Pharma News

BioCryst Pharmaceuticals received USFDA approval for RAPIVAB® (peramivir injection)

  • Posted on: 25 September 2017
  • By: PharmaTutor News

BioCryst Pharmaceuticals, Inc a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients 2 years and older who have been symptomatic for no more than two days. The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. Those results will be presented at the upcoming ID Week 2017 meeting in San Diego.


Roche receives EU approval of TECENTRIQ® (atezolizumab)

  • Posted on: 23 September 2017
  • By: PharmaTutor News

Roche announced that the European Commission (EC) has granted a marketing authorisation for TECENTRIQ (atezolizumab) as a monotherapy for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) after they have been previously treated with chemotherapy regardless of PD-L1 status. People with EGFR-activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving TECENTRIQ. This approval is based on results from the large randomised Phase III OAK study and the randomised Phase II POPLAR study.1,2 The Phase III OAKstudy showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months–4.2 months longer than those treated with docetaxel chemotherapy (median OS: 13.8 vs 9.6 months; hazard ratio [HR] = 0.73, 95% confidence interval [CI]: 0.62, 0.87).


GSK India to sell it’s land to Oberoi Realty Limited

  • Posted on: 23 September 2017
  • By: PharmaTutor News

The GlaxoSminthKline to sell it's thane based property to Oberoi Realty Limited in Rs. 555 crores. The proposed property in 60 acres located in thane, Maharashtra.


Guselkumab shows skin clearance in moderate to severe Psoriasis

  • Posted on: 22 September 2017
  • By: PharmaTutor News

Janssen Research & Development, LLC (Janssen) presented new longer-term data from the open-label extension of the VOYAGE1 trial demonstrating consistent rates of skin clearance with TREMFYA™ treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody. The longer-term findings from the Phase 3 VOYAGE 1 study presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress showed more than 80 percent of patients receiving TREMFYA™, including those initially treated with placebo or the anti-tumor necrosis factor (TNF)-alpha agent Humira® (adalimumab) achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90), or near complete skin clearance, and an Investigator’s Global Assessment (IGA) score of clearedor minimal disease at week 100. The findings, presented during an EADV late-breaker session, follow the recent European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of TREMFYA™, and the United States Food and Drug Administration (FDA) approval of TREMFYA™ in July.


Pfizer's Avelumab got EU nod for carcinoma

  • Posted on: 22 September 2017
  • By: PharmaTutor News

Merck KGaA, Darmstadt, Germany, and Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for BAVENCIO® (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. BAVENCIO will have marketing authorization in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. BAVENCIO is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.


Pfizer filed case against Johnson & Johnson over Remicade

  • Posted on: 22 September 2017
  • By: PharmaTutor News

Pfizer filed suit in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson (J&J).


Sun Pharma received USFDA for Odomzo® (sonidegib)

  • Posted on: 21 September 2017
  • By: PharmaTutor News

Sun Pharma and includes its subsidiaries or associate companies) announced that one of its wholly owned subsidiaries has received approval from the US Food and Drug Administration (FDA) for a new label for Odomzo® (sonidegib), an oral hedgehog inhibitor indicated for the treatment of patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.


Glenmark Pharmaceuticals receives USFDA approval for Nitroglycerin Sublingual Tablets

  • Posted on: 20 September 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 Nitroglycerin Sublingual Tablets USP, 0.3 mg, 0.4 mg, and 0.6 mg, the generic version of Nitrostat® Sublingual Tablets, 0.3 mg, 0.4 mg, and 0.6 mg, of Pfizer, Inc.


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