Latest news with #Bristol-MyersSquibb
Time of India
4 days ago
- Health
- Time of India
US FDA eliminates risk evaluation, mitigation strategies for CAR-T cancer therapies
Bengaluru: The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a safety program to protect patients from risky drugs, for currently approved CAR-T cell immunotherapies. REMS is required by the FDA to ensure a drug's benefits outweigh its risks by managing serious safety concerns. The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed warnings for cytokine release syndrome and neurological toxicities, and medication guides. The cancer therapies include Bristol-Myers Squibb's Breyanzi and its partnered therapy Abecma with 2seventy bio , Johnson & Johnson's unit Janssen and Legend Biotech's Carvykti, Novartis AG's Kymriah, and Gilead Sciences' unit Kite's Tecartus and Yescarta. Bristol-Myers Squibb and Gilead Sciences did not immediately respond to Reuters' requests for comment. These are gene therapies that are currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma, the health regulator said. CAR-T treatment generally involves extracting disease-fighting white blood cells known as T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body. In January 2024, the FDA asked several drugmakers to add a serious warning on the label of their cancer therapies that use CAR-T technology after reports of T-cell malignancies and adverse events identified since approval. The FDA earlier said the risk of T-cell malignancies including leukemia and lymphoma applies to all therapies in the class and can lead to hospitalization and death.
Yahoo
17-06-2025
- Business
- Yahoo
Wall Street Can't Ignore This: China's Biotech Stocks Are Exploding--One Is Up 283%
China's biotech sector is on a tear. The Hang Seng Biotech Index has climbed over 60% since Januaryhandily beating China tech's AI-fueled rallythanks to a wave of billion-dollar licensing deals and red-hot IPOs. Pfizer said last month it will pay up to $1.25 billion to license an experimental cancer drug from 3SBio (TRSBF) and invest another $100 million in the firm's stock. Just weeks later, Bristol-Myers Squibb inked a deal worth up to $11.5 billion for a cancer therapy originally licensed by Germany's BioNTech from China's Biotheus. Those two deals alone have ignited a frenzy. 3SBio shares have soared 283% year-to-date. RemeGen, another licensing contender, is up 270% as of June. Investors aren't just chasing dealsthey're also buying into the IPO pipeline. Duality Biotherapeutics, which focuses on cancer immunotherapies, more than doubled on its first day of trading in April and has since gained 189%. Jiangsu Hengrui, China's biggest drugmaker by market value, surged 25% on debut in May. Even more striking? The pace of dealmaking. M&A involving Chinese biotech firms hit $36.9 billion in Q1more than half of global totals. Chinese biotech is having its own DeepSeek moment, said Dong Chen, chief Asia strategist at Pictet Wealth Management, referencing the AI boom that fueled Chinese tech earlier this year. Still, not everyone's chasing the highs. Some healthcare-focused funds are rotating out, preferring stable compounders with steady dividends. Others see the recent mega-deals as one-offs, and aren't ready to assign premium multiples just yet. But even with macro headwinds, analysts like those at Jefferies remain optimistic. Many Chinese biotech firms already operate as partners to U.S. drugmakers, not exportersmeaning tariffs may have limited impact. And with top scientific talent returning home amid geopolitical tensions, R&D momentum could accelerate. In short: China's biotech surge might still be in the early innings. This article first appeared on GuruFocus.
