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Pharma News

Teva Suffers Another Blow in ‘Skinny Labeling’ Case Against GSK
Teva Suffers Another Blow in ‘Skinny Labeling’ Case Against GSK
A federal appeals court has upheld a decision ordering Teva Pharmaceuticals to pay $235.5 million to GlaxoSmithKline for infringing on the latter’s patent for its congestive heart failure drug Co...
FDA Grants Priority Review to BMS’ Supplemental BLA for Breyanzi
FDA Grants Priority Review to BMS’ Supplemental BLA for Breyanzi
The FDA has granted a Priority Review to Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) as a second-line treatment for adults with relapsed or refractory B-cell lymph...
Inside the tactical tug of war over the controversial Alzheimer's drug
Inside the tactical tug of war over the controversial Alzheimer's drug
The drug industry, patient advocates and congressional Republicans have all attacked federal officials' decision to decline routine Medicare coverage for a controversial Alzheimer's drug.  ...
Moderna’s commercial network grows
Moderna’s commercial network grows

Vaccine pioneers expand presence throughout Europe with a view to leveraging technology.

FDA Halts Legend Biotech’s CAR-T Cell Therapy Trial After Just One Patient is Dosed
FDA Halts Legend Biotech’s CAR-T Cell Therapy Trial After Just One Patient is Dosed
After dosing just one patient in a phase 1 trial, the FDA put a clinical hold on Legend Biotech’s early-stage CAR-T cell therapy, LB1901, which targets malignant CD4+ T-cells. ...
EU Approves AstraZeneca’s Lupus Drug Saphnelo
EU Approves AstraZeneca’s Lupus Drug Saphnelo
The European Union has approved AstraZeneca’s lupus drug Saphnelo (anifrolumab), a first-in-class type 1 interferon receptor antibody as an add-on therapy for the treatment of severe, active aut...
Califf Wins Narrow Senate Vote for Second Turn as FDA Commissioner
Califf Wins Narrow Senate Vote for Second Turn as FDA Commissioner
Robert Califf, MD, received Senate approval today to become FDA commissioner in a 50-46 vote, in which 6 Republicans supported him and 5 Democrats voted against his confirmation.
EMA Follows FDA in Reviewing Safety of JAK Inhibitors
EMA Follows FDA in Reviewing Safety of JAK Inhibitors
The European Medicines Agency (EMA) safety committee has begun a safety review of Janus kinase (JAK) inhibitors made by Pfizer, AbbVie, Eli Lilly and Belgian biotech Galapagos for the treatment of...
GSK Limits Its 340B Drug Discount Program
GSK Limits Its 340B Drug Discount Program

GlaxoSmithKline (GSK) has become the 14th drugmaker to limit its involvement in the 340B Drug Discount Program.

US FDA grants Fast-Track status to Axcella’s AXA1125 for NASH treatment
US FDA grants Fast-Track status to Axcella’s AXA1125 for NASH treatment
The US Food and Drug Administration (FDA) has granted a Fast-Track Designation to Axcella Therapeutics’ AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. ...
Sensonics wins FDA approval for Eversense E3 CGM with implantable sensor
Sensonics wins FDA approval for Eversense E3 CGM with implantable sensor
Continuous Glucose Monitoring System Manufacturer Sensonics has received FDA approval for its Eversense E3, which can be used to measure glucose levels in adults with diabetes for up to six months....
Pfizer, Biohaven Tout Positive Phase 3 Results for Migraine Drug Study in Asia
Pfizer, Biohaven Tout Positive Phase 3 Results for Migraine Drug Study in Asia
Pfizer and Biohaven said a single 75-mg dose of their experimental migraine drug, rimegepant, significantly reduced acute symptoms starting at two hours and lasting for up to 48 hours. ...
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