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Activist shareholders urge drugmakers to re-evaluate patent strategies, human rights policies

Over the years, shareholders at the Interfaith Center on Corporate Responsibility (ICCR) have repeatedly voiced concerns on a variety of subjects to top pharma companies. Now, as 2023 comes to a close, the group is taking pharma giants to task over their patenting strategies and potential human rights shortfalls. In proposals to AbbVie, Eli Lilly, Gilead, Johnson & Johnson, Merck and Pfizer, the group is pushing the companies to review how add-on patents for medicines can affect patient access. Additionally, Bristol Myers Squibb, Pfizer and Eli Lilly face calls to review and update their human rights policies. While ICCR has voiced pharma-related complaints plenty of times in the past, its proposals haven’t been met with much enthusiasm by the companies’ larger pools of shareholders. In 2019, for instance, investors at several large pharma companies rejected the group’s proposals to study the potential link between CEO pay and drug prices. In ...
- Source: drugdu
- 103
- December 20, 2023
Artificial Intelligence workplan to guide use of AI in medicines regulation

EMA and the Heads of Medicines Agencies (HMAs) have published an Artificial Intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks. The workplan will help the European medicines regulatory network (EMRN) to embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit public and animal health. The AI workplan, prepared under the joint HMA-EMA Big Data Steering Group (BDSG), ensures the EMRN remains at the forefront in benefiting from AI in medicines regulation. The workplan was adopted by EMA’s Management Board at its December meeting. The field of AI is developing swiftly. Pharmaceutical companies increasingly use AI-powered tools in research, development and monitoring of medicines. National competent authorities are responding to the new opportunities and challenges by starting to use and develop ...
- Source: drugdu
- 102
- December 20, 2023
Innovent Announces Publication of Mazdutide (IBI362) Phase 2 Full Results in Chinese Patients with Overweight or Obesity in Nature Communications

ROCKVILLE, U.S. and SUZHOU, China, Dec 18, 2023，— Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that results of a Phase 2 clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese patients with overweight or obesity were published in Nature Communications. Professor Linong Ji, the leading principal investigator of the study, Peking University People’s Hospital, stated, “As a chronic disease with complex underlying causes, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, joint diseases, sleep apnea in addition to cancers. Obesity requires increased public awareness of long-term treatment and management with effective and science-backed approaches. China has the largest obese population; however, no safe and efficacious ...
- Source: drugdu
- 121
- December 20, 2023
Self-Heating Microfluidic Devices Can Detect Diseases in Tiny Blood or Fluid Samples

Microfluidics, which are miniature devices that control the flow of liquids and facilitate chemical reactions, play a key role in disease detection from small samples of blood or other fluids. Commonly known examples include at-home Covid-19 test kits, which use basic microfluidic technology. However, more complex microfluidic applications often require chemical reactions at precise temperatures. Typically, these advanced devices are produced in clean rooms and include heating elements made of expensive materials like gold or platinum, making the manufacturing process costly and challenging to scale. Researchers have now made a breakthrough by employing 3D printing to build self-heating microfluidic devices, potentially paving the way for the creation of affordable and efficient tools that could detect various diseases. Scientists at the Massachusetts Institute of Technology (MIT, Cambridge, MA, USA) innovatively utilized multimaterial 3D printing to fabricate microfluidic devices with integrated heating elements. This development allows for precise temperature control of fluids ...
- Source: drugdu
- 89
- December 19, 2023
Glaukos wins FDA approval for drug-releasing eye implant to treat glaucoma

Dive Brief Glaukos Corporation received Food and Drug Administration approval for a drug-releasing implant that is designed to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The implant was approved for single administration per eye. The device continuously delivers a formulation of travoprost, an established treatment for high pressure in the eye, to provide patients with an alternative to eye drops and remove the risk that noncompliance with the treatment regimen will affect outcomes. Glaukos failed to secure approval for repeat dosing but plans to work with the FDA to change the label. The wholesale acquisition cost (WAC) is $13,950 per dose, or implant, well above analysts’ expectations. William Blair analysts estimated the price would fall in a range of from $3,000 to $4,000 per implant, while BTIG analysts said they modeled a price of $5,000. Dive Insight Glaukos expects to generate up to $310 million in ...
- Source: drugdu
- 95
- December 19, 2023
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
- 99
- 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
- 95
- 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
- 90
- 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
- 89
- December 19, 2023

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