PharmaFocus Today – Page 189 – media

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
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- January 12, 2024
J&J’s Megadyne restricts use of electrodes over burn risk, triggering Class I FDA notice

Dive Brief The Food and Drug Administration has categorized an urgent medical device correction from Johnson & Johnson’s Megadyne as a Class I event. Megadyne contacted customers last month to restrict the use of four electrode products in children under the age of 12 years. The products are staying on the market with a narrower label. The J&J unit took the action after receiving reports of burn injuries that could be particularly harmful to children. Megadyne has received reports of 99 injuries and no deaths, according to the FDA’s Monday recall notice. Dive Insight The electrode pads help direct currents from certain instruments used during surgery through the patient’s body to prevent the risk of energy concentrating in one area and burning the patient, according to the FDA. Megadyne sent an urgent field safety notice about the burn risk in June, leading to a Class I notice from the FDA ...
- Source: drugdu
- 177
- January 11, 2024
Multi-Cancer Early Detection Solution to Address Unmet Medical Needs in Clinical Diagnosis

Early detection, diagnosis, and treatment can significantly improve the survival and quality of life of cancer patients. Tumors continuously release fragmented genomic DNA into the bloodstream, although existing testing methods may find the signal too weak to be picked up in the early stages. Now, a revolutionary multi-cancer early detection solution leverages highly sensitive multi-omics technology to detect early cancer signals as well as predict the tissue of origin (TOO). Geneseeq Technology Inc.’s (Toronto, Canada) CanScan multi-cancer early detection solution is designed to enhance the early detection, diagnosis, and treatment of various cancers. This innovative solution harnesses the power of low-depth whole-genome sequencing (WGS) applied to circulating cell-free DNA (cfDNA) from a single tube of peripheral blood. It efficiently extracts genetic and fragmentomic features to identify early cancer signals with a high specificity of 99% and accurately predicts the TOO of cancers, thereby informing subsequent diagnostic and treatment strategies. Particularly ...
- Source: drugdu
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- January 11, 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
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- January 11, 2024
At JPM, Top GSK Cancer Executive Talks Drug Targets and Oncology Strategy

Though GSK divested much of its oncology assets to Novartis in 2015, the company has built it back through a internal R&D and business development deals. GSK Senior Vice President, Global Head of Oncology, R&D Hesham Abdullah explained the company’s evolving cancer strategy in an interview during the J.P. Morgan Healthcare Conference in San Francisco. By FRANK VINLUAN GSK committed $270 million up front in recent months to gain access to early-stage assets in the class of cancer therapies known as antibody drug conjugates, or ADCs. The deals are part of a broad industry to acquire assets in this therapeutic modality, GSK’s top cancer executive Hesham Abdullah acknowledges. But for GSK, the deals are just one part of an evolving oncology strategy. The strategy has been years in the making. In 2015, GSK divested its oncology business, which Novartis acquired for $16 billion. Abdullah, who is GSK’s senior vice president, ...
- Source: drugdu
- 119
- January 11, 2024
Kanglin Biotech’s KL003 cell injection successfully obtained IND approval!

Recently, according to the public information on the NMPA official website, the KL003 cell injection independently developed by Kanglin Biotechnology (Hangzhou) Co., Ltd. successfully obtained the NMPA’s implicit clinical trial license, with the acceptance number CXSL2300699, and is clinically used to treat transfusion-dependent beta in adults or children. -Thalassemia. The microspectrum biosafety service platform provides cell bank testing and strain library testing services for this product. β-thalassemia is a hemolytic anemia caused by defects or mutations in the β-globin gene (Hemoglobin β, HBB) on chromosome 11, resulting in partial or complete loss of β-globin-related functions, which brings great consequences to the patient’s life and health. The patients is more common in children and adolescents. Traditional treatments for thalassemia (blood transfusion, hematopoietic stem cell transplantation, etc.) are accompanied by side effects that cannot be ignored. The vast majority of patients lack the opportunity for radical cure, and there are obvious unmet ...
- Source: drugdu
- 195
- January 11, 2024
WHO decision improves children’s access to safer polio vaccine

Three years after it received its Emergency Use Listing (EUL) and with 950 million doses now delivered worldwide, nOPV2 has been prequalified by the WHO, following analysis of outcomes in vaccinated populations, confirming the strong safety profile and effectiveness of the vaccine. The nOPV2 vaccine helps to protect children from polio while lowering the risk of vaccine-derived outbreaks. Prequalification is a mark of quality assurance granted by the WHO and will make it easier for more countries to access and use nOPV2. Now it is granted, WHO member countries can obtain and use nOPV2 without the need to meet the strict readiness and monitoring requirements previously required under EUL. Prequalification will therefore ensure broad and long-term accessibility for international agencies to distribute nOPV2 in developing countries. Dr Andrew Macadam, Principal Scientist at the MHRA said: Until it has been completely eradicated, polio will continue to be a threat to children ...
- Source: drugdu
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- 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
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- January 11, 2024
Merck expects $20B+ in new cancer sales thanks to Daiichi ADC deal, Moderna vaccine

While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” Make no mistake, given Keytruda’s size, an overall business decline will likely still hit. But Merck is focused on making “the hill to dip as small as possible and the return to growth as fast as possible,” Davis said Monday at the 2024 annual J.P. Morgan Healthcare Conference. Davis and Merck Research Laboratories President Dean Li, M.D., Ph.D., pointed to the breadth of Merck’s portfolio across oncology, infectious disease, cardiometabolic, immunology and neuroscience to explain Merck’s potential for growth. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. 2028, it’s just another year, it’s just another point. We’re focused on 2030 to 2040.” At last year’s J.P. ...
- Source: drugdu
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- 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
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- January 11, 2024

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