Search Results for “Novartis” – Page 15 – media

Drugmakers submit counteroffers to US Medicare pricing negotiations

The US Department of Health and Human Services (HHS), as part of the Centers for Medicare and Medicaid Services (CMS), has announced that all ten pharmaceutical manufacturers taking part in the Medicare drug price negotiations have submitted counteroffers. The announcement comes after the HHS sent initial offers on 1 February in an ongoing effort to lower drug prices in the US as part of the Inflation Reduction Act (IRA) and negotiations will continue over the next several months. First selected last August, the ten medicines subject to the first round of Medicare pricing negotiations included therapies for diabetes, heart failure, immunological disorders and cancer, as well as anticoagulants. The medicines selected included Bristol Myers Squibb/Pfizer’s Eliquis (apixaban), Novartis’ Entresto (valsartan/sacubitril), AstraZeneca’s Farxiga (dapagliflozin), AbbVie/Johnson & Johnson’s Imbruvica (ibrutinib), Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin), and Johnson & Johnson’s Stelara (ustekinumab) and Xarelto (rivaroxaban). According to the HHS, collectively, the drugs were ...
- Source: drugdu
- 78
- March 8, 2024
FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs

Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
- Source: drugdu
- 134
- March 7, 2024
Asthma Medication Xolair May Reduce Peanut Allergies, New Study Finds

Mike Hollan FDA has approved the medication in adults and children with allergies. A peanut allergy can be a difficult and terrifying thing to live with. People with these allergies have to be on constant alert, as coming into contact with even a small amount of the food can cause a severe reaction. Thousands of Americans live with these allergies, and they are responsible for a similar number of emergency room visits. Typically, the best way to treat a peanut is to just avoid them altogether, which can be difficult due to how common nuts and nut oils are used in cooking. A recent announcement from Novartis, however, may make life a lot easier (and much less scary) for people living with these allergies. Novartis released that data from a new study which suggests that asthma medication Xolair can be used to treat certain food allergies, including nuts, eggs, milk, ...
- Source: drugdu
- 93
- February 28, 2024
GSK’s Omjjara recommended by NICE to treat myelofibrosis patients with anaemia

GSK’s Omjjara (momelotinib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment option for myelofibrosis-related splenomegaly or symptoms in adults with moderate-to-severe anaemia. The agency’s final draft guidance applies to both newly diagnosed and previously treated patients, although those eligible will need to have either not been treated with JAK inhibitors before or been treated with Novartis’ Jakavi (ruxolitinib). Estimated to affect more than 1,900 people in England, Wales and Northern Ireland, myelofibrosis is a rare blood cancer that disrupts the body’s normal production of blood cells. About 40% of myelofibrosis patients have moderate-to-severe anaemia at the time of diagnosis and nearly all patients develop anaemia at some point over the course of their disease. Omjjara is a once-a-day oral JAK1/JAK2 and ACVR1 inhibitor that aims to address the key manifestations of the disease. NICE’s recommendation comes shortly after the Medicines and Healthcare ...
- Source: drugdu
- 160
- February 21, 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
Stalicla secures funds for late-stage assets amid CNS buzz

Stalicla announced the successful closing of a $17.4m Series B funding round as deal-making interest stirs in the central nervous system disorder space. “In the current environment, we see this [financing round] as a huge success, but we’re targeting a much larger round in Q3 2024 with the involvement of large venture capital funds,” says Stalicla CEO Lynn Durham in an exclusive interview with Pharmaceutical Technology. Stalicla aims to use the extra funds to launch a Phase III substance use disorder (SUD) study for its STP7 mGluR5 Negative Allosteric Modulator (mGluR5 NAM) platform in 2025. The US National Institute on Drug Abuse and the National Institutes of Health are supporting Stalicla’s development of STP7.Stalicla acquired the therapy through an in-licensing agreement with Novartis in January 2023. In this deal, the Swiss company acquired the worldwide rights for studies using the STP7 platform for SUD, neurodevelopmental disorders, and other indications in ...
- Source: drugdu
- 103
- February 8, 2024
FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting to discuss applications for Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti. The FDA will convene its Oncologic Drugs Advisory Committee (ODAC) for a full-day meeting March 15 to review the applications for BMS and 2seventy bio’s Abecma and J&J and Legend Biotech’s Carvykti in earlier treatment of multiple myeloma, a government filing shows. External experts invited by the FDA will review clinical data from Carvykti’s CARTITUDE-4 trial and Abecma’s KarMMa-3 study. In both cases, overall survival data will be the focus of the discussions. The meeting is expected to carry a lot of weight in the oncology community. For one, industry watchers are trying to take the FDA’s pulse around the benefit-risk profile of CAR-T cell therapies amid an investigation into a new safety signal ...
- Source: drugdu
- 98
- February 6, 2024
Neuro Biotech Alto Adds $128M in IPO Cash for Biomarker-Based Psych Drugs

Alto Neuroscience will apply the IPO proceeds toward clinical tests of its psychiatric drugs in patients who exhibit certain biomarkers. The company’s two most advanced programs are depression drugs in mid-stage development. By FRANK VINLUAN Matching a drug to a patient’s biology is not a new idea, but it hasn’t caught on in neuropsychiatric disorders, which have high failure rates in drug studies. The technology of Alto Neuroscience brings precision medicine to psychiatric drug research and its IPO has raised $128.6 million to see if this approach can yield better clinical trial results. Alto priced its IPO late Thursday, offering more than 8 million shares for $16 apiece. The Los Altos, California-based company was able to raise more than planned. When Alto set preliminary financial terms earlier this week, it projected offering 6.7 million shares in the range of $14 and $16 each, which would have raised $100.5 million at ...
- Source: drugdu
- 87
- February 5, 2024
FDA rejects Defender Pharma’s motion sickness nasal gel candidate

A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. regulator has sent a complete response letter (CRL) to Defender Pharmaceuticals, rejecting DPI-396 for the prevention of nausea and vomiting induced by motion. Barry Feinberg, M.D., the CEO of Defender, a privately held St. Louis company, said in a release that the firm will schedule a meeting with the FDA so it can “understand the issues raised in the CRL so we can develop and implement a comprehensive action plan.” “We remain confident that our intranasal scopolamine is a safe and effective therapy,” Feinberg added. In 2012, the NASA teamed with Irvine, California-based Epiomed Therapeutics to develop a nasal spray version of scopolamine. Astronauts often experience motion sickness in space. Two years later, Defender purchased Epiomed, according to the St. Louis Post-Dispatch. Also working to develop the treatment has ...
- Source: drugdu
- 111
- February 1, 2024
FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy

January 24, 2024 Don Tracy, Associate Editor New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products. On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.” Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The letter stating these requirements has been sent to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, ...
- Source: drugdu
- 103
- January 26, 2024

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.