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 Genomic Health, Inc., the world's leading provider of genomic-based diagnostic tests (NASDAQ: GHDX) and Biocartis Group NV, an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced an exclusive agreement to develop an IVD version of the Oncotype DX Breast Recurrence Score® test on Biocartis' Idylla(TM) platform that can be performed locally by laboratory partners and in hospitals around the world.  The Oncotype DX Breast Recurrence Score test examines the activity of 21 genes in a patient's breast tumor tissue to provide personalized information for tailoring treatment based on the biology of their individual disease. As the only test proven to predict chemotherapy benefit, the Oncotype DX Breast Recurrence Score test is included in all major…
Viral Hepatitis Research and Development to Focus on Addressing Significant Unmet Needs in Chronic Hepatitis B    Janssen Sciences Ireland UC (Janssen), today announced a strategic decision to discontinue further development of the investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct acting antivirals - AL-335, odalasvir and simeprevir. The ongoing phase II studies with JNJ-4178 will be completed as planned, but there will be no additional development thereafter. This decision was made in light of the increasing availability of a number of highly effective therapies addressing the medical need in hepatitis C. "Going forward, our hepatitis R&D efforts will focus on chronic hepatitis B, where a high unmet medical need still exists. O…
ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced it has acquired Biomedical Systems, a well-recognized provider of reliable imaging, as well as cardiac safety and respiratory data collection solutions. Financial terms of the transaction were not disclosed. Coupled with its recent addition of imaging technology invented by the Cleveland Clinic, the acquisition of Biomedical Systems enables ERT to further expand its ability to reduce customer risk and uncertainty when imaging, cardiac safety and respiratory data collection are required. In particular, the acquisition positions ERT to better meet the significant demand for imaging in clinical trials, which is being driven from regulators’ increasing requests that imaging data b…
Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology drug development, announced today it has entered into a collaboration agreement with Pfizer and Merck KGaA, Darmstadt, Germany, to evaluate PT-112, a novel small molecule inducer of apoptosis with evidence of downstream immunogenic cell death (ICD) properties, currently in Phase I development, in combination with avelumab*, a human anti-PD-L1 IgG1 monoclonal antibody. Avelumab has received accelerated approval by the US Food and Drug Administration (FDA) for the treatment of metastatic Merkel cell carcinoma, and previously treated patients with locally advanced and metastatic urothelial carcinoma, and is under further clinical investigation across a range of tumor types under a global strategic allian…
Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and the Saint Regis Mohawk Tribe today announced that the Tribe now owns all Orange Book-listed patents for RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%, and that Allergan has been granted exclusive licenses in the patents related to the product. The Tribe, a recognized sovereign tribal government, is filing a motion to dismiss the ongoing inter partes review (IPR) of the RESTASIS® patents based on their sovereign immunity from IPR challenges.  The agreement with the Tribe has no impact on the pending abbreviated new drug application (ANDA) patent litigations regarding the RESTASIS® patent family which recently completed a five-day trial in Federal District Court in Marshall, Texas.  "The Saint Regis M…
Allergan plc, a leading global pharmaceutical company, today announced that Allergan USA, Inc. has filed lawsuits against Imprimis Pharmaceuticals, Inc., Prescriber's Choice, Inc., and Sincerus Florida, LLC alleging that those companies are unlawfully manufacturing and selling unapproved new drugs and violating the Lanham Act and state law by engaging in false and misleading advertising and promotion of their unapproved new drugs.  The suits have been filed in the United States District Court for the Central District of California. Commenting on the lawsuits, the Company issued the following statement: "Biopharmaceutical companies like Allergan have a duty to put the safety of their patients first. This commitment is the cornerstone of our manufacturing, marketing and advertising of…
Nexeon MedSystems ("Nexeon" or "the Company") (OTCQB: NXNN) announced today that it has exercised its option to acquire Nexeon Medsystems Belgium, SPRL ("NMB").  This Belgian-based company has been operating since 2013 developing neurostimulation products. NMB recently acquired Medi-Line, a Belgian medical device manufacturer with financing support provided by KBC and CBC Bank.  Medi-Line has expertise in active and non-active implants, and it has been profitable for its complete 25-year corporate history. For more information about the transaction, please review the Form 8-K. "We have focused our careers on building a company with a reputation for consistent and high quality delivery, a community-based team of talented employees, and well-executed long-term inter…
