Pharma News
08 Sep 2024 to 14 Sep 2024
Sep 14, 2024
Pharmaceutical companies provide financial support to patient organizations in Europe through multi-million dollar contributions
Drug companies in the European Union, Norway, Switzerland, and the UK have spent €110m in 2022 funding patient groups, according to an investigation by Investigate Europe. Pfizer, Novo Nordisk, and AstraZeneca were among the firms described as pouring money into groups, renewing concerns over the pharmaceutical industry’s influence on the sector. Some patient groups admitted to excessively relying on the income, while companies argued that funding patient groups was an opportunity to cooperate in areas they both specialised in. Lack of transparency on how the funds are utilized was also a concern highlighted in the investigation.
Sep 13, 2024
Roche's injectable version of popular multiple sclerosis drug receives FDA approval
Swiss pharma giant Roche has received FDA approval for an injectable version of its multiple sclerosis therapy, Ocrevus. The approval was based on the results of a late-stage trial, OCARINA II, which showed that the injectable version was as effective as the current intravenous infusion approach. The availability of the injectable drug starting in October will allow multiple sclerosis patients to receive treatment in neurologist's offices and potentially help Roche fend off competition from Novartis and TG Therapeutics.
Sep 13, 2024
Cork leads the way in the pharmaceutical industry's newest breakthrough medication - Report from the Irish Examiner
Danish pharmaceutical company Novo Nordisk's drug Ozempic, initially designed to treat type 2 diabetes, has gained popularity as a treatment for obesity and metabolic disorders. The demand for Ozempic has led to Novo Nordisk struggling to keep up with supply, prompting rival Eli Lilly to commit €1.6bn ($1.8bn) to expand its manufacturing capacity in Ireland. Eli Lilly's investment will help meet the demand for its diabetes and obesity treatments. Analysts predict the market for weight loss and obesity drugs could be split between Eli Lilly and Novo Nordisk by the end of this year, potentially reaching $130bn annually by the 2030s.
Sep 12, 2024
FDA in the United States broadens approval for J&J's Tremfya treatment from psoriasis to inflammatory bowel disease
The US FDA has granted expanded use of Johnson & Johnson's drug Tremfya to treat adults with ulcerative colitis, a type of chronic inflammatory bowel disease. Tremfya, which targets the protein IL-23 involved in inflammatory responses, will provide another treatment option for patients. This approval comes as J&J's other drug for ulcerative colitis, Stelara, faces a patent cliff, allowing cheaper biosimilars into the market. In clinical trials, Tremfya helped patients achieve endoscopic remission, where no signs of inflammation, ulcers, or bleeding are visible.
Sep 12, 2024
New weight loss drug outperforms Ozempic and Wegovy in early study - Gizmodo
Danish pharmaceutical company Novo Nordisk has revealed preliminary data suggesting that its experimental drug amycretin can help people lose even more weight than its already successful drug semaglutide. In a Phase I trial of obese individuals, those taking amycretin lost an average of 13.1% of their body weight over a 12-week period. This surpasses the average weight loss seen in those taking a placebo and could potentially exceed the success of semaglutide. Amycretin is taken orally, unlike the injections required for semaglutide, making it an attractive option for weight loss treatment.
Sep 12, 2024
FDA in the US broadens approval for J&J's psoriasis medication to include treatment for inflammatory bowel disease - ET HealthWorld
The US FDA has approved J&J's psoriasis drug, Tremfya, for the treatment of inflammatory bowel disease. This expansion of usage comes as J&J's other drug, Stelara, faces potential competition from cheaper biosimilars after losing its patent protection.
Sep 11, 2024
After a 16-month delay, the weight-loss medication Wegovy will finally be available for purchase in Korea.
The weight-loss drug Wegovy, manufactured by Novo Nordisk, will finally be available for sale in the Korean market next month, after a 16-month wait following regulatory approval. The price for Wegovy has yet to be confirmed, but it is estimated to be around 500,000 won ($373), similar to its predecessor Saxenda. Wegovy, a once-weekly injectable drug, mimics the action of a gut hormone to regulate appetite. Korea is the second Asian country, after Japan, to approve and sell Wegovy.
