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Q&A With Dr. Mike McCullar, CEO of RegCell

Mike Hollan McCullar discusses his new role as CEO of RegCell. Dr. Mike McCullar CEO RegCell Pharmaceutical Executive: How did you end up as CEO? Dr. Mike McCullar: Prior to joining RegCell as CEO and president, I was a toxicologist by training. I was fortunate to work in multiple operating roles over the years. I ended up working in Japan for a decade, and I was approached by a leading Japanese venture fund and asked if could help them start to migrate leading Japanese companies to the US. RegCell was one of those companies, and I felt it had the potential to have the best-in-class platform in terms of how we think about treating autoimmune disorders. It’s been an interesting journey so far. PE: What are the companies plans for the coming year? McCullar: What we’re focused on right now is launching a first in-human clinical trial. That takes quite ...
- Source: drugdu
- 115
- November 20, 2023
World’s first CRISPR-based gene therapy approved for sickle cell anaemia

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel), marking the world’s first approval of a CRISPR-based gene editing therapy. Casgevy has been approved to treat patients with sickle cell disease with recurrent vaso-occlusive crises and transfusion-dependent beta-thalassemia aged 12 years or older, for whom a human leukocyte antigen (HLA) matched related hematopoietic stem cell donor is not available. Also known as exa-cel, Casgevy is currently being evaluated by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for the drug is set for 8 December in severe sickle cell disease and 30 March 2024 in beta-thalassemia, as per a 16 November press release. Casgevy is a genetically modified autologous CD34+ cell population that contains clustered regularly interspaced short palindromic repeats (CRISPR) edited human haematopoietic stem and progenitor ...
- Source: drugdu
- 104
- November 20, 2023
BMS strengthens NSCLC market share with ROS1 drug Augtyro

The US Food and Drug Administration (FDA) has approved Bristol Myer Squibs’ (BMS) Augtyro (repotrectinib) for adults with non-small cell lung cancer (NSCLC). Augtyro is an orally administered tyrosine kinase inhibitor (TKI) designed to selectively bind to active kinase formations in ROS1-positive NSCLC and suppress uncontrolled cell proliferation and tumor growth caused by ROS1 oncogenic fusions. It is the only FDA-approved TKI for ROS1-positive NSCLC. The FDA approval was based on data from the ongoing Phase I/II TRIDENT-1 (NCT03093116) trial, which is evaluating repotrectinib in 500 patients with advanced solid tumours characterized by ALK, ROS1, or NTRK1-3 fusions. The Phase I portion assessed the safety, tolerability, and pharmacokinetics of repotrectinib. Patients previously treated with a TKI and no chemotherapy demonstrated an overall response rate (ORR) of 38% and a median DOR of 14.8 months. Patients with no prior treatment with a TKI had an ORR of 79% and a median ...
- Source: drugdu
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- November 20, 2023
FDA approves study of Versameb’s mRNA therapy in urinary incontinence

Swiss company Versameb will initiate a clinical trial investigating a messenger ribonucleic acid (mRNA) to treat stress urinary incontinence, after receiving clearance from the US Food and Drug Administration (FDA). The FDA approved the company’s investigational new drug (IND) application for a Phase IIa trial of VMB-100 – an intramuscularly locally delivered, sequence-engineered mRNA. The study is scheduled to start in the first half of 2024. Versameb’s candidate encodes human insulin-like growth factor-1 (IGF-1). According to Versameb, preclinical studies have shown that VMB-100 can induce the expression of IGF-1 in human muscle cells, and the candidate accelerated the regeneration of the urinary sphincter muscle and restored urinary sphincter function in animal models of stress urinary incontinence, after a single dose of treatment. Stress urinary incontinence is a condition where there is an involuntary leakage of urine due to a weakened urinary sphincter muscle. It is a condition that particularly affects ...
- Source: drugdu
- 171
- November 20, 2023
Kite and Arcellx expand strategic collaboration

Gilead company Kite has expanded its existing partnership with Arcellx for the latter’s CART-ddBCMA candidate to include lymphomas. The parties entered an international strategic deal in December 2022 to jointly develop and market a CART-ddBCMA candidate for relapsed or refractory multiple myeloma. Kite has now exercised its licence option for ACLX-001, an ARC-SparX programme of Arcellx in multiple myeloma. Arcellx is entitled to receive an equity investment of $200m in exchange for 3,242,542 shares of its common stock. The funding will offer 13% ownership of Arcellx to Gilead. Arcellx is also eligible to receive $85m in upfront non-dilutive cash payment, separately from milestone payments in the future. The deal will close by the end of 2023. A BCMA-specific CAR-modified T-cell therapy of Arcellx, CART-ddBCMA is currently in a Phase II clinical trial. Kite executive vice-president Cindy Perettie stated: “We are pleased to see the momentum with the CART-ddBCMA multiple myeloma ...
- Source: drugdu
- 156
- November 20, 2023
AstraZeneca shares positive phase 3 results for Imfinzi combination in liver cancer

