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Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
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- 197
- October 10, 2023
FDA wants more testing in Philips recall

BY SEAN WHOOLEY The FDA has issued a communication stating its desire for more testing in the massive respiratory device recall at Philips (NYSE: PHG)+.The morning after the FDA’s evening announcement, PHG shares were down more than 7% on the NYSE to $18.31 apiece. PHIA shares in Amsterdam closed the day down more than 8%. (MassDevice’s MedTech 100 Index was up slightly.) Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. Here’s a timeline of the events of the ongoing saga. FDA’s statement follows a scathing investigational report from ProPublica and the Pittsburgh Post-Gazette. The report outlined the alleged withholding of information around the issues with the devices even as they became more alarming. “The FDA remains unsatisfied with the status of this recall, and we continue to ...
- Source: drugdu
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- October 10, 2023
Roche presents positive results for spinal muscular atrophy treatment Evrysdi in babies

Roche has presented positive results from an ongoing study evaluating its spinal muscular atrophy (SMA) treatment Evrysdi (risdiplam) in babies aged from birth to six weeks with pre-symptomatic disease. SMA is a severe and progressive neuromuscular disease affecting approximately one in every 10,000 babies. Those living with the condition have insufficient levels of the SMN protein, which is essential to the function of nerves that control muscles and other functions such as swallowing, speaking, breathing and movement. Roche’s Evrysdi, which can be administered at home in liquid form by mouth or by feeding tube, is designed to treat the disease by increasing and sustaining the production of SMN protein in the central nervous system and peripheral tissues. Clinical studies have shown that the loss of motor neurons may begin before symptoms start, so beginning treatment early is seen as critical for improved outcomes. Results from the ongoing RAINBOWFISH study, which ...
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- October 10, 2023
Korean CDMO Lotte Biologics buys land, sets out to build 3 new plants by 2030

Aiming to hit a corporate value of around $15 billion by the end of the decade, Korean CDMO Lotte Biologics has laid out plans to stand up three new manufacturing facilities in the same time frame. Lotte this week unveiled a land purchase agreement with the Incheon Free Economic Zone Authority in Incheon, Korea. With the new real estate, Lotte plans to build out three separate bio plants by 2030. Each plant will be capable of cranking out 120 kiloliters of antibody drugs for a total planned production capacity of 360 kiloliters, Lotte explained in a press release. The company is also weighing whether to add small-scale bioreactors for clinical material production. Plants 1, 2 and 3 are expected to be completed in 2025, 2027 and 2030, respectively. Once full-scale operations kick off around 2034, Lotte will boast 400 kiloliters of total production capacity, the company said. Groundbreaking for the ...
- Source: drugdu
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- October 10, 2023
FDA panel says Amgen’s Phase III lung cancer KRAS drug data is unreliable

AUS Food and Drug Administration (FDA’s) Oncology Advisory Committee (AdCom) has raised questions about the upcoming decision to grant traditional approval of Amgen’s high-profile KRAS G12C inhibitor Lumakras (sotorasib). Lumakras was granted accelerated approval in May 2021 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations, who had received at least one prior systemic therapy. This approval was based on the CodeBreaK 200 trial (NCT04303780) of sotorasib versus docetaxel. Lumakras generated $285m in sales last year worldwide, according to Amgen’s 2022 annual report to shareholders. The latest AdCom questioned the reliability of the data In the briefing document released by the FDA from the meeting, several features of the Codebreak trial were listed that were inconsistent with a sufficient well-controlled trial. The main issue noted was that too many patients were allowed to swap between the treatment and control arms ...
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- October 10, 2023
Ocular launches ocular implant trial to combat macular degeneration

