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FDA says Philips’ testing of recalled devices is inadequate

Dive Brief The Food and Drug Administration called for further testing by Philips to evaluate the risks of soundproofing foam used in its recalled sleep apnea machines and ventilators. “We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Thursday statement that included more details on the recall and the agency’s actions. Philips has claimed use of the devices is “not expected to result in appreciable harm to health in patients,” but agreed with the FDA’s recommendations to run additional testing. Dive Insight Philips’ recall of sleep apnea devices and ventilators has continued since June 2021, when the company began an effort to repair or replace millions of devices that used polyester-based polyurethane (PE-PUR) foam for soundproofing. ...
- Source: drugdu
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- October 8, 2023
Merck’s Keytruda Poised for Bladder Cancer Expansion with New Phase III Data

Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma. Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival (OS), the study’s second primary endpoint. The promising initial data from AMBASSADOR point to the “potential of Keytruda to prevent recurrence” in patients who had undergone surgery, Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, said in a statement. AMBASSADOR, also known as KEYNOTE-123, is a randomized and open-label study enrolling approximately 740 patients with localized muscle-invasive or locally advanced urothelial carcinoma. Pembrolizumab was ...
- Source: drugdu
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- October 8, 2023
Bloomberg

Sanofi appears to be considering a buyout of cancer drugmaker Mirati Therapeutics, according to Bloomberg reporting on Thursday, citing sources familiar with the matter. Deliberations surrounding the potential acquisition are ongoing and there is no certainty that Sanofi will push through with the deal, Bloomberg noted. Still, the possibility of the buyout has energized the market and Mirati was trading 45% higher Thursday afternoon in reaction to the rumors. A Sanofi spokesperson declined to confirm or deny the acquisition in a statement to Reuters, saying that the company does not comment on market rumors. Mirati was likewise tight-lipped about the matter. This is not new territory for Mirati. In October 2021, Merck had expressed interest in acquiring Mirati, according to people briefed on the matter. In November 2022, Mirati was attracting “fresh takeover interest” from large pharma companies, also reported by Bloomberg. At the time, the California-based biotech was still ...
- Source: drugdu
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- October 8, 2023
Lokavant receives $8 million from investment giant, Mitsui to expand AI platform

Clinical trial platform company, Lokavant, has received an $8 million strategic investment from global trading and investment giant, Mitsui & Co. Ltd. The investment will be used to expand its AI-optimized platform across the Asia-Pacific (APAC) region. Lokavant entered Japan’s established clinical research market through one of its earliest customers, CMIC Group, the country’s largest contract research organization (CRO). Now with the backing from Mitsui, the company is poised to open a new APAC headquarters in Tokyo. The investment has come about following a year of efforts between the two companies which saw Mitsui’s extensive due diligence of the clinical trials landscape. Encouraged by Lokavant’s clinical trial intelligence technology and proven track record in Japan with current customers, Mitsui has vowed to offer operational support, including business development, staffing, and product localization to help expand Lokavant further in APAC after an initial focus on Japan. The regional headquarters will serve ...
- Source: drugdu
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- October 8, 2023
Amgen Completes Purchase of Horizon Therapeutics

Acquisition includes company’s inflammatory disease medicines. Image Credit: Adobe Stock Images/SciePro Amgen revealed in a company press release that it has officially finished its purchase of Horizon Therapeutics for an approximate value of $27.8 billion. According to the company, the acquisition includes: • Alignment with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases. • Strengthening of Amgen’s leading inflammation portfolio by adding first-in-class, early-in-lifecycle medicines such as Tepezza (teprotumumab-trbw), Krystexxa (pegloticase) and Uplizna (inebilizumab-cdon), which treat rare inflammatory diseases. • Leveraging of Amgen’s world-class capabilities in biologics research and development, process development and manufacturing, as well as Amgen’s presence in more than 100 countries around the world. • Generating robust cash flow to support capital allocation priorities, including ongoing investment in innovation while sustaining a commitment to an investment grade credit rating. • Acceleration of revenue growth; expected to be ...
- Source: drugdu
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- October 8, 2023
Ounce Raises $5.2M for Housing and Care Coordination Platform

