Search Results for “EU” – Page 38 – media

Biogen Boosts Neuro Pipeline with $7.3B Reata Buy Amid Layoffs

Published: Jul 28, 2023 By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is dropping $7.3 billion in cash to acquire Texas-based Reata Pharmaceuticals aimed at bolstering its neurological and rare disease businesses, the companies announced Friday. Reata, whose shares soared 51% in premarket trading following the buyout news, recently won the FDA’s approval for Skyclarys (omaveloxolone), the first and so far only authorized treatment for Friedrich’s ataxia in the U.S. Reata is currently working on launching Skyclarys, which it will price at $370,000 per year. Under the terms of the agreement, Biogen will pay a per-share price of $172.50, which represents an approximately 58% premium to Reata’s closing price Friday. Biogen will make the payment in cash, supplemented by the issuance of term debt. The companies expect to close the deal in the fourth quarter of 2023, though it must first pass the heightened scrutiny ...
- Source: drugdu
- 98
- August 1, 2023
Mirati’s Flagship KRAS Inhibitor Krazati Gets Rebuffed in Europe

An approval from the U.S. FDA doesn’t guarantee a green light overseas—a lesson Mirati Therapeutics has learned the hard way after European regulators rebuffed the company’s flagship KRAS inhibitor Krazati. Friday, Mirati revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had spurned the company’s conditional marketing authorization application for Krazati, also known as adagrasib, to treat patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). In a release, Mirati said it “disagrees with the opinion” and intends to file for a formal re-examination. Once considered an undruggable target, KRAS now has two FDA-approved therapies competing in a potential blockbuster cancer market in the United States. After Amgen won an accelerated nod for its rival KRAS inhibitor Lumakras in May 2021, Mirati entered the fray with Krazati—the biotech’s first commercial product—in December. While Amgen’s drug has suffered a sequential sales decline in the U.S., Mirati’s med recently surprised ...
- Source: drugdu
- 128
- July 25, 2023
ADC Therapeutics Pulls the Plug on Zynlonta Study After Partial FDA Hold

A week after ADC Therapeutics paused its Zynlonta trial to review seven deaths and five other respiratory events in patients who received the drug, the company has scrapped the study altogether following an FDA partial clinical hold. The trial was testing the drug, combined with Roche’s Rituxan, in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Citing the “challenges of defining the addressable segment” of the difficult-to-treat population, ADC believes the benefit-risk profile “does not support” the continuation of the study, the company said in a release. The call came after a meeting with the FDA, in which the agency slapped a partial hold on enrolling new patients in the trial. However, the agency said patients who are already on the drug and seeing clinical benefits can remain enrolled after reconsenting. After those patients are treated, ADC will take steps to wrap up the trial. ...
- Source: drugdu
- 112
- July 25, 2023
New ultra-flexible neural implant records single-neuron activity in deep-brain regions

A new ultra-small and ultra-flexible electronic neural implant, delivered via blood vessels, can record single-neuron activity deep within the brains of rats, according to new study. “This technology could enable long-term, minimally invasive bioelectronic interfaces with deep-brain regions, writes Brian Timko in a related Perspective. Brain-machine interfaces (BMIs) enable direct electrical communication between the brain and external electronic systems. They allow brain activity to directly control devices such as prostheses or modulate nerve or muscle function, which can help individuals with paralysis or neurological disorders regain function. However, most conventional BMIs are limited to measuring neural activity at the brain’s surface. Recording single-neuron activity from deep brain regions often requires invasive intracranial surgery to implant probes, which can result in infection, inflammation, and damage to brain tissues. An alternative approach to implanting bioprobes into deep-brain regions is via the brain’s vascular network. Here, Anqi Zhang and colleagues present ultra-flexible micro-endovascular ...
- Source: drugdu
- 110
- July 22, 2023
EU Prepares for the Winter With Plans to Avoid an Antibiotic Shortage

The European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) have issued recommendations to prevent shortages of antibiotics. Drug shortages have become the norm in recent years, with the US Food and Drug Administration (FDA) reporting 295 active shortages in the last quarter of 2022 and the EMA reporting that a shortage of cardiovascular medications is expected to continue until next year. The EMA has said that the EU has an adequate supply of oral antibiotics for the treatment of respiratory infections, if the demand remains comparable to previous years, as per a 17 July press release. Nonetheless, the agency has issued several recommendations to ensure robust preparedness. It has also announced plans to engage with marketing authorisation holders to increase production and continue to monitor supply and demand without resorting to stockpiling. In addition, the agency wants to increase ...
- Source: drugdu
- 100
- July 20, 2023
Alnylam Presents Promising Results for RNAi Therapeutic in Alzheimer’s Disease at AAIC

