BioSpace News Archive

Once the user fees run out, the employees paid by them will be furloughed if the government doesn’t get back to work. There are numerous companies with PDUFA dates later than the dates that have been noted.

On Thursday, regulators with both the FDA and EMA announced that patients prescribed the drug should ask their doctors if it is wise to continue taking it. This comes after Lartruvo failed to hit endpoints in a Phase III study of advanced or metastatic soft tissue sarcoma.

Notable will donate the commercial rights to price, manufacture, and distribute ND-1000 for pediatric leukemia to Cures Within Reach.

The company planned originally to offer 14 drugs in 2019. Because it has far exceeded its expectations for developing relationships with generic drug manufacturers and participating hospitals—approximately 800 now—it expects to offer 20.

AbbVie reported a loss of $1.83 billion for the fourth quarter of 2018. Overall revenues were up for the full year, however, hitting $32.75 billion compared to $28.2 billion in 2017.

Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the R&D company focused on delivering innovative oncology and rare disease products to patients, is pleased to announce that further to its announcement on 20 December 2018 (the “Update Announcement”) it has received feedback from the FDA on the regulatory study for its lead product MTD201 Q-Octreotide.

As the United Kingdom nears closer and closer to exiting the European Union without a deal, drug manufacturers like Novartis are preparing contingencies for how they will continue to provide medications, many of them life-saving, for patients in the U.K.

This week, the U.S. Supreme Court rejected Swiss pharmaceutical company Helsinn Healthcare S.A.’s claim that Teva Pharmaceutical violated patent rights when the Israel-based company released a generic version of its anti-nausea medicine, Aloxi.

Here’s a look at this week’s calendar for decisions coming down from the U.S. Food and Drug Administration (FDA).

As the chief executive officer of Ovid Therapeutics, Jeremy Levin has a lot on his plate. But, there is one thing always in the forefront of Levin’s mind – the patients his company can serve.