Search Results for “EC” – Page 45 – media

Fresenius Kabi receives FDA warning letter over issues at ex-Ivenix site

Dive Brief Fresenius Kabi has received a warning letter related to the large-volume infusion pumps that it acquired through its $240 million takeover of Ivenix. The Food and Drug Administration sent the letter after inspectors found fault with the handling of corrective and preventive actions for the Ivenix Infusion System. Fresenius took too long to complete investigations, the inspectors found, and failed to establish certain procedures. FDA inspectors visited the site in Massachusetts five months after Fresenius began recalling Ivenix infusion pumps in response to a leak risk that could cause the devices to fail. Dive Insight Fresenius bought Ivenix to strengthen its medtech business, particularly in the U.S., and support its growth strategy. Management has called for patience as Ivenix rolls out its new pump, with Fresenius CEO Michael Sen telling investors that “any new product takes time to hit [its] stride” on an earnings call in February. The ...
- Source: drugdu
- 139
- March 18, 2024
AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda

AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug. By FRANK VINLUAN AstraZeneca is bolstering its rare disease pipeline with a deal to buy Amolyt Pharma, a biotech company in late-stage development with a therapy designed to treat a rare hormone deficiency whose only FDA-approved treatment will soon cease production. According to deal terms announced Thursday, AstraZeneca is paying Amolyt shareholders $800 million up front. Another $250 million is tied to the achievement of a regulatory milestone that was not disclosed. Considering that the drug is in Phase 3 testing, that milestone could be a regulatory approval. Lyon, France-based Amolyt is developing a therapy for hypoparathyroidism, a disease in which the parathyroid glands do not produce enough parathyroid hormone. This ...
- Source: drugdu
- 152
- March 18, 2024
First Subject Dosed for Phase 1 Clinical Trial of Henlius’ ADC Candidate HLX42

Shanghai, China, March 14, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the first subject was dosed for a phase 1 clinical trial of HLX42 (NCT06210815), an investigational EGFR-Targeting antibody-drug conjugate (ADC), for the treatment of advanced/metastatic solid tumours. HLX42 was developed by the company based on the collaboration with MediLink Therapeutics and was approved for conducting clinical trial by the National Medical Products Administration (NMPA) and U.S. Food and Drug Administration (FDA). In December 2023, FDA granted Fast Track Designation to HLX42 for the treatment of advanced/metastatic non-small cell lung cancer (NSCLC) patients with disease progression on EGFR targeted therapies. Epidermal growth factor receptor (EGFR) belongs to the receptor tyrosine kinases family and plays an important role in maintaining normal cell functions such as cell proliferation, differentiation and migration. Mutation or overexpression of EGFR is considered to be closely associated with the occurrence of various solid tumours ...
- Source: drugdu
- 83
- March 18, 2024
POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics. Traditionally, exosomes are isolated through ultrasound centrifugation, a process that requires eight hours or more, requires large sample volumes, and often harms the integrity of these delicate structures. Alternative methods also present challenges, including low purity and yield. Now, researchers have devised a diagnostic technique that employs sound waves to spin a single water droplet at speeds reaching 6,000 revolutions per minute, thereby facilitating the separation of tiny biological particles for exosome-based diagnostics. This novel approach involves a lightweight disk atop the spinning droplet and featuring etched channels that incorporate star-shaped nanoparticles designed for the label-free identification of exosomes. This method surpasses traditional techniques in efficiency, requiring less time and smaller sample volumes, and minimizes damage to the exosomes. It represents a significant ...
- Source: drugdu
- 148
- March 16, 2024
New Study Finds Direct-to-Consumer Pharmaceutical Advertising Can Benefit Public Health Goals When Incentives Align

Don Tracy, Associate Editor Data shows that from 2014-2019, pneumococcal vaccinations in seniors increased by 10%, growing sales for Prevnar 13 due to government recommendation in addition to a high-profile advertising campaign.A 2014 recommendation by the Advisory Committee on Immunization Practices (ACIP) for adults aged 65 years and over to receive Prevnar 13 was followed by Pfizer initiating a high-profile advertisement campaign for the vaccinations. During this time, Medicare and private insurance companies began covering the vaccine as well. According to a new study published in the Journal of Policy Analysis and Management, over the next five years, this resulted in a 10% increase in vaccination among seniors and a corresponding $1 billion annual increase in Prevnar 13 sales. According to the authors of the study, government vaccine recommendations may offer substantial value to pharmaceutical manufacturers, further implying that direct-to-consumer (DTC) advertising can lead to successfully achieving public health goals ...
- Source: drugdu
- 201
- March 16, 2024
First UK patients receive experimental mRNA therapy for cancer in global trial

