Pharma News

AstraZeneca withdraw European MAA for cediranib

  • Posted on: 23 September 2016
  • By: Shalini.Sharma

AstraZeneca announced its decision to withdraw the Marketing Authorisation Application (MAA) submitted to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2015 for cediranib in combination with platinum-based chemotherapy followed by maintenance monotherapy for the treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal sub types).


US FDA approves Sarepta's Exondys 51 inj

  • Posted on: 22 September 2016
  • By: Shalini.Sharma

Sarepta Therapeutics, Inc., a developer of innovative RNA-targeted therapeutics, announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Exondys 51 (eteplirsen) as a once weekly intravenous infusion of 30 milligrams per kilogram for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.


Syngene sign deal with Strand Life Sciences to purchase systems biology and pharma services practice

  • Posted on: 22 September 2016
  • By: Shalini.Sharma

Syngene International Ltd., Asia’s leading contract research organization, and Strand Life Sciences, have completed a deal through which Syngene has purchased assets of Strand Life Sciences related to systems biology, Heptox and pharma bioinformatics services. This includes target dossier business and rights to NGS data analytics and Sarchitect platforms, supported by a strong scientific team. Financial details of the deal were not disclosed.


DBV Technologies Receives FDA Fast Track Designation for Viaskin Milk

  • Posted on: 22 September 2016
  • By: Shalini.Sharma

DBV Technologies announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Viaskin Milk, the Company’s investigational treatment for pediatric patients two years of age and older with Immunoglobulin E (IgE)-mediated cow’s milk protein allergy (CMPA), currently under clinical investigation in a Phase IIb trial. There are currently no approved treatments for CMPA, the most common food allergy in infants and young children. Fast Track is a process designed by the FDA to facilitate the development, expedite the review of drugs to treat serious conditions and fill an unmet medical need.


Baxter launch NUMETA G13E in Europe for preterm infants at risk for malnutrition

  • Posted on: 22 September 2016
  • By: Shalini.Sharma

Baxter International Inc., a global leader in PN therapy, announced the European launch of NUMETA G13E 300 ml, the only ready-to-use parenteral (intravenous) nutrition (PN) product available to treat preterm infants (less than 37 weeks gestation age) who are at high risk for infection and malnutrition in the early hours and days of their lives. The announcement was made during the 38th ESPEN (The European Society for Clinical Nutrition and Metabolism) Congress in Copenhagen, September 17-20, with recognition that the first preterm patients have received PN therapy on NUMETA G13E in Sweden.


Vical, Astellas phase 2 study of CMV vaccine, ASP0113 meet primary endpoint

  • Posted on: 21 September 2016
  • By: Shalini.Sharma

Vical Incorporated and Astellas Pharma Inc. announced topline results from a randomized, double-blind, placebo-controlled phase 2 study evaluating the safety and efficacy of cytomegalovirus (CMV) vaccine, ASP0113, versus placebo in kidney transplant patients receiving an organ from a CMV-seropositive donor. Results from the study demonstrated that the trial did not meet its primary endpoint, which was the proportion of patients having CMV viremia defined as a plasma viral load of = 1000 IU/ml by central laboratory assay through one year after first injection of study drug. Additionally, the secondary endpoints of CMV-associated disease and CMV-specific antiviral therapy, which were evaluated by an independent, blinded Adjudication Committee, were similar in both treatment groups.


US FDA completes Lannett’s 3 manufacturing facilities cGMP inspection

  • Posted on: 21 September 2016
  • By: Shalini.Sharma

Lannett Company, Inc., a company manufactures and distributes high quality affordable generic medications, announced that the US Food and Drug Administration (FDA) recently completed a cGMP inspection of the company's manufacturing facility in Philadelphia, as well as inspections of two facilities located in Armenia: Darmantest Laboratory, the company's pharmacokinetic subsidiary, and Firmplace, a stability laboratory with which the company has a strategic relationship.  The inspections concluded with two minor 483 observations at the company's facility in Philadelphia and zero observations at the laboratories in Armenia.


Lannett’s Buprenorphine & Naloxone Sublingual Tablets, 2 mg/0.5 mg And 8 mg/2 mg get USFDA approval

  • Posted on: 21 September 2016
  • By: Shalini.Sharma

Lannett Company, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the therapeutic equivalent to the reference listed drug, Suboxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg.  According to IMS, total U.S. sales in 2015 of Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, at Average Wholesale Price (AWP) were approximately $270 million.


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