Top Biopharma News for 01/09/2024

Here are the latest stories being discussed in biopharma today:

Key Healthcare Market News

Signs of optimism and AI application in Pharma Industry

The atmosphere is positive at the #JPM24 event as most executives expressed optimism on industry outlook due to the surge in deal-making activities. The increased M&A activities have rekindled investor interest in the biotech sector.

Sanofi CEO Open to M&As in Venture for Business Transformation

Paul Hudson, Sanofi’s CEO, hints at the possibility of mergers and acquisitions under the comprehensive blueprint of reshaping the company. However, he emphasized that significant advancement or breakthrough in science would motivate any M&A initiative.

Grifols Stocks Drops Amid Accusations of Finance Manipulation

Healthcare conglomerate Grifols’ stocks fall by almost 20% following accusations by UK-based hedge fund Gotham City. The fund alleges financial manipulation in Grifols’ reported debt and EBITDA. Grifols denies these claims, labeling them as baseless speculations.

FDA Appoints New Chief of Staff

Elizabeth Jungman has been appointed by FDA Commissioner Robert Califf as Chief of Staff, a role she will assume on the 28th of January. She currently holds the position of Director of the Office of Regulatory Policy in CDER.

FDA Sends Warning Letter to MiMedx over Axiofill Production Issues

In a warning letter to MiMedx, the FDA has expressed concerns about the alleged deviation from good manufacturing practice for the Axiofill, a placenta-based product. The product is presently under review for its legal classification.

Increasing Orphan Drug Approvals

As per a new FDA and HHS analysis, 65% of the 491 orphan drug approvals, for the period 1990 – 2022, targeted a single rare disease. Congress is currently considering modifying the incentives of the Orphan Drug Act.