Here are the latest stories being discussed in biopharma today:

1. “Fast-Track Approvals to be New Norm for Gene Therapies, Says FDA Official”
Accelerated approval will increasingly be granted for gene therapies targeting rare conditions, according to Peter Marks, the FDA’s head of cell and gene therapies. Peter Marks revealed at a Washington workshop that the FDA will utilise its sped-up pathway to ensure more gene therapies reach patients and fewer therapies are abandoned.

2. “Minerva’s Stocks Dive Following Rejection of Schizophrenia Drug”
Following a serious setback resulting in the FDA rejecting Minerva’s schizophrenia drug roluperidone, shares in the company have plummeted by 58%. FDA feedback stated “at least one” additional well-controlled study would be needed to establish rolluperidone’s effectiveness.

3. “BioMarin Subpoenaed Over Rare Disease Drug Testing Program”
In a recent annual SEC filing, it was disclosed that biotechnology company BioMarin has been subpoenaed by the Department of Justice (DOJ). The subpoena calls for documents about BioMarin’s testing programs for two of its drugs for rare diseases, Vimizim and Naglazyme.

4. “FDA Refuses to File for Theratechnologies’ HIV Drug”
Theratechnologies has received a refusal to file letter from the FDA for its HIV drug Trogarzo. The FDA stated the application was insufficient and didn’t contain the required pharmacokinetic bridging data between the intravenous and intramuscular drug administration.

5. “Pharmaceutical Companies Consider Smaller Sales Forces”
Pharmaceutical companies are considering downsizing sales teams and adopting digital strategies after the COVID-19 pandemic disrupted traditional in-person sales models. With smaller sales forces and increased adoption of artificial intelligence, companies are having to rethink their marketing strategies.

6. “Roche Considers Selling IPF Drug Esbriet”
Pharmaceutical company Roche has confirmed that it is reviewing potential options for selling its drug for idiopathic pulmonary fibrosis (IPF), Esbriet, amid increasing patient preference for generic versions.

7. “Viking’s Agonist Helps Patients Lose Body Weight”
The GLP-1/GIP receptor agonist developed by Viking has been shown to assist patients in losing almost 15% of their body weight over 13 weeks.

8. “Novo Nordisk Enters Molecular Glues Partnership”
Novo Nordisk has signed a deal to discover ‘molecular glues’, a deal worth up to $1.46 billion.