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Showing "regulation regulatory" News Articles 51 to 75 of 6,500+

Friday 27th February 2015

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vitae Pharmaceuticals, Inc. - VTAE

NEW YORK, Feb. 27, 2015 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Vitae Pharmaceuticals, Inc. ("Vitae" or the "Company") (NASDAQ: VTAE).  Such investors are advised to contact Robert S. Willoughby at rswilloughby@pomlaw.com or 888-476-6529, ext. 237. The investigation concerns whether Vitae and certain of its officers and/or directors have violated ...

Cortendo Announces Proposed Changes to Board of Directors

Cortendo AB (publ) [ticker: CORT on NOTC-A], a global biopharmaceutical company focused on orphan endocrine disorders, today announced changes to the Company’s board of directors proposed by the company’s nomination committee. John H. Johnson has been nominated to serve as chairman and Richard Kollender to serve as a director. Both nominations are subj...

In Pre-Clinical Studies Ibrutinib Enhances Anti-tumor Activity When Combined With An Anti-PD-L1 Antibody

SUNNYVALE, Calif., Feb. 27, 2015 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today highlighted findings from a pre-clinical study published in the Proceedings of the National Academy of Sciences (www.pnas.org/cgi/doi/10.1073/pnas.1500712112) that showed when ibrutinib (IMBRUVICA®) was combined with an anti-PD-L1 antibody (a checkpoint inhibitor), suppression of tumor growth was en...

Pharmacyclics Provides Clinical Update on BTK Inhibitor for Autoimmune Diseases

SUNNYVALE, Calif., Feb. 27, 2015 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that longer-term toxicology studies for its newly developed Bruton's tyrosine kinase (BTK) inhibitor for rheumatoid arthritis, or RA, have been completed. The results of these preclinical evaluations have been communicated to the U.S. Food and Drug Administration. The feedback received from the...

Immunovaccine Inc. (TSX: IMV) receives Fast Track and Phase I trial approval for Ebola and Anthrax vaccine programs, signs co-development agreement with Gilead Sciences

Fast Track designation of two new proprietary DepoVax programs for critical diseases and comprehensive long-term agreement with major pharmaceutical company advances Immunovaccine's pipeline and significantly strengthen's company's financial position Halifax, Nova Scotia (PRWEB) February 27, 2015 Immunovaccine Inc. (“Immunovaccine”) (TSX: IMV), a clinical stage vaccine and immunot...

Genstar Capital Backed eResearch Technology to Acquire PHT Corporation

SAN FRANCISCO, Feb. 27, 2015 /PRNewswire/ -- Genstar Capital, a leading middle market private equity firm that focuses on investments in targeted segments of the healthcare, software, industrial technology, and financial services industries, today announced that its portfolio company eResearchTechnology, Inc. (ERT) signed a definitive agreement to acquire PHT Corporation, the eClinical innova...

St. Jude Medical to Present at the Barclays Global Healthcare Conference

St. Jude Medical, Inc. (NYSE:STJ) will present at the Barclays Healthcare Conference on Wednesday, March 11 in Miami. Don J. Zurbay, chief financial officer, will address the conference at 8:00 a.m. ET. The presentation will also be webcast live at investors.sjm.com. About St. Jude Medical St. Jude Medical is a global medical device manuf...

Epizyme to Present at Cowen and Company 35th Annual Health Care Conference

Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today announced its participation at the Cowen and Company 35th Annual Health Care Conference on Monday, March 2 at 3:30 p.m. ET at the Boston Marriott Copley Place in Boston. ...

Novartis lung cancer drug Zykadia® recommended for EU approval in patients with ALK+ NSCLC previously treated with crizotinib

Novartis International AG / Novartis lung cancer drug Zykadia® recommended for EU approval in patients with ALK+ NSCLC previously treated with crizotinib . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement. If approved, Zykadia (ceritinib) would be the first treatment option for patients in Europe with ALK+ NSCLC ...

Toujeo® Receives Positive Opinion from the European Regulatory Authorities

Toujeo® Receives Positive Opinionfrom the European Regulatory Authorities Paris, France - February 27, 2015 - Sanofi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), a next-generation b...

Drug research, development more efficient than expected

Despite ever increasing regulation in drug approval and the rising costs of research, drug research and development remains unexpectedly efficient, a new shows. To investigate the efficiency in the development of new drugs, the researchers analyzed a...

