Search Results for “EC” – Page 398 – media

FDA approves Skyline Therapeutics’ IND for macular degeneration trial

Chinese gene therapy company Skyline will initiate a global trial investigating a gene therapy to treat neovascular age-related macular degeneration (nAMD), after receiving clearance from the US Food and Drug Administration (FDA). The FDA granted the company’s investigational new drug (IND) application for a Phase I/IIa trial of SKG0106 – a one-time intravitreally delivered adeno-associated virus (AAV) gene therapy. Skyline has not disclosed when it expects to initiate the trial. Skyline Therapeutics’ candidate encompasses a new AAV capsid and unique transgene genome encoding an anti-VEGF protein. Vascular endothelial growth factor (VEGF) is a protein that promotes the growth of new blood vessels and also makes vessels more permeable or leaky. Patients with macular degeneration secrete too much of this protein. The company’s anti-angiogenic treatment is able to suppress neovascular lesions at a low dose with durable effects from a single injection. The prevention of neovascularisation provides relief of vascular leakage ...
- Source: drugdu
- 109
- July 6, 2023
Labcorp forms spin-off of Fortrea

Labcorp, the laboratory service supplier based in the US, has completed the spin-off of Fortrea, to create the newly formed contract research organisation that will give pharmaceutical and biotechnology organisations access to global Phase I-IV clinical trial management, patient access and technology solutions. Fortrea made a cash distribution of around $1.6bn as partial consideration for the assets that Labcorp contributed to Fortrea in connection with the spin-off. Labcorp will use the distribution toward a $1bn accelerated share repurchase program and pay down $300m of debt maturing this year. Whatever is left of the funds will be distributed among shareholders. The spin-off distribution was completed on 30 June 2023 to stockholders of record as of the close of business on 20 June 2023. Labcorp’s stockholders each received one share of Fortrea common stock for every share of Labcorp common stock they held as of the record date. The spin-off will pass ...
- Source: drugdu
- 111
- July 6, 2023
Boehringer’s spesolimab shows promise in generalised pustular psoriasis prevention

Boehringer Ingelheim has shared positive new 48-week data from a phase 2b trial of its anti-interleukin-36 receptor (IL-36R) antibody in patients with generalised pustular psoriasis (GPP). The results from the EFFISAYIL 2 trial, presented by the company at this year’s World Congress of Dermatology, show that spesolimab reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. The trial also demonstrated no flares after week four of spesolimab treatment in the high dose group, Boehringer said. GPP is a rare and chronic neutrophilic skin disease, which is genetically and clinically distinct from plaque psoriasis. GPP is caused by neutrophils – a type of white blood cell – accumulating in the skin, causing painful, sterile pustules all over the body. Despite the varying severity of GPP flares, if left untreated they can be life-threatening due to complications such as sepsis and multisystem organ failure, and the unpredictability ...
- Source: drugdu
- 195
- July 6, 2023
first interchangeable biosimilar to Humira rolls out across US

Boehringer Ingelheim’s new autoinjector pen administering Cyltezo (adalimumab-adbm) is now available to patients living with chronic inflammatory diseases in the US. The Cyltezo pen autoinjector, which is a biosimilar to AbbVie’s blockbuster Humira (adalimumab), received approval from the US Food and Drug Administration (FDA) in May 2023. Boehringer Ingelheim originally received FDA approval for the drug in 2017, and then further approval as an interchangeable biosimilar in 2021. The 40mg/0.8ml pre-filled Cyltezo Pen will be offered in two, four and six-pack options. AbbVie has enjoyed a prosperous monopoly of the adalimumab market with Humira generating $21.2bn in global sales in 2022. With several biosimilars likely to flood the market in 2023 and the company losing exclusivity, AbbVie said it expects its sales of the drug to decline 37% in 2023. Challengers to Humira are now vying for market share. Organon and Samsung Bioepsis launched an autoinjector pen on 1 July, ...
- Source: drugdu
- 131
- July 5, 2023
Zealand Pharma submits NDA for hyperinsulinism drug dasiglucagon

Zealand Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its treatment dasiglucagon for use in paediatric patients aged seven days or older with congenital hyperinsulinism (CHI). Based on an announcement released on 30 June, the application is based on clinical data from two Phase III studies and interim results from an ongoing long-term extension trial (NCT03941236). This includes results from a Phase III trial (NCT041724412), which tested dasiglucagon’s efficacy and safety in a hospital setting among 12 neonates and infants with CHI aged seven days to 12 months. In the first part of the trial, which took the form of a 48-hour crossover study, dasiglucagon reduced the need for glucose infusions by 55%. The application also features data from a second Phase III study (NCT03777176), which tested subcutaneous dasiglucagon infusions in 32 children with CHI aged three months to 12 years. ...
- Source: drugdu
- 112
- July 5, 2023
Roche’s Evrysdi shows continued improvement in children with spinal muscular atrophy

