FDA Confirms Paragraph IV Patent Litigation for Dalbavancin Hydrochloride
MONTREAL, Jan. 17, 2022 /PRNewswire/ -- Paladin Labs Inc., a subsidiary of Endo International plc (NASDAQ: ENDP), announced today the launch of Xydalba® (dalbavancin for injection), a 30-minute intravenous (IV) therapy for acute bacterial skin and skin structure infections (ABSSSI) that can be administered as a single- or two-dose regimen. Xydalba® is now available to patients nationwide in Canada.
A clinical trial to test the antibiotic dalbavancin for safety and efficacy in treating complicated Staphylococcus aureus (S. aureus) bacteremia has begun. The trial will enroll 200 adults hospitalized with complicated S. aureus infection at approximately 20 trial sites around the United States. The trial is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
According to Coherent Market Insights, the global methicillin-resistant Staphylococcus aureus (MRSA) drugs market is estimated to be valued at US$ 922.2 million in 2018, and is projected to exhibit a CAGR of 4.1% over the forecast period (2018–2026).
Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today highlighted that the U.S. Food and Drug Administration (FDA) has accepted for review United Therapeutics Corporation's (NASDAQ: UTHR) New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH). The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of April 27, 2020. Trevyent is a drug-device combination product that combines two-day, single use, disposable PatchPump® technology with treprostinil, for the subcutaneous treatment of PAH.
Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant bacterial infections, today announced the appointment of David Melnick, M.D., as Chief Medical Officer to oversee Spero’s clinical development and regulatory strategy. Dr. Melnick brings significant clinical experience to Spero with 18 years in anti-infective drug development including seven successful anti-infective drug approvals.
Cipher Pharmaceuticals and Cardiome Pharma Announce Strategic Transaction for Canadian Business Portfolio of Cardiome
MSD's Keytruda (pembrolizumab) was accepted for the treatment of late-stage non-small cell lung cancer (NSCLC) after being considered through SMC's Patient and Clinician Engagement (PACE) process, designed for appraising medicines used at the end of life and for very rare conditions.
Cardiome's Xydalba (dalbavancin) is cleared for administration as either one 1500mg dose or as a two-dose regimen of 1000mg followed one week later by 500mg, each administered intravenously over 30 minutes.
Cardiome Pharma Corp., a specialty pharmaceutical company, announced that Xydalba (dalbavancin) has been approved by the European Medicines Agency (EMA) for administration as a single, 30 minute, 1500mg infusion (three 500mg vials). This single dosing regimen is in addition to the initially approved dosing regimen of 1000 mg (two 500mg vials) followed one week later by 500 mg (a single 500mg vial).