Search Results for “FDA” – Page 130 – media

After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti

As Johnson & Johnson and Legend Biotech have sought to grow the reach of their multiple myeloma CAR-T drug Carvykti since winning FDA approval last year, they’ve occasionally run into manufacturing pitfalls. Now, with an eye on a big market expansion, J&J is laying out the state of its cell therapy production writ large. Over the past several months, J&J has been “progressively adding more and more capacity” to churn out Carvykti, John Reed, M.D., Ph.D., executive vice president of pharmaceuticals R&D, said on a Tuesday conference call. Aside from the company’s original launch site in New Jersey, Reed said J&J is close to having an additional Carvykti manufacturing site “up and rolling” in Belgium. The company also plans to boost output by leveraging excess capacity from Novartis under a relatively new partnership. Reed described the lentivirus portion of Carvykti as a “rate-limiting” component of the therapy. Lentiviral vectors are pricey delivery components used to ...
- Source: drugdu
- 108
- October 20, 2023
Ultimovacs Rebounds on New Universal Cancer Vaccine Data for Mesothelioma

Pictured: Artistic rendering of doctor diagnosing lungs on screen/iStock, greenbutterfly Despite missing the primary endpoint mark in June 2023, Ultimovacs hasn’t given up on trying to prove its universal cancer vaccine has a benefit for deadly mesothelioma. The Norwegian biotech reported new data Tuesday, proving strong clinical responses with extended overall survival in a follow up analysis. When combined with Bristol Myers Squibb’s Opdivo and Yervoy as a second-line treatment to platinum chemotherapy, Ultimovacs’ UV1 reduced risk of death by 27% for patients with malignant pleural mesothelioma, a cancer in the lining of the lungs. Caused by asbestos fibers that have embedded in the pleura, eventually leading to mesothelioma tumors, this cancer is aggressive and often incurable. The five-year survival rate for localized pleural mesothelioma, the most treatable type, is 24%. Median overall survival for patients receiving the vaccine combined with the checkpoint inhibitors was 15.4 months, compared to 11.1 months on the immunotherapy treatments alone. ...
- Source: drugdu
- 103
- October 20, 2023
CHMP recommends European authorisation for seven new drugs

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new drugs for authorisation. The drugs include Pfizer’s Elrexfio for the treatment of multiple myeloma and Astellas Pharma’s Veozah for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Elrexfio (elranatamab) is a subcutaneously administered bispecific B-cell maturation antigen-directed CD3 T-cell engager. The US Food and Drug Administration (FDA) granted accelerated approval for Elrexfio in August for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. According to GlobalData, sales for Elrexfio are expected to reach $536m by 2029. One of its competitors in the market is Talvey (talquetamab-tgvs), marketed by Janssen, which was approved as a fifth-line treatment for relapsed/refractory multiple myeloma in August. Talvey is forecasted to generate $1.9bn in sales by 2029. Astellas Pharma’s Veozah ...
- Source: drugdu
- 108
- October 19, 2023
Merck’s Keytruda receives approval greenlight from EU CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed a positive recommendation for Merck’s Keytruda (pembrolizumab) as part of a first-line treatment for advanced gastric and gastroesophageal junction cancer (GEJ). Keytruda, an anti-programmed death receptor-1 (PD-1) therapy, would be used in conjunction with fluoropyrimidine- and platinum-containing chemotherapy in adults whose tumours express PD-L1 with a combined positive score (CPS) ≥1. The intravenously administered drug is designed to improve the immune system’s anti-tumour response by inhibiting the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating tumor-fighting T-cells. Keytruda is also being studied as a treatment for hepatobiliary, oesophageal, pancreatic, and colorectal cancers. The EU CHMP’s positive recommendation was based on results from the Phase III KEYNOTE-859 (NCT03675737) study, a randomised, double-blind clinical trial evaluating the efficacy of Keytruda plus chemotherapy as a first-line treatment for human epidermal growth factor receptor-2 (HER2) negative, unresectable or ...
- Source: drugdu
- 170
- October 18, 2023
Novo Nordisk Strikes Deal for Late-Stage Hypertension & Kidney Disease Drug

The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes. By FRANK VINLUAN Novo Nordisk has again turned to dealmaking to expand its pipeline, but rather than adding yet another weight loss drug prospect the company is acquiring a molecule that’s a potential treatment for uncontrolled hypertension and chronic kidney disease. The Danish pharmaceutical giant has agreed to buy ocedurenone, a drug that KBP Biosciences has advanced to Phase 3 testing. Specific financial details, such as an upfront payment and milestones, were not disclosed Monday, but Novo Nordisk said it could end up paying out up to $1.3 billion. The target of KBP’s drug is the mineralocorticoid receptor, whose overactivation is associated with hypertension and chronic kidney ...
- Source: drugdu
- 218
- October 18, 2023
High-flying Novo Nordisk again dials up its 2023 sales and profit expectations

