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Important Factors Differentiating Prescription Versus OTC Hearing Aids

It is important to understand that the performance of over-the-counter hearing aids can vary widely from prescription hearing aids due to a number of factors. By DR. CLIFF OLSON In October 2022, new Food and Drug Administration guidelines brought notable changes to the hearing aid market. The guidelines, which were mandated by the Over-the-Counter Hearing Aid Act of 2017, aim to improve hearing aid adoption rates by increasing the accessibility and affordability of hearing aid devices. Under the guidelines, direct-to-consumer (DTC) hearing devices that have been available for years will now be regulated by the federal government as over-the-counter (OTC) hearing aids. One of the specific measures implemented by the FDA guidelines was the establishment of “prescription hearing aids” and “over-the-counter hearing aids” as two distinct hearing aid categories. Given that OTC hearing aids can now be obtained without a hearing aid evaluation, they can be purchased at a lower cost from retail ...
- Source: drugdu
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- November 14, 2023
Novo Pumps $6B into Manufacturing to Help Meet Sky-High Wegovy Demand

By Tristan Manalac Pictured: Novo Nordisk signage outside its office in California/iStock, Sundry Photography Novo Nordisk on Friday announced that it is investing more than $6 billion to boost manufacturing capacity in its home country of Denmark to meet current and future demand for products targeting serious chronic diseases. The Danish company will start rolling out the investment this year, with an initial $3.6 billion capital tranche and will continue to invest over the next six years. The additional funding will be channeled into facilities in Denmark, where the pharma giant currently has more than 23,000 employees—most of whom work at production sites. The multibillion-dollar manufacturing boost comes as Novo is struggling to keep up with the staggering demand for its weight-loss medication Wegovy (semaglutide). Manufacturing issues have also hounded the GLP-1 agonist, forcing the company to restrict the U.S. supply of the lower doses of the therapy. Novo will ...
- Source: drugdu
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- November 14, 2023
EU regulator changes its mind on Mirati’s KRAS inhibitor Krazati with a thumbs-up following initial snub

Mirati Therapeutics’ KRAS inhibitor Krazati’s EU prospects weren’t looking good after an initial rejection from Europe’s drugs regulator. Now, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has come around on the drug after taking a second look. The CHMP first rebuffed the med back in July, finding that it didn’t meet certain requirements for a conditional marketing authorization, despite acknowledging its positive risk-benefit profile. Mirati, disagreeing, filed for a formal re-examination that ultimately resulted in the recent positive opinion. Now, European patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) will soon have a new treatment option in Mirati’s flagship drug. The company was already supplying the therapy to eligible patients in the EU based on “individual requests” from healthcare professionals, it said in July. This will be good news for Bristol Myers Squibb, which last month put $5.8 billion on the table ...
- Source: drugdu
- 98
- November 14, 2023
Bristol Myers Squibb’s CAR-T Breyanzi wins FDA priority review

The US Food and Drug Administration (FDA) has granted priority review for Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) to treat patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The Prescription Drug User Fee Act (PDUFA) goal date for the therapy is now 14 March 2024. BMS submitted a supplemental biologics licence application (sBLA) to the FDA for the expanded use of Breyanzi for the treatment of patients with CLL and SLL who have previously received a Bruton tyrosine kinase inhibitor (BTKi) and a B-cell lymphoma 2 inhibitor (BCL2i). The application is based on results from the Phase I/II TRANSCEND CLL 004 study, which demonstrated clinical benefit with a CD19-directed CAR T cell therapy in patients with relapsed or refractory CLL after prior treatment with BTKi and BCL2i. In May 2023, BMS received approval from the European Commission (EC) for Breyanzi to treat relapsed ...
- Source: drugdu
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- November 14, 2023
Takeda’s Fruzaqla receives FDA approval for metastatic colorectal cancer

Takeda’s Fruzaqla (fruquintinib) has been approved by the US Food and Drug Administration (FDA) for use in certain patients with previously-treated metastatic colorectal cancer (mCRC). Fruzaqla, which inhibits all three VEGF receptor kinases, has been specifically authorised for use in adults with mCRC who have been previously treated with chemotherapy, an anti-VEGF therapy, and in some cases, an anti-EGFR therapy. The FDA’s decision makes Fruzaqla the first targeted treatment options approved in the US for metastatic CRC regardless of biomarker status or prior therapies in more than a decade and was supported by results from the late-stage FRESCO and FRESCO-2 trials, which evaluated Fruzaqla plus best supportive care versus placebo plus best supportive care in previously-treated mCRC patients. Both trials met their primary and key secondary efficacy endpoints and showed consistent benefit among a total of 734 patients treated with Fruzaqla, Takeda said, adding that the drug demonstrated a “manageable ...
- Source: drugdu
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- November 14, 2023
Valneva’s chikungunya vaccine approved by FDA for adults at increased exposure risk

