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IGM jettisons workforce and blood cancer programme to refocus pipeline

IGM Biosciences plans to axe 22% of its workforce, becoming the latest company to downsize in a bid to free cash resources. Amid the layoffs, the US-based biotechnology company will also reprioritise its pipeline, discontinuing operations for all haematologic oncology and targeted cytokine product development while doubling down on its efforts in the clinical development of T cell engagers for autoimmune diseases and a DR5 agonist for colorectal cancer. IGM expects the restructuring to extend the company’s cash runway into Q2 2026. The restructuring comes less than a month after the company said it anticipated an increase in headcount to support the research and development of its pipeline candidates, citing its intent to advance and expand its antibody product pipeline, in its 13 November 10-Q filing. In the same filing, the company acknowledged that it had significant net losses to date and that achieving profitability sufficient enough to offset the ...
- Source: drugdu
- 139
- December 8, 2023
Daiichi Sankyo scores $182M from Novartis settlement in long-running patent case

After years of back and forth with Daiichi Sankyo over cancer drug patent claims, Novartis has thrown in the towel with a $182 million settlement. The case stems back to 2017 and has its roots in Novartis’ Tafinlar, a melanoma therapy that the company acquired from GSK after a 2015 asset swap. Daiichi’s former subsidiary Plexxikon, which makes melanoma treatment Zelboraf, alleged that GSK scientists only gathered the knowledge necessary to develop the rival drug after consulting with Plexxikon for talks about a partnership that never came to fruition. Plexxikon’s patents date back to 2005, while GSK filed its first patent application on the drug in 2008, Plexxikon said. In 2021, a Northern California jury ruled in favor of Plexxikon, determining that Novartis stepped on two of the Daiichi subsidiary’s patents. Novartis was ordered to pay Daiichi’s subsidiary 9% royalty payments on future Tafinlar sales until certain Zelboraf patents expire ...
- Source: drugdu
- 147
- December 8, 2023
Novartis’ Fabhalta approved by FDA as first oral monotherapy for rare blood disease PNH

Novartis’ Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first oral monotherapy for adults with paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disease affecting approximately ten to 20 people per million worldwide. PNH patients have an acquired mutation that causes them to produce red blood cells susceptible to premature destruction by the complement system, which can cause anaemia, thrombosis, fatigue and other symptoms that can impact quality of life. The disease has a significant unmet need, Novartis reports, with a large proportion of patients on anti-C5 treatment remaining anaemic and dependent on blood transfusions. Fabhalta is a factor B inhibitor of the immune system’s complement pathway and offers an alternative to therapies that need to be delivered by infusion or injection. Victor Bultó, president US, Novartis, described the approval as an “extraordinary moment” for the PNH community. “This new, effective oral medicine may ...
- Source: drugdu
- 132
- December 8, 2023
AstraZeneca and generative AI company Absci enter $247m oncology partnership

AstraZeneca (AZ) and Absci have entered into a collaboration agreement worth up to $247m to develop an artificial intelligence (AI)-designed antibody drug for a specified oncology target. The partnership will combine AZ’s capabilities in oncology research and development with Absci’s Integrated Drug Creation platform, which the generative AI company says “unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimising multiple drug characteristics important to both development and therapeutic benefit”. The agreement includes an upfront commitment from AZ as well as research and development funding, milestone payments and royalties on product sales. Puja Sapra, senior vice president of biologics engineering and oncology targeted delivery at AZ, said: “This collaboration is an exciting opportunity to utilise Absci’s de novo AI antibody creation platform to design a potential new antibody therapy in oncology.” Absci outlines that its approach “overcomes the limits of traditional drug discovery”. ...
- Source: drugdu
- 167
- December 8, 2023
Hims & Hers Gets Into Weight Loss Treatment

Direct-to-consumer telemedicine platform Hims & Hers launched a new weight loss program Monday that offers weight loss medications, educational content and digital tracking tools. San Francisco-based Hims & Hers is a health and wellness platform that provides support for sexual health, hair, skin, primary care, mental health and other areas. The launch of the new weight loss offering comes at a time when more people are battling obesity. About 42% of U.S. adults struggle with obesity, according to the Centers for Disease Control and Prevention. Compare that to more than 20 years ago when a little over 30% struggled with obesity. The company’s new program starts with a consultation with a licensed healthcare provider from Hims & Hers. If considered appropriate, the patient will then receive a personalized treatment plan that is based on several factors, including the person’s body, health history and goals. The treatment plans have three elements. ...
- Source: drugdu
- 267
- December 7, 2023
Intuitive’s venture capital arm launches second investment fund

