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The Master Guide to Quality Risk Management (QRM) in Sterile Manufacturing: An ICH Q9 Perspective

by Prashant Suresh Devmore
  1. Introduction: From Reactive to Proactive Quality ​In the high-stakes environment of sterile injectables, waiting for a failure to occur is not an option. Quality Risk Management (QRM) is the systematic, proactive process of assessing, controlling, communicating, and reviewing risks to product quality. Drawing from my 11+ years of experience navigating USFDA and MHRA audits.  I have seen that a robust, scientifically sound QRM program is the fundamental difference between a minor observation and a severe Warning Letter. ​ 2. The Regulatory Bedrock: Understanding ICH Q9(R1) ​The International Council for Harmonisation (ICH) provides the global standard through the Q9 guideline. The recent revision, ICH Q9(R1) , emphasizes reducing subjectivity and ensuring a scientific basis for risk assessments. ​ Patient Protection: The core purpose of QRM is to safeguard the patient; all evaluations must link back to patient health. ​ Proportionality: The level of effort and doc...
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Recent Mergers and Acquisitions In The Pharmaceutical Industry

by Prashant Suresh Devmore

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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