Bristol Myers Squibb

Atomic AI Announces Appointments of New Independent Member to its Board of Directors and Additions to the Scientific Advisory Board

Retrieved on: 
Thursday, February 22, 2024
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Atomic AI, a biotechnology company fusing cutting-edge machine learning with state-of-the-art structural biology to unlock RNA drug discovery, today announced the appointment of Stuart Peltz, Ph.D. as an independent board member to the Atomic AI Board of Directors, and the additions of Percy Carter, MBA, Ph.D., and Nicholas Meanwell, Ph.D. to their Scientific Advisory Board (SAB).

Key Points: 
  • Atomic AI, a biotechnology company fusing cutting-edge machine learning with state-of-the-art structural biology to unlock RNA drug discovery, today announced the appointment of Stuart Peltz, Ph.D. as an independent board member to the Atomic AI Board of Directors, and the additions of Percy Carter, MBA, Ph.D., and Nicholas Meanwell, Ph.D. to their Scientific Advisory Board (SAB).
  • “We are extremely pleased to have these highly regarded, experienced biotech leaders join in our efforts and believe in our mission,” said Raphael Townshend, Ph.D., Founder and CEO of Atomic AI.
  • Peltz’s experience will help shape our strategy as we endeavor to streamline the discovery and development of novel therapies.
  • “They have demonstrated tremendous progress integrating deep learning foundation models with experimental results to be able to predict and optimize RNA structures to enable rational drug design.

Bristol Myers Squibb Announces Expiration of RayzeBio Tender Offer

Retrieved on: 
Friday, February 23, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Eastern Time Zone, BMY

Bristol Myers Squibb (NYSE: BMY) today announced that its previously announced tender offer (the “Offer”) to acquire all of the outstanding shares of RayzeBio, Inc. (Nasdaq: RYZB) common stock for a purchase price of $62.50 per share in cash, or approximately $4.1 billion, expired at one minute after 11:59 p.m., Eastern Time, on February 22, 2024 (the “Expiration Time”).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that its previously announced tender offer (the “Offer”) to acquire all of the outstanding shares of RayzeBio, Inc. (Nasdaq: RYZB) common stock for a purchase price of $62.50 per share in cash, or approximately $4.1 billion, expired at one minute after 11:59 p.m., Eastern Time, on February 22, 2024 (the “Expiration Time”).
  • Equiniti Trust Company, the depositary for the Offer, has advised that, as of the Expiration Time, approximately 53,052,499 shares of RazyeBio common stock were validly tendered and not validly withdrawn pursuant to the Offer, representing approximately 86% of the issued and outstanding shares of RayzeBio common stock at the Expiration Time.
  • The parties expect the transaction to close on February 26, 2024, promptly following the acceptance of all shares of common stock validly tendered and not validly withdrawn pursuant to the Offer.
  • RayzeBio stockholders can direct questions regarding the Offer to Georgeson LLC, the information agent for the Offer, toll free at 1-888-815-8542 or by email at [email protected] .

Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl® (luspatercept) for Treatment of Adults with Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS)

Retrieved on: 
Friday, February 23, 2024
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, BMY, European Commission, EMA, Committee, Transfusion-dependent anemia, Bristol Myers Squibb, RBC, European, MDS, Civil service commission, CHMP, European Medicines Agency, Patient

