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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
- 108
- 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
- 185
- 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
- 105
- 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
- 98
- December 7, 2023
EC approves UCB’s Zilbrysq as generalised myasthenia gravis add-on therapy

The European Commission (EC) has approved UCB’s Zilbrysq (zilucoplan) as an add-on therapy for certain patients with generalised myasthenia gravis (gMG), a rare autoimmune disease with a global prevalence of 100 to 350 cases per one million people. The marketing authorisation, which specifically applies to adults who are anti-acetylcholine receptor (AChR) antibody-positive, makes Zilbrysq the first once-daily subcutaneous, targeted component 5 (C5) complement inhibitor for gMG. Patients with gMG can experience a variety of symptoms, including severe muscular weakness that can result in double vision, drooping eyelids, difficulty swallowing, chewing and talking, and life-threatening weakness of the muscles of respiration. UCB’s Zilbrysq inhibits complement-mediated damage to the neuromuscular junction through its targeted dual mechanism of action, the company said, adding that the therapy can be used simultaneously with intravenous immunoglobulin and plasma exchange without the need for supplemental dosing. The EC’s decision was supported by positive results from the late-stage ...
- Source: drugdu
- 102
- December 7, 2023
Global donors pledge over $777m to fight neglected tropical diseases at COP28 summit

At the 2023 Reaching the Last Mile (RLM) Forum during the United Nations Climate Change Conference (COP28), global donors pledged $777.2m to help control, eliminate and eradicate neglected tropical diseases (NTDs). The funding will accelerate progress towards achieving the goals outlined in the World Health Organization’s (WHO) 2030 roadmap on NTDs. The forum, hosted by RLM in partnership with the Bill & Melinda Gates Foundation, comprised over 450 government ministers, global health leaders and development experts, philanthropists and civil society leaders to mitigate the effects of the climate crisis on human health. Established in 2020, WHO’s roadmap for NTDs includes eliminating at least one NTD in 100 countries by 2030 and reducing the number of people requiring NTD treatment by 90%. Despite progress, climate change has slowed the reach and prevalence of infectious diseases. NTDs are a diverse group of several parasitic viral, bacterial, fungal and non-communicable diseases that can ...
- Source: drugdu
- 94
- December 7, 2023
Roche Jumps into Lucrative Weight-Loss Space with $2.7B Carmot Buy

By Tristan Manalac Pictured: Roche’s building in California Roche on Monday announced it has entered into a definitive merger agreement with Berkeley, California-based Carmot Therapeutics, a move that could place it in the thick of the lucrative and increasingly competitive weight-loss market. As per the terms of the acquisition, Roche will make an upfront payment of $2.7 billion at the transaction’s close, which the companies anticipate will occur in the first quarter of 2024, pending regulatory and anti-trust clearance. Carmot’s equity holders will also be eligible for up to $400 million in additional payments, contingent on the achievement of certain milestones. In return, Roche will gain access to Carmot’s portfolio of preclinical and clinical assets, including three GLP-1 receptor agonists, which have “best-in-class potential to treat obesity,” according to Monday’s news release. Carmot’s lead asset is CT-388, a dual agonist of both the GLP-1 and GIP receptors that is ready ...
- Source: drugdu
- 107
- December 6, 2023
EyePoint Pharma Stock Surges on Phase II Wet AMD-Therapy Results

By Connor Lynch Pictured: A patient being examined by an eye doctor EyePoint Pharmaceuticals marked a major win Monday, with Phase II results of its anti-VEGF therapy for wet age-related macular degeneration showing comparable results to Regeneron’s Eylea on a less-frequent dosing regimen. Share prices jumped over 200% in premarket trading on the news that EYP-1901 had hit all primary and secondary endpoints in the DAVIO 2 trial. The trial was investigating EyePoint’s EYP-1901 therapy, an “investigational sustained delivery maintenance treatment” for wet age-related macular degeneration (AMD) that combines vorolanib, a selective tyrosine kinase inhibitor, with “bioerodible Durasert E,” an injectable drug delivery system. The study tested two doses of the therapy, both 2 mg and 3 mg in 160 patients, finding both met all of the primary and secondary endpoints. That included the primary endpoint of “statistical non-inferiority change in best corrected visual acuity,” compared to the control of ...
- Source: drugdu
- 118
- December 6, 2023
Elli Lilly Cancer Drug Lands Its Second FDA Approval This Year

Eli Lilly cancer drug Jaypirca is closing 2023 the same way it started—with an FDA approval. The latest regulatory nod adds two additional types of blood cancers to the list of indications for the therapy. Friday’s accelerated approval for Jaypirca covers the treatment of adults with either chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The once-daily oral drug is a small molecule designed to block Bruton’s tyrosine kinase, or BTK, a cancer-driving enzyme. While other drugs already do this, Lilly’s molecule has an edge. The FDA based its decision on the results of an open-label, single-arm Phase 1/2 study in blood cancers that included more than 100 patients with CLL or SLL previously treated with at least two prior lines of therapy. Participants had received a median of five prior lines of therapy; the FDA said 77% of these patients had discontinued a BTK inhibitor after their cancer ...
- Source: drugdu
- 115
- December 6, 2023
Aledade, Anthem Form New Value-Based Medicaid Partnership for Virginians

Anthem Blue Cross and Blue Shield in Virginia has partnered with Aledade, a network of independent primary care practices, to improve access to value-based primary care for Medicaid members, the companies announced last week. Bethesda, Maryland-based Aledade helps independent practices, health centers and clinics engage in value-based care through data insights, policy expertise and contracting support. It works with more than 1,500 practices and community health centers across 46 states and the District of Columbia. Through the partnership, Anthem’s Medicaid members will have better access to primary and preventive care, including health screenings. Aledade and Anthem began working together last year with the insurer’s Medicare Advantage and commercially insured members. The partnership enables Aledade to bring value-based care — in which clinicians are paid based on the quality of care they deliver versus the volume of care they provide — to more than 80 practices, 15 health centers and 25 ...
- Source: drugdu
- 97
- December 6, 2023

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