Bristol Myers Squibb drug Augtyro now has a tumor-agnostic approval permitting the drug to be used to treat all solid tumors positive for NTRK gene fusions. Augtyro came from BMS’s $4.1 billion acquisition of Turning Point Therapeutics.

The post New FDA Nod Brings Bristol Myers Squibb Cancer Drug to a Wider Range of Solid Tumors appeared first on MedCity News.

The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products.

The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

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.

The post FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies appeared first on MedCity News.

By acquiring RayzeBio, Bristol Myers Squibb gains a pipeline of radiopharmaceuticals and the infrastructure for manufacturing these targeted cancer therapies. In the second half of 2023 alone, BMS has committed about $24 billion to business development deals.

The post Bristol Myers Squibb Makes Another M&A Move, Striking $4B Deal for RayzeBio appeared first on MedCity News.

Bristol Myers Squibb is expanding its scope in cancer by acquiring rights to a Phase 1-ready Orum Therapeutics program that brings a new twist to antibody drug conjugates. The deal is the latest business development move in the hot field of ADCs.

The post BMS Pays $100M for Next-Gen Orum Therapeutics ADC for Blood Cancers appeared first on MedCity News.

Acquiring Mirati Therapeutics brings Bristol Myers Squibb Krazati, one of two FDA-approved therapies addressing a KRAS cancer mutation. The deal comes as BMS looks to add revenue-generating products as patent expirations loom for several of its cancer products.

The post Bristol Myers Squibb Bolsters Its Cancer Presence With $4.8B Mirati Acquisition appeared first on MedCity News.

Bristol Myers Squibb drug Reblozyl is now approved as a first-line therapy for anemia caused by myelodysplastic syndromes, a group of blood cancers. It’s the third indication for the drug, which analysts project could top $4 billion in peak sales.

The post BMS Cancer Drug’s New FDA Nod Puts It on Path to Reach Blockbuster Status appeared first on MedCity News.

Lawsuits filed in opposition to the White House’s drug pricing negotiation program are beginning to mount, but legal experts agree that the plaintiffs’ arguments probably won’t hold up during a court battle. However, these lawsuits still could delay when the government’s ability to negotiate price goes into effect.

The post Lawsuits Against Medicare Drug Negotiations Are Mounting, But They Probably Won’t Be Able to Stop The Plan appeared first on MedCity News.

Multiple efforts are underway to improve cell therapies for cancer. During the MedCity News INVEST conference in Chicago, a panel discussed the future of cell therapies and what the industry doing to manage the financial risks of these new treatments.

The post Where Cell Therapies Are Going Next, and How Insurers Are Getting Ready appeared first on MedCity News.

Cell therapy offers a treatment option for some advanced blood cancers, but the manufacturing process is lengthy and complex. The biopharmaceutical industry is working on various technologies that could make manufacturing faster and more efficient, or perhaps supplant the current process altogether.

The post As Cell Therapy Gains Ground, Efforts Emerge to Improve CAR T-Manufacturing appeared first on MedCity News.

Bristol Myers Squibb’s drug R&D includes targeted protein degradation, an approach that can require proteins that don’t normally interact to find a way to stick together. BMS is turning to startup A-Alpha Bio to discover “molecular glues” that can accomplish the task.

The post BMS protein degradation drug research turns to a startup to find molecular glues appeared first on MedCity News.

Bristol Myers Squibb has data showing that its multiple myeloma treatment Abecma beat the standard of care, preliminary Phase 3 results that could support moving the FDA-approved CAR T-cell therapy into an earlier line of treatment—ahead of a rival cell therapy. In other BMS cell therapy news, the pharma giant started an R&D alliance focused on inflammatory bowel disease.

The post BMS reports data that could give its cell therapy an edge over rival J&J product appeared first on MedCity News.

The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.

The post BMS cancer drug’s expanded approval gives it an edge over a Gilead cell therapy appeared first on MedCity News.

Bristol Myers Squibb is splashing out $4.1 billion to acquire Turning Point Therapeutics, a clinical-stage biotech whose lead drug is currently in pivotal testing as a treatment for certain lung cancers. Recently reported preliminary data suggest the small molecule could have advantages over currently available drugs in the same class from rivals Pfizer and Roche.

The post BMS bets $4.1B on lung cancer drug that could best products from Pfizer, Roche appeared first on MedCity News.

At the upcoming INVEST PharmaTech virtual conference scheduled for July 26, the conversations will span myriad topics at the intersection of digital health and drug development. Register today.

The post What has Covid-19 taught us about virtual clinical trials? appeared first on MedCity News.

Bristol Myer Squibb is getting rights to BBP-398, a contender in the chase for drugs that address difficult-to-target KRAS mutations. Meanwhile, BridgeBio Pharma receives some needed cash as it restructures in the wake of the Phase 3 failure of its lead program late last year.

