Stockwatch: Lax Approval Requirements Yield Blockbusters That Don’t Work

How Sarepta And Biogen Are Following The Actimmune Playbook

02 Mar 2020

• By Andy Smith

With the backdrop of Biogen’s BLA filing, and the FDA’s expected response for aducanumab in Alzheimer’s disease in 2020, the link between efficacy and approval seems to have broken. Conditional FDA approvals can’t help when the conditions are ignored.

Andy Smith gives a life sciences investor's perspective on biopharma business

I met the management of InterMune Inc. almost 20 years ago when it was a mid-sized US biotechnology company that had three approved products, two of them interferons. Virtually all of InterMune’s revenues came from one product − Actimmune (interferon gamma 1b), originally licensed from Genentech Inc. in 1998.

Actimmune was approved for two rare congenital disorders, but the vast majority of its sales were off-label in idiopathic pulmonary...

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Stock Watch: How GSK’s Nucala Info Drip Helped Share Price

03 Jun 2025

• By Andy Smith

The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.

Stock Watch: Q1 Sales Trends And Forex Muddle Pharma Outlook

26 May 2025

• By Andy Smith

Pharma firms tended to downplay first-quarter trends in full-year guidance. However, raised guidance seems fragile amid ongoing foreign exchange effects and Medicare Part D redesign pressures.

Stock Watch: Bayer, Bavarian Nordic Bring European Cheer To Pharma

20 May 2025

• By Andy Smith

Investors welcomed Bavarian Nordic’s and Bayer’s earnings announcements. However, both stock prices declined over the day of their reports as the impact of recent pressures weighed.

Stock Watch: Stock Watch: Lilly And Novo Duke Out Q1

13 May 2025

• By Andy Smith

Novo Nordisk enjoyed a surprise GLP-1 agonist contracting win in the first quarter of 2025. This provided a welcome boost to its stock after it had spent the previous quarter on the back foot against rival Lilly.

A MoonLake Buyout Would Boost Merck & Co’s Immunology Ambitions

05 Jun 2025

• By Andrew McConaghie

As the patent protection clock ticks down on Merck’s flagship blockbuster Keytruda, the company is reported to be pursuing the inflammation and immunology biotech. Such a move would bulk up its sparse I&I pipeline.