Biogen Idec and Sobi announce positive top-line efficacy and safety results from phase 3 Alprolix® paediatric study

Study Meets Primary Endpoint and Achieves Low Bleeding Rates with Once-Weekly Prophylactic Dosing in Children Results Support EU Regulatory Submission and Future Paediatric Indication Applications Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today announced positive top-line results of the Kids B-LONG Phase 3 clinical study that evaluated the ...

Eddingpharm Gains China Rights To Omega-3 Product in $169 Million Deal

Eddingpharm, a China in-licensing company, signed a deal worth up to $169 million for China rights to Vascepa®, a prescription omega-3 drug from Amarin Corp., an Irish-US pharma. Vascepa lowers triglyceride levels. The deal includes a $15 million...

Sanofi: Toujeo® Receives Positive Opinion from the European Regulatory Authorities

Toujeo® Receives Positive Opinionfrom the European Regulatory Authorities Paris, France - February 27, 2015 - Sanofi (http://en.sanofi.com/) announced today that the Committee for Medicinal Produc...

Biogen Idec and Sobi Announce Positive Top-Line Efficacy and Safety Results from Phase 3 ALPROLIX® Pediatric Study

-Study Meets Primary Endpoint and Achieves Low Bleeding Rates with Once-Weekly Prophylactic Dosing in Children - - Results Support EU Regulatory Submission and Future Pediatric Indication Applications- Biogen Idec (NASDAQ: BIIB) and

Alexion Joins Patient Organizations Worldwide in Support of International Rare Disease Day 2015

Company will participate in events across the globe to raise awareness of the need for improved diagnosis and treatment for patients with rare diseases Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) joins the European Organization for Rare Diseases (EURORDIS), the National Organization for Rare Disorders (NORD) and rare disease patient and healthcare advo...

Quality control for adult stem cell treatment

A team of European researchers has devised a strategy to ensure that adult epidermal stem cells are safe before they are used as treatments for patients. The approach involves a clonal strategy where stem cells are collected and cultivated, genetical...

Third-party medtech firm acquired by Globus Medical in $52.9M deal

Globus Medical agreed to pay $52.9 million to buy third-party medtech firm Branch Medical Group.  -More- Complimentary Webinar - Current FDA Initiatives and Regulatory Trends for the Medical Device Industry Please join Larry Spears, former ...

Sign-Up Season Is Over, But Special Enrollment Events Are About To Grow

A new regulation takes effect in April that expands the circumstances that enable people to sign up or switch health coverage, even though open enrollment officially ended Feb. 15.

Sign-Up Season Is Over, But List Of Special Enrollment Events Is Expanding

A new regulation takes effect in April that expands the circumstances that enable people to sign up or switch health coverage, even though open enrollment officially ended Feb. 15.

ERT Acquires PHT

Clinical Informatics News | ERT announced this morning that it has acquired PHT Corporation. Financial terms of the transaction were not disclosed, and the transaction is subject to regulatory review and is expected to close within the next several ...

Millicom Joins GSMA’s Mobile Health Partnership in Africa

Millicom (STO:MIC) (NASDAQ:MICC) announced today that it has joined the GSMA’s cross-ecosystem Pan-African mHealth initiative (PAMI) which is designed to connect people with the mobile industry and health services in eleven countries in Sub-Saharan Africa, including the Tigo operations in Ghana, Rwanda and Tanzania. PAMI aims to develop commerci...

New Drug Receives FDA Approval as Orphan Drug for the Treatment of Mesothelioma

Mesothelioma lawyers of The Law Office of Melinda J. Helbock A.P.C. say the FDA’s approval of a drug designed to kill cancer stem cells as “orphan drug designation” gives hope to the future of mesothelioma patients. (PRWEB) February 27, 2015 According to a Feb. 12, 2015 news release by Verastem, Inc., defactinib (VS-6063), a drug used to treat cancer by killing cancer stem cells, has receiv...

Medivir: Presentation of the Result of Medivir’s Voluntary Redemption Programme

Regulatory News: Medivir AB (STO:MVIRB) announces the result of Medivir’s voluntary redemption programme. The redemption programme comprised a total of 4,465,717 shares in Medivir. Upon completion of the application period, at total of 4,293,990 shares have been registered for redemption, whereof 53,642 series A shares and 4,240,348 series B sha...

Pfenex to Present at CALBIO 2015

SAN DIEGO, Feb. 27, 2015 /PRNewswire/ -- Pfenex Inc. (NYSE MKT: PFNX), a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics, today announced that it will be presenting at CALBIO 2015 at the San Francisco Marriott Marquis on March 2nd at 3pm PST. Patrick Lucy, chief business officer of Pfenex, will participate on a panel discussing the current state...


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