PharmaFocus Today – Page 253 – media

‘Extremely concerning’ chemo shortage persists despite FDA’s efforts, national cancer group reports

While the White House recently touted the FDA’s efforts to mitigate the ongoing chemotherapy shortage in the U.S., a recent survey by the National Comprehensive Cancer Network (NCCN) shows that many treatment centers do not have enough supply of key medicines.、 NCCN surveyed 29 of its member institutions throughout the month of September and found that 72% of centers are still experiencing a carboplatin shortage, while 59% are short on cisplatin. The report is a follow-up to a June survey evaluating supply levels of the key platinum-based chemotherapies carboplatin and cisplatin. The June survey showed that 93% of centers were experiencing a carboplatin shortage, while 70% were low on cisplatin. “It is extremely concerning that this situation continues despite significant attention and effort over the past few months,” NCCN’s CEO Robert Carlson, M.D., said in a statement. “We need enduring solutions in order to safeguard people with cancer and address ...
- Source: drugdu
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- October 9, 2023
Emergex and VIC to develop infectious disease therapies in the Gulf

Emergex Vaccines has signed a Memorandum of Understanding (MoU) with the Vaccine Industrial Company (VIC) to develop and commercialise T cell-priming immune set-point candidates against infectious disease therapies. The territories included in the agreement were Saudi Arabia and other specified territories, such as GCC member states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE), other Middle Eastern territories and specified regions. As per the deal, VIC will have an equity share in Emergex, contingent on the Saudi Arabian government’s support for Phase II/III clinical trials of Emergex’s T cell-priming candidates. These are beings studied for dengue, Covid-19, and others, including the add-on therapies related to these indications. In June, Emergex reported positive data from the Phase I trial of its T cell-priming immune set-point candidate, DengueTcP, for treating dengue. The results showed that the therapy was well tolerated in healthy volunteers. The company also reported positive data for CoronaTcP, a ...
- Source: drugdu
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- October 9, 2023
Ocular launches ocular implant trial to combat macular degeneration

US biopharmaceutical firm, Ocular Therapeutix has announced the start of its first clinical trial of an intravitreal eye implant intended to combat macular degeneration. Named OTX-TKI, the axitinib intravitreal implant is intended to treat wet age-related macular degeneration (wet AMD). Alongside the announcement the company has requested a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) as to how the trial is designed. Overall, the trial will recruit approximately 300 evaluable wet AMD patients. Antony Mattessich, CEO of Ocular Therapeutix said: “With the activation of our first clinical site in the US, we believe we are on target to enrol our first subject before year-end. “The trial is a crucial step forward for our clinical program as we make progress toward our goal of bringing a transformative new treatment that can truly make a difference for wet AMD to patients coping with vision loss.” The company ...
- Source: drugdu
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- October 9, 2023
Meet Drugdu.com at CPhI Barcelona 2023!

From October 24th to 26th, 2023, the world-renowned pharmaceutical trade show – CPhI Barcelona will once again open its doors to the elites of the global pharmaceutical industry. It’s a platform that showcases new technologies, advanced equipment, and innovative products. Drugdu.com – Your Trusted Partner As a global B2B online platform dedicated to the pharmaceutical industry, Drugdu.com will also be participating in this grand event. Our booth is located at Hall 2 / 2Y01. We warmly invite you to visit us. Why should you visit our booth? Global Exposure: Display your brand and products to a worldwide audience. Potential Business Opportunities: Explore and unlock collaboration opportunities with various potential buyers and suppliers. National Agent Recruitment: If you are a manufacturer looking for overseas agents or distributors, we can help you find the right partner. One-stop Digital Marketing: Learn how to promote your products and brand more effectively. Authoritative Industry Accreditation: ...
- Source: drugdu
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- October 9, 2023
Hospitals Turn to Backup Power When Extreme Weather Hits Propane Generators Offer Clean Solution

Summer 2023 saw an increase in patients seeking treatment for heat-related illnesses. States in the South, West, and Midwest grappled with unrelenting heat waves that made it difficult to survive without air conditioning. Northeastern states were flooded by heavy rainstorms. In addition, Canadian wildfires blanketed several U.S. states with dangerous levels of smog, making it difficult to breathe. I was in New York City in early June, and I couldn’t see the skyline for two days. Walking outside made my eyes burn and my nose run. I imagine it was much worse for those with pre-existing respiratory conditions. These extreme weather conditions and others will continue to drive up demand for electricity in nearly every state, which will strain the electric grid at the same time that older power plants are being taken offline. This combination recently prompted the North American Electric Reliability Corporation to project that two-thirds of North ...
- Source: drugdu
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- October 8, 2023
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

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