are pleased to receive the EIR with VAI status from the USFDA as an outcome of the recent inspection of our Aurangabad facility. It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide.”
- Source: https://www.lupin.com/lupin-receives-eir-from-us-fda-for-its-aurangabad-manufacturing-facility/
- 124
- May 3, 2024
FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. By Frank Vinluan Immunotherapy is already a treatment option for bladder cancer, but in many cases, these therapies fail or the cancer comes back. When it returns, the next option is removing the bladder. FDA approval of a novel immunotherapy gives bladder cancer patients an alternative to surgical removal of the organ. The FDA has approved ImmunityBio’s therapy, Anktivo, for the treatment of non-muscle invasive bladder cancer (NMIBC), which is cancer found only on the inner layer of the bladder wall. The regulatory decision announced late Monday covers adults whose disease is unresponsive to Bacillus Calmette-Guérin (BCG), a standard of care immunotherapy for bladder cancer. BCG is a benign type of bacteria. Delivered to the bladder via a catheter, the bacteria induce an immune ...
- Source: https://medcitynews.com/author/fvinluan/
- 135
- May 2, 2024
Navigate Pharma Trade with Ease – Essential Websites & Tools for Success

The pharmaceutical trade industry is fiercely competitive, requiring constant updates on the latest market information and technological tools for better business expansion. Today, we’ll introduce some indispensable websites and practical tools to help you conduct your business more efficiently. 1.Global Trade Alert (https://www.globaltradealert.org/) Global Trade Alert is a website offering real-time tracking of global trade data, policy, and regulatory changes, helping trade professionals understand each country’s import and export policies for pharmaceutical products, market dynamics, and potential risks. 2.gov (https://www.export.gov/) Export.gov, the official website of the U.S. International Trade Administration, provides vast information on exporting, including market intelligence, export planning, and trade policies. The pharmaceutical product export guide helps trade professionals comprehend the U.S. pharmaceutical market overview and export regulations. 3.FDA (https://www.fda.gov/) The FDA, the official website of the U.S. Food and Drug Administration, provides regulations, standards, and registration requirements for various pharmaceutical products, enabling trade professionals to ensure their ...
- Source: drugdu
- 258
- February 22, 2024
New Stool Test for Detecting Colorectal Cancer Could Reduce Unnecessary Colonoscopies

Globally, around 1.9 million people are diagnosed with colorectal cancer each year, resulting in approximately 935,000 deaths. Early detection is key, as colorectal cancer can be cured if found early. However, symptoms like weight loss or blood in the stool often emerge too late for effective intervention. Consequently, many countries have initiated population-based screening programs. These programs commonly utilize the fecal immunochemical test (FIT), which detects the blood protein hemoglobin in stool samples. Colorectal cancer screening programs have been effective in diagnosing the disease at earlier stages and reducing mortality rates. Despite the current test’s effectiveness, there is a need for improvement, particularly in detecting larger premalignant polyps before they become invasive. Early detection would allow for these polyps to be removed during a colonoscopy instead of requiring surgery. Researchers at the Netherlands Cancer Institute (Amsterdam, the Netherlandsl) have been developing a new test, the multitargetFIT-test (mtFIT), which measures hemoglobin ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294800242/new-stool-test-for-detecting-colorectal-cancer-could-reduce-unnecessary-colonoscopies.html
- 228
- February 15, 2024
Simple Blood Test Can Predict Heart Attack Risk within Six Months

Heart attacks are the leading cause of death globally, with their incidence on the rise. Despite this, many high-risk individuals either remain unidentified or fail to adhere to preventive treatments. Notably, the period preceding a heart attack is marked by significant biological changes. For instance, the risk of a heart attack doubles in the month following a divorce and increases fivefold in the week after a cancer diagnosis. Based on the hypothesis that several vital biological processes are active during the months before a heart attack, researchers have now suggested that these could be detected using a simple blood test. Researchers at Uppsala University (Uppsala, Sweden) have developed an online tool that, when used in conjunction with standard blood test results, can help clinicians determine if a person is at an elevated risk of experiencing a heart attack within the next six months. The study involved analyzing blood samples from ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294800241/simple-blood-test-can-predict-heart-attack-risk-within-six-months.html
- 194
- February 15, 2024
US Senate committee interrogates big pharma on “outrageously high” drug prices

The Senate Health, Education, Labor, and Pensions (HELP) Committee grilled the CEOs of major pharmaceutical companies on what chairman Senator Bernie Sanders labelled “the outrageously high cost of prescription drugs” in the US. Despite intense interrogation, the CEOs made no solid commitments to improve drug prices in the US. The February 8 hearing allowed US senators to question the CEOs of Merck & Co (MSD), Bristol Myers Squibb (BMS) and Johnson & Johnson (J&J) about their drug prices in the US and potential solutions to target high costs. Sanders highlighted price discrepancies between the US and other countries, pointing out that the list price for MSD’s Keytruda (pembrolizumab) is approximately $191,000 in the US, but $112,000 in Canada. On the issue of differential pricing in different countries, BMS CEO Chris Boerner said that the lower prices in countries such as Canada reduced access to essential medications. He said that patients ...
- Source: https://www.pharmaceutical-technology.com/news/us-senate-committee-interrogates-big-pharma-on-outrageously-high-drug-prices/?cf-view
- 373
- February 15, 2024

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