PharmaFocus Today – Page 186 – media

Menopause Startup Launches AI-Powered Hot Flash Care Product

Loewen Cavill, co-founder and CEO of Amira, never expected to work in the menopause space. But then her aunt was unexpectedly hospitalized due to severe menopause symptoms. “She was waking up five times a night for four years [because of hot flashes],” Cavill said in an interview. “Her sleep deprivation got so bad that she had to quit her job, that she would get sick all of the time, that she was no longer herself anymore, that she spent over $10,000 on doctors, naturopaths, and products. One of the things she tried sent her to the hospital with side effects.” Cavill thought her aunt’s experience had to be niche. But after digging deeper and speaking with hundreds of women, she learned that it was actually very common (in fact, three-quarters of women will battle sleep disruptions from hot flashes). This led Cavill to start Amira in 2021. The startup is ...
- Source: drugdu
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- January 15, 2024
FDA’s Preliminary Review of GLP-1 Meds Finds No Tie to Suicidal Thoughts, Actions

An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced by other factors, the FDA said. Consequently, the agency said it determined the reports did not demonstrate a clear relationship with GLP-1 drugs. This finding is preliminary. “However, because of the small number of suicidal thoughts or actions observed in both people ...
- Source: drugdu
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- January 15, 2024
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace

Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy uses mPNS to deliver a quick, painless and non-invasive treatment in sessions lasting just 13.5 minutes, according to Neuralace. Each session utilizes magnetic pulses to provide relief for a potential improvement in pain management. Neuralace said a recent trial of 71 patients demonstrated efficiency, plus significant improvements in subject outcomes. The company believes its therapy represents a paradigm shift in PDN treatment. Axon Therapy offers a non-pharmacological and non-invasive option that could reduce dependence on medications and their associated side effects. The company says FDA clearance paves the way for broader access to innovative pain ...
- Source: drugdu
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- January 15, 2024
S&P Global Releases Healthcare Industry Outlook for 2024

Mike Hollan While the industry as a whole still faces challenges, there are positive trends appearing for pharmaceutical and medical device companies. Anyone hoping for good news for the financial state of the healthcare industry may have to wait until mid-2024. S&P Global released its annual healthcare industry outlook, providing a thorough analysis of the state of the industry. The last few years have been a rollercoaster for the industry, with it seeing unbelievable highs during the pandemic, only to watch most of that enthusiasm (and the money that came with it) fade in 2023. According to S&P Global’s report, its ratings outlook for the pharmaceutical and medical device subsectors is stable. However, it notes that the ratings outlook for the industry remains negative. This is due to lower end companies, which are typically sponsor-owned, struggling to maintain positive cash flow. There are a variety of factors that play into ...
- Source: drugdu
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- January 15, 2024
3M Health receives grant to develop wound treatment solutions in US

3M Health Care’s Medical Solutions Division has received a $34.2m award to improve the treatment of traumatic wounds from point of injury to hospital. Provided by the US Army Medical Research Acquisition Activity, the funding will enable 3M to spearhead a programme that focuses on treatment strategies to be used in harsh settings, especially those related to delayed evacuation situations and mass casualties – the development of which is a Department of Defense Combat Casualty Care Capability Assessment objective. The programme’s scope includes developing solutions for infection prevention, wound management and healing. It will support the development of four product solutions, encompassing prototype creation, formulation development and the completion of two clinical studies for product registration. 3M’s collaboration involves partners such as the University of Minnesota Medical School, the 59th Medical Wing Science and Technology Office of the Chief Scientist, the Naval Medical Research Unit, San Antonio, and the University ...
- Source: drugdu
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- January 15, 2024
Evotec partners with Crohn’s & Colitis Foundation for IBD therapies

Evotec has announced a collaboration with the Crohn’s & Colitis Foundation to advance drug discovery and develop new therapies for IBD, which includes Crohn’s disease and ulcerative colitis. The collaboration between Evotec and the foundation’s IBD therapeutics incubator programme aims to translate academic research into medical innovations for patients with IBD, a debilitating chronic medical condition. The programme fosters partnerships between the foundation, academic researchers and industry partners. The partnership will leverage Evotec’s end-to-end integrated research and development platform to advance the development of drugs for fibrosis and impaired intestinal barrier function, two significant unmet medical needs for IBD patients. Evotec chief business officer Dr Matthias Evers stated: “Mission-driven foundations like the Crohn’s & Colitis Foundation are an essential part of the healthcare ecosystem as they drive medical progress in areas of significant unmet need that would otherwise not be pursued. “As we join forces within the foundation in this ...
- Source: drugdu
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- January 15, 2024
Biogen returns ex-U.S. rights of MS drug Fampyra to Acorda

