Top Biopharma News for 01/12/2024

Here are the latest stories being discussed in biopharma today:

1. BioMarin’s Chief Commercial Officer Stepping Down

Jeff Ajer, the Chief Commercial Officer of BioMarin, is set to step down in July. The company has begun a search for a successor, who will take over Ajer’s role in leading the commercial operations. Ajer’s departure follows the appointment of Alexander Hardy as the company’s new CEO.

2. Novartis Uses PRV to Speed Up Drug Approval

Novartis used a priority review voucher (PRV) to expedite the approval of its new treatment for adults with paroxysmal nocturnal hemoglobinuria, a rare blood disorder. The use of the PRV shortened the review process from 12 months to 8 months.

3. Pharmaceutical Companies Push Back on FDA’s Draft Guidance on Off-Label Use

PhRMA, Eli Lilly, and other pharmaceutical companies are challenging the FDA’s draft guidance on how to communicate with healthcare providers about off-label uses of approved medications. The companies believe the guidance is vague and infringes on their First and Fifth Amendment rights.

4. Health Policy Experts Challenge J&J’s Arguments

Economists and health policy experts from top universities have labelled Johnson & Johnson’s challenge to the Inflation Reduction Act as ‘overly simplistic.’ The company is one of several suing the federal government over what it considers to be unconstitutional elements of the Act’s Medicare negotiation provisions.

5. Evaluate Makes Acquisition to Improve Forecasting Software and Services

Data analysis firm Evaluate has acquired J+D Forecasting to improve its software solutions for the pharmaceutical industry. The partnership is expected to help them with market sizing, indication entry, company purchase, and competitive intelligence forecasting.

6. Vertex Founder Shares Valuable Industry Insights

Joshua Boger, the founder of Vertex Pharmaceuticals, advised biotech leaders at the JP Morgan Healthcare Conference to remain adaptable in the face of market volatility. He encouraged them to plan for fluctuating market conditions without setting firm expectations for when downturns might end.