Do not start ZEJULA until patients have recovered from haematological toxicity caused by prior chemotherapy (≤ Grade 1). That round — which also added deep-pocket player ARCH to the list of backers — came up with $77 million for the next step in the long journey toward the clinic, a nice add to the A round that launched the company. Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically thereafter. The trial incorporated an individualized niraparib starting dose of 200 mg once-daily in patients with baseline weight <77kg or platelet count <150K/μL and 300 mg in all other patients. Unlock this story instantly and join 91,500+ biopharma pros reading Endpoints daily — and it's free. It is also approved in Europe. Trade marks are owned by or licensed to the GSK group of companies.GlaxoSmithKline plc. Explore innovations in medicines, vaccines and consumer healthcare from inside and outside our labs, Archived Our consumer healthcare products, Warning against fraudulent internet recruitment activities. © 2001-2020 GlaxoSmithKline plc. As with their PARP inhibitor Zejula, dostarlimab would enter a crowded market — what has become, in fact, one of the most crowded markets in oncology, with six different PD-1/L1 therapies on the market and a clear giant in the field in Merck’s Keytruda. Jacob, Tanzania Communication and Development Centre, The race against malaria: handing the baton to the next generation, Giving mothers and babies a healthier start, Work experience, placements and internships, GSK actions to support the global response to COVID-19, COVID-19 prompts increased focus on self-care, GSK Study Register and patient level data, “Pull” the Science: 2020 Antimicrobial Resistance Benchmark. That broke down into 13% complete response rate and a 30% partial response rate. Hal Barron, head of R&D at GSK, indicated the company hopes the drug will show benefit in ovarian cancer patients beyond the BRCA mutation. The ongoing development program for niraparib includes the Phase 3 PRIMA trial, a Phase 3 trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial), and a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial). The duration of ZEJULA treatment in patients prior to developing MDS/AML varied from <1 month to 2 years. Registered in England and Wales No. The study met its primary endpoint of a statistically significant improvement in progression free survival for women regardless of their biomarker status. The lawsuit hopes to stop the merger from going forward, or if it does go through, to rescind it and award damages to shareholders. Information and tools for investors including share and dividend information, share price analysis, latest news and corporate reporting, Discover our latest financial performance announcement and search for historical quarterly results materials, Explore the latest news, different ways to stay in touch and available useful resources, Keep up to date with our news and recent announcements. Niraparib demonstrates significant improvement in progression free survival for women regardless of their biomarker status. Tuesday morning they found out, and it wasn’t pretty. By Mark Terry. Chief among them: a PD-1 inhibitor called dostarlimab. Johnson & Johnson has voluntarily ordered a halt to all of its Covid-19 vaccine studies so investigators can probe the unexplained illness of one of the people in their study. Grade ≥3 thrombocytopenia, anaemia and neutropenia were reported in 29%, 25%, and 20% of patients receiving ZEJULA, respectively. For further information please visit www.gsk.com/about-us/. And it was all a lie, according to US attorney William Hyslop, who runs the Eastern District of Washington. Responsible business is how we do business. “Also misleading and lacking key data to make informed conclusions, according to the suit, are Citi’s selected public companies analysis, its selected precedent transactions analysis and its discounted cash flow analysis, Scarantino said in the complaint.”. TESARO, an oncology-focused business within GSK, devoted to providing transformative therapies to people facing cancer. The $75 per share acquisition price represented a 110 percent premium to Tesaro’s 30-day Volume Weighted Average Price of $35.67. Common lab abnormalities (Grades 1-4) in ≥25% of patients included: decrease in haemoglobin (85%), decrease in platelet count (72%), decrease in white blood cell count (66%), decrease in absolute neutrophil count (53%), increase in AST (36%) and increase in ALT (28%). Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. For more information, visit www.tesarobio.com, and follow us on Twitter and LinkedIn. A dark horse asset from GlaxoSmithKline’s $5.1 billion buyout of Tesaro is out with its first batch of data in over a year — promising data that could line up the British drugmaker for the 7th FDA approved PD-1 drug, although it’s not clear when. (Business Wire), by Arsalan Arif — skimmable links and news at 7:15a ET, GSK flashes positive data for Tesaro drug that could become 7th approved PD-(L)1, UPDATED: Another safety incident triggers a halt to a pivotal Covid-19 vaccine study as J&J slams on the brakes. Today they’re back with another set that, while not overwhelming, helps confirm some of the promise of the initial round. Grade 3-4 hypertension occurred in 9% of patients receiving ZEJULA vs 2% of patients receiving placebo in Trial 1, with discontinuation occurring in <1% of patients. GlaxoSmithKline plc (LSE/NYSE: GSK) and TESARO Inc (NASDAQ: TSRO) today announced that the Companies have entered into a definitive agreement pursuant to which GSK will acquire TESARO… About GSK . Images can be downloaded in low and high resolution. But it was all a lie — and now he's been sentenced to 28 years, News briefing: Novo eyes the next kinases in a Finnish startup; Boehringer Ingelheim brings a bispecific to the clinic. Choose your path. Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three pivotal trials. Tesaro’s Zejula is an oral, once-daily PARP inhibitor approved by the U.S. Food and Drug Administration (FDA) for maintenance treatment for ovarian cancer in 2017. If haematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a haematologist for further investigations. Myelodysplastic Syndrome/Acute Myeloid Leukaemia (MDS/AML), including some fatal cases, was reported in 1.4% of patients receiving ZEJULA vs 1.1% of patients receiving placebo in Trial 1 (NOVA), and 0.9% of patients treated with ZEJULA in all clinical studies. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Tesaro shares soared nearly 59 per cent to $73.50 in New York on the news, close to the $75 a share offer from GSK. Four others are also underway and still enrolling for patients with different types of the endometrial cancer, which GSK cites as the most common gynaecologic malignancy. Ever since a key DP2 drug at Novartis called fevipiprant failed a pivotal lineup of clinical studies by the end of last year, a number of analysts have been sitting back waiting to see how the same kind of drug would fare at Gossamer. Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. In December, GSK chief executive officer Emma Walmsley stated, “The acquisition of Tesaro will strengthen our pharmaceuticals business by accelerating the build of our oncology pipeline and commercial footprint, along with providing access to new scientific capabilities. In one of two large studies for the drug, known chemically as cefiderocol and commercially as Fetroja, more patients died in the treatment arm than the control arm. “But we’ve forgotten that phosphotases are also important.”, Bioscience & Technology Business CenterThe University of KansasLawrence, Kansas. Last October, the FDA OK’d a semi-controversial new antibiotic from Shionogi. Advise females of reproductive potential of the potential risk to a foetus and to use effective contraception during treatment and for 6 months after receiving their final dose. For more information, visit www.tesarobio.com, and follow us on Twitter and LinkedIn. The complaint states in part: “The disclosure of projected financial information is material because it provides stockholders with a basis to project the future financial performance of a company and allows stockholders to better understand the financial analyses performed by the company’s financial advisor in support of its fairness opinion.”. Premium subscription required. John Carroll Editor & Founder. The government is probing Vaxart’s participation in a study funded by Operation Warp Speed and the company’s disclosure of the news, as well as grants, warrant transactions, and other financing matters beginning in March 2020, according to the filing.
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