Search Results for “EU” – Page 29 – media

Nalu Medical raises $65M for neurostim tech

BY SEAN WHOOLEY Nalu Medical announced today that it closed a $65 million equity financing to support its minimally invasive neurostimulation product. Carlsbad, California–based Nalu had its round led by new investor Novo Holdings. All existing significant investors — including Gilde Healthcare, MVM Partners, Endeavor Vision, Decheng Capital, Longitude Capital, Advent Life Sciences, Pura Vida and Aperture Venture Partners — participated, too. Nalu plans to use the proceeds to accelerate commercial growth and expand clinical and health-economic evidence. It also wants to use the funds to continue product development and scale operations. The company’s FDA-cleared spinal cord stimulation and peripheral nerve stimulation technology treats patients with chronic neuropathic pain. It delivers gentle electrical pulses to the nervous system to modulate pain signals before they reach the brain. Nalu system includes a fully featured, battery-free, miniaturized implantable pulse generator (IPG). An externally worn therapy disc wirelessly powers the IPG and ...
- Source: drugdu
- 176
- January 6, 2024
FDA Fast Tracks Candel Therapeutics’ Novel Treatment for Pancreatic Ductal Adenocarcinoma

Pharmaceutical Executive Editorial Staff Study results show an estimated 71.4% survival rate after both 24 and 36 months with aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma compared with 16.7% in the control group. The FDA granted Fast Track Designation to Candel Therapeutics, Inc’s aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC).1 The novel off-the-shelf therapy is administered by a localized injection that is believed to provide a safety benefit compared with standard systemic administration in this patient population. “We are pleased with the FDA’s decision to grant fast track designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD, FMedSci, president and chief executive officer of Candel Therapeutics, in a press release.1 “This milestone follows our first interim data report from the randomized Phase II clinical trial in patients with ...
- Source: drugdu
- 176
- January 5, 2024
Novartis Returns to Voyager Therapeutics to Reach New Gene Therapy Destinations

Novartis is paying Voyager Therapeutics $100 million up front to collaborate on gene therapies for Huntington’s disease and spinal muscular atrophy. The deal builds on a relationship the companies started in 2022. By FRANK VINLUAN Novartis is committing $100 million to Voyager Therapeutics to see if the biotech’s technology can lead to new gene therapies for Huntington’s disease and spinal muscular atrophy. According to deal terms announced Tuesday, the sum is an upfront payment that includes a $20 million equity investment in Voyager. Milestone payments could bring the Lexington, Massachusetts-based biotech up to $1.2 billion more. If the partnership leads to commercialized therapies, Voyager would also receive royalties from sales. Gene therapies reach their bodily destinations carried aboard an engineered virus. The therapy’s genetic cargo is enveloped by a protein shell called a capsid. Voyager’s TRACER technology platform discovers capsids that can target particular types of tissue. In addition to ...
- Source: drugdu
- 203
- January 4, 2024
MediLink Therapeutics and Roche reach exclusive global license agreement to collaborate on the development of next-generation antibody drug conjugates for cancer treatment

Suzhou, China, January 2, 2024 – Suzhou MediLink Therapeutics (“MediLink”) announced today that it has reached a global cooperation and licensing agreement with Roche. The two parties will collaborate to develop a next-generation antibody-drug conjugate product candidate YL211 (“c-MET ADC”) targeting mesenchymal epidermal transforming factor (c-MET) for the treatment of solid tumors. Under the terms of the agreement, Roche will obtain exclusive rights to the global development, manufacturing and commercialization of YL211. MediLink will work with the China Innovation Center of Roche (CICoR) to promote the YL211 project into phase I clinical trials, and Roche will be responsible for further development and commercialization work on a global scale. Roche will pay MediLink an upfront payment and near-term milestone payments of US$50 million, in addition to nearly US$1 billion in potential milestone payments for development, registration and commercialization, as well as future gradient royalties based on global annual net sales. About ...
- Source: drugdu
- 130
- January 4, 2024
FDA clears neurovascular aspiration, access catheters from Perfuze

BY SEAN WHOOLEY The Millipede catheter. [Image courtesy of Perfuze] Perfuze announced today that the FDA cleared its Millipede 070 aspiration catheter and second-generation Millipede 088 access catheter. Galway, Ireland-based Perfuze developed Millipede 070 to address critical unmet needs in ischemic stroke treatment. It aims to remove clots rapidly and safely through a novel, unique catheter. Millipede 070 has a unique design with a rib-and-recess surface architecture to improve navigability and reduce tip stiffness while maintaining durability. The design features superior deliverability and high procedural efficiency, enabling a more refined approach for restoring blood flow to the brain during endovascular thrombectomy procedures. The company currently has enrollment underway for its MARRS pivotal clinical study to support future regulatory submissions. “Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions, to maximize their opportunity to completely restore blood flow to the brain on their first attempt,” said Wayne Allen, CEO. “The ...
- Source: drugdu
- 176
- January 2, 2024
Organon pays $50M to pick up rights to pair of Eli Lilly migraine meds in Europe

