Search Results for “Janssen” – Page 7 – media

Gilead, Teva reach 11th-hour settlements with some groups in HIV antitrust case

Right before opening arguments were set to begin in Gilead Sciences and Teva’s HIV antitrust trial, the two came to a last-minute settlement with some of the plaintiff groups. Both companies settled with the pharmacy plaintiffs, a group that includes CVS Pharmacy, Rite Aid and Walgreens, while Gilead made a deal with the direct purchasers. Now, indirect purchasers and others involved in the suit can take their claims to a California federal jury. Gilead and Teva confirmed the settlements, and Gilead noted that the lawsuit with the other parties is ongoing. “The claims against Gilead in this lawsuit lack merit, do not accurately reflect antitrust laws, and ignore Gilead’s history of innovation and scientific advancements to help address the pressing challenges of the HIV epidemic,” a Gilead spokesperson said over email. The deals mark an eleventh hour end to a sprawling case that dates back to 2019, when plaintiffs including ...
- Source: drugdu
- 113
- May 31, 2023
Johnson & Johnson’s PARP combo nabs first global nod but faces tough fight against AZ, Merck’s Lynparza

Johnson & Johnson’s idea to carve out the prostate cancer indication from GSK’s PARP inhibitor Zejula has yielded its first global approval. Following a recommendation from the European Medicines Agency, the European Commission has officially approved J&J’s Akeega in metastatic castration-resistant prostate cancer (mCRPC), J&J said Friday. The drug is a fixed-dose combo of Zejula and J&J’s androgen-directed Zytiga, and it’s used alongside a corticosteroid. Under a 2016 deal with Zejula’s developer Tesaro, J&J specifically carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. Not all patients can get Akeega under the drug’s European label. To be eligible, a patient’s tumor must test positive for BRCA1/2 mutations, which account for 10% to 15% of all cases, J&J said. Akeega’s label in Europe is narrower than that of rival PARP inhibitor Lynparza from AstraZeneca and Merck. The European Commission in December cleared Lynparza and Zytiga for mCRPC ...
- Source: drugdu
- 127
- May 3, 2023
Pre- and post-surgical immunotherapy-based treatment significantly improved lung cancer outcomes

Reviewed by Emily Henderson, B.Sc.Apr 17 2023 A regimen of pre-surgical immunotherapy and chemotherapy followed by post-surgical immunotherapy significantly improved event-free survival (EFS) and pathologic complete response (pCR) rates compared to chemotherapy alone for patients with operable non-small cell lung cancer (NSCLC), according to Phase III trial results presented today by researchers from The University of Texas MD Anderson Cancer Center at the American Association for Cancer Research (AACR) Annual Meeting 2023. The AEGEAN trial evaluated durvalumab given perioperatively, meaning therapy is given both before and after surgery. Participants on the trial received either pre-surgical (neoadjuvant) durvalumab and platinum-based chemotherapy followed by post-surgical (adjuvant) durvalumab or neoadjuvant placebo and chemotherapy followed by adjuvant placebo. These represent the first data presented on the benefits of perioperative immunotherapy for resectable NSCLC and adds to the growing evidence supporting the benefits of both neoadjuvant and adjuvant immunotherapy for these patients. Our goal is to increase cures for lung cancer. ...
- Source: drugdu
- 124
- April 18, 2023
NICE green lights Tremfya to treat active psoriatic arthritis

Janssen’s IL-23 inhibitor Tremfya has been accepted for NHS use by the UK’s National Institute for Health and Care Excellence (NICE) for the treatment of active psoriatic arthritis (PsA). Tremfya (guselkumab) is a fully human monoclonal antibody (mAb) designed to selectively bind to and inhibit the IL-23 receptor – an key driver of progression in inflammatory diseases such as PsA. NICE’s final appraisal document (FAD) recommends Tremfya to treat moderate-to-severe PsA in adults who have responded inadequately to disease-modifying antirheumatic drug (DMARD) therapy or who cannot tolerate them. The positive recommendation is supported by results from the Phase III DISCOVER-1 and DISCOVER-2 clinical trials, which evaluated the safety and efficacy of Tremfya in adults with active PsA. Across both studies, Janssen’s drug demonstrated a favourable risk-benefit profile, showing statistically significant benefits compared to placebo on disease activity, joint and skin symptoms, functional capacity and health-related quality of life. “[Tremfya] is ...
- Source: drugdu
- 265
- May 31, 2021
Janssen
Calquence tops Imbruvica in chronic lymphocytic leukaemia study

AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) hit the primary endpoint in a Phase III study in chronic lymphocytic leukaemia (CLL). In the ELEVATE-RR trial, Calquence demonstrated non-inferior progression-free survival (PFS) compared to Janssen’s BTK inhibitor Imbruvica (ibrutinib) in adult patients with previously-treated, high risk CLL – the primary endpoint of the study. AZ’s drug also met a key secondary endpoint for safety, with Calquence-treated patients demonstrating a statistically significant lower incidence of atrial fibrillation compared to patients treated with Imbruvica. In a statement, AZ added that there was also a ‘descriptive’ trend for numerically favourable overall survival for Calquence. “With over forty months of follow-up, today’s results confirm that Calquence, a selective BTK inhibitor, displays superior safety in atrial fibrillation without compromising efficacy,” said José Baselga, executive vice president, Oncology R&D at AZ/ “The totality of the data confirm our confidence in the favourable benefit-risk profile of Calquence,” ...
- Source: drugdu
- 246
- January 26, 2021
Calquence
mHealth Wearable Effective in Detecting AFib, STSI Study Finds

iBeat, a San Francisco-based start-up, launched a new pulse sensitive feature called iBeat Heart Watch which alerts healthcare professionals if it detects someone going into cardiac arrest.
- Source: MobiHealthNews
- 783
- July 13, 2018
atrial fibrillation Company Insight mHealth
FDA Seeks Help From Social Media Giants To Help Stop Illegal Opioid Distribution

Scott Gottlieb, FDA Commissioner is looking for help from Facebook and Twitter to slow down the unauthorized opioid sales in the US. Gottlieb invited the two social media giants, among others, to participate in the FDA Online Opioid Summit which is set for June 27.
- Source: Fierce Pharma
- 575
- June 11, 2018
Company Insight digital health FDA opioid
AbbVie pressurized to keep low price for Imbruvica formula

This year AbbVie launched Imbruvica, a single tablet for blood cancer treatment. It has been designed as a convenient therapy measure for patients who used the old tablets as often as four times a day. Adapting the new single tablet in their treatment regimens will prove to be an expensive proposition for some patients as the new tablet comes with a price tag of $400 each, triple the cost of the older tablets.
- Source: Ddu
- 1,112
- May 17, 2018
AbbVie Company Insight pharma pharmaceutical
Johnson & Johnson’s Darzalex snags landmark myeloma approval in first-line patients

EHR vendor Allscripts has made an agreement to purchase patient communication app maker Health Grid for $60 million in cash, with an additional $50 million in earnout payments based on Health Grid achieving certain revenue targets over the next three years, according to a recently registered SEC filing. The merger of the two companies is expected to close sometime during Q2 2018.
- Source: fiercepharma
- 577
- May 10, 2018
Darzalex Johnson & Johnson myeloma
GSK reports Q1 sales decline

GlaxoSmithKline has booked a 2 percent dip in revenues for the first quarter to £7.2 billion, after results were hit by a “significant currency impact” and lower sales of prescription drugs. Profit after tax fell 38 percent to £759 million, while earnings per share dropped to 11.2p from 21.4p a year ago.
- Source: pharmatimes
- 495
- April 28, 2018
Company Insights GSK

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