Servier and Institut Curie have decided to prolong their partnership in the fight against cancer by three years, extending its scope to include new research areas such as immuno-oncology, haematology and cardiology.   The main goals of this partnership are to identify new therapeutic combinations (the use of two complementary treatments to increase efficacy while reducing adverse effects), including molecules from Servier’s development portfolio, and to better characterise patients who might benefit from certain molecules (targeted therapies). The joint research programmes, covered by this partnership launched in 2005, have already resulted in the identification of several therapeutic targets, for example TTK/MPS1 kinase, an enzyme involved in the cell cycle. The deregulation of this…
The not-for-profit Sutter Health network announced today that it will collaborate with Qventus to use the company's artificial intelligence (AI) platform to enhance inpatient pharmacy operations across its healthcare system. The real-time platform will help Sutter Health reduce inpatient drug spending and support clinical teams by improving the effectiveness of pharmacy workflows and quality practices. "Leveraging AI and analytics will help us deliver safer, more affordable care for our patients," said Sameer Badlani, MD, FACP, vice president and chief health information officer for Sutter Health. "We've built a reputation for transforming healthcare, always thinking ahead, learning and innovating. This collaboration is another next step to help those we serve achieve their best health." …
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that it has completed its acquisition of Patheon N.V. (NYSE: PTHN), a leading contract development and manufacturing organization (CDMO) serving the pharmaceutical and biotechnology sectors, for approximately $7.2 billion. Today's close follows the expiration of Thermo Fisher's initial tender offer for Patheon at $35.00 per share in cash. "We're pleased to complete our acquisition of Patheon and look forward to the significant value this transaction will create for our customers and our shareholders," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "By adding Patheon's highly complementary CDMO capabilities to our leading clinical trials services and bioproduct…
Sanofi announced that it has completed the acquisition of Protein Sciences, a vaccines biotechnology company based in Meriden, Connecticut in the United States. This completion follows Federal Trade Commission approval, having met all the conditions required for the closing of the transaction.   Through the acquisition, Sanofi Pasteur, the vaccines global business unit of Sanofi, adds a promising product to its influenza vaccine portfolio: Flublok® (Influenza Vaccine), the only recombinant protein-based influenza vaccine approved by the US Food and Drug Administration (FDA). In October 2016, Protein Sciences received approval from the FDA for the quadrivalent version of Flublok vaccine (Flublok Quadrivalent vaccine), indicated for adults 18 years and older.   "We are thrilled…
Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and its subsidiaries today announced that it has reached a settlement regarding its litigation with Famy Care Limited relating to Allergan's United States Patent Nos. 8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930 and 9,248,191 covering RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%. The patents are listed in the Orange Book and expire on August 27, 2024. As a result of the settlement, all Famy Care litigation regarding RESTASIS® patents will be dismissed and Famy Care will terminate its pending petitions for Inter Parties Review. Allergan will grant Famy Care a license to market a generic version of RESTASIS® in the United States beginning on February 27, 2024, or earlier under certain circumstances. Additional…
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that it has earned a $40 million milestone payment from Biogen associated with the pricing approval of SPINRAZA® (nusinersen) in Japan. SPINRAZA was approved for individuals with infantile-onset spinal muscular atrophy (SMA) by the Pharmaceuticals and Medical Devices Agency in Japan in June 2017. To date, Ionis has earned more than $435 million from Biogen related to SPINRAZA. "We are grateful to the Japanese SMA community, including the patients who participated in the clinical studies, along with their families and the investigators, for their dedication, perseverance and support. Each of them played a pivotal role in bringing SPINRAZA to the Japanese market and we are pleased that SPINRAZA is now available to Japanese infantile…
