PharmaFocus Today – Page 45 – media

AstraZeneca may pull plug on UK vaccine manufacturing plans

AstraZeneca is considering relocating its manufacturing facilities from the UK to the US, amidst potential cuts to state funding from the Labour government. UK Finance Minister Rachel Reeves has discussed plans to decrease state financial aid for the company’s £450m vaccine centre, as per the Financial Times. The pharmaceutical giant had announced plans to construct a manufacturing plant in Speke, Liverpool, as part of a £650m investment in the UK, in March 2024. Of this amount, £450m would be allocated to the facility in Speke while the other £200m would be used to develop facilities in Cambridge. Undisclosed sources briefed on discussions between the government and AstraZeneca said the Labour government may reduce the previous government’s pledge of £90m to £40m. Attracting manufacturing investment has been a key part of the life sciences strategy for the UK. The government has also pursued similar projects with other companies, similar to one ...
- Source: drugdu
- 75
- August 27, 2024
Q&A with Oren Gilad, CEO of Aprea Therapeutics

By Mike Hollan Gilad discusses the ways that this method can be used to treat various cancers without putting patients through the side effects of chemotherapy. Precision medicine is gaining momentum in the life sciences industry. It’s also changing the way that researchers are approaching new treatments and therapies. Pharmaceutical Executive spoke with Oren Gilad, PhD, president and CEO of Aprea Therapeutics, about some of the ways that the company is approaching cancer treatment with this new mindset. Pharmaceutical Executive: Can you discuss the concept of synthetic lethality and how it relates to your work? Oren Gilad: Synthetic lethality is a concept where the combination of two genetic mutations leads to cell death, whereas each mutation on its own would not be lethal. Cancer cells often have specific genetic mutations that normal cells do not carry, generally because they exist because a normal mutated to become cancer. So, there’s already ...
- Source: drugdu
- 57
- August 26, 2024
GLP-1 Therapy Significantly Increases Visceral Adipose Tissue Metabolic Activity in Patients with Obesity, Obstructive Sleep Apnea

By Don Tracy, Associate Editor Findings from a study published in the Journal of the Obesity Society may significantly advance the understanding of GLP-1 analogues and their role in treating obesity.In recent years, glucagon-like peptide-1 (GLP-1) analogues, such as Ozempic, have demonstrated promising weight loss results by promoting satiety and delaying gastric emptying, thus reducing energy intake. However, a number of studies conducted in animals suggest that GLP-1 therapies may also influence energy expenditure by increasing metabolic activity in visceral adipose tissue (VAT), a more metabolically active and harmful fat depot compared to subcutaneous fat. The study’s primary objective was to determine whether VAT metabolic activation also occurs in humans and how it contributes to the weight loss effect of GLP-1 analogues.1 “This study challenges the main narrative about these newer treatments which is that they simply make you eat less, and that any action on energy burn is minimal. ...
- Source: drugdu
- 71
- August 26, 2024
Eisai’s Leqembi deemed too costly for NHS

Though the UK became the first country in Europe to authorize use of Eisai and Biogen’s early Alzheimer’s disease drug, Leqembi (lecanemab), patients in the UK’s National Health Services (NHS) will not gain access to the drug as the anti-amyloid treatment was deemed too costly. As per the 22 August draft guidance consultation released by the National Institute for Health and Care Excellence (NICE), an independent committee found that the cost effectiveness estimates were “considerably above what NICE considers an acceptable use of NHS resources.” The committee cited a lack of evidence on the long-term effects of treatment with Leqembi and the costs of providing treatment infusions, monitoring side effects, and determining when to terminate treatment as uncertainties. According to the guidance, NICE has requested additional information from Eisai and NHS England to address the uncertainties and will consider the additional information alongside stakeholder comments in a second meeting. In ...
- Source: drugdu
- 66
- August 26, 2024
Lexicon to face FDA AdComm for Zynquista approval in diabetes and CKD

It looks like Lexicon Pharmaceuticals’ second bid to get US Food and Drug Administration (FDA) approval for Zynquista (sotagliflozin) will be as arduous as the first go around, as the regulatory agency has convened an advisory committee (AdComm) to evaluate its efficacy. The FDA’s Endocrinologic and Metabolic Drugs AdComm will discuss the benefit/risk profile of Zynquista as an adjunct to insulin therapy for glycaemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The AdComm is set to meet on 31 October 2024. Lexicon added that convening of the AdComm will not affect the Prescription Drug User Fee Act (PDUFA) goal date of 20 December 2024 set by the FDA. An AdComm is convened upon request of the FDA to review and evaluate the safety and efficacy data of a therapy. However, the AdComm recommendations are non-binding, with the final decision made by the FDA. The ...
- Source: drugdu
- 76
- August 26, 2024
Leo Pharma’s Timber bet falls flat following Phase III failure

