Pharma News

Insulin degludec lead to lesser hypoglycemia in compare to Insulin Glargine : Finding

  • Posted on: 8 December 2017
  • By: PharmaTutor News

People with either type 1 or type 2 diabetes treated with Tresiba® had fewer episodes of low blood sugar (hypoglycaemia) compared with people on insulin glargine U100 regardless of whether they had achieved blood sugar targets.These new post-hoc analyses from the SWITCH 1 and 2 trials were presented at the International Diabetes Federation (IDF) Annual Congress in Abu Dhabi.


Biosimilars Pegfilgrastim Shows action as Neulasta

  • Posted on: 8 December 2017
  • By: PharmaTutor News

Sandoz, a division of Novartis  and the global leader in biosimilars, announced data demonstrating the pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the reference biologic, Neulasta®*. The Phase I study, conducted in healthy volunteers, confirmed that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of PK, PD, safety and immunogenicity profiles. The data were presented during the 2017 San Antonio Breast Cancer Symposium.


USFDA approves Mylan and Biocon´s Ogivri for Treatment of HER2­Positive Breast and Gastric Cancers

  • Posted on: 8 December 2017
  • By: PharmaTutor News

Mylan N.V.and Biocon Ltd.  announced that the U.S. Food and Drug Administration (FDA) has approved Mylan´s OgivriTM (trastuzumab­dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon. OgivriTM has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).


Mitochondrial protein in cardiac muscle cells linked to heart failure : Research

  • Posted on: 6 December 2017
  • By: PharmaTutor News

Reducing a protein found in the mitochondria of cardiac muscle cells initiates cardiac dysfunction and heart failure, a finding that could provide insight for new treatments for cardiovascular diseases, a study led by Georgia State University has shown.


Sun Pharmaceutical Recall Riomet® (Metformin Hydrochloride Oral Solution) due to Microbial Contamination

  • Posted on: 28 November 2017
  • By: PharmaTutor News

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.


FDA approves first two-drug regimen for certain patients with HIV

  • Posted on: 24 November 2017
  • By: PharmaTutor News

The U.S. Food and Drug Administration approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.


Glenmark Pharmaceuticals receives USFDA approval for HAILEY Fe 1/20

  • Posted on: 24 November 2017
  • By: PharmaTutor News

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for HAILEYTM Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/20 mcg and Ferrous Fumarate Tablets), the generic version of Loestrin®1 Fe 1/20 Tablets, of Allergan Pharmaceuticals International Limited.


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