With sales declining for aging multiple sclerosis (MS) drug Fampyra, Biogen has exercised an option to return licensing rights outside of the United States to Acorda Therapeutics. The move, which becomes effective on January 1 of 2025, ends a 15-year arrangement between the companies. The drug was approved by the FDA in 2010, six months after Acorda of Ardsley, N.Y., signed over its ex-U.S. rights to Biogen. Acorda said it will assume commercialization responsibilities this year as marketing authorization transfers and distribution arrangements are finalized for each territory. “We are excited to bring Fampyra in-house, which we believe will add significant value to Acorda, and allow us to continue to provide access to this important medication for people with MS around the world,” Acorda’s CEO Ron Cohen, M.D., said in a release. The extended-release tablet was the first of its kind upon its approval, allowing patients with MS to have ...
- Source: drugdu
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- January 15, 2024
FDA rips MiMedx with warning letter for its placental collagen wound-care treatment

The FDA hit MiMedx Group with a warning letter, citing the maker of regenerative biomaterials products for the classification of its placental collagen matrix designed to treat wounds found in surgical settings. In its letter (PDF), the FDA said MiMedx’s Axiofill doesn’t fall under Section 361 of the U.S. Public Health Service (PHS) Act, which allows lower-risk and minimally processed cell- and tissue-based products to be sold under fewer regulatory requirements. Instead, the product should fall under Section 351 of the law, which regulates products such as biologics that require pre-market approval, according to the agency. In essence, the FDA has taken the stance that Axiofill is an unlicensed biological product. “Based upon this information, we have determined that your actions have violated the [Federal Food, Drug, and Cosmetic Act] and the PHS Act,” the regulatory agency said. The FDA issued the letter after visiting two MiMedx sites in Georgia ...
- Source: drugdu
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- January 15, 2024
BioMarin’s new CEO Hardy says top priority is expansion of dwarfism drug Voxzogo

In his first presentation as the new CEO of BioMarin, Alexander Hardy left no doubt about his mission for the rare and genetic disease specialist. The top priority for the former Genentech CEO is to accelerate and maximize the commercial potential of dwarfism drug Voxzogo, Hardy said Tuesday at the J.P. Morgan Healthcare Conference. His second objective is to ramp up the commercialization of Roctavian, a newly approved gene therapy for hemophilia A. Thirdly, it is up to Hardy to identify BioMarin’s most promising R&D projects and make tough decisions about what to cut. Given his experience heading up Roche subsidiary Genentech for the last five years, Hardy is equipped to take on these challenges. During his time in charge, Genentech launched 10 medicines, including blockbuster macular degeneration drug Vabysmo. The company’s revenue jumped 24% and did so efficiently as profit-per-employee grew by 69%. “Why did I choose BioMarin? I ...
- Source: drugdu
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- January 15, 2024
Hengrui Pharmaceuticals’ “Double Ai” Combination Study for Advanced Lung Adenocarcinoma Featured in The Lancet Supplement

Recently, the results of the prospective, multicenter, single-arm phase II clinical study of carilizumab in combination with apatinib and albumin paclitaxel in advanced lung adenocarcinoma (CAPAP-lung), led by Prof. Wu Lin of Hunan Cancer Hospital, have been published in The Lancet (IF=15.1) and eClinicalMedicine (IF=15.1), which is a subseries of The Lancet. eClinicalMedicine (IF=15.1).1 The results of the study showed that the first-line treatment of advanced lung adenocarcinoma negative for epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations with karelizumab in combination with apatinib (the “double-Ai” combination) and albumin paclitaxel demonstrated a clinically meaningful antitumor effect. Demonstrated clinically meaningful antitumor activity and a manageable safety profile with low hematological toxicity. This study is the first exploration of advanced non-small cell lung cancer (NSCLC) treated with platinum-free chemotherapy in combination with immunologic agents and anti-vascular drugs, and is expected to provide new options for first-line treatment of EGFR/ALK ...
- Source: drugdu
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- January 15, 2024

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