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14:15 EDT 23rd September 2017 | BioPortfolio

Eleven Biotherapeutics Announces Completion of Vicinium Manufacturing for Ongoing Clinical Trials in Non-Muscle Invasive Bladder Cancer

-- Topline Three-Month Data from Phase 3 Registration Trial Expected in Mid-2018 -- Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, today announced that it has completed the manufacturing of all Vicinium necessary for its ...

Comparable efficacy and safety observed in patients switched to biosimilar CT-P10

Rituximab is a monoclonal antibody that targets the CD20 protein that is primarily found on B lymphocytes. Through depletion of CD20-positive B cells in the peripheral blood and bone marrow, rituximab is effective for treating some haematological malignancies and immune-mediated diseases such as rheumatoid arthritis (RA). CT-P10 (Truxima) is a biosimilar of the rituximab reference product. It is t...

Biosimilars applications under review by EMA – August 2017

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ...

MilliporeSigma Opens China's First BioReliance® End-to-End Biodevelopment Center in Shanghai

- Company's first end-to-end center outside of Europe - Accelerates clinical development from molecule to commercial production BILLERICA, Mass., Sept. 22, 2017 /PRNewswire/ -- MilliporeSigma today announced the opening of its first BioReliance® End-to-End Biodevelopment Center in the Asia Pacific (APAC) region. Located in Shanghai, China, the center will provide a full range of pro...

Pfizer files suit claiming Johnson & Johnson stifles biosimilar competition

Pfizer, the manufacturer of Inflectra, a biosimilar to Janssen’s Remicade, filed a lawsuit against Johnson & Johnson, the parent company of Janssen, for “exclusionary contracts and other anticompetitive practices” that Pfizer maintains inhibits competition of their biosimilar in the approved markets.“As evident by their success in markets such as Europe, we know biosimilars can improve pat...

Iovance Biotherapeutics Announces Pricing Of Its Public Offering Of $50 Million Of Common Stock

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Provectus Biopharmaceuticals Inc PVCT Financial and Strategic SWOT Analysis Review [Report Updated: 07082017] Prices from USD $300

SummaryProvectus Biopharmaceuticals Inc Provectus, formerly Provectus pharmaceuticals, Inc. is a biopharmaceutical company that develops pharmaceuticals for oncology and dermatology indications. The company's pipeline products include PV10 for recurrent melanoma, PV10 for metastatic liver cancer and PV10 for recurrent breast cancer. It offers PH10 for psoriasis and PH10 for atopic dermatitis. Prov...

AAM-commissioned report: Biosimilars can save CMS $11.4B by 2027

David Salazar In order to realize the estimated $11.4 billion in savings, the Centers for Medicare and Medicaid Services would need to revise the way it currently reimburses for biosimilar drugs.   read more

Pfizer Goes to Court to Allow Competition for Biologics and Expand Options for Patients

Lawsuit Claims Johnson & Johnson Engaged in Unlawful Conduct to Stifle Competition From Inflectra To ensure patients and providers have access to important, lower cost biosimilar medicines, Pfizer (NYSE:PFE) today filed suit in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson (J&J). ...

Critical Analysis: Keryx Biopharmaceuticals (KERX) vs. Its Peers

Keryx Biopharmaceuticals is one of 288 public companies in the "Bio Therapeutic Drugs" industry, but how does it weigh in compared to its rivals? We will compare Keryx Biopharmaceuticals to related companies based on the strength of its risk, analyst recommendations, earnings, profitability, institutional ownership, dividends and valuation. Keryx Biopharmaceuticals' rivals have higher revenue ...

MYOS RENS Technology Inc. Appoints Joseph Mannello as Permanent Chief Executive Officer

CEDAR KNOLLS, N.J., Sept. 20, 2017 /PRNewswire/ -- MYOS RENS Technology Inc. ("MYOS" or "the Company") (NASDAQ: MYOS), a biotherapeutics and bionutrition company, today announced that it has entered into an employment agreement with Joseph Mannello to serve as its permanent Chief Executive Officer, effective August 24, 2017. As part of his employment agreement, Mr. Mannello agreed to for...

NW BIO Announces Registered Direct Offering Of $1.75 Million

BETHESDA, Md., Sept. 20, 2017 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that it has entered into definitive agreements with institutional investors for a registered direct offering with gross proceeds of $1.75 million. In the transaction, the Company ...

Covance Discusses the US Market Access Landscape for Biosimilars

Iselin, NJ, September 20, 2017 --(PR.com)-- SMi Group has announced that Mr John Carlsen, Vice President at Covance, has joined the speaker line-up for the 4th annual Biosimilars North America conference which takes place on November 15 & 16 in New Jersey. John will present a session that reviews key CMS policy developments for biosimilars and understanding the potential impact on commercial...

