BRISTOL MYERS SQUIBB

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• US FDA staff raises concerns on Geron's blood disorder drug

  Geron is seeking approval of the injectable drug, called imetelstat, for treating transfusion-dependent anemia in patients with a group of blood cancers called myelodysplastic syndromes (MDS).

  

• Bristol Myers Squibb opens new facility in Hyderabad

  The new site expands the company's global footprint and will serve as an innovation hub, as the company writes the next chapter in its history. The company has invested over $100 million in the creation of this cutting-edge facility.

  

• Global pharma giants pitch in for BioAsia ’24

  The five principal industry hosts will be joined by Medtronic, Aurobindo, Hetero and Aragen as industry co-hosts, while the CEO Conclave 2024 will be powered by ‘Rx Propellant, a UK based Actis portfolio company.

  

• US FDA requires 'boxed warning' for CAR-T cancer therapies

  The other cancer therapies include Bristol Myers Squibb's Breyanzi and its partnered therapy, Abecma, with 2seventy bio, J&J unit Janssen and Legend Biotech's Carvykti, Novartis AG's Kymriah, and Gilead unit Kite's Tecartus and Yescarta.

  

• EU regulator begins safety review of CAR-T cancer cell therapies

  The treatment for different types of blood cancer, known as chimeric antigen receptor T-cell therapies or CAR-T, 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.

  

• Agios Pharma's blood disorder drug meets goals of late-stage study

  Agios Pharmaceuticals' drug boosted hemoglobin levels in some patients with thalassemia in a late-stage study, taking the company closer to approval for the first ever oral treatment for less severe forms of the inherited blood disorder. The drug, mitapivat, met the main goal of the study as it showed a statistically significant increase in hemoglobin response compared with placebo in patients suffering from either alpha- or beta-thalassemia and were not dependent on transfusion, the firm said on Wednesday.

  

• Cytokinetics heart drug succeeds in closely watched study, shares surge

  Cytokinetics said on Wednesday that its experimental heart disease drug met the main goal of a keenly awaited late-stage study, putting it on track to compete with a rival treatment from Bristol Myers Squibb.

  

• US FDA turns down full approval of Amgen lung cancer drug Lumakras

  The U.S. Food and Drug Administration (FDA) now requires data from an additional confirmatory study to support the drug's full approval, which will be completed no later than February 2028, the company said.

  

• Bristol Myers strikes $4.1 bln RayzeBio deal for targeted cancer therapies

  With the RayzeBio deal, Bristol gains a late-stage targeted cancer therapy that uses radioactive particles to kill tumor cells. The drug, called RYZ101 by RayzeBio, is being tested in late-stage studies for a rare type of pancreatic cancer.

  

• Bristol Myers to pay $800 million to Chinese drugmaker to develop cancer drug

  Bristol Myers said it will pay Sichuan unit SystImmune up to $500 million in contingent near-term payments to co-develop an antibody-drug conjugate (ADC) that it said has shown promise against a range of solid tumors, including non-small cell lung cancer and breast cancer. The treatment is currently in early stage clinical trials.

  

• Mirati's lung cancer drug gets EU's regulatory backing

  The drug is designed to target a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers, the most common form of the disease. Earlier in October, Bristol Myers Squibb had agreed to buy Mirati for up to $5.8 billion, to diversify its oncology business with Krazati.