The post BMS builds on BridgeBio alliance, inking deal for rights to KRAS cancer drug appeared first on MedCity News.

As an oncologist, Kristen Hege first encountered cancer cell therapy research in the mid-1990s. Now as a Bristol Myers Squibb executive, she oversees efforts to improve the pharma giant’s first generation of cell therapies while also building a pipeline of next-generation treatments with better features and properties.

The post BMS shows what’s NEX-T for CAR T, plus its strategy for next-gen cancer cell therapy appeared first on MedCity News.

CAR T cell therapies for cancer still pose challenges in manufacturing, safety, and the ability to address solid tumors. A panel at the World Medical Innovation Forum discussed efforts to improve CAR T as well as new approaches for the next generation of cell therapies.

The post WMIF panel: How cell and gene therapy can overcome limitations of CAR T appeared first on MedCity News.

Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.

The post Potential blockbuster BMS cardio drug gets FDA nod, first in rare heart disease appeared first on MedCity News.

Bristol Myers Squibb and Nektar Therapeutics are ending a cancer drug research alliance after data showed the combination of their respective drugs failed clinical trials in kidney and bladder cancers. The disappointing results come one month after the drug combo failed a pivotal melanoma clinical trial.

The post BMS and Nektar end cancer drug alliance after two more clinical trial failures appeared first on MedCity News.

Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The drug is approved for advanced melanoma as part of a combination treatment that includes the already approved BMS cancer immunotherapy Opdivo.

The post BMS nabs FDA nod for first drug in new class of cancer immunotherapies appeared first on MedCity News.

Bristol Myers Squibb bet more than $1.8 billion that Nektar Therapeutics’ drug could be combined with the pharma giant’s Opdivo to expand the reach of that drug to more patients. The drug combination has failed its first Phase 3 in advanced melanoma; separate studies in kidney and bladder cancers are ongoing.

The post Nektar drug key to multi-billion dollar BMS deal fails pivotal test in melanoma appeared first on MedCity News.

Neuroscience drug developer Biohaven Pharmaceuticals is expanding its pipeline to include epilepsy and spinal muscular atrophy. The drug developer is acquiring Channel Bioscience and licensing global rights to a Phase 3-ready drug from Bristol Myers Squibb.

The post Biohaven pays $100M for epilepsy drug prospect; strikes deal for BMS muscle med appeared first on MedCity News.

Bristol Myers Squibb is partnering with Century Therapeutics, placing a $150 million bet that the biotech’s technology for engineering stem cells can produce new off-the-shelf cell therapies for cancer. If the four potential programs covered under the pact reach the market, milestone payments could bring Century more than $3 billion.

The post BMS puts $150M on the table in off-the-shelf cell therapy alliance with Century appeared first on MedCity News.

The insurers referred to deals Gilead struck with Janssen, Bristol Myers Squibb to prevent the generic version of its retroviral medications from being used as part of combination treatments. They also allege the company struck a deal with Teva to delay the release of its generic drug.

The post Humana, Centene file antitrust suit against Gilead for HIV drug agreements appeared first on MedCity News.

Bristol Myers Squibb has notched another FDA approval for its blockbuster immunology drug Orencia, this time for preventing acute graft versus host disease in bone marrow and stem cell transplant patients. The decision makes the BMS drug the first one approved for preventing this complication of transplant procedures.

The post FDA decision for BMS drug Orencia marks a first for acute graft versus host disease appeared first on MedCity News.

Bristol Myers Squibb is paying $150 million up front for global rights to an Immatics biologic drug designed to recruit a patient’s T cells to go after cancer cells. It’s the latest deal in the field of cancer drug developers aiming for off-the-shelf treatments intended to be easier and less expensive to manufacture, distribute, and administer compared to earlier cell therapies.

The post BMS joins off the shelf cancer therapy chase with Immatics’ T cell-engaging drug appeared first on MedCity News.

Bristol Myers Squibb drug deucravacitinib missed the main and secondary goals of a Phase 2 study in ulcerative colitis. Despite the clinical trial failure, the drug previously posted positive Phase 3 results in plaque psoriasis and BMS still projects the molecule will become a blockbuster seller in multiple autoimmune conditions.

The post Despite drug’s Phase 2 failure in ulcerative colitis, BMS keeps blockbuster hopes appeared first on MedCity News.

Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary withdrawal comes amid broader FDA scrutiny of cancer drugs that were given accelerated approval.

The post Bristol Myers pulls Opdivo for use in liver cancer amid broader FDA scrutiny of speedy approvals appeared first on MedCity News.

Bristol Myers Squibb reported Phase 3 data that show its experimental cancer immunotherapy relatlimab, combined with the company’s blockbuster drug Opdivo, was better at stopping melanoma from progressing. BMS will present the data at the upcoming annual meeting of the American Society of Clinical Oncology.

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