Search Results for “EC” – Page 307 – media

FDA’s Preliminary Review of GLP-1 Meds Finds No Tie to Suicidal Thoughts, Actions

The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing. By FRANK VINLUAN An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced ...
- Source: drugdu
- 97
- January 12, 2024
GSK

GSK has a lot of experience with its shingles vaccine Shingrix in getting the older population to take their shots; now, with the approval of the world’s first RSV vaccine last year, the U.K. Big Pharma is looking for a slow burn approach for its latest respiratory shot. During GSK’s official J.P. Morgan Healthcare Conference 2024 presentation, CEO Emma Walmsley and Chief Commercial Officer Luke Miels spoke on how the company is looking to carve out a RSV market with its new vax Arexvy. “Creating a market is absolutely fundamental,” Walmsley said during the JPM presentation. “Three years ago, I don’t know how broadly the awareness was of the general public about RSV for older adults, even though it’s a scale disease that hospitalizes tens of thousands of Americans that were on, sadly 15,000 died. “So, we’re at very early stages of penetration of the market. I think competition and ...
- Source: drugdu
- 158
- January 12, 2024
HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Treatment of Primary Immune Thrombocytopenia with Priority

Review Status Hong Kong, Shanghai & Florham Park, NJ — Thursday, January 11, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”). Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (“Syk”), being developed for the treatment of hematological malignancies and immune diseases. The NDA is supported by data from ESLIM-01, a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy. In August 2023, HUTCHMED announced that the trial had met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib ...
- Source: drugdu
- 102
- January 12, 2024
Henlius and Sermonix Announce Strategic Collaboration and Exclusive License Agreements for Novel Endocrine Therapy Lasofoxifene

COLUMBUS, Ohio, & SHANGHAI, Jan. 11, 2024 – Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, and Shanghai Henlius Biotech, Inc. (2696.HK), today announced a strategic collaboration agreement in which Henlius will receive exclusive rights to develop, manufacture and commercialize Sermonix’s lead investigational drug, lasofoxifene, in China. Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights. Sermonix received an upfront payment and is further eligible to receive up to $58 million in certain predetermined milestones, in addition to royalties upon Henlius commercialization in China. Breast cancer is the cancer with the highest incidence rate in the world, according to GLOBOCAN 2020. There were 2.26 million new cases of breast cancer in 2020 ...
- Source: drugdu
- 80
- January 12, 2024
A Detailed Guide to EU API WC Certification

Navigating the export of Active Pharmaceutical Ingredients (APIs) to the European Union involves a critical component: obtaining the WC (Written Confirmation) certification. This certification is essential to assure that your product aligns with the EU's stringent quality and safety standards prior to market entry. In the competitive landscape of global pharmaceuticals, understanding the intricacies of WC certification is key to ensuring a seamless export process to the EU. Here, Drugdu.com, a specialized cross-border medical trade B2B platform, offers an in-depth interpretation of the EU API WC certification process, aimed at providing a clear understanding of its requirements, application procedure, and necessary documentation.
- Source: drugdu
- 157
- January 12, 2024
What Was the Most-Repeated Word in CVS Health CEO’s JPM Presentation?

The word has gained greater urgency in recent years as the consumer trend in healthcare has forced payers, providers and all other kinds of healthcare stakeholders to swear by it. By ARUNDHATI PARMAR In a space of five minutes in the roughly 12:30-minute presentation on CVS Health at the 42nd annual J.P. Morgan Healthcare conference in San Francisco on Monday, Karen Lynch said a version of the word “transparency” six times. No surprises for guessing they were all largely in the context of pharmacy benefit management and pharmacy reimbursement models. “… we introduced CVS Caremark TrueCost, which is a new PBM model that will be available to our customers and our clients that strives for greater transparency for our consumers and offers a simplified pricing model,” Lynch said, underscoring what concrete steps the company is taking amidst withering scrutiny of PBMs. CVS Caremark expects to launch the TrueCost model for ...
- Source: drugdu
- 117
- January 11, 2024
Pfizer PARP inhibitor Talzenna nabs EU combo nod

• Pfizer’s PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas’ Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release. The European Commission approved Pfizer’s application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi. Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC. • In another regulatory win for Pfizer, the FDA is reviewing the company’s full approval application on Genmab-partnered Tivdak. Under its priority review timeline, the FDA is assessing whether to convert Tivdak’s accelerated approval into a full nod to treat ...
- Source: drugdu
- 120
- January 11, 2024
NOVARTIS Cosentyx® (stuccizumab) approved in China for new indication in psoriatic arthritis

On January 9, 2024, NOVARTIS China announced that its innovative biologic Cosentyx® (stavudine) was approved by the NMPA for the treatment of adult patients with active psoriatic arthritis. This is the third indication for which Cosentyx® has been approved in China, following “moderate-to-severe plaque psoriasis” and “ankylosing spondylitis”. Psoriasis is an immune-related, chronic, relapsing, inflammatory, systemic disease. Currently, there are more than 7 million psoriasis patients in China. Psoriatic arthritis (PsA) is an inflammatory arthropathy closely related to psoriasis, with most patients experiencing joint symptoms secondary to skin lesions, and a few patients experiencing joint symptoms prior to or concurrently with skin lesions. Joint symptoms may include swelling, pain, morning stiffness and limited joint movement. Psoriatic arthritis is prone to recurrence. If not treated in time, the long-term inflammation caused by psoriatic arthritis will bring irreversible structural damage to the joints, which will seriously affect the patient’s physical function and ...
- Source: drugdu
- 108
- January 11, 2024
New Biomarkers for Diabetic Kidney Disease to Improve Diagnosis and Monitoring

Diabetic kidney disease (DKD) is a major microvascular complication arising from type 2 diabetes mellitus (T2DM), leading to end-stage renal disease (ESRD). Despite advancements in treatment options such as hyperglycemic and blood pressure control and renin-angiotensin system blockades, DKD continues to prevail at alarming rates. Clinically, DKD often progresses from microalbuminuria to macroalbuminuria, marked by increased levels of albumin in the urine and an initial hyperfiltration phase followed by a gradual decline in renal function. However, variations in clinical presentations and progression rates to ESRD have been noted in recent studies. As scientific understanding evolves, the need for specific biomarkers for DKD has become increasingly vital. Now, an analysis of urinary and exosome proteome profiling by a team of scientists has led to the discovery of biomarkers for DKD, offering the potential for early diagnosis and treatment. The research carried out by scientists at the Chinese Academy of Sciences (Beijing, ...
- Source: drugdu
- 125
- January 10, 2024
J&J Joins the Cancer ADC Dealmaking Spree With $2B Ambrx Acquisition

Johnson & Johnson’s acquisition of antibody drug conjugate developer Ambrx Biopharma comes as Novartis and Merck also unveiled M&A deals on the first day of the J.P. Morgan Healthcare conference. In a report, the investment bank said big pharmas are looking for deals involving de-risked assets. By FRANK VINLUAN Big pharmaceutical companies splashed out big bucks in 2023 to acquire or license antibody drug conjugates, or ADCs. The trend is continuing into the new year with Johnson & Johnson reaching a $2 billion deal to acquire clinical-stage Ambrx Biopharma. According to deal terms announced Monday, J&J will pay $28 cash for each Ambrx share, which is a 105% premium to the biotech’s closing stock price on Friday. In other biopharma deal announcements, Merck is paying $680 million to acquire Harpoon Therapeutics, a developer of targeted cancer therapies, and Novartis is buying autoimmune disease drug developer Calypso Biotech for $250 ...
- Source: drugdu
- 134
- January 10, 2024

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