Roche acquires respiratory therapy firm at $8.3 bn -
InterMune's lead medicine pirfenidone is approved for idiopathic pulmonary fibrosis in the EU and Canada -
Singapore: Global biopharmaceutical company, Roche, has acquired InterMune, a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases, at USD8.3 billion. InterMune's lead medicine pirfenidone is approved for idiopathic pulmonary fibrosis (IPF) in the EU and Canada and under regulatory review in the United States. IPF is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis, or scarring, in the lungs. Roche markets Pulmozyme and Xolair in the US and has other novel therapeutic medicines targeting respiratory diseases in clinical development. Commenting on the transaction, Mr Severin Schwan, CEO, Roche, said, "We are very pleased that we reached this agreement with InterMune. Our offer provides significant value to InterMune's shareholders and this acquisition will complement Roche's strengths in pulmonary therapy. We look forward to welcoming InterMune employees into the Roche Group and to making a difference for patients with idiopathic pulmonary fibrosis, a devastating disease." Mr Dan Welch, chairman, CEO and president, InterMune, said, "This merger recognizes the significant value created by our team's commitment, hard work and execution for more than a decade to develop and commercialize treatment options for IPF patients and their families. Roche shares our passion and commitment to the IPF community and to ensuring that pirfenidone is available as quickly as possible to patients in the United States, pending FDA approval. Roche's global resources and scale will not only facilitate and accelerate our ability to deliver pirfenidone to more patients around the world, but also to realize our joint vision to bring additional innovative therapies to patients with respiratory diseases." Pirfenidone has been marketed by InterMune in the EU and Canada as Esbriet since regulatory approval in 2011 and 2012 respectively. After previous regulatory review in the USA in 2010, the Food and Drug Administration (FDA) recommended an additional Phase 3 clinical trial to support the efficacy of pirfenidone. -
FDA approves single dosage HIV drug -
Singapore: The US Food and Drug Administration (FDA) has approved US-based ViiV Healthcare's single dose Triumeq tablets for treatment of HIV-1 infection. Triumeq is ViiV Healthcare's first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine. Triumeq alone is not recommended for use in patients with current or past history of resistance to any components of Triumeq. Triumeq alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in Triumeq is insufficient in these populations. Before initiating treatment with abacavir-containing products, screening for the presence of a genetic marker, the HLA-B 5701 allele, should be performed in any HIV-infected patient, irrespective of racial origin. Products containing abacavir should not be used in patients known to carry the HLA-B5701 allele. Dr Dominique Limet, chief executive officer, ViiV Healthcare, said, "The approval of Triumeq offers many people living with HIV in the US, the first single-pill regimen containing dolutegravir. ViiV Healthcare is committed to delivering advances in care and new treatment options to physicians and people living with HIV. We are proud to announce this important milestone, marking the second new treatment to be approved in the US from our pipeline of medicines." -
US FDA approves GSK’s asthma drug -
GlaxoSmithKline’s inhaled corticosteroid Arnuity Ellipta (fluticasone furoate) has been granted approval by the US Food and Drug Administration -
Singapore: GlaxoSmithKline (GSK) has announced that the United States Food and Drug Administration (US FDA) has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. However, Arnuity is not indicated for relief of acute bronchospasm. It has been approved in the dosages of 100 mcg and 200 mcg. It is administered once daily via the dry powder inhaler Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio. "The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio. It is the first asthma treatment from our new portfolio to have gained approval in the US and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients," Mr Darrell Baker, SVP and head, GSK global respiratory franchise, said. The efficacy and safety of this drug have been evaluated in more than 3,600 patients with asthma. -
China to offer personalized chemotherapy-
Fosun diagnostics has joined hands with Saladax Biomedical to launch MyCare assays-a customized chemotherapy dosing for Chinese cancer patients -
Singapore: China-based Fosun diagnostics and Saladax Biomedical announced the launch of MyCare assay tests for chemotherapy in China. Saladax Biomedical in partnership with Fosun diagnostics has designed customized chemotherapy dosing for patients. MyCare tests provide oncologists with specific information about each patient's exposure to chemotherapy drug, helping the doctor to make informed decisions on dose adjustments. These tests were designed after extensive patient trials conducted by Saladax. Mr Ted Zhu, CEO, Fosun Diagnostics, said, "MyCare assays are blood tests that provide healthcare practitioners with a way to manage each patient individually and design the best suitable treatment for them." He added that such personalized cancer care would help in increasing the effectiveness of chemotherapy and reducing side effects. MyCare kits have received approval from Chinese Food and Drug Administration. Fosun aims to manage distributors and work directly with large healthcare facilities and oncologists to make this technology available to the large Chinese market. Mr Zhu added that he was very pleased to bring this personalized care to the Chinese. Mr Kevin M Harter, president and CEO of Saladax said, "The launch of Saladax's MyCare tests in China represents an important milestone for Saladax. With Fosun partnering us, we have high expectations from this market." The MyCare technology platform covers 80 percent to 90 percent of the routine anti-tumor drug monitoring market. For its accurate and authentic results, the MyCare technology platform and product portfolio are in a leading position in the world, for cancer care. -
Learn CR, CDM & PV. -DELHI
Fill this form to get to know the opportunities in Clinical Research Industry. You can join Short term program and build your career.
Screen reader support enabled.
0 comments:
Post a Comment