Positive CHMP approval for Takeda's Alunbrig in ALK advanced non-small lung cancer

Pharmafile: Home | March 04, 2020

The decision was based on Phase 3 comparing Alunbrig to crizotinib in the same indication. The findings for Alunbrig showed a 69% reduction in risk of intracranial disease progression or death in patients with brain metastases according to a blinded independent review committee, and a 76% reduction according to investigators. The drug also demonstrated a median progression-free survival of 24 months, more than double the 11 months presented by crizotinib. Because of the complex nature of ALK+ NSCLC and the way in which the disease often spreads to the brain, it is essential for physicians to have treatment options that demonstrate both overall and intracranial effectiveness,” explained Professor Sanjay Popat, Consultant Medical Oncologist, Royal Marsden NHS Foundation Trust. “In the ALTA-1L trial, brigatinib demonstrated significant responses in the brain and consistent overall efficacy compared to crizotinib. If approved by the EMA, brigatinib has the potential to become an important option for the first-line treatment of ALK+ advanced NSCLC patients in Europe.

Spotlight

Today’s pharmaceutical manufacturers face increasing pressure to deliver high-quality medicines quickly, efficiently and economically while complying with regulatory requirements and meeting sustainability goals.

Spotlight

Today’s pharmaceutical manufacturers face increasing pressure to deliver high-quality medicines quickly, efficiently and economically while complying with regulatory requirements and meeting sustainability goals.

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Ionis and AstraZeneca close deal to develop and commercialize eplontersen

Ionis Pharmaceuticals, Inc. | December 30, 2021

Ionis Pharmaceuticals, Inc. the leader in RNA-targeted therapies, announced the closing of the collaboration agreement with AstraZeneca to develop and commercialize eplontersen, Ionis' investigational antisense medicine for the treatment of transthyretin amyloidosis, following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Eplontersen, formerly known as IONIS-TTR-LRx, is designed to reduce the production of transthyretin, or TTR protein, to treat ATTR, a systemic, progressive and fatal disease. It uses Ionis' advanced LIgand-Conjugated Antisense technology. As previously announced, the companies will jointly develop and commercialize eplontersen in the U.S. AstraZeneca has an exclusive license for eplontersen outside the U.S., except certain countries in Latin America. Under the terms of the agreement, Ionis will receive a $200 million upfront payment, up to $485 million in development and approval milestones, and up to $2.9 billion in sales-related milestone payments. The collaboration includes territory-specific development, commercial and medical affairs cost-sharing provisions. Ionis is also eligible to earn royalties in the range of low double-digit to mid-20s percentage depending on region. Additional details about the agreement can be found in Ionis' Form 8-K filed with the Securities and Exchange Commission on Dec. 7, 2021. About Ionis Pharmaceuticals, Inc. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading neurological and cardiometabolic franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision of becoming one of the most successful biotechnology companies.

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Parexel and Veeva Collaborate to Speed-Up Clinical Trials

Parexel, Veeva Systems | May 04, 2021

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Stevanato Group Announces Expansion of Corporate Headquarters

Stevanato Group | November 18, 2021

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Forward-Looking Statements This press release may include forward-looking statements. The words "expected", "expects", “intended”, "plans" and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the size and use of the plant, the construction and timing of its plant, impact of the plant of the Company’s business and results of operations and the nature of the plant once complete. The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behavior of other market participants, the actions of regulators and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the political, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements.

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