AstraZeneca (AZ) has shared positive results from a late-stage study of its immunotherapy Imfinzi (durvalumab) when used as part of a combination treatment in a subset of patients with hepatocellular carcinoma (HCC), the most common type of liver cancer. The phase 3 EMERALD-1 trial has been evaluating Imfinzi plus transarterial chemoembolisation (TACE) followed by Imfinzi with or without Genentech’s Avastin (bevacizumab) until progression versus TACE alone in more than 600 patients with unresectable HCC eligible for embolisation. Approximately 75% of all primary liver cancers in adults are HCC and up to 30% of patients are eligible for embolisation, a procedure that blocks the blood supply to the tumour and can deliver chemotherapy or radiation therapy directly to the liver. Despite being the standard of care in this setting, most of those who receive embolisation experience rapid disease progression or recurrence. “Patients with liver cancer eligible for embolisation experience high rates ...
- Source: drugdu
- 222
- November 18, 2023
LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

Dive Brief The Food and Drug Administration has authorized the first chlamydia and gonorrhea test with at-home sample collection. LetsGetChecked received de novo authorization for the Simple 2 Test, an over-the-counter kit that uses vaginal swabs or urine specimens to detect the bacteria that cause the two sexually transmitted diseases (STDs). The authorization will move sample collection from the doctor’s office to the home — potentially increasing testing of STDs, which are on the rise — and create a 510(k) pathway for rival diagnostics. Dive Insight Until this week, the FDA had only authorized at-home sample collection for one STD, HIV. Sample collection for all other STDs occurred at the point of care, for example, in a doctor’s office. People may be less likely to get tested at the point of care, particularly for frequently asymptomatic infections such as chlamydia and gonorrhea, because of concerns about confidentiality and convenience. The ...
- Source: drugdu
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- November 18, 2023
UTS researcher tests new handheld device for rapidly and accurately identifying drug specimens

University of Technology Sydney (UTS) Centre for Forensic Science PhD candidate Harry Fursman is working on two fronts to prevent harm to people who use drugs: He is testing a new handheld device for rapidly and accurately identifying drug specimens and conducting ongoing chemical analysis of used syringes. Drugs that are contaminated or substituted with an unexpected substance are a leading cause of death among people who use drugs. In Sydney last week one person died and two people were taken to hospital due to heroin overdoses, after using what they thought was cocaine. Fursman aims to tackle this significant risk by providing objective insights into current trends and consumption habits among people who are injecting drugs. He will present his research on substance testing at the upcoming International Association of Forensic Sciences (IAFS) conference in Sydney on 20-24 November. Portable drug testing device: MicroNIR Fursman is testing a small ...
- Source: drugdu
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- November 18, 2023
Almirall and Absci announce $650m AI drug discovery partnership for dermatological diseases

Almirall and Absci have announced a drug discovery partnership aimed at developing and commercialising artificial intelligence (AI)-designed treatments for dermatological diseases, with the deal worth over $650m. The collaboration will combine Almirall’s dermatological capabilities with Absci’s Integrated Drug Creation platform, which the generative AI company says “unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimising multiple drug characteristics important to both development and therapeutic benefit”. Under the terms of the agreement, Absci will apply its de novo generative AI technology to create and commercialise therapeutic candidates for two dermatological targets. In addition to product royalties, Absci is eligible to receive up to approximately $650m in upfront fees, research and development (R&D) and post-approval milestone payments across the two programmes if all milestones are successfully completed. Dr Karl Ziegelbauer, Almirall’s executive vice president of R&D and chief scientific officer, said: “Almirall chose Absci ...
- Source: drugdu
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- November 18, 2023
Roche’s subcutaneous Tecentriq recommended by CHMP for multiple cancer types

Roche has announced that an injectable form of its PD-L1 inhibitor Tecentriq (atezolizumab) has been recommended by the European Medicines Agency’s human medicines committee for multiple cancer types. The subcutaneous (SC) formulation of Tecentriq can cut treatment time by approximately 80%, the company said, with most injections taking between four to eight minutes compared with 30 to 60 minutes for an intravenous (IV) infusion. The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that Tecentriq SC be authorised for use in all indications in which the drug’s IV form has previously been approved, including certain types of lung, liver, bladder and breast cancer. The committee’s decision will now be reviewed by the European Commission and, if approved, Tecentriq SC will be the first injectable PD-L1 cancer immunotherapy in the EU. Levi Garraway, Roche’s chief medical officer and head of global product development, said: “Tecentriq has helped to ...
- Source: drugdu
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- November 18, 2023

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