Roche has announced positive new four-year results from an open-label extension study of its spinal muscular atrophy (SMA) treatment, Evrysdi (risdiplam), in young children. SMA is a severe and progressive neuromuscular disease affecting approximately one in every 10,000 babies. People 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. Depending on the form of SMA, the patient’s physical strength and their ability to walk, eat or breathe can be considerably compromised or lost. Without treatment, children with type 1 SMA are not expected to live past age two and are never able to sit without support. 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 ...
- Source: drugdu
- 110
- July 5, 2023
Australia authorizes MDMA, magic mushrooms for medical treatment

Australia on Saturday became one of the first countries in the world to allow the use of MDMA and magic mushrooms for medical treatment, in a bid to tackle certain mental health conditions. From July 1, authorized psychiatrists will be able to prescribe the drugs, also known as ecstasy and psilocybin, for the treatment of post-traumatic stress disorder and some types of depression. Authorities in Canada and the United States allow the medical use of one or both of the drugs, but only in clinical trials or with special permits. In February, Australia reclassified the drug entirely, after the country’s Therapeutic Goods Administration said trials had found the substances to be “relatively safe” when used in a “medically-controlled environment”. Supporters of the move hope the drugs can provide breakthroughs for mental health patients, when other treatments have failed. Mike Musker, a mental health and suicide prevention researcher at the University ...
- Source: drugdu
- 110
- July 4, 2023
Researchers discover new weapon against antibiotic resistance—it also fights malaria

Florida International University scientists discovered the first and only known natural arsenic-containing antibiotic to fight antibiotic resistance. Now, research reveals it can stop transmission of a deadly disease spreading in the U.S. for the first time in 20 years: malaria. A team from FIU’s Herbert Wertheim College of Medicine developed arsinothricin (AST) to combat the rise of antibiotic-resistant bacteria. Lab tests proved AST effectively defeated the most notorious, including E. coli and Mycobacteria, which cause tuberculosis. Collaborating with malaria researchers in the College of Arts, Sciences & Education, they’ve recently also found AST prevents Plasmodium falciparum, the parasite that causes malaria, from infecting mosquitoes—unlike other current antimalarial drugs. The discovery, recently published in Microorganisms, paves the way for AST to one day be developed into a more effective antimalarial drug for humans. “Current antimalarials don’t completely stop transmission, meaning patients can continue to infect mosquitoes before they recover,” said lead ...
- Source: drugdu
- 115
- July 4, 2023
BioMarin Wins FDA Approval for First Gene Therapy for Hemophilia A

By Tristan Manalac Pictured: BioMarin headquarters/iStock, Michael Vi The FDA has approved BioMarin Pharmaceutical’s valoctocogene roxaparvovec-rvox, to be marketed as Roctavian in the U.S., for the treatment of adult patients with severe hemophilia A, the company announced Thursday. Roctavian, a one-time single-dose infusion, is authorized for use only in adults without antibodies against the adeno-associated virus serotype 5 (AAV5), as determined by an FDA-approved test. It is also the first gene therapy approved for hemophilia A, according to BioMarin’s news release. In an investor call Thursday afternoon, BioMarin Chief Commercial Officer Jeff Ajer said that “the product profile of Roctavian presents tremendous value to patients, including bleed control, good safety profile and freedom from the burden of chronic therapy.” Roctavian is “priced at a wholesale acquisition cost, or WAC, that equates to $2.9 million for the typical patient for this one-time, single-dose treatment,” Ajer said. Hemophilia A is an inherited ...
- Source: drugdu
- 105
- July 4, 2023
The first fully A.I.-generated drug enters clinical trials in human patients

The first drug fully generated by artificial intelligence entered clinical trials with human patients this week. Insilico Medicine, a Hong Kong-based biotech startup with more than $400 million in funding, created the drug, INS018_055, as a treatment for idiopathic pulmonary fibrosis, a chronic disease that causes scarring in the lungs. The condition, which has increased in prevalence in recent decades, currently affects about 100,000 people in the U.S. and can lead to death within two to five years if untreated, according to the National Institutes of Health. “It is the first fully generative AI drug to reach human clinical trials, and specifically Phase II trials with patients,” Alex Zhavoronkov, founder and CEO of Insilico Medicine, told CNBC. “While there are other AI-designed drugs in trials, ours is the first drug with both a novel AI-discovered target and a novel AI-generated design.” The discovery process for the new drug began in ...
- Source: drugdu
- 176
- July 3, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.