Ounce’s $5.2 million in seed funding was co-led by Meridian Street Capital and Flare Capital and included participation from Chelsea Clinton’s Metrodora Ventures, Wilshire Lane Capital, Hilton CEO Chris Nassetta and Unite Us Co-founder Taylor Justice. By MARISSA PLESCIA Ounce, a startup that aims to “bridge the gap” between health and housing, announced Thursday that it has secured $5.2 million in seed funding. In addition, the company announced its first set of partners: AmeriHealth Caritas D.C. and National Housing Trust. Washington, D.C.-based Ounce works with payers and affordable housing properties. It has a team of community health workers who work within affordable housing properties to support their residents. The workers evaluate residents for gaps in care and offer onsite health clinics and screenings. They also help residents enroll in public benefits like Medicaid or SNAP. In addition, the workers will direct them to healthcare and social services, including scheduling primary ...
- Source: drugdu
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- October 8, 2023
Sanofi, Teva Ink Deal to Develop Inflammatory Bowel Disease Treatment

Collaboration to focus on ulcerative colitis and Crohn’s disease. Image Credit: Adobe Stock Images/SciePro Sanofi and Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd., announced in a company press release plans to partner on development and commercialization of TEV’574, currently in Phase IIb clinical trials for the treatment of ulcerative colitis and Crohn’s disease, two types of inflammatory bowel disease. Under terms of the collaboration, Teva will receive an initial payment of $500 million with the potential to earn up to $1 billion in development and launch milestones. “This is a new era for Teva, and our robust, innovative pipeline is key to our Pivot to Growth strategy,” said Richard Francis, president, CEO, Teva, in the aforementioned release. “This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A. We are honored to partner with Sanofi to bring their proven capabilities, leadership, ...
- Source: drugdu
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- October 7, 2023
Novartis Launches Sandoz Spinoff, Creating Independent Company

Separate entity allows company to concentrate on status as focused medicines company. Image Credit: Adobe Stock Images/Livinskiy Novartis has officially completed the spinoff process for Sandoz, its generics and biosimilars division, with each shareholder receiving one Sandoz share for every five Novartis shares or one Sandoz American Depositary Receipt (ADR) for every five Novartis ADRs. In the future, Novartis intends to become solely a focused medicines company. “This is a truly historic moment for Novartis and Sandoz, as we begin new chapters as independent companies. With several consecutive quarters of sales growth, Sandoz starts out from a position of strength as a global leader in Generics and Biosimilars, and I am confident they are poised to deepen their impact on patients and society,” said Vas Narasimhan, MD, CEO, Novartis. “Today, after more than USD 100bn in transactions over the last few years, Novartis emerges as a fully focused innovative medicines ...
- Source: drugdu
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- October 7, 2023
ICHRAs Are Gaining Steam, But Employers are Still Out of the Know

ICHRAs provide employees with more choice on their health benefits. But many employers aren’t very familiar with the new insurance model, executives say. By MARISSA PLESCIA More employers are turning to Individual Coverage Health Reimbursement Arrangements (ICHRAs): the number of employers who adopted ICHRAs increased by 64% between 2022 and 2023, according to the HRA Council. Still, many employers aren’t super familiar with the model, industry experts say. ICHRAs first became available in 2020 and are an alternative to traditional group plans. They allow employers of any size — though smaller employers may particularly be interested — to provide a tax-free reimbursement to their employees so they can shop for a health plan of their choice, including through the individual ACA market on state exchanges. The amount employees are reimbursed varies based on several factors, such as age, family size or where they live. “This allows you as an employee ...
- Source: drugdu
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- October 7, 2023
AstraZeneca’s Forxiga meets primary endpoint for T2D

AstraZeneca has announced positive results from the T2NOW Phase III trial for paediatric patients treated with forxiga (dapagliflozin) for the treatment of type 2 diabetes (T2D). Forxiga is an oral sodium-glucose co-transporter-2 (SGLT2) inhibitor that lowers blood glucose levels. The drug is approved in 122 countries to improve glycaemic control in T2D patients in conjunction with diet and exercise. In the EU, paediatric patients above the age of 10 can be administered the drug after positive results from the T2GO study. Forxiga has not yet been approved for paediatric patients in the US. The T2NOW trial results showed a significant reduction in A1C, an average blood sugar marker in patients taking forxiga and metformin, insulin, or both, compared with patients receiving the placebo. Safety results in 10–17-year-olds are consistent with adult patients who take the drug. Forxiga is not the only SGLT2 inhibitor on the market. Invokana (canagliflozin) by J&J ...
- Source: drugdu
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- October 7, 2023

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