Gilead Sciences, Inc. (Nasdaq: GILD) and Kite Pharma, Inc. (Nasdaq: KITE) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Kite for $180.00 per share in cash. The transaction, which values Kite at approximately $11.9 billion, was unanimously approved by both the Gilead and Kite Boards of Directors and is anticipated to close in the fourth quarter of 2017. The transaction will provide opportunities for diversification of revenues, and is expected to be neutral to earnings by year three and accretive thereafter. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170828005415/en/ Kite is an industry leader in the emerging field of cell therapy, which uses a patient’…
Oncimmune Holdings plc (AIM: ONC.L), a leading early cancer detection company developing and commercialising its proprietary EarlyCDT® platform technology, and Scancell Holdings plc, (‘Scancell’) the developer of novel immunotherapies for the treatment of cancer, today announce the presentation of data on the use of Oncimmune’s autoantibody technology to successfully predict disease recurrence in subjects undergoing SCIB1 immunotherapy for malignant melanoma. The data will be presented at the Cambridge Healthtech Institute (CHI) Immuno-Oncology Summit 2017 on August 29th 2017.   The collaborative study, which also included a team at the University of Nottingham, developed a method using a panel of seven tumour associated autoantibodies to predict disease recurrence in patients with…
Sangamo Therapeutics, Inc. (Nasdaq: SGMO) and Pfizer Inc. (NYSE: PFE) today announced that the first patient received treatment in the Phase 1/2 clinical trial ("the Alta trial") evaluating SB-525, an investigational gene therapy for patients with Hemophilia A, a rare genetic blood disorder. "We are excited to announce the first patient infusion in this initial clinical trial of SB-525. Gene therapy holds promise as a potential one-time treatment to control Hemophilia A and prevent spontaneous bleeding," said Dr. Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics. The Alta trial is an open-label, adaptive, dose-ranging clinical study designed to assess the safety and tolerability of SB-525 investigational gene therapy in up to 20 adult subjects with severe Hemophilia A. …
Collaboration leverages digital technology to provide free and secure care monitoring tool   Lexington, Mass. – August 25, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the biotech leader in rare diseases, today announced a collaboration with MicroHealth to support a free and secure care monitoring tool for hemophilia A and B patients with inhibitors and their care teams. MicroHealth, a digital health company co-created by a hemophilia patient, developed the tool, in the form of an app, to help improve hemophilia patient care and outcomes through the ability to set reminders, track, store and selectively share personal health data, including photos and bleed alerts, with care team members. Shire’s collaboration with MicroHealth will help the start-up customize the tool with new feature…
The immuno-oncology research and development company focused on macrophage modulation in the tumour microenvironment (TME), announced today that it has raised additional funding from Merck Ventures to complete the Series A Financing announced in January 2017.  Merck Ventures joins the existing investor syndicate of CRT Pioneer Fund (CPF), Novo Holdings A/S and Aglaia Biomedical Ventures BV with an equal size of investment. Senior Investment Director Hakan Goker from Merck Ventures joins Macrophage Pharma’s Board of Directors.   The financing will enable Macrophage Pharma to complete the first clinical study of its lead development candidate, a macrophage targeted p38MAP kinase inhibitor, as well as advancing two additional discovery candidates into preclinical development. The…
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that all required antitrust clearances have been obtained for the previously announced all-cash tender offer by its wholly owned subsidiary, Thermo Fisher (CN) Luxembourg S.à r.l., to purchase all of the outstanding ordinary shares of Patheon N.V. (NYSE: PTHN). Competition authorities in Brazil approved the transaction on August 7, 2017, initiating a 15 calendar-day comment period, which expired on August 22, 2017. Additionally, the European Commission approved the transaction today. As a result of the antitrust approvals, Thermo Fisher expects to complete the tender offer promptly following the expiration of the offer, which is scheduled to expire at 5:00 p.m., New York City time, on August 28, 201…
NEW YORK, Aug. 22, 2017 /PRNewswire/ -- Argentum Pharmaceuticals LLC, a generic pharmaceutical company, announced that it has reached a settlement and license agreement with Eli Lilly and Company related to Argentum's generic version of CIALIS® (tadalifil). The agreement generally provides that Argentum may commence marketing its generic product no earlier than September 27, 2018. The specific date on which Argentum may launch its generic product and other details concerning the settlement have not been disclosed. CIALIS® is a registered trademark of Eli Lilly and Company.