Search Results for “Gilead Sciences” – Page 5 – media

Xilio fires 21% of its workforce and reprioritises pipeline

XIlio Therapeutics has implemented cost-cutting measures which include a 21% workforce reduction and the termination of investments for developing one of its assets, XTX202, as a monotherapy. Xilio expects to incur one-time cost of approximately $1m for reducing its workforce by 15 employees. The company has reported $44.7m in cash reserves, which are expected to fund the company’s activities into Q2 2025. The Waltham, Massachusetts-based company’s market cap currently stands at $42.1m. Following the recent round of layoffs, Xilio joins a list of pharmaceutical companies including Atreca, Candel Therapeutics, Kinnate Bio, and NexImmune that have fired workers to funnel more money into their clinical development pipelines in the last few months. The company plans to not investigate XTX202, a tumour-activated beta-gamma biased interleukin (IL)-2, as a monotherapy and instead will explore partnerships to develop the therapy as a combination treatment. The therapy was evaluated in an open label Phase I/II ...
- Source: drugdu
- 76
- April 5, 2024
Bristol Myers CEO outlines transition strategy featuring 11 key brands, more dealmaking

In his first earnings call as Bristol Myers Squibb’s CEO, Chris Boerner laid out his plan to quickly navigate the company through a period filled with patent cliffs and new government-mandated pricing pressure in the latter half of the decade. Bristol Myers will have a relatively stable business through 2025 as large legacy products, though declining, continue to generate sizable chunks of revenue. Still, the company’s focus will center on a growth portfolio that includes 11 key brands and about three dozen clinical candidates. Besides commercialization and R&D efforts, the company remains interested in dealmaking, Boerner said. “This, along with pipeline execution, can best position the company into the transition period,” the CEO told analysts Friday. Bristol Myers has “some clear strengths” compared with other companies that have successfully navigated similar periods of patent losses in the past, Boerner figures. The CEO touted the company’s “expanding growth portfolio across multiple ...
- Source: drugdu
- 85
- February 5, 2024
Daiichi Sankyo again dials up Enhertu sales forecast, advances 2nd AstraZeneca-partnered ADC

AstraZeneca-partnered Enhertu has become a bright spot in Daiichi Sankyo’s business, and the Japanese pharma has again increased its sales projection for the HER2-directed antibody-drug conjugate. But this time, the rosier outlook reflects developments outside the U.S. Daiichi now expects Enhertu sales to come in at 383.9 billion Japanese yen (about $2.6 billion) for the 12 months ending March 31. The number includes profits from regions where AstraZeneca books Enhertu sales. Daiichi had already once dialed up its Enhertu forecast for its current fiscal year. The drugmaker’s projection was originally 320 billion yen back in April 2023, then Daiichi raised it to 381.7 billion yen in October. Despite rolling out the higher global forecast, Daichii actually reduced Enhertu’s 12-month sales estimate in the U.S. by $30 million to $1.58 billion. For the first nine months of the company’s fiscal year, Enhertu generated $1.14 billion in the U.S., an increase of ...
- Source: drugdu
- 131
- February 2, 2024
FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply. By FRANK VINLUAN Post a comment / at 7:04 PM Stricter safety warnings are coming for the cancer treatments known as CAR T-therapies. The FDA is instructing makers of the six approved cell therapies in the class to revise their labels to state that these treatments for cancer come with the risk of causing new cancers. The labels of CAR T-therapies already come with black box warnings that alert physicians and patients of risks that include an excessive immune response and neurotoxicity. Letters sent to the drugmakers last Friday instruct them to add additional language to the boxed warning stating that T cell malignancies have occurred following the treatment of ...
- Source: drugdu
- 92
- January 25, 2024
CAR-T hype faces infrastructure reality check