Dive Brief Intuitive Surgical’s venture capital arm has launched a second investment fund with $150 million in new capital. The Intuitive Ventures fund will support startups focused on improving healthcare access and coordination, developing precision diagnostics and interventions, and integrating digital technology, the firm said Monday. The new fund follows the launch of Intuitive’s first venture capital fund three years ago and brings the firm’s total assets under management to $250 million. Dive Insight The robotic surgery leader is among a number of large medtech companies to establish a venture capital operation dedicated to supporting a portfolio of early-stage companies. GE HealthCare, Johnson & Johnson and Boston Scientific have also launched venture funds. The venture has since invested in more than 10 startups, supported by Intuitive Surgical’s network and corporate oversight. Those companies include Capstan Medical, Endogenex, Flywheel, KelaHealth, MedCrypt, Neocis Optellum and Surge Therapeutics. “Fund II deepens Intuitive’s commitment ...
- Source: drugdu
- 138
- December 7, 2023
Exactech wins clearance for new ankle surgery navigation system

BY CHRIS NEWMARKER ExactechGPS Ankle [Image courtesy of Exactech]Exactech announced today that its BlueOrtho subsidiary has received FDA 510(k) clearance for ExactechGPS Ankle. The Gainesville, Florida–based company described the system as the first of its kind for total ankle arthroplasty. It connects the preoperative plan with real-time intraoperative instrument guidance, confirming that resections meet the surgical plan. Designed to improve surgical precision, the ExactechGPS Ankle combines propriety active tracker technology with a touchscreen tablet, providing dynamic feedback to surgeons during procedures. “I am already a fan of Exactech’s patient-specific instrumentation solution and am thrilled how GPS Ankle provides intraoperative flexibility at my fingertips. The ability to quantify soft tissue laxity will be a game changer for me and my patients,” said design team surgeon Dr. Edward Haupt of the Mayo Clinic in Florida. GPS Ankle has compatibility with Exactech’s flagship Vantage Total Ankle System. It will be available to hospitals ...
- Source: drugdu
- 145
- December 7, 2023
Eli Lilly Announces Availability of Obesity Drug Zepbound at US Pharmacies

Pharmaceutical Executive Editorial Staff Patients with obesity are now able to access Zepbound (tirzepatide) with a prescription at retail and mail-order pharmacies across six dose strengths. Eli Lilly and Company announced today that its obesity treatment Zepbound (tirzepatide) is now commercially available at pharmacies in the United States.1 Last month, the FDA approved Zepbound injection as the first and only approved treatment for obesity that activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) hormone receptors.2 Image credit: Kurhan | stock.adobe.com Patients with obesity are now able to access Zepbound with a prescription at retail and mail-order pharmacies across six dose strengths—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg. “Today opens another chapter for adults living with obesity who have been looking for a new treatment option like Zepbound,” said Rhonda Pacheco, group vice president, Lilly Diabetes and Obesity, US, in a press release.1 The ...
- Source: drugdu
- 230
- December 7, 2023
ImmunoGen’s ADC Elahere wins FDA priority review for ovarian cancer

The US Food and Drug Administration (FDA) has granted priority review for the full approval of the antibody drug conjugate, Elahere (mirvetuximab soravtansine-gynx) and has set a Prescription Drug User Fee Act (PDUFA) action date of 5 April 2024. Elahere was a central element in the $10.1bn ImmunoGen acquisition deal announced by AbbVie last week (30 November). AbbVie expects the acquisition to complete in mid-2024. Elahere is an antibody drug conjugate (ADC) that targets folate receptor alpha (FRα). In November 2022, it was granted accelerated approval as the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer for patients who have received one to three prior systemic treatment regimens. The latest supplemental Biologics License Application (sBLA) for Elahere is supported by the data from the Phase III MIRASOL trial, which will allow for the accelerated approval to be converted to a full approval. ImmunoGen reported $105.2m in ...
- Source: drugdu
- 137
- December 7, 2023
As Stelara cliff looms, J&J expects 25 blockbuster drugs to drive future sales growth

As Johnson & Johnson places a magnifying glass on its pharmaceutical business, the focus for the remainder of the decade rests on the shoulders of some 25 new and upcoming drugs. Together, those meds will help the company deliver pharmaceutical sales growth of 5% to 7% between 2025 and 2030, the company said Tuesday. That phalanx of novel products will be essential as J&J’s longstanding immunology star, Stelara, nears its tumble over the patent cliff. Last year, the drug generated $9.7 billion and was J&J’s top product by sales. During an enterprise business review Tuesday, J&J laid out its expectations across the 2025 to 2030 timeframe. Chief among those, J&J says it will boast 10 or more drugs with peak sales potential of at least $5 billion, including cancer launches Talvey and Tecvayli, plus another 15-plus products with sales potential of at least $1 billion. The latter group of therapeutics ...
- Source: drugdu
- 119
- December 7, 2023

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