FDA rejects antibiotic developed by Basilea, J&J

The FDA is refusing to approve ceftobiprole, an antibiotic being developed by Basilea and Johnson & Johnson, thus laying the groundwork for a new round of claims as the two companies squabble over J&J's development program for the product.

Both companies say they are taking time to evaluate the FDA's response before determining how to proceed, but investors have been quick to take a bite out of Basilea's share price. Ceftobiprole was once regarded as a potential market winner with projected annual sales of $300 million, but now it probably won't hit the market for several years, according to Dow Jones.

The trouble with the program, according to the FDA, is that researchers cut corners when they set out to determine the treatment's efficacy. Earlier this year, Basilea filed an arbitration request claiming that J&J had broken its licensing pact for the therapy when it failed to gain an approval for the antibiotic. Now, new claims over the rejection are likely.

- check out Basilea's release
- read J&J's version of events
- here's the report from Dow Jones

Suggested Articles

Half of patients in an early trial of Allogene's off-the-shelf CAR-T cells for lymphoma who received a higher dose of its antibody ALLO-647 responded.

Takeda is tossing out a Shire pipeline med after it couldn't find a buyer.

Ipsen's new hire arrives at a company reeling from a torrent six months that have crushed hopes for its $1 billion bet on a rare disease drug.