Ayear after hedging its bets on Timber Pharmaceuticals’ dermatology pipeline, Leo Pharma has reported a Phase III failure for the lead asset it acquired at the time. TMB-001, a topical ointment formulation of isotretinoin, came up short in the late-stage trial for patients with moderate to severe congenital ichthyosis. Ichthyosis is an umbrella term for congenital skin conditions that cause dry and scaly skin. In the Phase III ASCEND trial (NCT05295732), Leo stated the therapy did not demonstrate a statistically significant improvement in patients compared to those treated with a vehicle. This meant the primary and key secondary endpoints were not met. The results do not support US regulatory submission, the Danish privately owned company stated in a 21 August press release. There is currently no treatment approved for ichthyosis by the US Food and Drug Administration (FDA). Instead, the condition is managed by hydrating the skin with creams and ...
- Source: drugdu
- 76
- August 26, 2024
CTI announces partnership for oncology drug development

CTI Clinical Trial & Consulting Services (CTI) and Crown Bioscience have announced a strategic partnership aimed at bolstering consulting services for oncology drug development. The collaboration brings together CTI’s clinical and regulatory expertise with Crown Bioscience’s preclinical and translational models, aiming to streamline the transition of oncology compounds from discovery to early-phase global studies. It is set to benefit customers by providing expert guidance that enhances the efficiency of oncology drug development. CTI Global Laboratory Services business development vice-president Ryan Gifford stated: “Crown Bioscience’s leadership in early-phase oncology research and suite of preclinical services complement CTI’s broad spectrum of capabilities. “Together, we can offer enhanced support to our oncology clients and deepen our commitment to advancing cancer research.” The combined expertise is expected to ensure an effective path to clinic, support long-term success in drug development and accelerate the delivery of new oncology treatments to patients. Through the alliance, customers ...
- Source: drugdu
- 65
- August 26, 2024
FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues

The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site. The complete response letter (CRL) was expected by Regeneron and disclosed in its Q2 results. The approval hold-up relates to findings from an FDA inspection of a third-party fill/finish manufacturing facility, which refers to the stage of processing that involves packaging drug products for storage and distribution. Regeneron stated that the issue was found when the agency was visiting the manufacturer as part of another company’s candidate application, and has since been resolved. An FDA re-inspection is now planned for the coming months, as per a 20 August press release. Regeneron submitted the biologics licence application (BLA) for linvoseltamab under priority review in February this year. The European Medicines Agency (EMA) is still reviewing the therapy in the same indication, and the application to the ...
- Source: drugdu
- 80
- August 23, 2024
Pathalys secures $105m to advance SHPT drug through approval

Pathalys Pharma has secured $105m in a Series B financing round to support its clinical trials, file a new drug application (NDA) with the US Food and Drug Administration (FDA), and accelerate preapproval commercialisation preparations. The company’s lead candidate is upacicalcet, a drug used to treat secondary hyperparathyroidism (SHPT) in patients undergoing dialysis due to chronic kidney disease (CKD). The calcimimetic drug mirrors the action of calcium on tissues, particularly the parathyroid glands. The medication is typically administered during dialysis sessions. Earlier this year, Pathalys launched two identical Phase III studies of upacicalcet, which will both enrol 375 patients. The PATH study program is designed to assess the efficacy of upacicalcet as measured by its ability to reduce intact parathyroid hormone (iPTH) by 30% or more in participants with SHPT and currently on haemodialysis. The funding round, led by TCGX, is set to support these clinical trials, and advance the ...
- Source: drugdu
- 68
- August 23, 2024
Theramex’s Eladynos recommended by NICE for post-menopausal bone disease

Osteoporosis currently affects 3.8 million people in the UK, particularly impacting older women after menopause Theramex’s Eladynos (abaloparatide) has been recommended by the National Institute for Health Care and Research (NICE) for treating bone disease after menopause. More than 14,000 people in the UK seek treatment for osteoporosis after menopause, and these patients will benefit from the drug (if there is a very high risk of fracture) once it becomes available in England on the NHS in three months’ time. Osteoporosis is a bone disease that affects 3.8 million people in the UK. It develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes, leading to a decrease in bone strength that can increase the risk of broken bones or fractures. The disease particularly affects older women after menopause, as oestrogen, the hormone important for maintaining bone density and strength, decreases and ...
- Source: drugdu
- 82
- August 23, 2024

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