Valneva’s chikungunya vaccine has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in individuals ages 18 years and older who are at an increased risk of exposure to the mosquito-borne disease. The decision makes Ixchiq, which is administered as a single intramuscular injection, the world’s first licensed chikungunya vaccine. Chikungunya often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. Infection leads to symptomatic disease in up to 97% of people after three to seven days following the mosquito bite, with clinical symptoms including fever, joint and muscle pain, headache, nausea and rash. “Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He added: ...
- Source: drugdu
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- November 14, 2023
How Real-Time Insights Can Counteract Market Forces Affecting Lab Staffing Shortages

Benjamin Franklin’s saying, “Lost time is never found again” is as applicable today as it was in the 1700s. One of the most important aspects of medical laboratory management is to deliver lab tests within a limited time as they shape approximately two-thirds of all medical decisions made by physicians. As the workforce of lab professionals continues to shrink due to retirement, an increase in demand for services and vacancy rates, real-time insights can play a crucial role in counteracting market forces affecting lab staffing shortages by enabling organizations to make data-driven decisions and take proactive measures to address staffing challenges. A few positive strategies labs can implement to proactively address these pain points are as follows. Identify staffing trends Real-time data analytics can help identify staffing patterns and trends, such as peak periods of demand or seasonal fluctuations in lab workloads. By understanding these trends, labs can plan ahead ...
- Source: drugdu
- 176
- November 13, 2023
Mini-summit to address how informatics can help resolve health effects of climate change

Regenstrief Institute, the International Medical Informatics Association (IMIA), the International Academy of Health Sciences Informatics (IAHSI) and the American Medical Informatics Association (AMIA) are hosting a mini-summit at the AMIA 2023 Annual Symposium to address how informatics can help resolve health issues caused by climate change. The event will bring together national and international experts to form an informatics infrastructure that will highlight and bring exposure to climate change’s effects on health. The event Mini-Summit 2023 — Climate and health: How can informatics help? was planned because of the growing awareness around the effects of climate change on health. Fittingly, the AMIA 2023 Annual Symposium will be in Louisiana, a state drastically affected by multiple manifestations of climate change, including heat waves, droughts, wildfires and saltwater intrusion. During the mini-summit, health informatics professionals will discuss lessons from current environmental challenges and the future of preparing for environmental disasters. Experts will ...
- Source: drugdu
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- November 13, 2023
AstraZeneca Targets Obesity Market with Potential $2B Deal for Early GLP-1 Candidate

Pictured: AstraZeneca office in Gothenburg, Sweden/iStock, Wirestock AstraZeneca has signed an exclusive license agreement with Shanghai-based biotech Eccogene for ECC5004, an early-stage investigational oral glucagon-like peptide 1 receptor agonist that is being developed for obesity, type 2 diabetes and other cardiometabolic diseases. Under the terms of the deal announced on Thursday, AstraZeneca will make an upfront payment of $185 million with the potential for nearly $1.83 billion in future clinical, regulatory and commercial milestones. Eccogene will also be eligible for tiered royalties on net product sales. In exchange for its investment, AstraZeneca will have the exclusive global rights to develop and commercialize ECC5004—except in China, where the pharma will share these rights with Eccogene. “We believe this oral GLP-1RA molecule could offer alternatives to current injectable therapies both as a potential monotherapy as well as in combination for cardiometabolic diseases such as type-2 diabetes, as well as for obesity,” Sharon ...
- Source: drugdu
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- November 13, 2023
Takeda Wins FDA Approval for Fruquintinib in Certain Colorectal Cancer Patients

The FDA on Wednesday approved Takeda’s fruquintinib for previously treated adults patients with metastatic colorectal cancer. The oral targeted therapy of the VEGF-1, -2 and -3 receptors will carry the brand name Fruzaqla. Fruzaqla’s label covers patients who had received prior lines of treatment with fluoropyrimidine, oxaliplatin and irinotecan chemotherapy, as well as an anti-VEGF agent. In wild-type RAS metastatic colorectal cancer (mCRC), and if medically appropriate, the therapy is also indicated for patients who had previously received anti-EGFR treatment. Wednesday’s approval comes more than 20 days before its scheduled target action date and makes Fruzaqla the “first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC regardless of biomarker status,” according to Takeda’s announcement. “Fruzaqla is the first novel chemotherapy-free treatment option approved for patients in the U.S. regardless of biomarker status in more than a decade,” Teresa Bitetti, president ...
- Source: drugdu
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- November 13, 2023

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