Sep 11, 2024
Improving medication adherence and minimizing side effects through the development of prodrugs and patent protection
Bristol Myers Squibb's (BMS) schizophrenia drug KarXT is expected to gain approval after the Prescription Drug User Fee Act (PDUFA) deadline of 26 September 2024. The drug has a strong clinical profile with a differentiated mechanism of action and is expected to address some of the limitations of traditional antipsychotic drugs. However, its twice-daily dosing schedule may pose challenges to patient adherence. Terran Biosciences is developing a prodrug version of KarXT, called TerXT, which offers a more convenient once-daily oral regimen and multi-month injectable options.
Sep 11, 2024
FDA in the US broadens the use of J&J's psoriasis medication for treating inflammatory bowel disease
The FDA has granted approval for Johnson & Johnson's drug Tremfya to be used in the treatment of ulcerative colitis, a type of chronic inflammatory bowel disease. This expands the treatment options available for patients with the condition. Tremfya targets the protein IL-23 and will be the fourth drug for ulcerative colitis in J&J's portfolio. This approval is significant for J&J as their blockbuster drug for psoriasis and ulcerative colitis, Stelara, is nearing the end of its patent protection.
Sep 11, 2024
UnitedHealth decides to swap Humira for more affordable biosimilars, following in the footsteps of rival companies.
UnitedHealth Group has announced that it will remove AbbVie's blockbuster drug Humira from its preferred reimbursement lists starting in 2025. The company will instead recommend lower-cost biosimilar versions of the drug. This move follows a larger trend in the US pharmaceutical market as health plans seek to cut costs by promoting alternatives to high-priced drugs. Other pharmacy benefit managers, including CVS and Cigna, have also made similar decisions to exclude Humira from their lists. Despite growing competition, AbbVie has managed to retain a dominant share of the US Humira market.
Sep 11, 2024
Dupixent, developed by Sanofi and Regeneron, successfully meets objectives in a late-stage urticaria study - according to TradingView.
Sanofi and Regeneron have announced positive results from a phase III study evaluating their drug Dupixent in patients with chronic spontaneous urticaria (CSU). The study showed a significant reduction in itch and hives severity in patients who received the Dupixent and standard of care (SOC) combination compared to those who received a placebo. Based on the positive data from this study and a previous phase III study, the companies plan to resubmit a regulatory filing seeking label expansion for Dupixent in CSU indication. Sanofi and Regeneron believe that if approved, Dupixent will be the first targeted therapy for CSU in a decade. Additionally, the companies reported positive results from a study evaluating Dupixent in adults with bullous pemphigoid, a rare skin condition, and plan to file a regulatory filing with the FDA for this indication.
Sep 11, 2024
Dupixent shows positive results in clinical trial for chronic hives, potentially boosting Sanofi and Regeneron's prospects
Sanofi and Regeneron are planning to make another attempt at expanding the use of their drug Dupixent for the treatment of chronic spontaneous urticaria (CSU), a chronic skin condition that causes hives. The companies previously had their application rejected by the FDA but now have new efficacy data to support the new use. A trial showed that patients who added Dupixent to their treatment regimen experienced a 50% reduction in itch and urticaria activity scores compared to those who received a placebo. Dupixent is already one of the top-selling drugs in the world with $11.6 billion in revenue last year and is prescribed for a variety of inflammatory conditions. Sanofi and Regeneron plan to submit a new application to the FDA by the end of the year.
Sep 11, 2024
UnitedHealth to Replace Humira with Different Medication on Select Preferred-Drug Lists
UnitedHealth Group has announced that it will remove AbbVie's arthritis drug, Humira, from some of its preferred drug lists for reimbursement, effective from January 1, 2025. The insurance company will instead recommend cheaper biosimilar alternatives. In other pharmaceutical news, Novo Nordisk's weight loss drug, Saxenda, has been found safe and effective for children aged 6 and under 12, while GSK's experimental herpes vaccine failed to meet its main goal in a mid-stage trial.
Sep 11, 2024
Sanofi Looks to Expand Market for Popular Asthma Medication
Sanofi's Dupixent shows promising results in reducing itching for patients with chronic hives, leading to plans for the drug's resubmission for this condition. In a late-stage trial, the treatment demonstrated a nearly 50% decrease in itching and hives scores, consistent with previous study findings.
Sep 11, 2024
Successful trial of Dupixent for chronic hives announced by Sanofi and Regeneron, according to STAT News
Sanofi and Regeneron’s Dupixent effectively treated patients with chronic spontaneous urticaria, a skin disease, in a Phase 3 trial. The trial showed that patients on Dupixent experienced a significant reduction in itch severity and frequency of hives compared to those on the placebo. The treatment also had a favorable safety profile. This brings the companies closer to obtaining FDA approval after their previous application was rejected.
