The U.S. Food and Drug Administration’s approval of the Alzheimer’s drug, aducanumab, ushered in both a likely blockbuster for developer Biogen and sparked a debate both within the biopharma industry and among health care providers. We also look at a major medical device acquisition, investment in synthetic biology, a White House report on supply chain risk, and the race for new pneumonia vaccines.
Each week, we highlight five things you need to know about in the life sciences industry. Here’s the latest.
1. Aducanumab approval not supported by most biopharma insiders, according to survey
With the controversial approval of Biogen’s aducanumab this week, Endpoints News surveyed members of the biopharma industry to get their thoughts. They were overwhelmingly opposed to the FDA’s decision with 80% of respondents disagreeing with the decision. Just as surprising, many (75%) felt the cost of the drug was too high given its low level of efficacy. It is a rare day when the majority of the industry comes out in opposition to a drug approval and in favor of lower prices.
2. A group of private equity firms buy majority stake in Medline
Blackstone Group Inc., Carlyle Group Inc. and Hellman & Friedman LLC announced over the weekend that they reached an agreement to purchase a majority stake in Medline Industries Inc. for $30 billion, making it one of the largest leveraged buyouts ever. Medline is the nation’s largest privately held manufacturer and distributor of health care supplies with revenue of $17.5 billion in 2020. The investment is expected to help the company accelerate its infrastructure and international expansion plans.
3. Venture capital is focused on the synthetic biology revolution
On Monday, Pitchbook published an article explaining that falling costs and demand from emerging industries has driven investor appetite in the synthetic biology space. They specifically reference Ginkgo Bioworks and Zymergen as two companies who have successfully pivoted their business model to become what they describe as “synthetic biology research and development as a service.” Cain McClary from KdT Ventures supported this view with his comments: “LPs are starting to understand that biology now is like technology was in the 70s.”
4. White House report on supply chain risk includes focus on pharmaceuticals
The White House released its first report pursuant to Executive Order 14107, “America’s Supply Chains.” The report assesses supply chain vulnerabilities across four key products, including pharmaceutical products and active pharmaceutical ingredients (APIs). According to the report, approximately 87% of API for generic drugs are manufactured overseas which has left U.S. supply chains of essential medicines vulnerable. To ensure more resilient supply chains a new approach is needed that includes improving transparency, building emergency capacity and investing in domestic production. Read the full report.
5. New pneumonia vaccine approval for Pfizer could be a prelude to serious competition
In a reminder that there is much more to vaccine research than COVID-19 vaccines, this week the FDA approved an updated version of Pfizer’s Prevnar 13 that covers seven more strains of pneumonia. The approval of the updated vaccine, Prevnar 20, is good news for Pfizer and for the large number of competitors from both big pharma and smaller biotechs that are currently in clinical trials.
