Search Results for “AbbVie ” – Page 8 – media

Positive Results from Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) in Patients with Giant Cell Arteritis

On April 18, AbbVie announced positive results from SELECT-GCA. Based on the results of this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, upadacitinib (RINVOQ®; 15 mg once daily) in combination with a 26-week hormone tapering regimen met the primary endpoint of sustained remissiona in adult patients with giant cell arteritis (GCA) from Week 12 to Week 52. In this study, 46% of patients treated with Rinvoq in combination with the 26-week hormone tapering regimen achieved sustained remission, compared to 29% of patients treated with placebo in combination with the 52-week hormone tapering regimen (p=0.0019). Dr. Kori Wallace, Vice President, Global Head of Clinical Development, Immunology at AbbVie, said, “Many patients with GCA continue to suffer from the potentially debilitating symptoms of the disease, and their treatment options are limited. These results demonstrate that there remains a significant medical need for this type of disease, and we are relentlessly committed to ...
- Source: drugdu
- 79
- April 25, 2024
Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder. A Neumora Therapeutics drug candidate addressing a promising and competitive target for schizophrenia has been placed under an FDA clinical hold after new preclinical data emerged showing convulsions in rabbits that received the experimental treatment. The Neumora drug, NMRA-266, began Phase 1 testing last November. The clinical hold announced Monday pauses the study, which had dosed about 30 healthy participants so far. Watertown, Massachusetts-based Neumora said no convulsions have been observed in any of the study participants. The company added that it is working with the FDA to resolve the clinical hold and will provide an update on the program’s status when new information becomes available. “We are ...
- Source: drugdu
- 84
- April 17, 2024
Disco tunes into new cancer drug targets

EUR 20m to identify new targets and develop first in class drugs DISCO Pharmaceuticals – a company specialising in unlocking the surfaceome of cancer cells at scale – has raided EUR 20m to identify new targets and develop first in class drugs. The funding round was backed by a formidable investor syndicate, including Sofinnova Partners, Panakes Partners, M Ventures and AbbVie Ventures. The development of new treatment modalities in oncology is increasing, however, the lack of cell surface targets limits the application to some clinically effective targets. Also, the development of new biologics, such as bi-specific antibodies and antibody drug conjugates, is increasing and there are currently less than 30 molecular targets, which form the basis of all antibody-based therapies. Consequently, there is a significant need to identify novel cancer-selective targets and target pairs. DISCO’s surfaceome mapping platform transforms the current approach of target discovery for large molecule R&D. This ...
- Source: drugdu
- 114
- April 7, 2024
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
- 80
- March 8, 2024
FDA Approves Imbruvica Label Expansion to Include Oral Suspension Formulation

Don Tracy, Associate Editor New label marks the first Bruton’s tyrosine kinase inhibitor to be approved with an oral suspension formulation. The FDA has approved an addendum to the Imbruvica (ibrutinib) label to include an oral suspension formulation across the drug’s indications. Johnson & Johnson (J&J), in partnership with Pharmacyclics LLC, an AbbVie Company, announced that the new formulation is approved to treat patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) following the failure of one or more lines of systemic therapy. This option is designed for patients who have difficulty swallowing pills, part of J&J’s ongoing efforts to provide multiple patient-friendly treatment options, the company stated in a press release.1 “As the most comprehensively studied therapy in its class, Imbruvica has helped change the standard of care for adults living with certain blood cancers and cGVHD. Nearly 300,000 ...
- Source: drugdu
- 132
- February 29, 2024
Lilly’s Jaypirca tipped to capture 60% of BTK leukemia market, leaving AstraZeneca, BeiGene in the dust

