Search Results for “Roche” – Page 13 – media

With MS & Fibrosis Trials Planned, J&J-Partnered Contineum Now Preps for IPO

Contineum Therapeutics, which emerged from a Verant Ventures startup creation engine, has filed paperwork for an IPO. The biotech’s clinical-stage pipeline spans multiple sclerosis, idiopathic pulmonary fibrosis, and depression. By FRANK VINLUAN Jhnson & Johnson is a partner on Contineum Therapeutics’ most advanced program, which is currently in mid-stage clinical testing for multiple sclerosis. As that research continues and Contineum plans to advance the development of its wholly owned assets, the biotech is moving forward with plans for an IPO. Contineum, which traces its origins to a startup creation engine of venture capital firm Versant Ventures, filed its IPO paperwork with the Securities and Exchange Commission late Friday. The company has not yet set any financial terms for its planned stock market debut, but IPO research firm Renaissance Capital said the offering could reach up to $150 million. The San Diego-based biotech has applied for a Nasdaq listing under the ...
- Source: drugdu
- 100
- March 20, 2024
BeiGene’s Tevimbra receives FDA approval to treat advanced oesophageal cancer

BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) has been approved by the US Food and Drug Administration (FDA) to treat advanced oesophageal squamous cell carcinoma (ESCC). The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost 90% of cases. More than two-thirds of patients with oesophageal cancer have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases. BeiGene’s Tevimbra, which is already approved in the EU for advanced or metastatic ESCC after prior chemotherapy, is designed to aid the body’s immune cells to detect and fight tumours. The FDA’s decision on the therapy was based on positive results from the late-stage RATIONALE 302 trial, which compared its ...
- Source: drugdu
- 123
- March 20, 2024
FDA Approves Madrigal Pharma NASH Drug

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence. By FRANK VINLUAN A chronic metabolic disease in which fat buildup leads to worsening liver function that can ultimately require an organ transplant now has its first FDA-approved therapy, a once-daily pill developed by Madrigal Pharmaceuticals. The FDA decision Thursday is for adults with noncirrhotic non-alcoholic steatohepatitis, or NASH. The approval specifically covers those who have reached the point of moderate-to-advanced liver scarring, which is also called fibrosis. The Conshohocken, Pennsylvania-based company’s drug, known in development as resmetirom, will be marketed under the brand name Rezdiffra. “We’ve had patients waiting and waiting for something that could impact underlying fibrosis in the setting of NASH, and this truly represents a milestone achievement that frankly I, and many ...
- Source: drugdu
- 119
- March 18, 2024
FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma

Davy James BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies. The FDA has granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) in combination with Roche’s Gazyva (obinutuzumab) for patients with relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy.1 Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies, such as chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma; Waldenström’s macroglobulinemia; patients with mantle cell lymphoma (MCL) previously treated with at least one prior therapy; and patients with relapsed or refractory marginal zone lymphoma previously treated with at least one anti-CD20-based regimen.1 Gazyva is a CD20-directed cytolytic antibody indicated in combination with chlorambucil for the treatment of patients with previously untreated CLL; in combination with chemotherapy ...
- Source: drugdu
- 133
- March 12, 2024
BeiGene’s Brukinsa granted FDA accelerated approval for advanced follicular lymphoma

BeiGene’s Brukinsa (zanubrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat relapsed or refractory follicular lymphoma. The BTK inhibitor has specifically been authorised for use alongside Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) in adult patients who have received at least two prior lines of systemic therapy. The FDA’s decision was supported by positive results from the mid-stage ROSEWOOD study, which demonstrated an overall response rate of 69% for the Brukinsa combination arm compared to 46% for Gazyva alone. An 18-month duration of response of 69% for the Brukinsa combination was also observed, BeiGene said, adding that safety results were consistent with previous studies of both medicines. Mehrdad Mobasher, chief medical officer, haematology at BeiGene, said: “This accelerated approval of Brukinsa represents an important advancement, offering the first and only BTK inhibitor treatment for follicular lymphoma patients in the US who have either not ...
- Source: drugdu
- 75
- March 12, 2024
Wireless Hepatitis B Test Kit Completes Screening and Data Collection in One Step