Alnylam Pharmaceuticals’ investigational RNAi therapeutic has shown promise in patients with early-onset Alzheimer’s disease, according to phase 1 results presented by the company at this year’s Alzheimer’s Association International Conference (AAIC). Interim results from the early-stage study showed that a single injection of ALN-APP, which is designed to switch off the production of amyloid precursor protein (APP) in the central nervous system, was able to rapidly reduce levels of the protein, with clinical effect sustained over six months. ALN-APP is being developed in collaboration with Regeneron Pharmaceuticals for both Alzheimer’s disease and the related disorder cerebral amyloid angiopathy (CAA) and is now the first investigational RNAi therapeutic to demonstrate gene silencing in the human brain. “We’ve known for decades that mutations that increase APP production, or alter its proteolysis, cause early-onset Alzheimer’s disease, early-onset CAA or both,” said Dr Sharon Cohen, neurologist and medical director, Toronto ...
- Source: drugdu
- 122
- July 20, 2023
Neumora Races Toward Phase III with New Driver in the Hot Seat

Pictured: A silhouette of a woman sitting on the floor with her head in her hands/iStock, simpson33 Neumora Therapeutics is making big moves this week. On Tuesday the young biotech announced the initiation of a Phase III program for its potential depression treatment along with a new CEO to lead the way. The nearly two-year-old startup posted statistically significant results for treating moderate-to-severe major depressive disorder (MDD) in its Phase II trial of navacaprant, a kappa opioid receptor (KOR) antagonist. Initiated by BlackThorn Therapeutics prior to its acquisition by Neumora, the trial was amended to include those more serious MDD patients, the population in which it appears to be most effective. In moderate-to-severe patients, navacaprant had statistically significant results in lowering patients’ 17-item Hamilton Rating Scale for Depression score by 3 points at week 4 and 2.8 points by week 8. Across all patients, which included mildly depressed patients, navacaprant did not achieve ...
- Source: drugdu
- 114
- July 20, 2023
Bicycle Therapeutics Plans $200m Public Offering

NASDAQ-listed Bicycle Therapeutics has announced that $200m worth of shares will be available at a price of $21.25 each. The company, which has offices in the UK and US, expects the underwritten public offering to close around 17 July. On 13 July, more than 12 times the volume of shares were traded on the exchange, compared to the previous day. The underwriters will also have the option to purchase a further $30m of shares in a 30-day period. The company has recently signed two lucrative deals with Novartis and Bayer for the use of its peptide technology to develop radio-conjugates. In March, Novartis paid an upfront sum of $50m, and a possible $1.7bn in milestone payments. Bayer then followed suit in May, with a $45m upfront deal, with a possibility of a further $1.7bn. Both partnerships involve undisclosed oncology targets. The company reported net losses of ...
- Source: drugdu
- 114
- July 18, 2023
EU Establishes €100m Funding Scheme for Projects Tackling Public Health Threats

The EU has established a €100m fund to support research and development into medical countermeasures that could tackle public health threats, including antimicrobial resistance and pathogens with “high pandemic potential”. The European Commission (EC) and the European Investment Bank (EIB) announced the creation of the HERA Invest fund, a top-up to the InvestEU programme that aims to give an additional boost to investment, innovation, and job creation in Europe. The fund will be run by the European Health Emergency Preparedness and Response Authority (HERA), which was established in 2021 to help prevent, detect, and rapidly respond to future health emergencies. “Currently, European companies find it difficult to access sufficient public and private funding for the development and scaling up of cutting-edge solutions in health and life sciences,” the EC and EIB explained in a joint statement. The HERA Invest funding is specifically geared towards small ...
- Source: drugdu
- 146
- July 18, 2023
Innovative Mixed Reality Training Platform to be Developed for Pharmaceutical Companies and Healthcare

UK immersive technology company FourPlus, along with collaborators Holosphere and the Cell and Gene Therapy Catapult, have been awarded funding from Innovate UK to create and test a mixed reality training platform that enables customized training delivery for pharmaceutical companies and healthcare. The project is a GBP 1 million investment, with almost 75% from Innovate UK, and has been awarded via the Digitalization and Automation of Medicines R&D and Manufacture competition. It will support the development of a customizable platform that leverages mixed reality and multi-player capabilities. The digital and automated training platform will be designed specifically for a number of manufacturing roles within cell and gene therapy, biopharmaceutical and wider life science sectors, including those at hospital sites. It will support initial training of staff, validation and the creation of digital training records. The platform will also enable healthcare trainers and trainees to collaborate seamlessly within virtual ...
- Source: drugdu
- 112
- July 18, 2023

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