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European Commission Decision Is a Reprieve for PTC Therapeutics’ Rare Muscle Disease Drug

The PTC Therapeutics drug Translarna failed its confirmatory study in Duchenne muscular dystrophy. Analysts say the European Commission’s decision to not adopt the Committee on Medicinal Products for Human Use’s negative opinion on the drug is unusual, if not unprecedented. By Frank VinluanA PTC Therapeutics drug that failed a confirmatory study in the rare muscle-wasting disorder Duchenne muscular dystrophy may remain on the market in Europe for now. Regulators there took the rare step of declining to adopt a recommendation opposing renewal of the product’s marketing authorization. The PTC drug, Translarna, received conditional marketing authorization in 2014 based on Phase 2 data. The conditional nature of this pathway requires a company to seek annual renewals of the authorization until it generates the clinical data that supports a standard marketing authorization. In a placebo-controlled Phase 3 study, Translarna failed to achieve the main goal of showing a significant change according to ...
- Source: drugdu
- 76
- May 22, 2024
Amgen and AstraZeneca ponder label expansion for Tezspire in COPD

Amgen and AstraZeneca have highlighted the potential of Tezspire (tezepelumab) in chronic obstructive pulmonary disease (COPD) in a subgroup of patients in a Phase IIb study even though the trial missed the primary endpoint. The therapy failed to show a significant reduction in the annual rate of moderate to severe exacerbations compared to the placebo, the trial’s primary endpoint. The data from the placebo-controlled Phase IIa COURSE trial (NCT04039113) was presented at the American Thoracic Society (ATS) International Conference taking place in San Diego, US, from 16 to 21 May. However, a pre-determined subgroup analysis of COPD patients based on the levels of eosinophils, measured as baseline eosinophil count (BEC), showed significant reductions in COPD exacerbations. The therapy also demonstrated a 48% reduction in severe exacerbations compared to the placebo. Patients who received Tezspire while having a BEC of 150 cells/μL or more, which is associated with increased COPD-related emergency ...
- Source: drugdu
- 79
- May 22, 2024
Chiatai Tianqing Participated in China Biologics Conference and Shared Recombinant Coagulation Factor Drug Development Achievements

On May 16-18, the “23rd China Biologics Conference (CBioPC 2024)” was held in Guangzhou. This is an academic event in the field of biomedicine in China. Zhong Nanshan, recipient of the Order of the Republic and academician of the Chinese Academy of Engineering, Zhang Hui, vice president of the China Academy of Food and Drug Administration, Zhao Bingxiang, general manager of China National Pharmaceutical Group Corporation, and Shao Jingbo, deputy director of Guangzhou Development District Administrative Committee, attended the opening ceremony and delivered speeches. Dr. Wei Zhao, Vice President of Chiatai Tianqing, was invited to attend the conference and introduced the company’s experience in pharmacological development of recombinant coagulation factor drugs. The theme of this conference is biopharmaceutical innovation and public health security, aiming to build biopharmaceutical science and technology capacity with core competitiveness and independent intellectual property rights, vigorously develop new productivity of biopharmaceuticals with Chinese characteristics, and actively ...
- Source: drugdu
- 82
- May 22, 2024
Glenmark launches the next phase of ‘India First Heart First’ Campaign

On World Hypertension Day 2024, the second phase of the ‘India First Heart First’ Campaign was launched. Glenmark collaborated with gemstone carver artist Prithviraj Kumawat to sculpt a monumental human heart from a single stone of Rose quartz, a stone associated with the heart chakra which promotes emotional balance. This sculpture, standing 8 feet tall and weighing 3.5 tons, was unveiled on May 17, 2024, and was attended by cardiologists from Delhi and Jaipur, including Dr Deepak Maheshwari, Dr J S Makkar, and Dr Manoj Kumar. The event featured talks from cardiologists Dr J S Hiremath, Dr A Sreenivas Kumar, Dr JPS Sawhney and Dr Dilip Kumar highlighting the importance of heart health. Mr Kumawat spoke about his journey of creating the gemstone sculpture. Reportedly, 35,000 doctors from across India sent in their pledges to support cardiovascular disease awareness. Their signed pledge cards were displayed at the base of the ...
- Source: drugdu
- 89
- May 22, 2024
GVSAP collaborates with Biocytogen

GV Safety Assessment Platform (GVSAP), an integrated R&D enabler offering comprehensive preclinical research solutions, recently announced a partnership with Biocytogen. This collaboration aims to boost the R&D endeavours of Indian researchers by democratising tools and technologies. According to a press release, through this alliance, Indian biomedical researchers will gain access to Biocytogen’s expertise in providing humanised research models, other off-the-shelf models and products, and Gene Targeting Services offered under Biocytogen’s sub-brand BioMice. https://www.expresspharma.in/gvsap-collaborates-with-biocytogen/
- Source: drugdu
- 75
- May 22, 2024
Comprehensive cost and utilization of commercial CAR-T therapy in pediatric B-ALL patients

