Search Results for “Janssen” – Page 6 – media

Chasing AstraZeneca and Pfizer, Johnson & Johnson snags FDA nod for prostate cancer combo Akeega

Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s androgen-directed Zytiga (abiraterone acetate) and the PARP inhibitor niraparib, which is sold by GSK as Zejula in other indications. The FDA has signed off on its use along with the corticosteroid prednisone, but only in a subset of mCRPC patients—those with BRCA mutations. Akeega will compete with AstraZeneca and Merck’s Lynparza as well as Pfizer’s Talzenna in the indication. Eleven weeks ago, the FDA gave Lynparza the same narrow label for those with the BRCA-positive tumors. Talzenna’s approval covers a broader population, including other mutations in the homologous recombination deficiency family. Under a 2016 deal with Zejula’s developer Tesaro, J&J carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. The ...
- Source: drugdu
- 118
- August 16, 2023
FDA Approves J&J’s Akeega for BRCA-Positive Prostate Cancer

By Tristan Manalac Pictured: Janssen headquarters in California/iStock, Sundry Photography The FDA on Friday signed off on Janssen Pharmaceutical’s niraparib and abiraterone acetate tablets, now to be marketed as Akeega, for the treatment of metastatic castration-resistant prostate cancer in patients carrying the BRCA mutation. According to Janssen’s announcement, Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga. Janssen is a subsidiary of Johnson & Johnson. The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients. Akeega also led to a trend toward better overall survival, though this effect fell short of ...
- Source: drugdu
- 187
- August 16, 2023
Alkermes, Nearing Oncology Split, Posts Big Q2 Sales Gain After Winning J&J Arbitration Case

With winnings from its arbitration battle against Johnson & Johnson in hand—alongside a jump in its own product sales—Alkermes seems to be feeling itself heading into the second half of 2023. After the Dublin-based drugmaker won a high-stakes case versus J&J last month, the company bumped up its 2023 sales forecast by $425 million to between $1.55 billion and $1.68 billion. In revealing second-quarter results, the company provided some details behind the new guidance. Alkermes expects J&J’s royalties and interest on late payments for 2022 to come in at around $197 million, while 2023 royalties should land between $265 to $280 million, the company said in an investor presentation (PDF). Those payments relate to J&J’s schizophrenia drug Invega, which uses Alkermes’ NanoCrystal technology and delivered sales of $4.1 billion last year. With the arbitration win in tow, Alkermes generated $617 million this quarter, including $248 million of back royalties and interest from ...
- Source: drugdu
- 114
- July 28, 2023
J&J’s Darzalex Stays on its Upward Trajectory as Company Adds $1B to Annual Sales Projection

In 2017, when Genmab CEO Jan van de Winkel declared its multiple myeloma drug Darzalex—which is marketed by Johnson & Johnson—had the potential for peak sales of $13 billion, he relented that it was a best-case scenario.Six years later, that best-case scenario appears possible. On Thursday, J&J reported another quarter of strong sales for the monoclonal antibody. Darzalex generated $2.43 billion in the period, a 22% increase from the second quarter of last year. After realizing sales of $6 billion in 2021 and $8 billion last year, Darzalex is on track to approach revenue of $10 billion in 2023. The drug, which was approved in 2015, was boosted in 2020 with the development of Darzalex Faspro, a subcutaneous version of the treatment which allows patients to receive doses in minutes compared to hours for the previous intravenous administration. A year ago, J&J reported that 85% of patients receiving Darzalex were using Faspro. ...
- Source: drugdu
- 115
- July 24, 2023
Johnson & Johnson Becomes 4th Drugmaker to File Suit Against IRA’s Drug Price Negotiations

Johnson & Johnson has hopped on the litigation bandwagon, becoming the fourth large drugmaker to sue the U.S. government over drug price negotiations in the Inflation Reduction Act (IRA).In U.S. District Court in New Jersey, J&J claimed (PDF) that price negotiations by Medicare would violate the First and Fifth Amendments of the U.S. Constitution. Merck, Bristol Myers Squibb and Astellas have made the same argument in separate lawsuits. Last week in federal court in Washington, D.C., Merck applied more pressure, filing for a decision in its case without a trial. The U.S. Chamber of Commerce and industry association PhRMA have also filed suits with similar claims. “The government is forcing (J&J) to provide its innovative, patented medicines on pricing terms that by law must be significantly below market prices,” J&J said in a release. “This would upend the current self-sustaining cycle of pharmaceutical innovation that provides patients with access ...
- Source: drugdu
- 279
- July 20, 2023
Neumora Races Toward Phase III with New Driver in the Hot Seat

