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Roche’s Subcutaneous Ocrevus Rivals IV Formulation in Phase III MS Trial

By Kate Goodwin Pictured: Roche Building in Pleasanton/iStock, JHVEPhoto Roche’s Genentech claimed victory for the subcutaneous formulation of its multiple sclerosis blockbuster Ocrevus on Wednesday, with plans to submit Phase III data for regulatory approval. In the OCARINA II study, twice-yearly, 10-minute subcutaneous injections of Ocrevus were pitted against the currently approved IV formulation for multiple sclerosis (MS). The subcutaneous dosing proved as effective in patients with relapsing or primary progressive MS over a 24-week period as the IV version on pharmacokinetic, biomarker and MRI measures. Ocrevus works by targeting and removing a type of B cells that attack the myelin covering around the brain and spinal cord nerve cells. In the Phase III study, the subcutaneous injection provided rapid and sustained B-cell depletion similar to the IV infusion—97% and 98%, respectively, had levels of 5 cells/µL or less at two weeks, which was sustained over 24 weeks. Both formulations ...
- Source: drugdu
- 116
- October 13, 2023
Novo Ends Semaglutide Kidney Study Early Due to Strong Efficacy Signals

By Tristan Manalac Novo Nordisk is ending its Phase III FLOW trial ahead of schedule after an interim analysis of the kidney outcomes study of semaglutide found a very high likelihood of study success, the company announced Tuesday. FLOW, a large randomized, double-blinded and placebo-controlled superiority trial, was assessing the effects of Novo’s GLP-1 agonist semaglutide on the progression of renal impairment and on the risk of renal and cardiovascular mortality in patients with type 2 diabetes and chronic kidney disease (CKD). Semaglutide is the active ingredient in Novo’s diabetes drug Ozempic and weight-loss treatment Wegovy, approved in January 2020 and June 2021, respectively. The study enrolled more than 3,500 patients worldwide and administered semaglutide as an adjunct to standard of care. FLOW’s protocol allowed for an interim analysis once a specific and pre-determined number of primary endpoint events had already occurred. At this interim analysis, an independent Data Monitoring ...
- Source: drugdu
- 119
- October 13, 2023
Biogen lays off staffers at newly acquired Reata, with 113 set to lose positions

Biogen just closed its Reata Pharmaceuticals buyout in September. Now, 100-plus Reata staffers are losing their jobs because their roles were already covered at the Massachusetts Big Biotech. That didn’t take long.Just two weeks after Biogen completed its buyout of Reata Pharmaceuticals, the combined company is trimming its staff. In a recent Worker Adjustment and Retraining Notification (WARN) notice sent to state officials in Texas, Reata said it’s cutting 113 positions. The layoffs will take effect late next month. Reata employed 321 people at the start of the year, an annual Securities and Exchange Commission filing (PDF) shows, so the layoffs are set to affect about a third of the acquired company’s staff. Biogen inked its Reata buyout in July, picking up the potential blockbuster Skyclarys, which is approved by the FDA to treat the rare, inherited neurological disorder Friedreich ataxia. The companies completed the deal in September. At the ...
- Source: drugdu
- 150
- October 13, 2023
Pfizer inks another EpiPen antitrust settlement, this one worth $50M

Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine.The lawsuit, which dates to 2020 and was brought in federal court in Kansas, was filed by direct purchaser plaintiffs who claimed Pfizer and its EpiPen marketing and distribution partner Mylan conspired with Teva to delay the entry of a generic version of EpiPen. The settlement was revealed in a court filing this week. The suit claimed Mylan agreed to delay entry of its generic version of Teva’s branded blockbuster drug Nuvigil in exchange for Teva delaying entry of its EpiPen generic. The direct purchasers claimed they paid more for EpiPen than they would have if Teva’s generic was on the market. Under a prior partnership with Mylan, a Pfizer subsidiary was responsible for manufacturing EpiPen ...
- Source: drugdu
- 124
- October 13, 2023
AstraZeneca’s Forxiga shows promise in paediatric type 2 diabetes trial

AstraZeneca (AZ) has shared positive results from a late-stage trial evaluating its oral SGLT2 inhibitor Forxiga (dapagliflozin) in children and adolescents with type 2 diabetes (T2D). T2D is the most common type of diabetes, accounting for over 90% of cases worldwide, and its prevalence in children and adolescents is increasing globally. The disease is characterised by pathophysiologic defects leading to elevated glucose levels, which over time contribute to further disease progression. “Despite the growing global burden of T2D among children and adolescents, the treatment options available are currently limited,” said Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AZ. “It is well documented that some patients find injectable therapies challenging, making the need for effective oral treatment alternatives paramount,” he added. AZ’s phase 3 T2NOW, which is one of the largest paediatric T2D studies performed to date, assessed the efficacy and safety of Forxiga as an add-on treatment in children ...
- Source: drugdu
- 98
- October 13, 2023
Elligo Health Research expands Study Marketplace with Syneos Health

