AstraZeneca

CHARM Therapeutics Announces Foundation of Scientific Advisory Board (SAB)

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Tuesday, March 19, 2024
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LONDON – 19 March 2024 -- CHARM Therapeutics (“CHARM”, “The Company”), a 3D deep-learning research company discovering and developing transformational medicines, today announces the foundation of its Scientific Advisory Board (SAB) to provide expert insight and guidance to the Company on the optimal application of 3D deep learning, protein design and prediction in real world medicine.

Key Points: 
  • LONDON – 19 March 2024 -- CHARM Therapeutics (“CHARM”, “The Company”), a 3D deep-learning research company discovering and developing transformational medicines, today announces the foundation of its Scientific Advisory Board (SAB) to provide expert insight and guidance to the Company on the optimal application of 3D deep learning, protein design and prediction in real world medicine.
  • This pioneering technology enables CHARM to target and develop treatments for previously hard-to-drug targets in cancer and other therapeutic areas.
  • Laksh Aithani, Co-Founder, Chief Executive Officer and Board Member of CHARM Therapeutics, said: “As CHARM advances its 3D deep learning platform in discovery it’s critical to maintain aligned oversight of our priorities and keep abreast of this emerging field.
  • Founding members of CHARM’s SAB:
    David Baker, Ph.D. is a Scientific Co-Founder at CHARM and Chair of the SAB.

AAFA Statement in Response to AstraZeneca Asthma Inhaler Cost Announcement

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Monday, March 18, 2024
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Washington, DC, March 18, 2024 (GLOBE NEWSWIRE) -- The Asthma and Allergy Foundation of America (AAFA) welcomes efforts to make asthma medicines more affordable and accessible.

Key Points: 
  • Washington, DC, March 18, 2024 (GLOBE NEWSWIRE) -- The Asthma and Allergy Foundation of America (AAFA) welcomes efforts to make asthma medicines more affordable and accessible.
  • AAFA continues to lead advocacy efforts to change the drug pricing ecosystem on behalf of the 27 million people in the United States with asthma.
  • "AAFA applauds AstraZeneca’s announcement to cap costs of asthma inhalers and urges other manufacturers to take similar steps to make medications more affordable and accessible,” said AAFA President and CEO Kenneth Mendez.
  • AAFA’s research indicates that when the cost of medicine becomes a barrier to treatment , people with asthma resort to rationing or simply discontinue use.

Amolyt Pharma Enters into Definitive Agreement to be Acquired by AstraZeneca

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Thursday, March 14, 2024
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LYON, France and CAMBRIDGE, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global, clinical-stage biopharmaceutical company specializing in developing therapeutic peptides for rare endocrine and related diseases, today announced it has entered into a definitive agreement for AstraZeneca to acquire Amolyt Pharma at a purchase price of $800 million upfront and a potential milestone payment of $250 million. Alexion, AstraZeneca Rare Disease is looking forward to welcoming talent from Amolyt Pharma.

Key Points: 
  • Alexion, AstraZeneca Rare Disease is looking forward to welcoming talent from Amolyt Pharma.
  • We are grateful to the investigators, patients, and patient associations who have supported us to reach these goals,” said Thierry Abribat, Ph.D., Founder and Chief Executive Officer of Amolyt Pharma.
  • Under the terms of the agreement, AstraZeneca will acquire all of Amolyt Pharma’s outstanding shares for a total consideration of up to $1.05B, on a cash and debt free basis.
  • Centerview Partners LLC and Goldman Sachs Bank Europe SE acted as financial advisors to Amolyt, and Cooley LLP and Jones Day acted as legal counsels for Amolyt and its shareholders.

ENHERTU® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors

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Saturday, April 6, 2024
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The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .

Key Points: 
  • The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .
  • In DESTINY-PanTumor02, efficacy was assessed in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive (IHC 3+) solid tumors including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors.
  • In DESTINY-Lung01, efficacy was assessed in a subgroup of patients (n=17) with centrally confirmed HER2 positive (IHC 3+) non-small cell lung cancer (NSCLC).
  • In DESTINY-CRC02, efficacy was assessed in the subgroup of patients (n=64) with centrally confirmed HER2 positive (IHC 3+) colorectal cancer.

IMFINZI® (durvalumab) significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial

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Friday, April 5, 2024
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Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

Key Points: 
  • Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
  • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (
  • Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.
  • Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

MMS Hires Pharmaceutical Industry Veteran James Zee for Global Biometrics Leadership in Europe Amid Strong Regional Growth

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Thursday, April 4, 2024
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MMS, a leading, data-focused clinical research organization (CRO), announced today that the company has expanded its biometrics leadership within European operations by hiring James Zee as Director of Global Statistical Programming.

Key Points: 
  • MMS, a leading, data-focused clinical research organization (CRO), announced today that the company has expanded its biometrics leadership within European operations by hiring James Zee as Director of Global Statistical Programming.
  • Based in the United Kingdom (UK), Zee brings 25 years of experience across several leading pharmaceutical companies, including AstraZeneca, MSD, Novartis, Roche, and others.
  • With extended drug development experience, Zee helps to guide the statistical programming team at MMS to support some of the timely execution and evolving regulations for the development of NCEs.
  • Since 2020, the global biometrics CRO has experienced 133 percent growth in Europe.

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

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Tuesday, April 2, 2024
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The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

Retrieved on: 
Tuesday, April 2, 2024
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Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.

Key Points: 
  • Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • “The FDA’s acceptance of the BLA brings us closer to providing patients with previously treated HR positive, HER2 negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

Nucleus RadioPharma Announces Appointment of Chris McDonald from Kite, a Gilead Company, to Board of Directors

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Wednesday, March 27, 2024
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Nucleus RadioPharma , the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals, today announced the appointment of Chris McDonald, Global Head of Technical Operations at Kite, a Gilead Company, to its Board of Directors.

Key Points: 
  • Nucleus RadioPharma , the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals, today announced the appointment of Chris McDonald, Global Head of Technical Operations at Kite, a Gilead Company, to its Board of Directors.
  • This addition underscores Nucleus RadioPharma's focus on operational excellence and its commitment to research and development, specifically tailored to the unique demands of the radiopharmaceutical sector.
  • View the full release here: https://www.businesswire.com/news/home/20240327530225/en/
    With the industry shifting towards isotopes that demand rapid production and distribution, McDonald's appointment is timely.
  • With Chris on board, we are poised to transform the radiopharmaceutical industry, making cancer treatments more accessible and saving the lives of patients with cancer.

Juvisé Pharmaceuticals Acquires Multiple Sclerosis Drug PONVORY® (ex-US/Canada) and Opens Its Capital to Bpifrance and Pemberton

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Tuesday, March 26, 2024
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To fund this acquisition, the French sovereign fund Bpifrance and Pemberton Asset Management (‘Pemberton’), a leading European private credit manager, have acquired a minority stake in Juvisé Pharmaceuticals.

Key Points: 
  • To fund this acquisition, the French sovereign fund Bpifrance and Pemberton Asset Management (‘Pemberton’), a leading European private credit manager, have acquired a minority stake in Juvisé Pharmaceuticals.
  • “We are very excited about Ponvory® and its potential to have a very positive impact on the lives of patients with multiple sclerosis” announces Frédéric Mascha, founder and President of Juvisé Pharmaceuticals.
  • Juvisé Pharmaceuticals will work closely with Johnson & Johnson to ensure a seamless transition and continuous availability of Ponvory® for patients.
  • Finally, Juvisé Pharmaceuticals will assume the worldwide manufacturing duties for Ponvory® from sites based in France and Switzerland.