Pharma News

Shire launch pediatric indication for HyQvia in Europe

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

Shire plc, a leading global biotechnology company, has announced that the company is launching a pediatric indication for HyQvia (Human Normal Immunoglobulin (10%), Recombinant Human Hyaluronidase) across Europe. This follows the recent marketing authorisation granted by the European Commission to Baxalta, now part of Shire, in June 2016.


AstraZeneca’s antibiotic Zavicefta show positive results in Phase III trial

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

AstraZeneca announced positive results from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for the treatment of a broad range of serious Gram-negative bacterial infections in hospitalised patients. Zavicefta has been developed in response to the urgent need for new antibiotics to treat serious infections that are becoming increasingly resistant to current antibiotics commonly used for serious infections, such as carbapenems and polymixins, including colistin.


AstraZeneca receives approval in the EU for Qtern for Type 2 diabetes patients

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

AstraZeneca announced that the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway. The fixed-dose combination of saxagliptin and dapagliflozin is the first DPP-4i/SGLT-2i combination product to be approved in Europe.


Amgen, UCB submit BLA for romosozumab to US FDA

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

Amgen and UCB announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and inhibiting sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.


Inclusion of coronary stent in NLEM is weakening the industry sentiment: FICCI

  • Posted on: 23 July 2016
  • By: PharmaTutor News

As the Indian medical device industry braces up for new opportunities, it remains tied up in the restrictive business environment. With the recent announcement on inclusion of coronary stent of all categories in National List of Essential Medicine the industry sentiment has further weakened.


U.S. FDA grant Spark Therapeutics & Pfizer Breakthrough Therapy Designation for SPK-9001

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

Spark Therapeutics and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies' SPK-FIX program, in development for the treatment of hemophilia B. SPK-9001, a novel bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized, high-activity human factor IX variant, is being investigated in an ongoing Phase 1/2 trial as a potential one-time therapy.


Relievant Medsystems, Inc. Receives FDA 510(k) Clearance for INTRACEPT

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

Relievant Medsystems, Inc., a privately held medical device company pioneering the therapy of nerve ablation within vertebral bodies for the treatment of chronic low back pain, announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the INTRACEPT® Intraosseous Nerve Ablation System.


CytoDyn Submits Orphan Drug Application to FDA for Pretreatment With PRO 140

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

CytoDyn Inc. announces that it has submitted to the U.S. Food And Drug Administration (FDA) an application for orphan drug designation for the use of PRO 140 (humanized monoclonal antibody to CCR5) in the pretreatment of HIV Type-1 (HIV-1) infection in treatment-naïve adults while they are waiting for drug resistance assay results to construct a subsequent Highly Active Antiretroviral Therapy (HAART) regimen.  The generation of these assay results typically takes approximately two weeks.


Advaxis’ AXAL Receives Fast Track Designation by the FDA

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

Advaxis, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), as a Fast Track product for adjuvant therapy for high-risk locally advanced cervical cancer patients. The investigation of AXAL in this under-served population will be conducted in accordance with the Special Protocol Assessment (SPA) recently granted by the FDA.   


FDA Authorize Viracor-IBT Laboratories, Inc.’s Zika Virus RT-PCR Test for Emergency Use

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

Viracor-IBT Laboratories, Inc., a wholly-owned subsidiary of Eurofins Scientific (EUFI.PA), announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Zika Virus Real-time RT-PCR assay.  


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