Hepatitis B, a significant global health concern, is responsible for chronic liver diseases like cirrhosis and liver cancer which is one of the most common cancers worldwide. The challenge with hepatitis B is that most carriers are asymptomatic, remaining unaware of their infection, which can lead to its unintentional spread. Thus, early diagnosis is vital to halt the spread, initiate timely treatment, and reduce the risk of liver complications primarily caused by the hepatitis B virus. However, conventional tests for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) are complex, requiring specialized skills and large, expensive machine-based assays typically found in major hospitals. To overcome the problem of inadequate access to screening for Hepatitis B, researchers have developed a wireless, point-of-care test for the Hepatitis B Virus that can make diagnosis simpler and faster. Researchers from Chulalongkorn University (Bangkok, Thailand) have developed a testing kit that enables ...
- Source: drugdu
- 95
- February 22, 2024
Xolair Approved by FDA as First Treatment for Multiple Food Allergies in Adult, Pediatric Patients

Davy James Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above. The FDA has approved an expanded indication for Novartis’ and Roche’s Xolair (omalizumab) as the first medication indicated to reduce allergic reactions from exposure to one or more food allergens in individuals over 1 year of age with immunoglobulin E (IgE)-mediated food allergy. Xolair is a monoclonal antibody that binds to and inhibits IgE, which is involved in the pathophysiology of the allergic inflammation characteristic of asthma. Through this mechanism of action, IgE down-regulates the immune response to help gain control over allergy-driven inflammation. “Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction that could happen as a result. Today’s ...
- Source: drugdu
- 170
- February 20, 2024
Sarepta’s Elevidys makes advances towards expanded DMD label

Following an eventful couple of months with Elevidys (delandistrogene moxeparvovec-rokl), Sarepta Therapeutics has announced that the efficacy supplement for its biologics license application (BLA) of the Duchenne muscular dystrophy (DMD) gene therapy has received priority review by the FDA. As per the 16 February press release, the purpose of the efficacy supplement is to change Elevidys’ accelerated approval to a traditional approval while also expanding the therapy’s label to treat all DMD patients with a confirmed mutation in the DMD gene. The FDA has set a priority review goal date of 21 June 2024 and will not discuss the supplement in an advisory committee meeting. Elevidys, which was granted approval in June 2023, is currently indicated to treat ambulatory pediatric DMD patients between the ages of four and five years with a confirmed mutation in the DMD gene. The single-dose gene transfer therapy uses a recombinant adeno-associated virus vector serotype ...
- Source: drugdu
- 104
- February 19, 2024
Automated Mass Spectrometry-Based Clinical Analyzer Could Transform Lab Testing

Mass spectrometry, known for its higher sensitivity and specificity compared to immunoassays, is particularly effective for testing molecules like Vitamin D and certain hormones where antibody-based tests struggle to differentiate between similar forms. This method allows for more precise testing. Researchers and clinicians have been investigating the use of mass spectrometry for such assays for several years. However, due to its complexity compared to standard immunoassays, mass spectrometry has largely been limited to large clinical reference laboratories and specialized testing companies that have the necessary resources and expertise to develop and conduct these tests. Now, a fully automated clinical mass spectrometry system being developed for routine lab testing could change that. Roche Diagnostics (Basel, Switzerland) is currently developing a fully automated, standardized liquid chromatography-mass spectrometry (LC-MS) solution that will seamlessly integrate into existing clinical chemistry and immunochemistry testing as part of its cobas Pro integrated solutions, as well as laboratory ...
- Source: drugdu
- 117
- February 7, 2024
Merck’s Keytruda extends life for kidney cancer patients after surgery, while Bristol’s Opdivo fails again

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. Keytruda slashed the risk of death by 38% compared with placebo when used after kidney removal in patients with clear cell renal carcinoma, the most common form of kidney cancer, according to newly released trial results. After four years of treatment, investigators estimated that 91.2% of patients in the Keytruda arm were still alive, versus 86% for the control group. The results, which reached statistical significance, come from an update of the Keynote-564 trial. Previously, disease-free survival results from the same trial supported Keytruda’s 2021 approval as an adjuvant therapy for certain kidney cancer patients at risk of recurrence after surgery. Keytruda’s survival win comes just as Bristol Myers Squibb’s rival PD-1 inhibitor, Opdivo, failed for a second time in ...
- Source: drugdu
- 98
- January 30, 2024

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