Since the FDA approved the first CAR-T therapy back in August 2017, high prices, small patients pools and limited manufacturing capacity have at times hindered these cell-based treatments. As biopharma companies clear those hurdles, a larger, more systemic problem now threatens the drug class. Six CAR-T therapies targeting either CD19 or BCMA have reached the U.S. market to treat various blood cancers. Impressive efficacy data, wide reimbursement acceptance, earlier-line approvals and steady production expansions have fueled blockbuster revenue predictions. But drug developers and Wall Street may have underestimated the bottlenecks from the healthcare infrastructure needed to deliver a cell therapy, Leerink Partners analyst Daina Graybosch, Ph.D., warns. CAR-T therapies are indeed on a fast trajectory of growth. By 2027, when the drug class celebrates its first decennial anniversary, Johnson & Johnson expects its Legend Biotech-partnered Carvykti—the last of the six existing CAR-T products to hit the market—will have reached about ...
- Source: drugdu
- 302
- January 17, 2024
Big Pharma reworks China strategy, and job cuts are part of it

Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, ...
- Source: drugdu
- 195
- December 27, 2023
Elli Lilly Cancer Drug Lands Its Second FDA Approval This Year

Eli Lilly cancer drug Jaypirca is closing 2023 the same way it started—with an FDA approval. The latest regulatory nod adds two additional types of blood cancers to the list of indications for the therapy. Friday’s accelerated approval for Jaypirca covers the treatment of adults with either chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The once-daily oral drug is a small molecule designed to block Bruton’s tyrosine kinase, or BTK, a cancer-driving enzyme. While other drugs already do this, Lilly’s molecule has an edge. The FDA based its decision on the results of an open-label, single-arm Phase 1/2 study in blood cancers that included more than 100 patients with CLL or SLL previously treated with at least two prior lines of therapy. Participants had received a median of five prior lines of therapy; the FDA said 77% of these patients had discontinued a BTK inhibitor after their cancer ...
- Source: drugdu
- 112
- December 6, 2023
FDA opens investigation into secondary cancer risk with CAR-T therapies

The US Food and Drug Administration (FDA) has started an investigation to review the safety of chimeric antigen receptor (CAR)-T cell immunotherapies following reports of T cell malignancies in patients who received these immunotherapies. The therapies under investigation include six approved B cell maturation antigen (BCMA)- or CD19-directed CAR-T cell therapies. The investigation follows reports collected from clinical trials and post-marketing adverse event surveillance. The FDA had required companies to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies as part of the respective therapy’s approval. The risk of post-therapy malignancies applies to all FDA-approved BCMA- or CD19-directed CAR-T cell therapies, as per a 28 November press release. The agency added that although the therapy benefits “continue to outweigh their potential risks for their approved uses”, the FDA is evaluating the need for regulatory action regarding the risk of T-cell ...
- Source: drugdu
- 97
- December 1, 2023
FDA investigates ‘serious risk’ of secondary cancer following CAR-T treatment

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. The FDA unveiled the probe Tuesday. The agency said it has received reports of T-cell malignancies, including CAR-positive lymphoma, among patients who received BCMA- or CD19-directed CAR-T cell immunotherapies. Some patients involved have had to be hospitalized or died, according to the agency. The cases stem from clinical trials and postmarketing adverse event surveillance, the FDA said. The FDA has determined that the potential risk is applicable to all currently approved CAR-T therapies, as T-cell malignancies have occurred after patients received several different products. The FDA is now weighing potential regulatory action—even as the potential risk of developing secondary cancer is already included as a class warning on the labels of the CAR-T therapies. Currently marketed CD19 CAR-Ts include Yescarta and Tecartus from Gilead ...
- Source: drugdu
- 228
- November 30, 2023
Biogen lays off staffers at newly acquired Reata, with 113 set to lose positions

Biogen just closed its Reata Pharmaceuticals buyout in September. Now, 100-plus Reata staffers are losing their jobs because their roles were already covered at the Massachusetts Big Biotech. That didn’t take long.Just two weeks after Biogen completed its buyout of Reata Pharmaceuticals, the combined company is trimming its staff. In a recent Worker Adjustment and Retraining Notification (WARN) notice sent to state officials in Texas, Reata said it’s cutting 113 positions. The layoffs will take effect late next month. Reata employed 321 people at the start of the year, an annual Securities and Exchange Commission filing (PDF) shows, so the layoffs are set to affect about a third of the acquired company’s staff. Biogen inked its Reata buyout in July, picking up the potential blockbuster Skyclarys, which is approved by the FDA to treat the rare, inherited neurological disorder Friedreich ataxia. The companies completed the deal in September. At the ...
- Source: drugdu
- 150
- October 13, 2023

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