Yahoo
17-06-2025
- Business
- Yahoo
Wall Street Can't Ignore This: China's Biotech Stocks Are Exploding--One Is Up 283%
China's biotech sector is on a tear. The Hang Seng Biotech Index has climbed over 60% since Januaryhandily beating China tech's AI-fueled rallythanks to a wave of billion-dollar licensing deals and red-hot IPOs. Pfizer said last month it will pay up to $1.25 billion to license an experimental cancer drug from 3SBio (TRSBF) and invest another $100 million in the firm's stock. Just weeks later, Bristol-Myers Squibb inked a deal worth up to $11.5 billion for a cancer therapy originally licensed by Germany's BioNTech from China's Biotheus. Those two deals alone have ignited a frenzy. 3SBio shares have soared 283% year-to-date. RemeGen, another licensing contender, is up 270% as of June. Investors aren't just chasing dealsthey're also buying into the IPO pipeline. Duality Biotherapeutics, which focuses on cancer immunotherapies, more than doubled on its first day of trading in April and has since gained 189%. Jiangsu Hengrui, China's biggest drugmaker by market value, surged 25% on debut in May. Even more striking? The pace of dealmaking. M&A involving Chinese biotech firms hit $36.9 billion in Q1more than half of global totals. Chinese biotech is having its own DeepSeek moment, said Dong Chen, chief Asia strategist at Pictet Wealth Management, referencing the AI boom that fueled Chinese tech earlier this year. Still, not everyone's chasing the highs. Some healthcare-focused funds are rotating out, preferring stable compounders with steady dividends. Others see the recent mega-deals as one-offs, and aren't ready to assign premium multiples just yet. But even with macro headwinds, analysts like those at Jefferies remain optimistic. Many Chinese biotech firms already operate as partners to U.S. drugmakers, not exportersmeaning tariffs may have limited impact. And with top scientific talent returning home amid geopolitical tensions, R&D momentum could accelerate. In short: China's biotech surge might still be in the early innings. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-06-2025
- Business
- Yahoo
Cancer Moonshot: Bristol-Myers Just Dropped $11 Billion on a Single BioNTech Drug
Bristol-Myers Squibb (NYSE:BMY) is doubling down on its oncology ambitions with a deal that could reach $11.1 billion, partnering with BioNTech (NASDAQ:BNTX) to co-develop a next-generation cancer therapy known as BNT327. The German biotech will receive $1.5 billion upfront, $2 billion in staggered payments through 2028, and stands to gain another $7.6 billion if clinical and commercial milestones are met. Both companies will share development costs and future profits. The deal reflects growing urgency among pharma giants to replenish their pipelines, as legacy blockbusters face generic competition. Bloomberg Intelligence estimates this class of immunotherapy drugs could generate $60 billion annually by 2027. BNT327's backstory adds intrigue. BioNTech originally licensed the compound from Chinese biotech Biotheus in 2023 before acquiring the company outright for up to $950 million. It's now positioning the therapy as a core asset in its oncology portfolio. While early trial data suggests Pfizer's competing drug may show stronger efficacy, BioNTech is further along in developing broader cancer indications. The approach behind these drugs is evolving fastmerging immunotherapy with anti-angiogenesis mechanisms to cut off tumors' blood and oxygen supply. This model gained traction after Akeso and Summit Therapeutics' combination therapy showed promising results against Merck's Keytruda in a major Chinese trial. Still, the bar remains high. These new therapies haven't yet demonstrated a consistent survival advantage over standard treatments, and head-to-head data outside China could take years. For BioNTech, though, this deal marks a decisive return to its original focuscancerafter riding a pandemic-era wave with its COVID-19 vaccine. Bristol-Myers also gains optionality: the ability to pair BNT327 with other in-house experimental compounds. With both firms now locked into a shared bet on combo therapies, this could be a pivotal move in a rapidly shifting oncology landscape. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
02-06-2025
- Business
- Yahoo
Cancer Moonshot: Bristol-Myers Just Dropped $11 Billion on a Single BioNTech Drug
Bristol-Myers Squibb (NYSE:BMY) is doubling down on its oncology ambitions with a deal that could reach $11.1 billion, partnering with BioNTech (NASDAQ:BNTX) to co-develop a next-generation cancer therapy known as BNT327. The German biotech will receive $1.5 billion upfront, $2 billion in staggered payments through 2028, and stands to gain another $7.6 billion if clinical and commercial milestones are met. Both companies will share development costs and future profits. The deal reflects growing urgency among pharma giants to replenish their pipelines, as legacy blockbusters face generic competition. Bloomberg Intelligence estimates this class of immunotherapy drugs could generate $60 billion annually by 2027. BNT327's backstory adds intrigue. BioNTech originally licensed the compound from Chinese biotech Biotheus in 2023 before acquiring the company outright for up to $950 million. It's now positioning the therapy as a core asset in its oncology portfolio. While early trial data suggests Pfizer's competing drug may show stronger efficacy, BioNTech is further along in developing broader cancer indications. The approach behind these drugs is evolving fastmerging immunotherapy with anti-angiogenesis mechanisms to cut off tumors' blood and oxygen supply. This model gained traction after Akeso and Summit Therapeutics' combination therapy showed promising results against Merck's Keytruda in a major Chinese trial. Still, the bar remains high. These new therapies haven't yet demonstrated a consistent survival advantage over standard treatments, and head-to-head data outside China could take years. For BioNTech, though, this deal marks a decisive return to its original focuscancerafter riding a pandemic-era wave with its COVID-19 vaccine. Bristol-Myers also gains optionality: the ability to pair BNT327 with other in-house experimental compounds. With both firms now locked into a shared bet on combo therapies, this could be a pivotal move in a rapidly shifting oncology landscape. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