The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again. The Danish company now expects full-year sales to grow between 32% and 38% at constant exchange rates. The new projection, released on Friday, represents a 5-percentage-point increase on both ends of the range from an August estimate, which itself was 3 percentage points higher than a previous forecast from April. Novo’s share price at one point traded at around $104 on the New York Stock Exchange on Friday, a new all-time high. Huge demand for Ozempic—which is often used off-label to treat obesity—plus new discount adjustments for Ozempic and Wegovy in the U.S. drove the updated sales outlook, Novo explained in a release. Novo on Friday also dialed up its estimated profit growth rate by 9 percentage points to a range of 40% to 46%. The company released the ...
- Source: drugdu
- 191
- October 17, 2023
Interest in RNA Editing Accelerates as Therapies Approach the Clinic

By Gerard Platenburg Pictured: RNA/iStock, Artur Plawgo Based on the significant progress made over the last few decades with RNA therapeutics, RNA editing is widely considered the next generation of promising medicines in this field. RNA therapies have made significant progress over the last few years, with an increasing number of FDA approvals beginning in 1998 with Vitravene for CMV retinitis, followed by Macugen for macular degeneration in 2004 and Spinraza for spinal muscular atrophy in 2016. There have also been multiple siRNA-based drugs, including Onpattro for polyneuropathy of hereditary transthyretin-mediated amyloidosis in 2018. And finally, in 2020, perhaps the most well-known products in the RNA space were introduced: the mRNA-based COVID-19 vaccines. All of these demonstrate the strength of RNA therapies and their potential impact on diseases with high unmet need. RNA therapeutics are indeed elegant approaches to altering RNA and thus protein expression, opening the potential to target ...
- Source: drugdu
- 133
- October 17, 2023
Akero’s Three-Step Plan to Win Back Investors

By Jia Jie Chen Pictured: Stocks trending down/iStock, lerbank Shares of Akero Therapeutics crashed this week after the biotech released data from a late-stage trial of its lead candidate, efruxifermin, in nonalcoholic steatohepatitis. Although the Phase IIb study met multiple secondary endpoints, the effect on the primary endpoint was not considered statistically significant. The SYMMETRY trial compared 182 patients with compensated cirrhosis—also known as F4 fibrosis—who were treated with efruxifermin (EFX) with a placebo control group. The data showed that 22% of patients treated weekly with 28 mg of efruxifermin (EFX) saw at least a one-stage improvement in liver fibrosis with no non-alcoholic steatohepatitis (NASH) worsening, while 24% of those treated with 50 mgs of EFX achieved this result; this compared to 14% of patients in the placebo arm who experienced similar improvement. The differences between the placebo group and both experimental arms were not statistically significant, with p-values at ...
- Source: drugdu
- 115
- October 16, 2023
Biogen’s Aduhelm headache returns as appeals court revives part of investor lawsuit

For more than a year, Biogen has been working to turn the page from its Aduhelm fiasco and focus on its newer Eisai-partnered Alzheimer’s disease medicine Leqembi. But a new ruling from the U.S. Court of Appeals for the First Circuit will make that effort a little tougher. After Biogen last year won the dismissal of an investor lawsuit surrounding disclosures into its Aduhelm research, the appeals court has reversed the ruling—in part—by focusing on one statement made by Biogen’s former chief medical officer Al Sandrock. Specifically, the appeals court flagged Sandrock’s statement from the company’s second-quarter earnings call in 2020. During the call, Sandrock stated that “[Y]ou really need to get to the higher dose,” adding, “I think our data are all consistent with that.” The court dubbed this the “all data” statement and painstakingly broke down the context behind the remark. To refresh readers’ memory, Biogen in March ...
- Source: drugdu
- 132
- October 14, 2023
Lilly’s Mirikizumab Shows Long-Term Remission in Phase III Crohn’s Trial

By Kate Goodwin Pictured: Eli Lilly world headquarters/iStock, jetcityimage A 52-week study finds Eli Lilly’s mirikizumab to be effective for long-term remission in over half of patients with Crohn’s disease. The company announced Thursday plans to submit a marketing application to the FDA for approval in 2024, followed by submissions to other global regulatory agencies. In the Phase III trial, moderately to severely active Crohn’s disease patients on mirikizumab demonstrated clinical remission as well as endoscopic response at the one-year mark. Over 54% of the patients in the treatment arm achieved clinical remission at week 52, versus 19.6% of those receiving placebo. The endoscopic response was seen in 38% of those on mirikizumab versus 9% on placebo. Safety was consistent with the known profile of the therapy with the frequency of serious adverse events greater in the placebo arm than the treated group, according to Lilly. The interleukin-23p19 antagonist demonstrated ...
- Source: drugdu
- 107
- October 14, 2023

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