Industry News

- Read more about Iran's Pharmaceutical sector to become a pharma powerhouse post sanction era - Biotechnology sector to have lucrative opportunities
With annual consumption of 30 billion units of various generic medicines, Iran, the second-biggest consumer of generics in the Asian continent spent over USD 4.5 billion on drugs in 2015. While per capita consumption of generic drugs is three times higher than average per capita consumption in the world, biological medicines and drugs for special diseases suffers from limited access. Cardiovascular, Anti-Cancer & chemotherapy drugs, MAB, pain relievers & Hydrocortisones, Anti infections, Plasma products & Recombinants as well as Diabetes control over 55% of the total sales market. Solid dose (Tablet &Capsules) and injection forms control 42% and 38% of total sales market, respectively.
- Read more about Biocon introduces CIMIVIR-L™ for Hepatitis-C in India
Biocon Ltd, Asia's premier biotechnology company, introduces an advanced novel therapy CIMIVIR-L™ for the treatment of Hepatitis C in India. CIMIVIR-L™ is a fixed dose combination of Ledipasvir 90 mg and Sofosbuvir 400 mg, which is an equivalent of the innovator product commercialized by Gilead Sciences in the US.
- Read more about Boehringer Ingelheim Expands Biopharmaceutical Production at Vienna Site
Boehringer Ingelheim will make a significant investment in biopharmaceutical production at its Vienna (Austria) site. There the research-driven pharmaceutical company will establish a new large-scale biopharmaceutical production facility for active ingredients manufactured using cell cultures. With the roughly half billion euro investment Boehringer Ingelheim will also create more than 400 new jobs in the Austrian capital. The exact investment and job numbers will be established as details are ironed out.
- Read more about FDA approves new orphan drug to treat pulmonary arterial hypertension
U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation. Uptravi is marketed by San Francisco-based Actelion Pharmaceuticals US, Inc.
- Read more about FDA approves Zurampic to treat high blood uric acid levels associated with gout
The U.S. Food and Drug Administration approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Zurampic is manufactured by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.
- Read more about Merck KGaA, Darmstadt, Germany and Pfizer Advance Clinical Development Program with Two Additional Phase III trial of Avelumab
Merck KGaA, Darmstadt, Germany and Pfizer announced the opening of trial sites for an international Phase III study of avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with platinum-resistant/refractory ovarian cancer. The JAVELIN Ovarian 200 trial is the first Phase III study of a PD-L1 inhibitor investigated as a treatment for platinum-resistant/refractory ovarian cancer. The alliance also announced that the US Food and Drug Administration has provided approval to move forward with a Phase III study of avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer. The first trial sites are expected to open shortly.
- Read more about Brilique receive positive opinion of EMA committee for extended treatment of patients with history of heart attack
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Astrazeneca's Brilique (ticagrelor) 60mg for the treatment of patients with a history of heart attack and at high risk of having a further atherothrombotic event. The opinion states that, treatment may be started as continuation therapy after an initial one-year treatment with dual anti platelet therapy.

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- Read more about Boehringer Ingelheim's BI 1482694 get US FDA Breakthrough Therapy status
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Boehringer Ingelheim's novel, 3rd-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI), BI 1482694 (HM61713). The BTD is based on results from the phase I/II HM-EMSI-101 clinical trial which were presented at the ESMO Asia 2015 Congress in Singapore.
- Read more about EMA committee recommends marketing approval for AstraZeneca's Tagrisso
AstraZeneca, a global, science-led biopharmaceutical business, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
- Read more about Torax Medical get US FDA approval for Fenix continence restoration system
The US Food and Drug Administration approved Torax Medical In's Fenix continence restoration system to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.