The phase 1/2 Mobilize trial is evaluating the safety and efficacy of mRNA-4359 Imperial College Healthcare NHS Trust (ICHT) and Imperial College London (ICL) have announced that the first UK patients have received the experimental mRNA therapy in an ongoing phase 1/2 clinical trial to treat melanoma, lung cancer and other solid tumour cancers. The patients received the treatment at the National Institute for Health and Care Research’s Imperial Clinical Research facility at Hammersmith Hospital. In the UK, around one in two people will be diagnosed with cancer in their lifetime. While a range of therapies, including chemotherapy and immune therapies, have been successful, some cancer cells can become resistant to drugs, making tumours more challenging to treat. Sponsored by Moderna and undertaken through the Moderna-UK strategic partnership, the global Mobilize trial is evaluating the safety and efficacy of an immunotherapy known as mRNA-4359, as well as its ability to ...
- Source: drugdu
- 82
- March 16, 2024
Swedish researchers develop new AI computer model to detect lymphatic cancer

In the study, the Lymphoma Artificial Reader System accurately detected 90% of lymphatic cancersResearchers from Chalmers University of Technology in Sweden have developed a new computer model using artificial intelligence (AI), which successfully identifies signs of lymphatic cancer. The model was developed in collaboration with researchers from Memorial Sloan Kettering Cancer Center, Chalmers University of Technology, Medical University in Vienna, Icahn School of Medicine at Mount Sinai and NYU Langone Health, with results published in The Lancet Digital Health. Lymphoma is a cancer of the lymphatic system, including the lymph nodes, spleen, thymus gland and bone marrow, and can affect other organs throughout the body. The two main subtypes of lymphoma are Hodgkin’s lymphoma and non-Hodgkin’s lymphoma, which is the sixth most common cancer in the UK, responsible for around 14,200 cases every year, according to Cancer Research UK. Using AI-assisted image analysis of lymphoma, researchers developed a deep learning ...
- Source: drugdu
- 144
- March 16, 2024
Par Pharmaceutical Issues Recall of Single Lot of Treprostinil

Mike Hollan The voluntary recall was ordered due to potential silicon particulate exposure. Endo International plc issued a press release announcing that one of its pharmaceutical companies, Par Pharmaceuticals, is issuing a voluntary recall of a single lot of one of its medications.1 The lot, which is being recalled on the consumer, may potentially be tainted with silicon particulates in the product solution. The recalls order is for one lot of Treprostinil Injection 20mg/20ml (1mg/mL). This specific lot was reportedly distributed to wholesalers between June 16, 2022 and October 17, 2022. According to the company, it has yet to receive any reports of injuries due to the contamination, and the recall appears to be a preemptive move. Endo warns that particulates entering the body through an injected solution may cause of a variety of problems. The particulates may simply cause local irritation or swelling at the site of the injection. ...
- Source: drugdu
- 127
- March 15, 2024
Novartis Pays $90M for Molecules That Could Take STING Out of Inflammation

Placing research in the hands of a large pharmaceutical company is a goal of many biotech companies. IFM Therapeutics has now done it three times and its latest deal is the second time Novartis is the acquirer. By FRANK VINLUANFor more than four years, Novartis has foot the bill for a partner’s preclinical development of molecules with the potential to target a pathway implicated in inflammatory disorders. Now the pharmaceutical giant has seen enough progress to plunk down $90 million to buy the company, IFM Due, and continue its inflammation drug research. The acquisition announced Wednesday is the culmination of a 2019 agreement that Novartis reached with IFM Due’s parent company, IFM Therapeutics. In exchange for fully funding IFM Due’s R&D, Novartis gained an option to acquire all of that biotech’s stock. IFM Due’s research focuses on cGAS, a protein that regulates STING, a pathway in the innate immune system ...
- Source: drugdu
- 153
- March 15, 2024
Hengrui Medicine’s new “PARP inhibitor” HRS-1167 combination therapy for advanced solid tumors received clinical approval

Recently, Hengrui and its subsidiaries SUZHOU SUNCADIA BIOPHARMACEUTICALS and Chengdu Suncadia Medicine received the “Drug Clinical Trial Approval Notice” approved and issued by the National Medical Products Administration to conduction a Ib/Phase II clinical study for HRS-1167 tablet (Merck code: M9466) combined with SHR-A1921 for injection or combined with bevacizumab or combined with abiraterone acetate tablets (I) and prednisone/prednisolone (AA-P) for the treatment of with advanced solid tumors. In October 2023, Hengrui and Merck reached a strategic cooperation. Merck obtained the exclusive rights to develop, produce and commercialize HRS-1167 (M9466) outside mainland China. This is also the first time for Hengrui to reach a strategic cooperation with large multinational companies. Poly(ADP-ribose) polymerase (PARP) is a multifunctional protein post-translational modification enzyme widely found in eukaryotic cells. It plays a role in maintaining gene stability and maintaining telomere length. Studies have found that PARP inhibitors can hinder DNA damage repair by selectively ...
- Source: drugdu
- 161
- March 15, 2024

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