FDA OK's Cubist's Sivextro; another antibiotic 'GAIN'

After the markets closed on 20 June, the FDA gave the good news to Cubist Pharmaceuticals that its antibiotic Sivextro (tedizolid phosphate) gained the agency's approval as a treatment for acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant (MRSA) and methicillin-susceptible strains, various Streptococcus species and Enterococcus faecalis.

After the markets closed on 20 June, the FDA gave the good news to Cubist Pharmaceuticals that its antibiotic Sivextro (tedizolid phosphate) gained the agency's approval as a treatment for acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant (MRSA) and methicillin-susceptible strains, various Streptococcus species and Enterococcus faecalis.

Sivextro, a once-daily oxazolidinone available in intravenous and oral forms, was beat, however, getting across the finish line by Durata...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Alimentary/Metabolic

ProKidney Pins Hopes On Accelerated Approval For Rilparencel

 

After posting encouraging Phase II results, the company plans to meet with the US FDA about using data from an ongoing Phase III study for an accelerated approval.

Eolo Pharma Advances In Obesity With Thermogenesis Approach

 
• By 

Emerging Company Profile: Early-stage biotech Eolo will seek cash and deals for its novel obesity drug SANA after positive Phase I results for weight loss, lean muscle mass preservation and fat mass reduction.

Protagonist Hopes To Come From Behind In Obesity With Oral Triple Agonist

 

The company announced plans to move an oral GLP-1/GIP/GCG receptor agonist peptide into clinical development for obesity in 2026.

Altimmune’s Phase IIb MASH Data Send Share Price Plunging

 
• By 

Altimmune’s stock price did not recover on June 27, after a 57% dip the day before, despite efforts to position pemvidutide as both resolving MASH and offering weight loss.

More from Therapy Areas

Actithera Raises $75m To Enter Competitive FAP-Targeting Radioligand Field

 

While companies such as Eli Lilly and Roche have faced setbacks to their fibroblast activation protein-targeting oncology therapies, Actithera believes its radiopharmaceuticals platform will prove more successful.

J&J Seeks Schizophrenia Relapse Indication For Caplyta

 

The company is expecting US FDA approval of the drug in a bigger indication, major depressive disorder, later this year.

Stock Watch: US CAR-T And Vaccine Actions: Net Negative For Access

 
• By 

Relaxing CAR-T restrictions may not be an access panacea because of patient fragility and lack of payer incentive. Conversely, the ACIP’s recent recommendation on Thiomersal-containing flu vaccines is probably the thin edge of a more restrictive wedge.