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Bayer to present new research findings on Xofigo (radium Ra 223 dichloride) injection at ASCO GU 2016

Bayer announced today that new research findings on Xofigo (radium Ra 223 dichloride) injection will be presented at the 2016 Genitourinary Cancers Symposium of the American Society of Clinical Oncology (ASCO GU) taking place January 7 – 9 in San Francisco.

4 Jan 2016

Turing Pharmaceuticals emphasizes continued availability of Daraprim

Turing Pharmaceuticals AG, a privately-held biopharmaceutical company focused on developing and commercializing innovative treatments for serious diseases and conditions, today emphasizes the continued availability of Daraprim and cautions healthcare providers of proposed alternatives to Daraprim.

20 Dec 2015

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy.

26 Aug 2015

Turing Pharmaceuticals acquires rights to market Daraprim (pyrimethamine) in the U.S.

Turing Pharmaceuticals AG today announced that it has acquired the exclusive rights to market Daraprim (pyrimethamine) in the U.S. from Impax Laboratories, Inc. The acquisition by Turing is part of a strategic effort focused on treatments for toxoplasmosis and other serious infectious diseases. The company also announced plans to invest in the development of new drug candidates for toxoplasmosis.

10 Aug 2015

CMC Biologics, River Vision sign manufacturing agreement for Teprotumumab to treat Grave's Orbitopathy

CMC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, and River Vision Development Corporation (River Vision), a private company focused on ophthalmology, announced today that they have entered into an agreement for the process transfer and cGMP production of RV001 (Teprotumumab) – a recombinant monoclonal antibody targeting insulin-like growth factor 1 that is in development for treatment of Grave's Orbitopathy and other indications.

29 Jul 2015

Anika Therapeutics announces positive results from CINGAL phase 3 trial for knee osteoarthritis

Anika Therapeutics, Inc.,, a leader in products for tissue protection, healing, and repair based on hyaluronic acid technology, today reported positive results from the CINGAL 13-02 study evaluating the safety of a repeat injection of Cingal for symptomatic relief of osteoarthritis of the knee.

10 Jul 2015

MSD announces EC approval of SIMPONI (golimumab) for treatment of adult patients with nr-axial SpA

MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA) today announced that on 22 June the European Commission approved SIMPONI (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA).

26 Jun 2015

GSK welcomes U.S. CDC's vote on use of meningococcal group B vaccines

GlaxoSmithKline announced today that the U.S. Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) voted for a Category B recommendation for meningococcal group B vaccination, including BEXSERO (Meningococcal Group B Vaccine), in individuals aged 16 to 23 (with a preferred age of 16-18).

25 Jun 2015

$Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC$

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone.

19 Jun 2015

Allergan agrees to acquire KYTHERA Biopharmaceuticals for $2.1 billion

Allergan plc, a leading global pharmaceutical company, and KYTHERA Biopharmaceuticals, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market, today announced that they have entered into a definitive agreement under which Allergan has agreed to acquire KYTHERA in a cash and equity transaction valued at $75 per KYTHERA share, or approximately $2.1 billion.

17 Jun 2015

Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib.

1 Jun 2015

Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Pharmacyclics LLC today announced interim results from the ongoing Phase Ib/II PCYC-1129 study suggesting that ibrutinib (IMBRUVICA) may be a safe and effective treatment for patients with chronic graft-versus-host-disease (cGVHD) who were either refractory to steroid treatment or were steroid-dependent.

1 Jun 2015

Orexigen Therapeutics provides update on business and financial results for Q1 2015

Orexigen Therapeutics, Inc. today announced business and financial results for the first quarter ended March 31, 2015.

8 May 2015

New simeprevir clinical data to be presented at EASL's International Liver Congress 2015

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress 2015 of the European Association for the Study of the Liver taking place in Vienna from April 22-26.

8 Apr 2015

Merck announces availability of GARDASIL 9 HPV vaccine in Canada

Merck, known as MSD outside the United States and Canada, announced today that GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck's 9-valent human papillomavirus (HPV) vaccine, is now available in Canada.

1 Apr 2015

Elusys presents positive results of obiltoxaximab for treating inhalational anthrax, post-exposure prophylaxis

Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing antibody therapies to treat infectious disease, presented data demonstrating that obiltoxaximab (ETI-204) demonstrated a statistically significant survival benefit across a range of disease severity in animal model studies assessing treatment of inhalational anthrax, as well as effectiveness in post-exposure prophylaxis.

13 Feb 2015

Sebacia reports positive clinical results from two independent studies in people with acne

Sebacia, Inc., a company dedicated to delivering breakthrough topical treatments to advance dermatology, has announced the presentation of positive clinical results from two independent studies conducted in Europeinvestigating the use of Sebacia gold microparticles to treat acne.

29 Jan 2015

FDA approves Fluzone Intradermal Quadrivalent vaccine to prevent four strains of influenza virus

Sanofi Pasteur, the vaccines division of Sanofi, today announced that the U.S. Food and Drug Administration has approved the supplemental biologics license application (sBLA) for Fluzone Intradermal Quadrivalent vaccine.

13 Dec 2014

FDA approves Fluzone High-Dose vaccine sBLA to include efficacy data in Prescribing Information

3 Nov 2014

Eisai, Helsinn Group announce FDA approval of AKYNZEO for prevention of CINV

Helsinn Group and Eisai Inc. announced today that the Food and Drug Administration (FDA) approved AKYNZEO® for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

13 Oct 2014