Industry News

- Read more about KCDA and Lupin penalised by CCI on anticompetitive conduct
The Competition Commission of India (Commission) has found the Karnataka Chemists and Druggist Association (KCDA) and Lupin Ltd. (Lupin) to be in contravention of the provisions of the Competition Act, 2002 (the Act). In a case filed by M/s Maruti & Co., it was brought to the notice of the Commission that KCDA restraints pharmaceutical companies from appointing new stockists in the State of Karnataka unless a No Objection Certificate (NOC) is obtained from it.
- Read more about Vanda Pharma launches Hetlioz in Germany
Vanda Pharmaceuticals Inc. (Vanda), a specialty pharmaceutical company, announced that Hetlioz (tasimelteon) is now available for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in Germany.
- Read more about Vaccinex Receives FDA Fast Track Designation for VX15 Antibody for Huntington’s Disease
Vaccinex, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VX15 as a potential treatment for Huntington’s disease (HD).
- Read more about US FDA approves Shire's Adynovate with Baxject III reconstitution system
Shire plc, a leading global biotechnology company, announced that the US Food and Drug Administration (FDA) has approved the Baxject III reconstitution system for Adynovate [Antihemophilic Factor, (Recombinant), PEGylated].
- Read more about Ipsen Announces FDA Approval of Dysport (abobotulinumtoxinA) for injection
Ipsen announced that the U.S. Food and Drug Administration (FDA) has approved Dysport® (abobotulinumtoxinA) for injection for the treatment of pediatric lower limb (PLL) spasticity in children two years of age and older.
- Read more about Shire’s SHP626 (Volixibat) Receives FDA Fast Track Designation
Shire plc announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. Shire is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter (ASBT), a protein which is primarily responsible for recycling bile acids from the intestine to the liver. NASH is a serious, chronic liver disease for which there are currently no approved drugs.
- Read more about Pfizer reports positive results from phase 3 maintenance study of Xeljanz
Pfizer Inc. announced top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third phase 3 study of Xeljanz (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain is a 52 week study that evaluated oral tofacitinib 5 mg and 10 mg twice daily (BID) as a maintenance treatment in adult patients with moderately to severely active UC who previously completed and achieved clinical response in either the OCTAVE Induction 1 or OCTAVE Induction 2 studies.
- Read more about Caladrius Biosciences gets US FDA fast track status for CLBS03 to treat type 1 diabetes
Caladrius Biosciences, Inc., a cell therapy company combining an industry-leading development and manufacturing services provider, PCT, with a select therapeutic development pipeline, announces that its product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of type 1 diabetes mellitus (TID), making it the first known therapeutic candidate for treatment of T1D to receive the designation.
- Read more about Sanofi Get FDA Approval Of Adlyxin For Treatment Of Adults With Type 2 Diabetes
Sanofi announced that the U.S. Food and Drug Administration (FDA) approved AdlyxinTM (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.
- Read more about FDA approves lixisenatide as AdlyxinTM in the U.S.
Zealand Pharma (Zealand), a biotechnology company, announces that the U.S. Food and Drug Administration (FDA) has granted approval of lixisenatide for the treatment of adults with type 2 diabetes. Lixisenatide, a once-daily prandial GLP-1 receptor agonist, was invented by Zealand and global development and commercial rights are licensed to Sanofi.