The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

Key Points: 
  • The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
  • Upon approval, this would represent the fourth authorized indication for Reblozyl in the EU.
  • The CHMP adopted a positive opinion based on results from the pivotal Phase 3 COMMANDS trial.
  • Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
Thursday, March 7, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Orbis, BMY, PFS, Progression-free survival, Confidence interval, Research, Recurrence, MD, Pneumonitis, Immunotherapy, Hematology, Kidney, Food, Cancer, Bladder cancer, HSCT, Hepatotoxicity, Checkmate, Risk, Bristol Myers Squibb, Hepatitis, Dexamethasone, Cisplatin, History, Death, Patient, Colitis, Multiple myeloma, Nephritis, Disease, Mortality, Priority review, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1
    In the trial, with a median follow-up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171).1,4 Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone (HR 0.72; 95% CI: 0.59, 0.88; p=0.0012).1
    Additionally, in exploratory analyses, treatment with Opdivo in combination with cisplatin and gemcitabine resulted in an objective response rate (ORR) of 57.6% (n=175) (95% CI: 51.8, 63.2) versus 43.1% (n=131) (95% CI: 37.5, 48.9) with cisplatin-gemcitabine alone.1,4 The complete response (CR) rate and partial response (PR) rate seen in patients treated with Opdivo in combination with cisplatin and gemcitabine was 22% (n=66) and 36% (n=109), respectively, versus 12% (n=36) and 31% (n=95) with cisplatin-gemcitabine alone.1
    “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients a chance to live longer,”5 said Guru P. Sonpavde, MD, Medical Director of Genitourinary Oncology and the Phase I Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, Orlando, Florida.
  • “Based on outcomes and the safety profile seen in the CheckMate -901 clinical trial, the approval of Opdivo in combination with cisplatin and gemcitabine has the potential to change how metastatic or unresectable UC is treated for certain patients and offers them new hope.”1
    Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.
  • Please see Important Safety Information below.1
    “Bringing Opdivo to the first-line setting in UC with chemotherapy is the latest realization of our history of research and progress in immunotherapy, which has helped transform the treatment landscape for many cancers, including bladder cancer,”1,6 said Wendy Short Bartie, senior vice president and general manager, U.S. Hematology and Oncology at Bristol Myers Squibb.
  • “This milestone adds a meaningful expansion to our portfolio of Opdivo-based treatments in genitourinary cancers, where we now have offerings in UC spanning three indications across stages of disease and treatment needs.”1
    The FDA previously approved Opdivo for the adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC; it also previously approved Opdivo for the treatment of adult patients with locally advanced or metastatic UC who have had disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.1
    Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) leading to today’s approval was granted Priority Review status by the FDA, and was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.7 The review was also conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries where the application remains under review.

U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI® (adagrasib) in Combination with Cetuximab as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or...

Retrieved on: 
Tuesday, February 20, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, BMY, Progression-free survival, Cetuximab, Physician, Food, Shanda, PDUFA, CRC, Bristol Myers Squibb, Safety, Patient, Pharmaceutical industry

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.

Key Points: 
  • The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.
  • “The acceptance of this filing for KRAZATI in combination with cetuximab is a positive step toward providing a potential new option for patients and their physicians.
  • The secondary endpoints for the pooled cohorts included duration of response, progression-free survival, overall survival and safety.
  • The safety profile for KRAZATI plus cetuximab was manageable and consistent with previous reports, and with the known safety profile of each drug individually.

"Double Life" of Key Immune Protein Reveals New Strategies for Treating Cancer and Autoimmune Diseases

Retrieved on: 
Friday, March 8, 2024
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The same findings also support experimental treatment strategies for autoimmune diseases, in which the immune system attacks the body, because stimulating the action of PD-1, as opposed to restricting it, can potentially block an overactive immune response.

Key Points: 
  • The same findings also support experimental treatment strategies for autoimmune diseases, in which the immune system attacks the body, because stimulating the action of PD-1, as opposed to restricting it, can potentially block an overactive immune response.
  • The study results revolve around the body's immune system, which is primed to attack virally infected and cancerous cells while leaving normal cells alone.
  • The immune system recognizes tumors as abnormal, but cancer cells can hijack checkpoints to turn off immune responses.
  • At the same time, PD-1 signaling is slowed in autoimmune diseases like rheumatoid arthritis, lupus, and type 1 diabetes, such that the action of unchecked immune cells creates inflammation that can damage tissues.

Find Therapeutics Announces Appointment of Dr. Anthony Johnson to its Board of Directors

Retrieved on: 
Monday, March 4, 2024
University, OrbiMed, Pharmacology, AstraZeneca, MD, University of Cambridge, Royal Australasian College, Bristol Myers Squibb, BMS, Homerton College, Cambridge, Therapy, Find, Royal college, Internal medicine, GSK plc, MBBS, Physician, Discovery Medicine, Pharmaceutical industry

"On behalf of the Board of Directors, I am delighted to welcome Tony to the team," said Philippe Douville, President and CEO of Find Therapeutics.

