PharmaFocus Today – Page 207 – media

FDA Approves Padcev/Keytruda Combo for Locally Advanced, Metastatic Urothelial Cancer

Pharmaceutical Executive Editorial Staff In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer. Image credit: Olivier Le Moal | stock.adobe.com The FDA has approved Padcev (enfortumab vedotin-ejfv; Astellas Pharma and Seagen [now owned by Pfizer]) plus Keytruda (pembrolizumab; Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC).1 The FDA previously granted the application with priority review and breakthrough designation. The efficacy of the combination was evaluated in the open-label, randomized EV-302/KN-A39 (NCT04223856) trial, which enrolled 886 patients with la/mUC who received no prior systemic therapy for advanced disease. Patients were randomly assigned 1:1 to receive either Padcev with Keytruda or platinum-based chemotherapy consisting of gemcitabine with either cisplatin or carboplatin. The trial’s major efficacy outcomes were overall survival (OS) and progression-free survival (PFS) as assessed by blinded ...
- Source: drugdu
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- December 19, 2023
AI-Enabled Prescription Digital Therapeutics Should Be An Investment Priority

To identify true growth opportunities, investors must consider how companies are using AI to revolutionize the treatment journey. Some companies are doing just that via Software as a Medical Device (SaMD), particularly by developing prescription digital therapeutics (PDTs). By DAVID B. KLEIN The excitement around artificial intelligence has been palpable for some time, dominating industry discussions and mobilizing capital for investment opportunities, but as of late, there’s been a change in the air. The optimism that reached a fever pitch in the first half of the year has dissipated. Now begins the hard work of sorting through what it all means. As the healthcare industry responds to the burgeoning opportunities AI presents, especially in developing new, more effective therapeutics and enabling access to treatment, it’s critical that investors prioritize proof over positivity. They must determine if a company’s AI strategy will lead to a high return on investment, or if ...
- Source: drugdu
- 92
- December 19, 2023
With new FDA approval, Merck’s Welireg takes another step toward blockbuster goal

Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod on Thursday for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor. The U.S. regulator has given a thumbs up for Welireg to treat relapsed or refractory renal cell carcinoma (RCC) for adult patients who have not responded to a PD-1 or PD-L1 inhibitor and who have also been treated with a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TK1). Welireg becomes the first drug in its class for patients with advanced RCC and the first novel-class treatment in the indication since 2015, Merck noted. The nod comes on top of its original approval to treat the rare von Hippel-Lindau disease, a hereditary condition that causes tumor growth in ...
- Source: drugdu
- 92
- December 19, 2023
Arcutis’ Zoryve bags 2nd FDA nod, this time as a foam to treat ‘the great neglected disease in dermatology’

About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK. Late Friday, Arcutis’ roflumilast—now approved in both cream and foam form under the brand name Zoryve—passed muster with U.S. regulators to treat seborrheic dermatitis in patients ages 9 and older. Arcutis has previously estimated there are more than 10 million people in the U.S. with seborrheic dermatitis, which causes red patches on the skin covered with large, flaking scales and a persistent itch. The disease most often affects parts of the body with oil-producing glands, such as the scalp, face, upper chest and back. Back in July 2022, roflumilast’s cream formulation won the company’s first approval in plaque psoriasis. In both its forms, roflumilast targets phosphodiesterase-4 (PDE4), an intracellular enzyme that boosts production of pro-inflammatory mediators and decreases production of ...
- Source: drugdu
- 87
- December 19, 2023
WHO officially recognizes noma as a neglected tropical disease

In a pivotal move towards addressing one of the world’s most underrecognized health challenges, the World Health Organization (WHO) today announced the inclusion of noma (cancrum oris or gangrenous stomatitis) in its official list of neglected tropical diseases (NTDs). This decision, which was recommended by the 17th meeting of the Strategic and Technical Advisory Group for Neglected Tropical Diseases (STAG-NTD), underscores WHO’s commitment to expanding health services to the world’s most vulnerable populations. Noma, a severe gangrenous disease of the mouth and face, primarily affects malnourished young children (between the ages of 2 and 6 years) in regions of extreme poverty. It starts as an inflammation of the gums, which, if not treated early, spreads quickly to destroy facial tissues and bones. It frequently leads to death, with survivors suffering severe disfigurement. Accurate estimation of the number of noma cases is challenging due to the rapid progression of the disease ...
- Source: drugdu
- 87
- December 19, 2023
Harbour BioMed’s Wholly-owned Subsidiary Nona Biosciences Enters into a Global License Agreement with Pfizer for HBM9033, an MSLN-Targeted Antibody-Drug Conjugate (ADC)