The agreement builds on the companies’s existing partnership Elligo Health Research has announced it is expanding its IntElligo Study Marketplace platform with Syneos Health. The platform aims to make sales, site selection and application processes more transparent and efficient for clinical trial sponsors, clinical research organisations and sites, while also tracking progress. As part of the agreement, Syneos will utilise Study Marketplace to expand access to clinical trials, increase efficiencies for sites and sponsors across over 500 of Elligo’s US site networks and cover a broad range of therapeutic areas. Launched in 2022 by the healthcare-enabling research organisation, Study Marketplace is a one-stop platform that aims to accelerate participation in clinical research and allows sites to manage their entire pipeline process on a single, user-friendly portal. Updated in June this year, IntElligo Study Marketplace allows sites to easily access and browse available studies and study documents, apply for those of ...
- Source: drugdu
- 151
- October 13, 2023
FDA Clears IND for Kyverna Therapeutics’ Scleroderma Treatment

KYV-101 designed as a CD19 CAR T-cell therapy. Image Credit: Adobe Stock Images/Trsakaoe Kyverna Therapeutics revealed in a company press release that FDA has approved an investigational new drug (IND) application for KYV-101 for the treatment of scleroderma. It marks the third IND clearance for the drug candidate. Reportedly, this will result in a multicenter study of KYV-101, an autologous fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for the treatment of diffuse cutaneous systemic sclerosis (scleroderma). “We are immensely proud of being able to bring KYV-101 to patients suffering from scleroderma,” said Peter Maag, PhD, CEO, Kyverna Therapeutics. “We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals. With the deep B cell depletion from KYV-101 treatment, patients with scleroderma may have a full reset of their immune system to stop the vicious cycle of their ...
- Source: drugdu
- 110
- October 13, 2023
Employers Are Extremely Concerned About Cost

Cancer and pharmacy services are driving up costs for employers. One Mercer exec recently laid out several recommendations for employers to manage these costs. By MARISSA PLESCIA Employers have a long list of concerns when it comes to healthcare, and at the top of that list is cost, one expert said. “Employers are extremely concerned about cost. They are focused on most of their top cost drivers,” said Agnes Quiggle, principal health transformation collaborative leader at Mercer, a consulting firm. Quiggle made these comments Tuesday during an interview at HLTH 2023 in Las Vegas. The top cost driver for employers is cancer, she noted. Cancer overtook musculoskeletal conditions in this category last year, according to Business Group on Health. Quiggle said that cancer diagnoses are “increasing rapidly” and people are living longer with the disease. Pharmacy spending is also a key driver of healthcare costs, Quiggle stated. “Our clients are ...
- Source: drugdu
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- October 13, 2023
Best Buy to sell continuous glucose monitoring systems

Dive Brief Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales. The company plans to sell the Dexcom G7 CGM at launch, and is looking to offer additional CGM systems from other manufacturers, according to the company. Customers who want to buy a CGM will be routed to virtual care platform Wheel, where clinicians will determine a patient’s eligibility and write a prescription. Pharmacy tech provider HealthDyne will receive and process prescriptions, and consumers can then purchase the CGMs on Best Buy’s website for delivery to their homes. Dive Insight Best Buy has been increasingly active in healthcare as it angles to solidify itself as a valuable partner for hospitals and health plans looking for ways to help consumers manage their health at home. The company has sold medical devices for at-home use for ...
- Source: drugdu
- 114
- October 12, 2023
Study supports genetic predisposition to chronic regional pain syndrome in a third of cases

Genes may be responsible for third of complex regional pain syndrome cases. But the condition is less common in men, even though they are more likely to have the 4 genetic variations implicated in heightened risk, suggesting that there may be sex specific causes, say the researchers. Most cases of CRPS are usually triggered by an injury, with the skin of the affected body part hypersensitive to the slightest touch or temperature change. CRPS is difficult to treat, and while it often improves with time, some people experience intense pain for many years. But why some people develop CRPS yet others don’t after the same injury, isn’t clear. A heritable component to CRPS has been suggested, sparking the theory that some people might be genetically predisposed to the condition. To explore this further, the researchers looked for variations in genes, formally known as single nucleotide polymorphisms, or SNPs for short, ...
- Source: drugdu
- 233
- October 12, 2023

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