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- Read more about e-Pharmacy to Provide Growth Opportunities for Pharma Companies : Frost & Sullivan
The launch was followed by an intense panel discussion on the importance of the concept of e-Pharmacies and the deliberations on the need of guidelines / policies to ensure legitimate players delivering the benefits of the model to consumers, thereby, enabling wider access to medicines and improving public health. The panel’s participants included officials from the Ministry of Health & Family Welfare, Central Drugs Standard Control Organization, World Health Organization (WHO), and consumer activists. The event witnessed an engaging discussion between the concerned stakeholders of the Government as well as the industry.
- Read more about Immunicum submits IND application to FDA for ongoing phase II-trial in the United States
Immunicum announced that the Company has submitted an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) in the U.S. The application is requesting approval to treat kidney cancer patients in the U.S. with Immunicum’s lead cancer immune primer, INTUVAX®, in its ongoing MERECA (MEtastatic REnal cell CArcinoma) phase II-trial.
- Read more about Glenmark Pharmaceuticals receives ANDA approval for Rosuvastatin Calcium Tablets
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Rosuvastatin Calcium Tablets, 5 mg (base), 10 mg (base), 20 mg (base), and 40 mg (base), the generic version of Crestor® Tablets, 5 mg, 10 mg, 20 mg, and 40 mg of IPR Pharmaceuticals, Inc. (IPR).
- Read more about Gilead 's two phase 3b studies evaluating Odefsey meets primary objectives
Gilead Sciences, Inc. announced that two phase 3b switch studies evaluating Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) for the treatment of HIV-1 infection met their primary objectives. The ongoing studies were designed to explore the efficacy and safety of Odefsey among virologically suppressed adult patients switching from the tenofovir disoproxil fumarate (TDF)-based regimens Complera (emtricitabine 200mg/rilpivirine 25mg/tenofovir disoproxil fumarate 300mg) (Study 1216) or Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) (Study 1160). Odefsey combines Gilead's emtricitabine and tenofovir alafenamide with rilpivirine, marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
- Read more about Gilead’s Type II Variation Application for Truvada Receive Positive Opinion by European CHMP
Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Type II variation application for once-daily Truvada^®(emtricitabine 200 mg/tenofovir disoproxil 245 mg) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. Truvada was approved by the EMA in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.
- Read more about Shire launch pediatric indication for HyQvia in Europe
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.
- Read more about AstraZeneca’s antibiotic Zavicefta show positive results in Phase III trial
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.

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- Read more about AstraZeneca receives approval in the EU for Qtern for Type 2 diabetes patients
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.
- Read more about Amgen, UCB submit BLA for romosozumab to US FDA
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.
- Read more about Inclusion of coronary stent in NLEM is weakening the industry sentiment: FICCI
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.