Pharma News

Braeburn Pharmaceuticals announces that the U.S. Food & Drug Administration (FDA) approved Probuphine, the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Probuphine delivers buprenorphine continuously for up to six months and should be used as part of a complete treatment program to include counseling and psychosocial support.

Novavax, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax’ RSV F-Protein nanoparticle vaccine candidate (RSV F Vaccine) for the protection of older adults (60 years of age and older).

Seqirus announced that the US Food and Drug Administration (FDA) has approved FLUCELVAX QUADRIVALENT™(Influenza Vaccine),the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. The use of a four-strain influenza vaccine like FLUCELVAX QUADRIVALENT may now provide protection against both B lineages, which may lead to a decrease in the influenza burden.

Symbiomix announced positive results from the second pivotal trial of lead product candidate SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV). SYM-1219 (secnidazole) is a potent, next-generation 5-nitroimidazole antibiotic with superior pharmacokinetic properties that enable efficacy with significantly less total drug exposure than first generation nitroimidazoles, leading to excellent safety, tolerability and adherence.

Viamet Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted orphan drug designation to VT-1598 for the treatment of coccidioidomycosis, or Valley Fever. VT-1598 is a selective, orally available inhibitor of fungal CYP51 that has demonstrated high potency in preclinical studies against Coccidioides species, the fungal pathogens responsible for Valley Fever.

DelMar Pharmaceutical Inc. announced the successful completion of an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA).

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DS Biopharma (DS) announced plans to develop its anti-fibrotic and anti-inflammatory compound DS102 in chronic obstructive pulmonary disease (COPD) patients as well as in non-alcoholic steatohepatitis (NASH) patients.

Allergan plc. announced that the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, has been accepted by the U.S. Food and Drug Administration (FDA) for standard review. Allergan expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of 2017.

Zambon S.p.A., an international pharmaceutical company committed to the CNS therapeutic area, and its partner Newron Pharmaceuticals S.p.A. (Newron), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the CNS and pain, announced the availability of Xadago (safinamide) in the United Kingdom.

Hyderabad, India and Princeton, NJ, USA Dr.Reddy’s Laboratories Ltd.(BSE: 500124, NSE:DRREDDY, NYSE: RDY) today announced the acquisition of an  eminent portfolio of over the counter (OTC) brands in the cough and cold, pain, and dermatology categories. The company acquired six OTC brands from Ducere Pharma, including DOAN’S®, BUFFERIN®, NUPERCAINAL® Ointment, CRUEX ® Nail  Gel, COMTREX ® , and MYOFLEX ®.