Key Points: 
  • "On behalf of the Board of Directors, I am delighted to welcome Tony to the team," said Philippe Douville, President and CEO of Find Therapeutics.
  • He currently serves as President and CEO of Domain Therapeutics, Chairman of the Board for Outrun Therapeutics and Board Director for Nanosyrinx.
  • Dr. Johnson was previously President and CEO of Goldfinch Bio and, prior to that, Head of Early Clinical Development.
  • Find Therapeutics also announces that Pascal Neuville, Ph.D., has stepped down from the board as a Non-Executive Director effective March 3, 2024.

Breakthrough 2024 Speaker Lineup Announced - Industry Experts to Discuss the Evolution of Life Sciences Through Technology, Automation, and Artificial Intelligence

Retrieved on: 
Wednesday, February 21, 2024
Name, Merck, AI, Roche, FDA, Food, Johnson & Johnson, Quality, Blueprint, Bristol Myers Squibb, Pharmacovigilance, LLM, Sanofi, Boehringer Ingelheim, Change management, Astellas Pharma, Automation, Philip Morris International

LONDON, Feb. 21, 2024 /PRNewswire/ -- ArisGlobal, an innovative life sciences technology company and creator of LifeSphere®, today revealed the speaker line-up for Breakthrough 2024, its annual industry event. Taking place from March 19-20 in London, England, Breakthrough 2024 will facilitate the brightest, forward-looking life sciences industry conversations and serve as the company's showcase where it will announce latest LifeSphere developments.  

Key Points: 
  • Taking place from March 19-20 in London, England, Breakthrough 2024 will facilitate the brightest, forward-looking life sciences industry conversations and serve as the company's showcase where it will announce latest LifeSphere developments.
  • A deep-dive into GenAI's potential role in R&D transformation, as envisioned by a major industry player
    Announcements of the very latest LifeSphere developments.
  • "Breakthrough 2024's content-rich program is designed to inspire and focus industry players in making their next moves as AI continues to evolve and disrupt," said Julie Springer , Chief Marketing Officer at ArisGlobal.
  • Breakthrough2024 will take place March 19-20 at the Leonardo Royal Hotel in London, UK.

Breakthrough 2024 Speaker Lineup Announced - Industry Experts to Discuss the Evolution of Life Sciences Through Technology, Automation, and Artificial Intelligence

Retrieved on: 
Wednesday, February 21, 2024
Name, Merck, AI, Roche, FDA, Food, Johnson & Johnson, Quality, Blueprint, Bristol Myers Squibb, Pharmacovigilance, LLM, Sanofi, Boehringer Ingelheim, Change management, Astellas Pharma, Automation, Philip Morris International

LONDON, Feb. 21, 2024 /PRNewswire/ -- ArisGlobal, an innovative life sciences technology company and creator of LifeSphere®, today revealed the speaker line-up for Breakthrough 2024, its annual industry event. Taking place from March 19-20 in London, England, Breakthrough 2024 will facilitate the brightest, forward-looking life sciences industry conversations and serve as the company's showcase where it will announce latest LifeSphere developments.  

Key Points: 
  • Taking place from March 19-20 in London, England, Breakthrough 2024 will facilitate the brightest, forward-looking life sciences industry conversations and serve as the company's showcase where it will announce latest LifeSphere developments.
  • A deep-dive into GenAI's potential role in R&D transformation, as envisioned by a major industry player
    Announcements of the very latest LifeSphere developments.
  • "Breakthrough 2024's content-rich program is designed to inspire and focus industry players in making their next moves as AI continues to evolve and disrupt," said Julie Springer , Chief Marketing Officer at ArisGlobal.
  • Breakthrough2024 will take place March 19-20 at the Leonardo Royal Hotel in London, UK.

Aurora Cannabis Announces CFO Transition and Completion of Previously Announced Share Consolidation

Retrieved on: 
Tuesday, February 20, 2024
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She served nearly 20 years with Bristol Myers-Squibb, where she held increasingly senior finance roles and enabled the company's growth strategy.

Key Points: 
  • She served nearly 20 years with Bristol Myers-Squibb, where she held increasingly senior finance roles and enabled the company's growth strategy.
  • Glen Ibbott, current Chief Financial Officer, will be stepping down from his full-time role effective today to pursue new opportunities.
  • He will remain in an advisory role over the next few months to ensure a smooth transition of responsibilities to Simona.
  • Aurora also announces the completion of its previously announced consolidation of the common shares of the Company (the "Common Shares") on a 10 to 1 basis (the "Consolidation").