Pictured: A silhouette of a woman sitting on the floor with her head in her hands/iStock, simpson33 Neumora Therapeutics is making big moves this week. On Tuesday the young biotech announced the initiation of a Phase III program for its potential depression treatment along with a new CEO to lead the way. The nearly two-year-old startup posted statistically significant results for treating moderate-to-severe major depressive disorder (MDD) in its Phase II trial of navacaprant, a kappa opioid receptor (KOR) antagonist. Initiated by BlackThorn Therapeutics prior to its acquisition by Neumora, the trial was amended to include those more serious MDD patients, the population in which it appears to be most effective. In moderate-to-severe patients, navacaprant had statistically significant results in lowering patients’ 17-item Hamilton Rating Scale for Depression score by 3 points at week 4 and 2.8 points by week 8. Across all patients, which included mildly depressed patients, navacaprant did not achieve ...
- Source: drugdu
- 112
- July 20, 2023
FDA rejects Alvotech’s Humira biosimilar for the third time

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Humira biosimilar AVT02, further delaying the company’s plans to launch the drug in a landmark year. The agency rejected the drug’s biologics licence application (BLA) over deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland, according to Alvotech’s press release on 28 June. While the FDA did not make a note of any other deficiencies in the BLA, issues related to the Reykjavik facility need to be resolved to facilitate the drug’s potential approval. This marks the second time that the FDA has rejected AVT02’s BLA this year. In April, the regulator issued a CRL to Alvotech, which also noted the deficiencies seen in the company’s Reykjavik plant. Prior to that, the company received a CRL from the FDA over deficiencies in the plant in September 2022. Alvotech plans to resubmit ...
- Source: drugdu
- 108
- July 1, 2023
States Back FTC in Lawsuit Seeking to Block Amgen-Horizon Deal

Pictured: FTC sign on a wall/iStock Six U.S. states are joining the Federal Trade Commission’s lawsuit seeking to block Amgen’s $27.8 billion buyout of rare disease biotech Horizon Therapeutics, Reuters reported on Thursday. The acquisition “would allow Amgen to monopolize the market for certain crucial medications,” which would make these treatments less affordable and accessible to patients, Illinois Attorney General Kwame Raoul said in a statement. Illinois is one of the states joining the FTC’s lawsuit, along with California, Minnesota, New York, Washington and Wisconsin. In the amended lawsuit, the six states and the FTC are asking the District Court of the Northern District of Illinois to issue a preliminary injunction against the Amgen-Horizon deal while the Commission prepares an administrative complaint, and until decisions have been made about the complaint. The plaintiffs are also seeking a temporary restraining order against the acquisition and any other related transactions. “When drug ...
- Source: drugdu
- 117
- June 25, 2023
Empress Therapeutics emerges with $50m to fund small molecule development

Life sciences venture capital firm Flagship Pioneering has unveiled Empress Therapeutics, a small molecule drug development startup. The Moderna-backed venture fund has launched Empress with a $50m investment. This will support development of its proprietary Chemilogics platform and drug discovery pipeline. So far, Empress claims to have generated 15 drug leads across multiple indications. These span multiple structural classes and target several classes of proteins, including cytokines, enzymes, G protein-coupled receptors (GPCRs), and ion channels. With this pipeline, Empress hopes to address unmet clinical needs in immune and inflammatory conditions, and metabolic, neurologic, oncologic, and pain disorders. The company expects to file multiple IND applications in these areas over the next couple of years. Empress benefits from a wealth of clinical data, and recent advances in genomics, artificial intelligence (AI) and synthetic biology. This allows the company’s platform to read genetic code and use biosynthetic instructions to find, make and ...
- Source: drugdu
- 121
- June 23, 2023
AbbVie Files Patent Infringement Lawsuit Against BeiGene’s Brukinsa

By Alejandra Manjarrez www.biospace.com Pictured: Judicial gavel and scales of justice/iStock AbbVie has filed a lawsuit accusing China-based BeiGene’s new blood cancer drug Brukinsa (zanubrutinib) of infringing on its patent for Imbruvica (ibrutinib). Imbruvica was co-developed by J&J’s Janssen and AbbVie’s Pharmacyclics and approved in 2014 by the FDA as a treatment for chronic lymphocytic leukemia. Brukinsa, which gained its FDA approval in January 2023, had its patent issued on Tuesday. Through its complaint, filed that same day in federal court in Delaware, AbbVie is seeking a declaratory judgment of infringement plus damages, Bloomberg Law reported. BeiGene’s shares in Hong Kong and mainland China have fallen more than 10% since the announcement. Both Brukinsa and Imbruvica are BTK inhibitors designed as oral medications to treat the slow-growing blood cancers chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). They are different forms of the same disease and account for about ...
- Source: drugdu
- 112
- June 17, 2023

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