Search Results for “immune” – Page 58 – media

Citius Seeks Approval for I/ONTAK Ahead of Spin-Off Plans

Citius Pharmaceuticals is planning to spin out its immune asset I/ONTAK into a separate publicly-traded entity, pending the FDA’s verdict on the candidate, due July 28. I/ONTAK, which Citius is proposing as a treatment for T-cell lymphoma, is a reformulation of Eisai’s Ontak (denileukin diftitox), which won initial approval in 1999 for the same indication. Citius’ candidate is a recombinant fusion protein that combines a diphtheria toxin with the interleukin-2 protein. It works by specifically binding to IL-2 receptors to precisely deliver its toxic payload, thereby preventing protein synthesis in malignant T cells. I/ONTAK also targets the immunosuppressive regulatory T cells, which in turn allows the body to produce a stronger immune response against the cancer. The therapeutic fusion protein is approved in Japan, where it is marketed under the brand name Lymphir. The FDA accepted Citius’ Biologics License Application for I/ONTAK in December 2022 and initially gave it a target action ...
- Source: drugdu
- 100
- July 19, 2023
Roche in Talks to Buy Stomach Drug from Roivant for $7B

Ulcerative colitis and Crohn’s disease are big business, and Roche could be all in, according to a report that has the Swiss pharma in talks to acquire a late-stage candidate from Roivant Sciences for upwards of $7 billion. The deal—which would be one of the largest struck by newly seated CEO Thomas Schinecker—could be announced in the coming days, according to The Wall Street Journal, which broke the news Thursday evening. Sources familiar with the talks cautioned that they could still break down and that another suitor could emerge, the WSJ reported. The drug at the center of the rumored discussions is RVT-3101, an anti-TL1A antibody that recently showed positive results in a Phase IIb study in patients with moderate to severe ulcerative colitis (UC). After 56 weeks of treatment, 36% of participants who received the optimum dose of the drug achieved clinical remission, according to Roivant, which announced the results in June. This was a marked increase ...
- Source: drugdu
- 126
- July 18, 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
InnoCare and ArriVent Announce Clinical Development Collaboration

Companies will collaborate on investigating a novel SHP2 inhibitor in combination with furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR inhibitor, in patients with advanced non-small cell lung cancer BEIJING and NEWTOWN SQUARE, Pa., July 13, 2023 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases and ArriVent Biopharma, a clinical stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced a clinical development collaboration to evaluate the combination of InnoCare’s novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, ICP-189, with ArriVent’s furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor. Under the agreement, InnoCare and ArriVent will jointly conduct a clinical study to evaluate the anti-tumor activity and safety of ICP-189 combined with furmonertinib in patients with advanced non-small cell lung cancer (NSCLC). Furmonertinib ...
- Source: drugdu
- 232
- July 17, 2023
Roche’s Ocrevus Shows Promise as a Subcutaneous Injection in Phase 3 MS Trial

Roche has announced positive results from a late-stage study of Ocrevus (ocrelizumab) as a twice-yearly subcutaneous injection in patients with relapsing forms of multiple sclerosis (MS) or primary progressive MS. Over 2.8 million people worldwide are affected by MS, a disabling and unpredictable neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves, disrupting communication between the brain and the rest of the body. Relapsing-remitting MS accounts for approximately 85% of MS cases and is characterised by episodes of new or worsening signs or symptoms followed by periods of recovery, while primary progressive MS affects about 15% of patients and is marked by steadily worsening symptoms. Roche’s Ocrevus is a humanised monoclonal antibody designed to target a type of immune cell thought to be a key contributor to myelin and axonal damage, which can lead to disability in people with ...
- Source: drugdu
- 132
- July 17, 2023
A Rare but Important Cause of Chronic Sinusitis

