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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.
The direct selling industry is booming and USANA is no exception. The Cellular Nutrition Company announced today that it will be expanding in four European countries beginning mid-year 2018. The new markets—Romania, Germany, Italy, and Spain—will increase USANA's global footprint from 20 to 24 markets worldwide. "Further expansion of USANA in Europe broadens our international reach, and we couldn't be more excited," said USANA CEO, Kevin Guest. "This expansion is a great way for us to impact the health of even more individuals in Europe, which is in-line with our ultimate goal of creating the healthiest family on earth." These new European markets will be supported by both in-country Field Development Managers and by USANA's European headquarters in Paris, France.  Currently, all fo…
Two of the nation's leading health organizations, health and well-being company Humana Inc. and biotechnology company Amgen (NASDAQ: AMGN), have teamed up to identify opportunities to improve health outcomes and improve efficiency by unlocking new insights from the real world health care experiences of Humana's 13 million members.  In the collaboration agreement between Amgen and Humana, six projects are currently underway or planned, with more expected over the term of the agreement. Both organizations are committed to expanding the work into further therapeutic areas where the partnership can bring value to both Amgen and Humana. The goal is the same across all projects: deliver increased value to patients and the health care system by focusing on working to improve quality and out…
Clinerion has filed an international patent application following the PCT route for a new technology for patient search and identification based on the electronic medical records of patients held by hospitals. The “anonymized identification” (ANID) technology involves exclusively the use of anonymized data, ensuring the privacy and security of patient information. The new “anonymized identification” (ANID) technology, implemented in Clinerion’s Patient Recruitment System (PRS), significantly reduces any risk of private information being revealed when using patient medical records to evaluate study feasibility, or identifying patients for enrollment in clinical trials. The new technology uses exclusively anonymized records, but enables the duly authorized clinical trial manager at the hos…
CareFinders Total Care LLC ("CareFinders"), a leading home healthcare company based in New Jersey, announced that it has completed the acquisition of Sovereign Home Health of Connecticut, LLC ("Sovereign"). Based in Norwalk, Connecticut, Sovereign provides personal care and companion services to its clients in their homes and other facilities. CareFinders, based in Hasbrouck Heights, New Jersey, also provides non-skilled home care services to more than 8000 patients throughout New Jersey with 16 offices in the state. "The completion of this transaction provides CareFinders with a great platform for growth in the state of Connecticut and creates a strong initial presence for the Company outside of New Jersey," said Kevin Rogers, Chief Executive Officer of CareFinders. "Sovereign…
Crescita Therapeutics Inc. (TSX:CTX) (Crescita or the Company), a commercial dermatology company with a portfolio of non-prescription skincare products and prescription drug products, today announced it has entered into an amended loan agreement with Knight Therapeutics Inc. (Knight) (TSX:GUD).  On September 1, 2016, the Company acquired 100% of the equity of INTEGA Skin Sciences Inc. (INTEGA), a private company located in Laval, Québec that develops, manufactures, sells and markets science-based quality non-prescription skincare products.  Concurrent with the Company's acquisition of INTEGA, the Company assumed approximately $6.8 million (currently $6.6 million of principal outstanding) of an INTEGA loan from Knight, which was secured by a letter of credit issued by a Canadian…
The Mundipharma network of independent associated companies announced today that it has acquired from CellAct the worldwide development, commercialization and manufacturing rights to CAP7.1.  CAP7.1 is a novel pro-drug of anticancer agent etoposide which is metabolized into an active form by enzymes in the gastrointestinal tract that are particularly active in tumor cells. This innovative drug, invented at Charité – Universitätsmedizin Berlin, Germany, enables the focused release of this chemotherapeutic agent into tumor cells in higher doses while maintaining a good safety and tolerability profile1. The treatment will be progressed through Phase III trials by EDO, a company with a worldwide network of clinical connections and expertise in developing cancer therapies. Biliary tract ca…
Acella Pharmaceuticals, LLC, a leading U.S. manufacturer of specialty pharmaceuticals across several therapeutic categories, today announced an exclusive, multi-year, multi-product development and licensing partnership with Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, to develop, manufacture, and commercialize a new portfolio of abuse-deterrent pain relief products leveraging Catalent's OptiGel™ Lock Technology. Abuse of prescription opioids is a very serious and rapidly growing issue, with ninety-one Americans dying every day from an opioid overdose.1-2 Since 1999, the number of overdose deaths involving opioids (including prescription opioids and heroin) quadrupled,&n…
BioreclamationIVT, a leading provider of biospecimens and related services, today announced that it has acquired Asterand Bioscience™, a global provider of high quality, well-characterized human tissue and research solutions with a focus on the oncology market. Asterand Bioscience advances drug research by accelerating target identification and biomarker validation, and improving drug candidate selection to increase the likelihood of clinical success. "We are delighted that Asterand Bioscience's talented staff is joining BioreclamationIVT. This is a great fit between two complementary companies," said BioreclamationIVT Chief Executive Officer Jeff Gatz. "This acquisition will expand BioreclamationIVT's portfolio of highly-annotated disease-state biospecimens. After combining Asterand Bios…
C. R. Bard, Inc. (NYSE: BCR) ("Bard") and Becton, Dickinson and Company (NYSE: BDX) ("BD") today announced the results of Bard's special meeting of shareholders, held on August 8, 2017 and at which a quorum was present, for Bard shareholders to consider and vote upon the proposed merger of Bard with BD. Bard shareholders approved the definitive merger agreement, with approximately 99% of shares voting cast in favor of the proposal. As previously announced on April 23, 2017, Bard and BD entered into a definitive agreement pursuant to which BD would acquire Bard in a stock and cash transaction. Bard shareholder approval was a condition to the transaction. The proposed transaction remains subject to certain other conditions and approvals, and is presently expected to close in the fourth cale…
Selvita S.A. (WSE: SLV) and The Leukemia & Lymphoma Society (LLS) announced today a partnership to co-fund further preclinical and clinical development of a targeted therapy to treat patients with acute myeloid leukemia (AML). Selvita has discovered and is developing SEL120, a therapy that targets the cyclin-dependent kinase 8 (CDK8) protein, which plays a unique and critical role in gene regulation. Laboratory studies have shown the agent to be effective in certain types of AML cells. SEL120 is an ATP-competitive and selective inhibitor of CDK8 and a closely related serine kinase, CDK19. CDK8 is a part of a multi-protein complex that regulates gene expression and is distinct from CDK4 or CDK6, which play a role in cell cycle progression. In laboratory experiments, treatment with SEL1…
Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, and InfaCare Pharmaceutical Corporation today announced that they have entered into an agreement under which Mallinckrodt will acquire InfaCare, a privately held specialty pharmaceutical company focused on development and commercialization of proprietary pharmaceuticals for neonatal and pediatric patient populations. InfaCare's developmental product stannsoporfin, a heme oxygenase inhibitor, is under investigation for its potential to reduce the production of bilirubin, the elevation of which can contribute to serious consequences in infants. In July 2016 InfaCare and the U.S. Food and Drug Administration (FDA) reached agreement that a New Drug Application (NDA) could be filed for stannsoporfin using the tota…