US biopharmaceutical firm, Ocular Therapeutix has announced the start of its first clinical trial of an intravitreal eye implant intended to combat macular degeneration. Named OTX-TKI, the axitinib intravitreal implant is intended to treat wet age-related macular degeneration (wet AMD). Alongside the announcement the company has requested a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) as to how the trial is designed. Overall, the trial will recruit approximately 300 evaluable wet AMD patients. Antony Mattessich, CEO of Ocular Therapeutix said: “With the activation of our first clinical site in the US, we believe we are on target to enrol our first subject before year-end. “The trial is a crucial step forward for our clinical program as we make progress toward our goal of bringing a transformative new treatment that can truly make a difference for wet AMD to patients coping with vision loss.” The company ...
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- October 10, 2023
Catheter ablation beats drugs in J&J retrospective study of AFib heart failure risk

Dive Brief Catheter ablation is better than antiarrhythmic drugs at cutting heart failure risk as a second-line treatment for atrial fibrillation patients, according to a retrospective study funded by Johnson & Johnson. The study, which was published in Heart Rhythm O2, compared the incidence of heart failure in a claims database to evaluate whether patients who have previously tried an antiarrhythmic drug should receive catheter ablation or a different medicine. Across a dataset of more than 18,000 patients, people who received catheter ablation had a 57% lower risk of developing heart failure than their counterparts on antiarrhythmic drugs. Dive Insight In 2019, a randomized clinical trial funded by the National Institutes of Health and medtech companies including J&J’s Biosense Webster found catheter ablation is no better at reducing the composite risk of death and major cardiovascular events than antiarrhythmic drugs. However, the trial linked ablation to a lower risk of ...
- Source: drugdu
- 141
- October 9, 2023
More walkable neighborhoods have a lower incidence of obesity-related cancers among women

In a recent study published in the journal Environmental Health Perspectives, researchers have found that women living in neighborhoods characterized as walkable, based on factors like population density and accessibility to destinations, have a reduced risk of obesity-related cancers, including postmenopausal breast cancer, as well as multiple myeloma, ovarian, and endometrial cancers. Background Obesity is a growing health concern, with over 40% of adults in the United States being obese or overweight. This condition also significantly increases the risk of various cancers, particularly among women. About 55% of diagnosed cancers in women are linked to obesity, while the figure is approximately 24% for men. Inactivity among women is believed to further exacerbate the risk of obesity-related cancers. Increasing evidence highlights walking as a moderate-intensity physical activity that contributes significantly to recommended exercise levels for maintaining good health. Recent research has focused on how the built environment affects physical activity and, ...
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- October 9, 2023
Amgen Fails to Secure FDA Adcomm Support for Full Lumakras Approval

By Tristan Manalac Pictured: Amgen’s office in Massachusetts/iStock, hapabapa The FDA’s Oncologic Drugs Advisory Committee on Thursday voted against Amgen, which is seeking to convert the accelerated approval of its oral G12C KRAS inhibitor Lumakras (sotorasib) to full approval in non-small cell lung cancer. In a 10-2 vote, the panel of external experts found that Amgen’s progression-free survival (PFS) data from the Phase III confirmatory CodeBreaK 200 study could not be reliably interpreted. In particular, the adcomm noted the high number of study dropouts, the small sample size and potentially biased behavior of the trial’s investigators. “No one expects a perfect [randomized controlled trial] but what we hope for is a small number of issues in trial conduct and an effect large enough to withstand the uncertainties caused by those issues,” committee member Mark Conaway, professor at the Division of Translational Research and Applied Statistics at the University of Virginia ...
- Source: drugdu
- 123
- October 9, 2023
Merck’s Keytruda Poised for Bladder Cancer Expansion with New Phase III Data

By Tristan Manalac Pictured: Merck signage outside its office in California/iStock, hapabapa Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma. Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival (OS), the study’s second primary endpoint. The promising initial data from AMBASSADOR point to the “potential of Keytruda to prevent recurrence” in patients who had undergone surgery, Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, said in a statement. AMBASSADOR, also known as KEYNOTE-123, is a randomized and open-label study enrolling approximately ...
- Source: drugdu
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- October 9, 2023

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