Industry News

Stemline Therapeutics, Inc. announced today that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to SL-401, a targeted therapy directed to the interleukin-3 receptor, for the treatment of blastic plasmacytoid dendritic cell neoplasm.. The FDA’ s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate for serious or life-threatening conditions."/>
Stemline Therapeutics Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for SL-401
Cempra, Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the European Medicines Agency has validated the company’ s marketing authorization application seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired bacterial pneumonia.."/>
Cempra Announces European Medicines Agency Validates MAA for Solithromycin for Treatment of CABP
Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the third quarter of 2016.. The cash dividend of $0.24 per share will be paid on or about October 28, 2016 to stockholders of record as of the close of business on September 23, 2016. Future declarations of dividends are subject to approval of the Board of..."/>
Zimmer Biomet Announces Quarterly Dividend for Third Quarter of 2016
Genmab A/S announced today that Janssen Pharmaceutica NV has submitted a variation to the Marketing Authorization to the European Medicines Agency seeking to broaden the existing marketing..."/>
Genmab Announces European Regulatory Submission for Daratumumab in Relapsed Multiple Myeloma
Gilead Sciences reported on Monday the receipt of marketing authorisation from the European Commission for once-daily Truvada to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk. The company said European Commission has approved the once-daily Truvada in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy..."/>
Gilead awarded European Commission marketing authorisation for Truvada for reducing risk of sexually acquired HIV-1
Veeva Vault enables Daiichi Sankyo to standardize business processes worldwide. PLEASANTON, Calif.& TOKYO---- Veeva Systems today announced that Daiichi Sankyo Company, Limited based in Japan, selected Veeva Vault eTMF, Veeva Vault QualityDocs, and Veeva Vault Submissions to unify content management throughout its research and development operations worldwide. The unique multitenant cloud capabilities of Veeva Vault enable Daiichi Sankyo to easily streamline management..."/>
Daiichi Sankyo Selects Veeva Vault to Streamline Submissions, eTMF, and Quality Management
Trillium Therapeutics Inc., a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, announced today that the company is scheduled to present an update on the company's programs and progress at several upcoming conferences. --Ladenburg Thalmann 2016 Healthcare Conference Presenter: Dr. Niclas Stiernholm, Chief Executive Officer Date and Time: September 27, 2016 at 1:30 p.m. EDT Location: Hotel..."/>
Trillium Therapeutics to Present at Investor and Scientific Conferences in September
Pfizer Inc. announced today that 19 abstracts will be presented at ESC Congress 2016, to be held August 27– 31 in Rome, Italy. These new data from post-hoc analyses from ARISTOTLE and retrospective real-world data analyses continue to underscore..."/>
Bristol-Myers Squibb and Pfizer to Present New Eliquis (apixaban) Analyses at ESC Congress 2016
Premier stated on Monday that its net income was USD50.4m for the fiscal fourth quarter ended 30 June 2016.. This marks an improvement when compared with net income of USD32.1m for the same period a year ago. The company said the increase in earnings is primarily due to reduced income tax expense in the fiscal 2016 quarter relative to the year ago period, due to the timing of recording deferred tax expense in the prior year."/>
Premier achieves net income of USD50.4m for Q4 fiscal 2016
CytoDyn Inc., a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus infection, announces that the first of 11 HIV-1 patients receiving PRO 140 as a monotherapy in a Phase 2 b extension study has reached two years of complete virologic suppression. Four additional patients are expected to reach the two-year benchmark in the next three weeks and five more patients are..."/>
Patients Approach Two Years of Complete HIV Viral Load Suppression in Phase 2b PRO 140 Monotherapy Extension Study
DaVita HealthCare Partners Inc., and a leading independent provider of integrated health and kidney care services in the United States, welcomes Jeffrey Allen Giullian, MD, MBA, as a vice president of medical affairs and member of the Office of the Chief Medical Officer, DaVita's physician leadership team. Giullian will hold the position of national group medical director and will also be the clinical leader for the..."/>
