Industry News

- Read more about FDA Approve lupin’s Generic Ortho Cyclen® 28 Tablets
Pharma Major Lupin Limited (Lupin) announced that it has received final approval for Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg from the United States Food and Drug Administration (FDA) to market a generic version of Janssen Pharmaceuticals, Inc.’s Ortho-Cyclen® 28 Tablets (Norgestimate/Ethinyl Estradiol). The approved product will be manufactured at Lupin’s Pithampur facility.
- Read more about FDA Advisory Committee Votes(7-6) to Cempra's Solithromycin
Cempra, Inc. announced that the majority of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted (7-6) that efficacy results of Cempra's solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP).
- Read more about AbbVie get FDA Orphan Drug Designation for Investigational Medicine Veliparib
AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to veliparib, an oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, being investigated in combination with chemotherapies, such as carboplatin and paclitaxel, or radiation for the treatment of advanced squamous non-small cell lung cancer (NSCLC).
- Read more about US regulatory department fires generic pharmaceutical companies
The US regulatory department is all set to launch criminal report against 14 generic pharmaceuticals for conspiring to set medicine prices.
- Read more about Roche show new data from Actemra/RoActemra & Rituxan/MabTheraon at ACR/ARHP annual meeting
Roche, a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives, announced that new data from Actemra/RoActemra and Rituxan/MabThera will be presented during the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting from 11-16 November in Washington, D.C, US. These data add to the significant body of evidence for Actemra/RoActemra and Rituxan/MabThera in RA and other serious immune-mediated conditions including GCA, systemic sclerosis (SSc), Takayasu arteritis, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
- Read more about FDA Accepts Genentech's BLA For Subcutaneous Formulation Of Rituximab
Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Genentech's Biologics License Application for a subcutaneous formulation of rituximab in multiple blood cancer indications.
- Read more about Eli Lilly & Incyte Corporation announce New data from pivotal RA-BEACON study
Eli Lilly and Company and Incyte Corporation announced that new data from RA-BEACON - a pivotal phase 3 study of baricitinib in the treatment of moderate-to-severe rheumatoid arthritis (RA) - showed baricitinib demonstrated significant improvement in patient-reported outcomes and health-related quality of life (HRQOL) measures, fatigue and pain compared with placebo. The results of the study were published in Annals of the Rheumatic Diseases. The global trial is part of the ongoing study of baricitinib, a once-daily oral medication currently under regulatory review for the treatment of moderate-to-severe RA.
- Read more about Biocon and Mylan's MAA for insulin glargine accepted by EMA
Biocon and Mylan have announced that the European Medicines Agency (EMA) has accepted for review marketing authorization application (MAA) for insulin glargine, a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.

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- Read more about Pfizer’s Prevenar 13® get Approval For Use in Infants and Children in China
Pfizer China announced that it has received approval from the Chinese Food and Drug Administration (CFDA) to market its pneumococcal 13-valent conjugate vaccine, Prevenar 13®, in China for active immunization for the prevention of invasive diseases (including bacteremic pneumonia, meningitis, septicemia, and bacteremia) caused by Streptococcus pneumoniae (S. Pneumoniae) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and children aged 6 weeks to 15 months. S. pneumoniae is the most common cause of invasive disease as well as pneumonia and upper respiratory tract infections
- Read more about Pfizer discontinues clinical development of PCSK9 inhibitor, bococizumab
Pfizer Inc. announced the discontinuation of the global clinical development programmeme for bococizumab, its investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i). The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide value to patients, physicians, or shareholders. As a result, Pfizer has decided to discontinue the development programme, including the two ongoing cardiovascular outcome studies.