Iovance Biotherapeutics, Inc. Announces Pricing of Its Public Offering of $50 Million of Common Stock

SAN CARLOS, Calif., Sept. 20, 2017 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced the pricing of an underwritten public offering of 7,692,308 shares of its common stock at a public offering price of $6.50 per share. The gross proceeds from ...

Iovance Biotherapeutics Announces Public Offering Of Common Stock

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New Report Indicates Revising CMS Policy on Biosimilars Could Save $11.4 Billion On Medicines Over 10 Years

WASHINGTON, Sept. 19, 2017 /PRNewswire/ -- Today, the Association for Accessible Medicines (AAM) and its Biosimilars Council released an analysis finding that if the Centers for Medicare & Medicaid Services (CMS) were to revise its current reimbursement policy for biosimilar medicines, the federal government could save $11.4 billion on medicines over the next 10 years. "The Fiscal Implicat...

New Live CME Outfitters Webcast on Biosimilars to Treat Inflammatory Disease Launching Soon

Dr. Leonard Calabrese to host live Q&A webcast on the interchangeability, efficacy, and safety of biosimilars to treat inflammatory diseases on October 10, 2017 (PRWEB) September 19, 2017 CME Outfitters, LLC, a leading accredited provider in continuing medical education, is excited to announce a new live webcast, where participant questions from two free CME Snacks (short, focused activities)...

CME Outfitters Launches New Online Biosimilars Hub

CME Outfitters is excited to announce its newest online education hub featuring free CE activities and resources on the use of biosimilars in clinical practice to treat inflammatory diseases Bethesda, MD (PRWEB) September 19, 2017 CME Outfitters (CMEO), a leading accredited provider in continuing medical education, has launched a unique Biosimilars Education Hub where clinicians can find up to da...

CME Outfitters Offering Two New Snacks on the Use of Biosimilars in the Treatment of Inflammatory Diseases

Two new CME “Snacks” on using biosimilars to treat inflammatory disease are now available for free participation and CE credit from CME Outfitters Bethesda, MD (PRWEB) September 19, 2017 CME Outfitters, LLC, a leading accredited provider in continuing medical education, announces the launch of a new pair of CME Snacks (short online CME activities) discussing the newly approved biosimilar, inf...

Sillajen Biotherapeutics 215600 Pharmaceuticals Healthcare Deals and Alliances Profile [Report Updated: 22082017] Prices from USD $250

SummarySillajen Biotherapeutics SillaJen, formerly SillaJen Inc is a biotechnology company that designs and develops oncolytic immunotherapeutics for the treatment of cancer. The company's pipeline product includes PexaVec, an oncolytic immunotherapeutic virus which is in Phase III trial that is used for the treatment of primary liver cancer. It also develops JX929, a chemosensitizing oncolytic im...

CSL Behring Will Help Transform Biotech Education and Research with $4.92 Million Gift to Penn State

UNIVERSITY PARK, Pa., Sept. 19, 2017 /PRNewswire/ -- Penn State today announced that CSL Behring, a global specialty biotherapeutics leader, has committed $4.92 million to Penn State over the next six years to create the multidisciplinary Center of Excellence in Biotechnology, and to revitalize the Shared Fermentation Facility, an engine for collaboration and innovation in biological tra...

Molecular Devices and Cytena Partner to Launch the CloneSelect Single-Cell Printer

Announcing the Single-Cell Printer for documented isolation of cells in clonal cell line development Sunnyvale, Calif., USA and Freiburg, Germany, September 19, 2017 / B3C newswire / -- Molecular Devices, LLC, a leader in protein and cell biology technologies, today announced a partnership with Cytena GmbH to launch the CloneSelect™ Single-Cell Printer™ in North America.  This novel...

Protalix BioTherapeutics Inc PLX Financial and Strategic SWOT Analysis Review [Report Updated: 07082017] Prices from USD $300

SummaryProtalix BioTherapeutics Inc Protalix is a biopharmaceutical company that develops and commercializes recombinant therapeutic proteins. The company's pipeline products include PRX102, a therapeutic enzyme for the treatment of Fabry disease; PRX110, a plant cellexpressed recombinant form of human deoxyribonuclease I and is intended for the treatment of cystic fibrosis. Its PRX106 is an orall...

Iovance Biotherapeutics, Inc. Announces Public Offering of Common Stock

SAN CARLOS, Calif., Sept. 19, 2017 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced that it intends to offer and sell $50 million of its common stock, subject to market and other conditions, in an underwritten public offering. All of the shar...

Zenotech Laboratories Ltd 532039 Financial and Strategic SWOT Analysis Review [Report Updated: 06092017] Prices from USD $125

Zenotech Laboratories Ltd 532039 Financial and Strategic SWOT Analysis Review provides you an indepth strategic SWOT analysis of the company's businesses and operations. The profile has been compiled by GlobalData to bring to you a clear and an unbiased view of the company's key strengths and weaknesses and the potential opportunities and threats. The profile helps you formulate strategies that a...

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