Harbour BioMed’s Wholly-owned Subsidiary, Nona Biosciences, announced today that it has entered into an exclusive license agreement with Pfizer Inc. for the global clinical development and commercialization of Nona Biosciences’ MSLN-targeted antibody-drug conjugate (ADC), HBM9033. Under the terms of the agreement, Nona Biosciences will receive a total of up to $53 million in upfront and near-term payments, with the potential for additional payments of up to $1.05 billion upon achieving certain development and commercial milestones. Nona Biosciences is also eligible to receive tiered royalties on net sales ranging from high single digits to high teens. “We are delighted to collaborate with Pfizer, a company that is committed to developing high-impact medicines for people living with cancer,” said Jingsong Wang, M.D., Ph.D., Chairman of Nona Biosciences. “This agreement represents a significant milestone in the advancement of our proprietary Harbour Mice® platform and the ADC ecosystem, affirming Nona’s robust capabilities and expertise ...
- Source: drugdu
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- December 19, 2023
BAT1308 (anti-PD-1 monoclonal antibody) injection combined with platinum-containing chemotherapy for endometrial cancer approved in Phase II/III clinical

On December 15, 2023, BIO-THERA Bio-Pharmaceutical Co., Ltd. announced that it had received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, which approved the application for a Phase II/III clinical trial of the investigational drug BAT1308 injection in combination with platinum-containing chemotherapy for the first-line treatment of advanced or recurrent mismatch-modification-repaired protein-deficient (dMMR) endometrial cancer. BAT1308 is a humanized anti-PD-1 monoclonal antibody independently developed by BIO-THERA, which belongs to IgG4κ subtype and is expressed by Chinese hamster ovary cells.PD-1 is mainly expressed by activated T-lymphocytes, and is an inhibitory immune checkpoint.PD-L1 and PD-L2 are the two ligands of PD-1, and when PD-L1 or PD-L2 bind to PD-1, it can inhibit immune activation of T-cells through the downstream signaling pathway to inhibit immune activation of T cells. It has been found that a variety of tumor cells can express PD-L1 and PD-L2 and bind to PD-1 ...
- Source: drugdu
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- December 19, 2023
Listing Meeting of Domestic Sacubitril Valsartan Yixintan® was Successfully Held

On December 16th, during the 18th Asia-Pacific Symposium on Hypertension, the National Launching Meeting of Sacubitril Valsartan Sodium Tablets (trade name: Yixintan®), which is exclusively commercialized by Fosun Pharmaceuticals and researched, developed and manufactured by Nanjing Fangshenghe Pharmaceuticals, was held grandly in Shanghai. The approved indications of Yixintan® (sacubitril valsartan sodium tablets) are for use in adult patients with chronic heart failure (NYHA class II-IV, LVEF ≤ 40%) with reduced ejection fraction, to reduce the risk of cardiovascular death and hospitalization for heart failure; and for the treatment of essential hypertension. The product is a first-line drug for the treatment of heart failure and hypertension with an innovative crystalline form with independent intellectual property rights. After the launching ceremony, a press conference on the national launching of Yixintan® was held, in which experts appeared and answered questions from the media about the current situation of cardiovascular prevention and treatment, the ...
- Source: drugdu
- 115
- December 19, 2023
GLP-1 agonists can blunt obesity-associated health problems

Science has named the development of glucagon like peptide-1 (GLP-1) agonists and this year’s discovery that these drugs can blunt obesity-associated health problems as its 2023 Breakthrough of The Year. Although obesity’s causes span genetic, physiological, environmental, and social factors, as a medical problem, obesity’s risks can be life-threatening – including heart disease, diabetes, arthritis, liver disease, and certain cancers. Drug treatments for obesity have had “a sorry past, one often intertwined with social pressure to lose weight and the widespread belief that excess weight reflects weak willpower,” writes Jennifer Couzin-Frankel in the Breakthrough news feature. However, a new class of drug therapies for weight loss has emerged and is showing promising results. Originally developed to treat diabetes nearly 20 years ago, the excitement surrounding GLP-1 drugs to treat obesity has recently exploded. And this year, two landmark clinical trials that showed in large numbers that GLP-1 agonists produced meaningful ...
- Source: drugdu
- 121
- December 18, 2023
Next-Generation Colorectal Cancer Screening Test Enables Earlier Disease Detection

Colorectal cancer (CRC) stands as the second leading cause of cancer-related deaths in the U.S. and is particularly prevalent in men under 50. Notably, there’s been a shift in CRC affecting younger individuals, with 20% of cases in 2019 occurring in people 54 and younger, a rise from 11% in 1995. Additionally, there has been an increase in advanced disease incidence, particularly in individuals under 65. A significant number of CRC cases and deaths can be prevented through regular screening, surveillance, and quality treatment. Now, a new technology offers convenient at-home test collection with the highest sensitivity available for non-invasive CRC screening. Geneoscopy Inc. (St. Louis, MO, USA) has developed a multi-target stool RNA (mt-sRNA) biomarker panel for detecting precancerous lesions and colorectal cancer. RNA, a dynamic molecule crucial for protein synthesis, adapts to disease conditions and regulates numerous genes in cellular processes. Changes in RNA pathways are linked to ...
- Source: drugdu
- 115
- December 18, 2023

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