A new editorial paper was published in Oncoscience (Volume 11) on April 25, 2024, entitled, “The price of hope: CAR-T therapy in pediatric leukemia.” We stand at the crossroads of medical innovation, where cutting-edge scientific discoveries intersect with the resilience of the human body, providing hope to families grappling with a diagnosis of pediatric leukemia. In this new editorial, researcher Alex Hoover from the University of Minnesota Medical School’s Division of Pediatric Blood and Marrow Transplantation discusses the chimeric antigen receptor T-cell (CAR-T) therapy tisagenlecleucel (tisa-cel) -; a groundbreaking development in the treatment of B-cell lineage acute lymphoblastic leukemia (B-ALL) (the most common childhood cancer). Following the pivotal ELIANA trial, tisa-cel was approved in the United States for the treatment of refractory or second or greater relapse of B-ALL in patients under age 25. This innovative therapy involves genetically modifying a patient’s native T-cells – immune cells with the ability ...
- Source: drugdu
- 99
- May 21, 2024
HPV Self-Collection Solution Improves Access to Cervical Cancer Testing

Annually, over 604,000 women across the world are diagnosed with cervical cancer, and about 342,000 die from this disease, which is preventable and primarily caused by the Human Papillomavirus (HPV). A staggering 90% of these deaths occur in low- and middle-income countries. Screening for HPV is crucial as it helps identify women at risk of developing cervical cancer, thereby enabling early intervention before the cancer can develop. In regions where healthcare resources are scarce, enhancing the accessibility of screening and reducing obstacles to sample collection are critical to preventing this disease. Now, a novel HPV self-sampling method expands the availability of cervical cancer screening by allowing patients to collect their samples privately while at a healthcare facility. Roche (Basel, Switzerland) has received FDA approval for its HPV self-collection solution, one of the first available in the United States where more than half of the women diagnosed with cervical cancer have ...
- Source: drugdu
- 108
- May 21, 2024
FDA Grants Accelerated Approval to Amgen’s Imdelltra for the Treatment of Adults with Extensive-Stage Small Cell Lung Cancer

Don Tracy, Associate Editor Imdelltra (tarlatamab-dlle) is the first T-cell engager therapy approved for extensive stage small cell lung cancer. The FDA has granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following treatment with platinum-based chemotherapy. According to the company, the regulatory action was based on the promising response rate and duration of response (DoR) with Imdelltra observed in clinical studies. The action represents the first and only T-cell engager therapy approved by the FDA for ES-SLCS, and Amgen stated that further indications for the use of Imdelltra could soon follow.1 “The FDA’s approval of Imdelltra marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients,” said Jay Bradner, MD, EVP, research and development, chief scientific officer, Amgen, in a press release. “This ...
- Source: drugdu
- 87
- May 21, 2024
CNS-Focused Rapport Therapeutics Preps IPO to Back Phase 2-Ready Epilepsy Drug

Rapport Therapeutics’ lead program could offer more targeted epilepsy treatment compared to currently available anti-seizure medications, which introduce many side effects. The IPO will support plans to develop the oral small molecule in focal epilepsy as well as chronic pain and bipolar disorder. By Frank VinluanRapport Therapeutics, a young biotech company with technology from the labs of Johnson & Johnson, is now preparing to enter the public markets to finance clinical research for a lead program that could help patients whose epilepsy doesn’t respond to currently available anti-seizure medications. Rapport’s IPO paperwork filed with securities regulators late Friday does not yet specify how many shares it plans to offer and in what price range. IPO research firm Renaissance Capital has penciled in a $100 million placeholder figure for the proposed stock offering. The biotech company, which is headquartered in Boston and maintains additional office and lab space in San Diego, ...
- Source: drugdu
- 91
- May 21, 2024
J&J expands dermatology portfolio with $850m Proteologix acquisition

In a bid to solidify its footing in dermatology, Johnson & Johnson (J&J) has announced that it will purchase the immune-mediated disease-focused biotech Proteologix in a $850m cash buyout, with the potential for additional milestone payments. The host of bispecific antibodies brought by Proteologix to the deal will add depth to J&J’s immunology pipeline, and more specifically, bolster its position to address atopic dermatitis (AD). Among Proteologix’s assets is PX128, a bispecific antibody designed to target interleukin (IL)-13, as well as the cytokine TSLP, which is being developed for the treatment of patients with moderate to severe AD and moderate to severe asthma. The acquisition also covers the preclinical stage candidate, PX130, a bispecific antibody designed to target both IL-13 and IL-22 to inhibit inflammation, restore the skin barrier, and prevent environmental trigger-mediated inflammation of the skin. The asset is under development for the treatment of moderate to severe AD. ...
- Source: drugdu
- 92
- May 21, 2024

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