Organon, the women’s health-focused spinoff of Merck, has picked up the rights to distribute and promote a pair of migraine medicines overseas. Monday, Organon unveiled a marketing pact with Eli Lilly to take charge of Emgality and Rayvow in Europe. Emgality is approved to help prevent migraines in adults who have at least four migraine days per month, while Rayvow is cleared for acute treatment of the headache phase of migraine attacks. The commercialization agreement bolsters Organon’s existing suite of central nervous system treatments and furthers the company’s mission to help women, who are disproportionately affected by migraines, Organon’s CEO, Kevin Ali, said in a statement. Under the deal, Lilly will maintain marketing authorizations for its drugs and continue to manufacture the products. In exchange for the rights, Organon is handing over an upfront payment of $50 million. Lilly is also in line to receive other sales-based milestone payouts, the ...
- Source: drugdu
- 171
- December 30, 2023
Fosun Diagnostics’ Fully Automated Chemiluminescence Immunoassay Analyzer F-i1000 Obtains EU IVDR Certification

Recently, Fosun Diagnostics announced that its fully automated chemiluminescence immunoassay analyzer, F-i1000, has received approval for EU IVDR CE registration. The issuance of the registration certificate under the IVDR regulation signifies international recognition of the quality of Fosun Diagnostics’ chemiluminescence products and the ability to meet diverse testing requirements for projects in various levels of medical institutions such as hospitals, core laboratories, and clinics, both domestically and internationally. CE certification is granted based on relevant EU laws, regulations, and standards, serving as a passport for products to freely circulate in the EU market. On May 5, 2017, the EU released the In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746), replacing the original EU In Vitro Diagnostic Medical Devices Directive (IVDD, Directive 98/79/EC). After the transition period following the regulation’s implementation, in vitro diagnostic medical devices without IVDR CE certification will no longer be allowed to enter the EU ...
- Source: drugdu
- 105
- December 29, 2023
BMS agrees to acquire Karuna Therapeutics for $14bn

Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of all outstanding shares of common stock of biopharmaceutical company Karuna Therapeutics for an equity value totalling $14bn in cash. The new strategic merger deal is part of BMS’ strategy to bolster its neuroscience portfolio. Karuna focuses on the discovery and development of therapies for psychiatric and neurological ailments. Through the transaction, BMS will gain access to Karuna’s lead asset KarXT (xanomeline-trospium). It is a potential antipsychotic therapy for patients with schizophrenia and Alzheimer’s disease psychosis. KarXT possesses a new mechanism of action with varied distinguished efficacy and safety profiles. The US Food and Drug Administration (FDA) recently has accepted Karuna’s new drug application (NDA) for KarXT to treat adult patients with an approval decision anticipated on 26 September next year under the Prescription Drug User Fee Act (PDUFA). The antipsychotic is currently being analysed in registrational clinical ...
- Source: drugdu
- 209
- December 28, 2023
Hengrui Biopharmaceutical’s JAK1 Inhibitor SHR0302 Approved for Clinical Use in Systemic Lupus Erythematosus

Recently, Hengrui Biopharmaceuticals received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration, granting approval for the company’s JAK1 inhibitor and innovative drug SHR0302 sustained-release tablets to conduct clinical trials for the indication of systemic lupus erythematosus (SLE). Currently, there is no globally approved medication targeting the same pathway for treating systemic lupus erythematosus. Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease with a complex etiology involving various factors such as genetics, sex hormones, and environmental factors like viral and bacterial infections. The prevalence of SLE in China is estimated to be around 30-70 per 100,000, with an estimated affected population of approximately one million. SLE manifests with complex clinical presentations, affecting multiple organ systems, including joints, skin, kidneys, lungs, blood systems, nervous systems, and blood vessels, potentially leading to severe complications and even death. The situation of SLE in China is characterized by a ...
- Source: drugdu
- 173
- December 27, 2023
Arcutis Biotherapeutics, Inc’s Zoryve Gets FDA Approval for Seborrheic Dermatitis

Pharmaceutical Executive Editorial Staff Zoryve (roflumilast) topical foam, 0.3% is the first approved treatment for seborrheic dermatitis with a new mechanism of action in more than two decades. The FDA has approved Arcutis Biotherapeutics, Inc’s Zoryve (roflumilast) topical foam, 0.3% to treat seborrheic dermatitis in patients aged 9 years and older. The once-daily, steroid-free foam is the first approved treatment for seborrheic dermatitis with a new mechanism of action in more than two decades, according to Arcutis Biotherapeutics. Zoryve (roflumilast) topical foam, 0.3%. Credit: Arcutis Biotherapeutics. “We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, said in a press release. “Zoryve foam is a once-daily, ...
- Source: drugdu
- 151
- December 26, 2023

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