Sep 11, 2024
The US FDA approves J&J's psoriasis medication for the treatment of inflammatory bowel disease - as reported by AOL.com
The FDA has expanded the use of Johnson & Johnson's drug, Tremfya, to treat adults with ulcerative colitis, a type of chronic inflammatory bowel disease. Tremfya, which targets a protein involved in inflammatory responses, will provide a new treatment option for patients with the condition. J&J has been relying on Tremfya as its other drug for ulcerative colitis, Stelara, is facing patent expiration. The company expects to make Tremfya available to eligible patients within a couple of weeks.
Sep 10, 2024
Bayer's Investment in Roivant Sciences' New 'Vant' Increases Competitiveness Against a United Therapeutics Lung Drug
Roivant Sciences has announced the launch of its subsidiary, Pulmovant, which will develop mosliciguat as a treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD). Pulmovant secured the licensing of the drug from Bayer and presented positive Phase 1b clinical data for the treatment at the recent European Respiratory Society Congress. Mosliciguat achieved average percentage reductions in pulmonary vascular resistance between 25.9% and 38.1% in the different doses tested. Pulmovant plans to kick off a global, placebo-controlled Phase 2 study in PH-ILD imminently.
Sep 10, 2024
UnitedHealth plans to exclude AbbVie's Humira from certain US drug reimbursement lists in the coming year
UnitedHealth Group will remove AbbVie's Humira drug from some of its preferred drug reimbursement lists starting January 1, 2025, in favor of cheaper biosimilar versions. The move follows similar actions by other pharmacy benefits managers, including CVS Health's Caremark unit and Cigna. UnitedHealth stated that patients will have coverage for Humira until the preferred biosimilars receive the interchangeable designation from the FDA, which is expected in 2025. Humira has largely retained its market share this year, despite the launch of multiple biosimilar alternatives.
Sep 10, 2024
AZ's new lung cancer medication fails to meet expectations, as reported by European Biotechnology Magazine.
Datopotamab deruxtecan (Dato-DXd), a TROP2-directed DXd antibody drug conjugate jointly developed by AstraZeneca and Daiichi Sankyo, showed promising results in a phase III trial for non-squamous non-small cell lung cancer (NSCLC) patients. While the overall survival rates did not reach statistical significance compared to the current standard chemotherapy, the subgroup of patients with non-squamous NSCLC experienced a clinically meaningful improvement in overall survival. AstraZeneca is now shifting its focus to this subgroup and remains confident in the potential of datopotamab deruxtecan in treating NSCLC.
Sep 10, 2024
AstraZeneca experiences a 5% drop in shares following disappointing results for their new cancer drug's impact on survival.
Pharmaceutical giant AstraZeneca's stock fell over 5% on disappointing data from a late-stage clinical trial of its precision lung cancer drug Dato-DxD. The trial did not show statistically significant improvement in overall survival rates for patients with non-small cell lung cancer. This raises doubts about the drug's potential US regulatory approval and its projected sales of $5 billion. AstraZeneca's shares had been performing well prior to this setback. Data-DxD is being developed in partnership with Daiichi Sango.
Sep 10, 2024
New research shows that ivonescimab outperforms Keytruda in a clinical trial for non-small cell lung cancer, according to BioWorld.
Summit Therapeutics and Akeso Pharmaceuticals' PD-1/VEGF-targeting bispecific antibody, ivonescimab, has shown promising results in a phase III trial for non-small-cell lung cancer, outperforming Merck's blockbuster drug, Keytruda. The trial demonstrated a near doubling of progression-free survival, with a median PFS of 11.14 months vs. 5.82 months. Shares of Summit and Akeso increased significantly on the news.
Sep 10, 2024
Wegovy, a highly anticipated weight loss medication from Novo Nordisk, set to be available in South Korea by mid-October, according to reports by KBR.
Novo Nordisk Korea has announced the launch of its obesity treatment, Wegovy Prefilled Pen (semaglutide), in Korea in mid-October. Wegovy is a once-weekly injection approved for weight loss and management in obese patients with an initial body mass index (BMI) of 30 kg/m2 or greater, as well as overweight patients with a BMI of 27 kg/m2 or greater and weight-related comorbidities. The treatment gained an additional indication in July to reduce the risk of major cardiovascular events. Novo Nordisk Korea aims to provide access to Wegovy for the approximately 16 million people affected by obesity in Korea.