A new research perspective was published in Oncoscience (Volume 10) on May 27, 2023, entitled, “Think outside the box – atypical infections in chronic sinusitis.” Inflammations of the paranasal sinuses represent a common clinical picture. The annual prevalence of chronic sinusitis in Europe is up to 10%. Sinusitis can be divided into acute and chronic forms. In particular, the chronic forms (>12 weeks duration) are often challenging in the context of therapy. Generally, all ventilation disorders of the paranasal sinuses (concha bullosa, nasal septal deviations, etc.,) represent risk factors for the development of any form of sinusitis. In addition, an immune deficiency or systemic diseases relevant to the immune system predispose to infections with atypical pathogens. Most sinusitis are caused by viruses, sometimes bacteria and, in rare cases, fungal infections. Furthermore, sinusitis can be differentiated with regard to the affected paranasal sinuses. In addition to conservative ...
- Source: drugdu
- 134
- July 17, 2023
NHS Extends Eligibility for Shingles Vaccine to Almost One Million People

The NHS has announced that almost a million more people (900,000) will become eligible for a shingles vaccination with the newly available vaccine, Shingrix, starting in September. The decision was made after the Joint Committee on Vaccination and Immunisation (JCVI) recommended that the Shingrix vaccine be given to a wider cohort of people after trials showed that the vaccine was highly effective and safe for people in those groups. Shingles is an infection that can occur at any age. It causes a rash that can be extremely painful and the pain can remain for many years after the rash has disappeared. Although it cannot be transmitted from other people, it develops in people who have previously been infected with chickenpox over their lifetime. Studies have shown that nine out of ten adults are already infected with the virus that causes shingles, and around one in four ...
- Source: drugdu
- 216
- July 15, 2023
Macrophages May Play a Major Role in the Development of Atrial Fibrillation

Current treatments for atrial fibrillation (AFib), a common heart condition characterized by fast and irregular beats that can lead to stroke and heart failure, have multiple side effects and are ineffective for preventing AFib recurrence. New research led by investigators at Massachusetts General Hospital (MGH) and published in Science reveals that certain immune cells play a major role in the development of AFib. Targeting these cells may therefore represent a promising strategy to treat and prevent AFib. For the work, senior author Matthias Nahrendorf, MD, PhD, an investigator in MGH’s Center for Systems Biology and the Richard Moerschner Endowed MGH Research Institute Chair in Men’s Health, and colleagues analyzed single cells from atrial heart tissue collected from patients with and without AFib. The analyses indicated that immune cells called macrophages are the most dynamic cell population in the atria during AFib, and these cells expand more than any ...
- Source: drugdu
- 94
- July 15, 2023
Takeda Withdraws Dengue Vaccine Application After FDA Request for More Data

Takeda has voluntarily withdrawn the Biologics License Application for its dengue vaccine candidate TAK-003 following discussions with the FDA regarding additional data collection, the Japanese pharma company announced Tuesday. According to Takeda, it will not be able to address the regulator’s concerns within the current BLA review cycle. The company is currently assessing its future options and plans for TAK-003, as well as evaluating the requirements for a potential BLA resubmission in the U.S., a spokesperson told Fierce Pharma. The FDA accepted Takeda’s BLA for TAK-003 in November 2022 and put the application under Priority Review, which typically results in a decision within six months versus the standard 10-month review period. “We will continue to progress regulatory reviews and provide access for people living in and traveling to dengue-endemic areas while we work to determine next steps in the U.S.,” Gary Dubin, president of Takeda’s vaccines business unit, said in a statement. TAK-003 is a tetravalent live-attenuated vaccine ...
- Source: drugdu
- 124
- July 14, 2023
Novavax’s COVID-19 Vaccine Granted Full Marketing Authorisation in EU

Novavax has announced that its COVID-19 vaccine, Nuvaxovid, has been granted full marketing authorisation in the EU. The vaccine is now fully authorised for use as a primary series in individuals aged 12 and older for COVID-19 prevention and as a booster dose in adults aged 18 and older, the company said. Novavax’s protein-based vaccine, which was originally granted a conditional marketing authorisation in the EU for these indications, contains the SARS-CoV-2 spike protein and Matrix-M adjuvant to enhance immune response and stimulate high levels of neutralising antibodies. The European Commission’s latest decision follows a recommendation by the European Medicines Agency’s human medicines committee earlier this year and is supported by positive results from the phase 3 PREVENT trial that evaluated the safety, immunogenicity, and efficacy of Nuvaxovid. John Jacobs, president and chief executive officer of Novavax, said: “This marketing authorisation establishes the foundation for all ...
- Source: drugdu
- 199
- July 12, 2023

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