DaVita Kidney Care Welcomes Dr. Jeff Giullian to Physician Leadership Team
Provectus Biopharmaceuticals, Inc., a clinical-stage oncology and dermatology biopharmaceutical company today announced that it has received a U.S. patent covering additional aspects of its process for synthesizing halogenated xanthenes, the family of compound to which rose bengal belongs. The patent covers use of certain halogenated..."/>
Provectus Biopharmaceuticals, Inc. Receives Patent from USPTO Related to Rose Bengal Analogs
Danaher Corporation announced that Executive Vice President and Chief Financial Officer, Daniel L. Comas, will be presenting at the Vertical Research Partners Industrial Conference in Westbrook, Connecticut on Wednesday, September 7, 2016 at 10:15 a.m. ET. Danaher is a global science and technology innovator committed to helping its customers solve complex challenges and improving quality of life around the world."/>
Danaher to Present At Vertical Research Partners Industrial Conference
Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today its unaudited second quarter ended June 30, 2016.. Weidong Yin, Chairman, President and CEO of the Sinovac, commented, "As forecasted on our first quarter earnings call, we experienced a continued decline to our financial results in the second quarter due to the incident involving the improper distribution and sale of vaccines in Shandong province."/>
Sinovac Reports Unaudited Second Quarter 2016 Financial Results
Eisai to Launch Chocola BB Mouth Ulcer Repair Shot
Biostar Pharmaceuticals disclosed on Tuesday that it recorded a net loss of USD6.9m for the second quarter ended 30 June 2016.. This is compared with a lower net loss of USD0.5m for the second quarter 2015.. Net sales of USD0.6m were recorded for the second quarter ended 30 June 2016, down USD13.6m, or 95.6% over the net sales of USD14.18m in the same period in 2015.."/>
Biostar Pharmaceuticals incurs higher net loss of USD6.9m for Q2 2016
Presbia PLC, an ophthalmic device company and a provider of near-vision restoration, announced on Monday that on 2 August 2016, its wholly-owned subsidiary, Presbia Ireland Ltd, completed the purchase of the assets of Neoptics AG, including its intellectual property portfolio. Financial details of this acquisition were not available. According to the company, the acquisition of Neoptics' assets, including its patent portfolio, consolidates the principal intellectual..."/>
Presbia’s subsidiary completes acquisition of patent portfolio of Neoptics
Imprivata ®, the healthcare IT security company. has joined the Imprivata Developer Partner program, utilizing the Imprivata OneSign ® Print Connector to establish connectivity between UniPrint’..."/>
UniPrint Partners with Healthcare IT Security Leader, Imprivata, to Enable Clinicians To Securely Print Protected Health Information
Claris Lifesciences Ltd last year, is readying a bid for the Indian company's injectable drugs business, reported Mint."/>
Deals Buzz: Future Group explores deal with Aditya Birla Retail [Mint, New Delhi]
Claris Lifesciences Ltd last year, is readying a bid for the Indian company's injectable drugs business, according to two people familiar with the development. The private equity firm will partner with a drug maker to acquire Claris's business that is valued at about $400-450 million, said one of the two people cited above, requesting anonymity. The name of Carlyle's partner for the bid could not be..."/>
Carlyle Group readies bid for Claris's injectable drugs business [Mint, New Delhi]
Piramal Enterprises Ltd's structured investment group unit has agreed to invest Rs.150 crore in Smaaash Entertainment Pvt. Ltd, a sports-based entertainment company co-owned by cricketer Sachin Tendulkar, two people aware of the development said. Currently, Smaaash has five gaming arcades in Mumbai, Bengaluru, Gurgaon, Noida and Hyderabad."/>
Piramal invests Rs150 crore in Smaaash Entertainment [Mint, New Delhi]
Lupin Ltd, India's third largest drug maker, said on Monday that it had received approval from the Central Drugs Standard Control Organisation to launch a 100 mg acotiamide tablet used to treat indigestion. Lupin said it will commence promotion of the product in India shortly. Acotiamide was developed by Japan's Zeria Pharmaceutical Co. Ltd and approved by the country's Pharmaceuticals and Medical Devices Agency, a regulatory agency similar to India's CDSCO."/>
Lupin gets nod for a new indigestion drug [Mint, New Delhi]

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