Eli Lilly’s attempt to wrestle a leukemia market from companies including AbbVie, AstraZeneca, BeiGene and Johnson & Johnson has analysts purring, with the GlobalData team tipping the drugmaker to capture 60% of demand and deliver $3 billion in annual sales. The GlobalData report covers the use of BTK inhibitors in the treatment of chronic lymphocytic leukemia (CLL). Pharmacyclics, now part of AbbVie, and J&J created the market with Imbruvica but now face a sea of threats, with the Inflation Reduction Act, increased competition and the looming prospect of generics pointing to a downward trajectory. AstraZeneca’s Calquence began challenging Imbruvica for the CLL market in 2019 and BeiGene’s Brukinsa joined the party last year. But the GlobalData analysts expect Lilly to come from behind to become the dominant force in CLL in the coming years. Lilly won accelerated FDA approval for Jaypirca in CLL last month. While the drugmaker, which acquired Jaypirca in its $8 billion ...
- Source: https://www.pharma.com/marketing/lillys-jaypirca-tipped-capture-60-btk-leukemia-market-leaving-astrazeneca-beigene-dust
- 161
- January 24, 2024
Lundbeck launches ‘Say Yep’ for new Vyepti multi-media migraine campaign

Lundbeck wants migraine suffers to say “nope” to doing more and “yep” to doing less with their condition as the core message of its new campaign for Vyepti. The “Say Yep” initiative plays on the yep in Vyepti, the pharma’s intravenous migraine prevention therapy that was approved by the FDA exactly four years ago next month. The therapy brought in DKK 1 billion ($145.9 million) in 2022, double what it made in 2021 and driven by what Lundbeck said was “strong demand.” The multi-channel media campaign is trying to reach the 40 million Americans who suffer from the often-debilitating condition. The message is to slow down and not push through the pain of a migraine. The campaign “brings to life the brand’s empathetic understanding that people are doing a lot to manage migraine and deserve to do a little less, if possible,” a spokesperson from Lundbeck said. “Say Yep subtly ...
- Source: drugdu
- 142
- January 20, 2024
J&J Joins the Cancer ADC Dealmaking Spree With $2B Ambrx Acquisition

Johnson & Johnson’s acquisition of antibody drug conjugate developer Ambrx Biopharma comes as Novartis and Merck also unveiled M&A deals on the first day of the J.P. Morgan Healthcare conference. In a report, the investment bank said big pharmas are looking for deals involving de-risked assets. By FRANK VINLUAN Big pharmaceutical companies splashed out big bucks in 2023 to acquire or license antibody drug conjugates, or ADCs. The trend is continuing into the new year with Johnson & Johnson reaching a $2 billion deal to acquire clinical-stage Ambrx Biopharma. According to deal terms announced Monday, J&J will pay $28 cash for each Ambrx share, which is a 105% premium to the biotech’s closing stock price on Friday. In other biopharma deal announcements, Merck is paying $680 million to acquire Harpoon Therapeutics, a developer of targeted cancer therapies, and Novartis is buying autoimmune disease drug developer Calypso Biotech for $250 ...
- Source: drugdu
- 138
- January 10, 2024
As cancer players jump head-first into ADC field, Novartis CEO explains how he’s resisted the temptation

San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. On Monday, the Swiss pharma’s CEO Vas Narasimhan explained how he’s resisted the temptation. The answer is radioligand therapies, Narasimhan said Monday during the 2024 J.P. Morgan Healthcare Conference in response to a question from Fierce Pharma. “We have a long history within research of ADCs, but we have not been successful,” Narasimhan said. “To be clear, part of our focus strategy is looking at places where we think we can create long-term sustainable leadership. And we are investing in radioligand therapies.” ADCs and radioligand therapies are similar in that both technologies act as guided missiles. For ADCs, the guiding force is an antibody, and the cancer-killing payload is a chemotherapy. A radioligand therapy uses a ligand to target cancer cells and kills them with a therapeutic radioisotope. Radiotherapies may have a safety ...
- Source: drugdu
- 90
- January 10, 2024
After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer

In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
- Source: drugdu
- 224
- January 4, 2024

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