media – Page 203 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

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
- 147
- 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
- 182
- 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
- 178
- 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
- 181
- 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
- 147
- 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
- 110
- 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
- 100
- 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
- 93
- January 15, 2024
In booming obesity field, Novo Nordisk is ‘just getting going,’ CEO says

Despite persistent supply hitches since Wegovy’s launch in 2021, Novo Nordisk has quickly garnered blockbuster sales in the newly untapped obesity market. And to hear Novo’s CEO Lars Fruergaard Jørgensen tell it, the company is “just getting going” in the field. In 2024, Novo Nordisk plans to entrench itself even deeper into the burgeoning obesity market, Jørgensen said Tuesday at the 42nd annual J.P. Morgan Healthcare Conference. To get there, Novo will rely on expanded manufacturing capacity, new cardiovascular outcomes data and a surprise boost from Eli Lilly’s rival weight-loss drug Zepbound, which snagged its own obesity nod in November. Novo’s Wegovy proved immensely popular out the gate. Initially, the company struggled to contend with the unprecedented spike in demand for its new semaglutide-based medicine. But after a sustained manufacturing expansion campaign over the past two years, Jørgensen figures Novo is in a comfortable position moving into 2024. In 2023, ...
- Source: drugdu
- 179
- January 13, 2024
FDA clears penicillin imports from French drugmaker amid Pfizer shortage

With U.S. syphilis cases on the rise and Pfizer’s Bicillin treatment still in short supply, France’s Laboratoires Delbert is stepping in to help with temporary imports. The French drugmaker is working with the FDA to bring in shipments of its Extencilline to the U.S. The product, while not approved in the U.S., is made up of penicillin G benzathine (or benzathine benzylpenicillin), which Pfizer has branded as Bicillin. In a letter (PDF) published by the FDA, Laboratoires Delbert noted that it will import 1,200,000 units of its powdered Extencilline and 2,400,000 units of the diluent version for reconstitution for injection. The meds are manufactured in Italy and both lots have an expiration date of 2025. Bicillin is used for an array of bacterial infections such as strep throat, but it’s the preferred treatment for syphilis and gonorrhea. The FDA first reported a shortage of the treatment in April. In June, ...
- Source: drugdu
- 113
- January 13, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.