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OOS Investigation Tools: Streamlining Out-of-Specification Investigations

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OOS Investigation Tools: Streamlining Out-of-Specification Investigations Out-of-specification (OOS) events are critical occurrences in pharmaceutical manufacturing, representing deviations from established specifications and potentially impacting product quality and patient safety. Efficient and thorough investigations are crucial to identify root causes, prevent recurrence, and ensure product compliance. This post explores essential tools that streamline OOS investigations. Key Tools and Examples of OOS investigation Tools: 1. Electronic Data Capture (EDC) Systems:   These systems are crucial for managing clinical trial data, but their principles of data integrity, audit trails, and secure storage are highly relevant to OOS investigations. Veeva Vault EDC: Veeva is a well-established name in the life sciences industry. Vault EDC is a cloud-based platform specifically designed for clinical data management. Its features like audit trails, electronic signatures, and version contro...
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Recent Mergers and Acquisitions In The Pharmaceutical Industry

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1. Roche's Acquisition of Carmot Therapeutics:

  • On December 4, 2023, Roche entered into definitive merger agreements with Carmot Therapeutics.
  • Roche will acquire Carmot and its gamut of clinical-stage obesity drugs for $2.7 billion.
  • Additionally, there may be $400 million in milestone payments.
Pharmaceutical industry merger and Acquisitions

2. Abbott's Plan to Acquire Bigfoot Biomedical:

  • In the third quarter of 2023, Abbott announced plans to acquire Bigfoot Biomedical.
  • If successful, this acquisition could significantly enhance Abbott's diabetes management portfolio.

3. Eli Lilly's Acquisition of Dice Therapeutics:

  • In June 2023, Eli Lilly announced the acquisition of Dice Therapeutics for $2.4 billion in cash.
  • This represents a 40% premium on the recent trading value of the smaller firm.

4. FTC's Lawsuit Against Amgen-Horizon Deal:

  • The Federal Trade Commission (FTC) is taking Amgen and Horizon to court in September 2023.
  • The lawsuit aims to block a prospective pharmaceutical acquisition of the two companies.

5. GSK's Acquisition of Bellus Health:

  • In April 2023, GSK reached an agreement to acquire Bellus Health Inc. for nearly $2 billion.
  • Bellus, a Canada-based biopharmaceutical company, will provide GSK access to camlipixant.

6. Sanofi's Acquisition of Provention Bio:

  • In March 2023, Sanofi announced a $2.9 billion acquisition deal with Provention Bio.
  • Sanofi will pay $25 per share in cash for this US-based company.

7. Pfizer's Consideration of Seagen Acquisition:

  • Pfizer Inc. is reportedly in talks to buy the cancer drugmaker Seagen Inc.
  • This comes after a potential acquisition by Merck fell through in the previous year.

8. Sun Pharmaceutical Industries' Acquisition of Concert Pharma:

  • Sun Pharma announced its acquisition of Concert for a total of $576 million in cash.
  • Concert recorded a net loss of nearly $576 million during the first three quarters of 2022.

9. Envision Pharma Group's Acquisition of OKRA.ai:

  • Envision Pharma Group acquired OKRA.ai, a leader in artificial intelligence solutions for pharmaceutical operations.

10. Senator Elizabeth Warren's Antitrust Action:

  • Senator Elizabeth Warren expressed concern about recent consolidation in the pharmaceutical industry.
  • She characterized it as a potential antitrust issue.

These pharmaceutical mergers and acquisitions reflect the dynamic landscape of the pharmaceutical sector, where companies seek to enhance their portfolios, expand capabilities, and drive innovation. 🌐💼.

References:

(1) Mergers & Acquisitions News - PharmaNewsIntelligence. .

(2) The Pharma Pulse: Mergers and Acquisitions.

(3) Biotech, Medical Device & Pharmaceutical Mergers | BioSpace.

(4) The top 10 biopharma M&A deals of 2022 - Fierce Pharma.

(5) Biotech M&A is on the upswing. Track the latest deals here.

(6) Getty.

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