Search Results for “Johnson ” – Page 25 – 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
Bristol Myers’ $4B plan for Reblozyl takes shape in blood cancer anemia—with one caveat

Bristol Myers Squibb’s Reblozyl could be an effective initial treatment for anemia patients who are suffering from a group of blood cancers called myelodysplastic syndromes (MDS) and are at a relatively lower risk of progression. That’s the conclusion reached by Olatoyosi Odenike, M.D., from the University of Chicago Medical Center, after she reviewed data from the phase 3 COMMANDS trial that are slated to be presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. Odenike is an invited ASCO expert and an opinion leader in the MDS field. The COMMANDS trial is the first study in decades that has shown a benefit for a new agent against erythropoiesis-stimulating agents (ESAs) in low- to intermediate-risk MDS, Noah Berkowitz, M.D., Ph.D., senior vice president of hematology development at BMS, said in an interview with Fierce Pharma. If the FDA eventually agrees with Odenike’s finding, Reblozyl could move from behind ...
- Source: drugdu
- 260
- May 29, 2023
BMS pitches Breyanzi as the first CAR-T for CLL. But will a single-arm trial persuade the FDA?

CAR-T therapies have been around for six years, but it was only in January that Bristol Myers Squibb unveiled the first positive readout for such a personalized immunotherapy in chronic lymphocytic leukemia (CLL), the most common form of leukemia, from a pivotal multicenter study. In new data released Thursday, Bristol Myers Squibb said that Breyanzi eradicated signs of cancer in 18.4% of patients with heavily pretreated CLL or small lymphocytic lymphoma (SLL). The phase 1/2 trial coded TRANSCEND CLL 004 has therefore met its primary endpoint. Among those who achieved a complete response, the median duration of response wasn’t reached after a median follow-up of 21.1 months. No patients in that group experienced disease progression or deaths by the data cutoff. The results will be presented during the 2023 American Society of Clinical Oncology annual meeting on June 6. Bristol released the findings ahead of the meeting Thursday. Breyanzi’s complete response data “are remarkable and ...
- Source: drugdu
- 151
- May 27, 2023
Amgen, J&J ink patent settlement

After the recent high-profile loss of exclusivity for AbbVie’s megablockbuster immunology drug Humira, industry watchers’ eyes moved to Johnson & Johnson’s Stelara as one of the next major drugs expected to face biosim competition. Tuesday, the industry got more information about when exactly that biosimilar clash might occur. In J&J’s patent case over Amgen’s proposed biosimilar to J&J’s Stelara, the companies have settled, according to a Tuesday filing in Delaware federal court. An Amgen spokesperson told Reuters the deal will allow the company to launch its Stelara biosimilar “no later than January 1st, 2025.” With that, the market exclusivity clock is ticking on J&J’s biggest drug by sales. Last year, the medicine pulled down $9.72 billion across its range of indications, including plaque psoriasis, psoriatic arthritis and Crohn’s disease. Amgen has yet to win FDA approval for its proposed biosimilar. The company filed its biosim application last November, so the ...
- Source: drugdu
- 106
- May 25, 2023
Despite rough quarter, Bayer’s duo of Nubeqa and Kerendia continue to excel

As Bayer presented its first-quarter earnings, much of the focus centered on the company’s struggling agricultural sector, which has been hindered by the poor performance of its glyphosate-based weedkillers. Somewhat under the radar is Bayer’s pharma business, which could use a boost as well. On the company’s list of best-selling medicines, seven of the top 10 posted a sales decline from the first quarter of last year. That list doesn’t include the aging eye treatment Eylea, which was up 2% on the quarter. Still, the drug posted a sequential (PDF) sales decline of 4% from the fourth quarter of last year. It all adds up to lots of pressure to perform for Bayer’s most promising new treatments—prostate cancer drug Nubeqa and kidney disease therapy Kerendia. Bayer’s small dose of good news on Thursday is that both are progressing nicely. The company has projected the drugs will generate 3 billion euros ($3.2 billion) each at peak. During the ...
- Source: https://www.fiercepharma.com/pharma/rough-quarter-bayers-duo-nubeqa-kerendia-continue-excel
- 124
- May 14, 2023
Janssen signs $245m deal with Cellular Biomedicine for pair of CAR T-cell therapies

Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has entered into a worldwide collaboration and licensing agreement with Cellular Biomedicine Group (CBMG) for a pair of CAR T-cell therapy candidates. Under the terms of the agreement, Janssen will pay CBMG an upfront fee of $245m, with the Chinese biotech also eligible for certain milestone payments, as well as tiered royalties. In exchange, CBMG will grant Janssen a worldwide licence to develop and commercialise the CAR-T assets, except in Greater China, with the companies set to negotiate an option for the pharma to commercialise the products in the China territory. The investigational CAR-Ts have shown promising early-stage results in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL), the companies said, with the majority of patients in the studies having diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of aggressive lymphoma, accounting for approximately one-third of ...
- Source: drugdu
- 152
- May 6, 2023
Acelyrin follows Kenvue with largest IPO for a biotech startup since 2021

Acelyrin has raised $540 million in an initial public offering, the largest for a biotechnology startup since early 2021 and one of only a handful by young drugmakers this year. The company said Thursday it sold 30 million shares at $18 apiece, exceeding the projections it set earlier this week. It will start trading Friday on the Nasdaq under the ticker symbol “SLRN.” The pace of biotech IPOs has slowed considerably since 2021, when a record 104 startups flooded Wall Street, according to data compiled by BioPharma Dive. The following year, the number of new stock offerings fell by about 80%. Until this week, only five companies had priced a new offering in 2023, the sector’s slowest start in at least five years. The value of those offerings has also trended downwards. Prior to Acelyrin’s offering, nine of the last 15 biotech startups that went public raised $15 million or ...
- Source: drugdu
- 119
- May 6, 2023
Merck results beat expectations despite a big drop in sales of Covid antiviral treatment

Merck on Thursday reported first-quarter revenue and adjusted earnings that topped Wall Street’s expectations, despite a steep drop in sales of its Covid antiviral treatment molnupiravir. Sales of molnupiravir plunged to $392 million during the period, down 88% from the $3.2 billion reported for the first quarter of 2022. Merck said the decrease is primarily the result of lower sales in the U.S., U.K., Japan and Australia. The company reported total revenue of $14.5 billion for the quarter, down 9% from a year earlier. But excluding the Covid drug, Merck said its revenue grew 11%. Here’s what Merck reported compared with Wall Street’s expectations, based on a survey of analysts by Refinitiv: Earnings per share: $1.40 adjusted, vs. $1.32 expected Revenue: $14.49 billion, vs. $13.78 billion expected Merck’s stock closed more than 1% higher Thursday. The shares are up more than 3% for ...
- Source: drugdu
- 126
- May 1, 2023
Biogen’s new strategy brings more pipeline cuts, but leaves deal options open

Biogen has stopped or paused several drug programs as part of a larger effort to cut costs and prioritize certain research. The decision, disclosed Tuesday in the company’s latest earnings report, comes as sales of its marketed medicines for brain and nervous system disorders continue to fall. Biogen recorded $2.46 billion in total revenue between January and March, a 3% decline from the same period a year prior. Revenue was down across most business segments, with the company’s flagship multiple sclerosis franchise taking the biggest hit, decreasing by 19%. Christopher Viehbacher, the former chief executive at Sanofi and the recently minted CEO of Biogen, is now trying to reshape a research and development organization that, for many years, revolved around high-risk, high-reward neuroscience programs. ““Having a few of those projects in our pipeline is good,” he said in February, “having 100% … is challenging.” On Tuesday, Biogen ...
- Source: drugdu
- 182
- April 27, 2023
Drugmakers take sides in Amgen, Regeneron fight over antibody patents

Christopher Newman Editor “This is a showdown about whether the most valuable patents in the entirety of the patent system are valid,” one law expert said. The nearly decade-long patent feud between Amgen and rivals Sanofi and Regeneron has divided the biopharmaceutical industry, with drugmakers taking different sides in a U.S. Supreme Court case that could have far-reaching effects. At issue are patents for powerful cholesterol-lowering medicines known as PCSK9 inhibitors. Regeneron and Sanofi brought the first, Praluent, to market in 2015. Amgen followed one month later with a similar medicine, called Repatha. The drugs work by boosting liver cells’ ability to hoover up LDL, or “bad,” cholesterol. Amgen has long claimed Sanofi and Regeneron infringed on patents it secured for Praluent. The fight has slowly winded its way through the U.S. legal system to reach the Supreme Court. There, judges could disrupt the $160 billion-per-year market for antibodies by deciding how broadly ...
- Source: drugdu
- 171
- April 25, 2023

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