Sep 9, 2024
Stocks of Summit rise after cancer drug outperforms Keytruda in direct comparison study - ET HealthWorld
Summit Therapeutics shares jumped 37% after a study showed that patients with lung cancer who were on Summit's experimental drug had better survival rates than those on Merck's Keytruda. The late-stage study conducted by Akeso showed that Summit's therapy had a median of 11.14 months of progression-free survival compared to 5.82 months for Keytruda. However, analysts believe that Summit's therapy is still years away from entering the market.
Sep 9, 2024
TradingView reports that Summit's stock prices rise after its cancer drug outperforms Keytruda in a direct comparison study
Summit Therapeutics shares surged 37% after a study in China showed that some lung cancer patients on the company's experimental drug had better survival rates than those on Merck's blockbuster therapy Keytruda. The study showed that Summit's drug had a median of over 11 months of progression-free survival, compared to 5.82 months for Keytruda. However, analysts believe that Summit's drug is still years away from the market and does not pose a significant threat to Keytruda, which is due to go off-patent in the coming years.
Sep 9, 2024
Summit Therapeutics Surges Over 60% Today, Reports The Globe and Mail
Shares of Summit Therapeutics surged on Monday after the biotech firm released positive results from a Phase III study on its lung cancer treatment Ivonescimab. The trial showed that Ivonescimab outperformed Merck's Keytruda, the current standard of care. Ivonescimab achieved a median progression-free survival time of 11.14 months compared to 5.82 months for Keytruda. Analysts have raised their price targets for Summit Therapeutics, highlighting the potential for Ivonescimab as a replacement for Keytruda in lung cancer treatment.
Sep 9, 2024
GSK's new asthma medication significantly reduced attacks in late-stage study
GlaxoSmithKline's (GSK) asthma treatment, depemokimab, has been shown in phase 3 trials to reduce the number of attacks by 54% over 52 weeks compared to a placebo. However, depemokimab did not meet all of the secondary endpoints, including measures of quality of life and asthma control. GSK remains committed to depemokimab and is planning to submit the relevant data to health authorities for approval. The drug is expected to generate peak-year sales of £3 billion ($3.9 billion) if approved.
Sep 9, 2024
Checkpoint inhibitor from Summit outperforms Keytruda in lung cancer study - Clinical Trials Arena
Summit Therapeutics has announced positive Phase III data for its drug ivonescimab, showing a statistically significant reduction in the risk of lung cancer progression or death compared to MSD's Keytruda. The study involved 398 patients with PD-L1-positive, advanced non-small cell lung cancer in China. The results revealed that ivonescimab extended the time patients did not have tumor progression to slightly more than 11 months, compared to nearly six months for patients treated with Keytruda. Summit plans to initiate a Phase III trial to compare ivonescimab monotherapy to Keytruda monotherapy in patients with metastatic NSCLC.
Sep 9, 2024
TradingView reports that Summit's stock reaches all-time high after successful trial in China where its cancer drug outperformed Keytruda.
Shares of Summit Therapeutics (SMMT) surged 75% after a study in China showed that lung cancer patients on their experimental drug, invonescimab, had better survival rates than those on Merck's Keytruda. The study revealed that patients lived a median of over 11 months without disease progression, a statistically significant improvement over Keytruda. While analysts downplayed concerns about Keytruda facing a challenge, data from a global trial next year will be crucial to validate the results and determine if invonescimab could become the new standard.
Sep 8, 2024
Summit therapy outperformed Merck's popular drug Keytruda in advanced lung cancer study, reports STAT News
Summit Therapeutics has presented detailed data at the World Conference on Lung Cancer, demonstrating that its experimental therapy, ivonescimab, has outperformed Merck's Keytruda in a head-to-head late-stage trial for lung cancer. In the trial, ivonescimab reduced the risk of tumor progression by 49% compared to Keytruda, with patients on ivonescimab experiencing a median of 11.1 months before tumor growth resumed, compared to 5.8 months for those on Keytruda. The Phase 3 study was conducted by Akeso, the Chinese company that invented ivonescimab and licensed it to Summit.
