Biopharmaceutical News and Research

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AbbVie's global sales reduce 1.8% to $5.111B in fourth quarter 2013

AbbVie today announced financial results for the fourth quarter and full year ended Dec. 31, 2013.

31 Jan 2014

Biogen Idec, UCB sign agreements to commercialize treatment of MS and hemophilia in Asia

Biogen Idec and UCB announced today that they have signed exclusive agreements granting UCB the right to commercialize Biogen Idec products in South Korea, Hong Kong, Thailand, Singapore, Malaysia and Taiwan, and both develop and commercialize products in China.

30 Jan 2014

New pre-clinical data shows potential protective effects of GFT505 in different types of cancer

GENFIT, a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, today announces new pre-clinical data demonstrating the inhibitory effects of GFT505 on the proliferation of cancer cells of different origins.

30 Jan 2014

Intelsius introduces revisions to PharmaTherm line of solutions

Intelsius, a DGP company, a designer, manufacturer and distributor of temperature-controlled packaging solutions, introduced revisions to its PharmaTherm™ line of solutions to pharmaceutical industry professionals today at the 13th Annual Cool Chain Europe Summit in Luxembourg.

28 Jan 2014

FDA meeting streamlines pathway to initial U.S. approval of Provectus's PV-10 oncology drug

Provectus Biopharmaceuticals, Inc. (PVCT), a development-stage oncology and dermatology biopharmaceutical company, today announced that it has received the official minutes from the Type C meeting held with the FDA's Division of Oncology Products 2 on December 16, 2013.

27 Jan 2014

ResearchDx expands operations to focus on Middle East clinical laboratory and diagnostics markets

ResearchDx, LLC of Irvine, California, USA today announced an expansion of its operations to focus on the important Middle East clinical laboratory and diagnostics markets.

27 Jan 2014

Hols conveys product’s safety and cost effectiveness to managed care groups

Health Outcomes Liaisons (HOLs) play a critical role in conveying a therapy's safety and cost effectiveness to managed care groups. With billions in sales riding on effectively communicating with these organizations regarding products' cost effectiveness and safety, the biopharmaceutical industry has turned to HOLs to fill this critical communication role.

27 Jan 2014

CytRx initiates aldoxorubicin Phase 2 trial in HIV-infected patients with Kaposi's sarcoma

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced it has initiated a Phase 2 clinical trial to determine preliminary efficacy and safety of aldoxorubicin for HIV-infected patients with Kaposi's sarcoma.

23 Jan 2014

BioLineRx's BL-8040 gets FDA Orphan Drug Designation for stem cell mobilization treatment

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has received notice from the U.S. Food & Drug Administration confirming an Orphan Drug Designation of BL-8040 as a treatment for stem cell mobilization, in addition to the Orphan Drug Designation previously granted to BL-8040 as a treatment for Acute Myeloid Leukemia.

23 Jan 2014

CytRx receives FDA approval to continue dosing aldoxorubicin for patients with soft tissue sarcomas

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has received approval from the U.S. Food and Drug Administration (FDA) to continue dosing patients with aldoxorubicin until disease progression in a planned pivotal, global Phase 3 clinical trial with aldoxorubicin as a second-line treatment for soft tissue sarcomas.

22 Jan 2014

Kolltan Pharmaceuticals announces treatment of first cancer patient with KTN3379

Kolltan Pharmaceuticals, a privately held biopharmaceutical company, today announced treatment of the first cancer patient with Kolltan's lead drug candidate, KTN3379, as part of a Phase 1 clinical study evaluating safety, preliminary evidence of antitumor activity, and pharmacokinetics. KTN3379 is a human monoclonal antibody that blocks the activity of ErbB3, a member of the ErbB family of receptor tyrosine kinases.

21 Jan 2014

BioLineRx gets approval to begin CE Mark registration trial of BL-5010P for skin lesion treatment

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to commence a pivotal, CE Mark registration trial for BL-5010P, for the non-surgical removal of benign skin lesions.

21 Jan 2014

Auxilium Pharmaceuticals reports interim data from XIAFLEX Phase 4 study in patients with DC

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, today announced that interim data from its Phase 4 retreatment study (AUX-CC-862) evaluating XIAFLEX (collagenase clostridium histolyticum or CCH) in adult patients with Dupuytren's contracture and a recurrent contracture with a palpable cord will be presented for the first time at the American Association for Hand Surgery 2014 Annual Meeting being held January 8-11, 2014 in Kauai, Hawaii.

9 Jan 2014

Proteon's PRT-201 gets orphan drug designation for prevention of arteriovenous access dysfunction

Proteon Therapeutics, Inc., a privately held biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases, today announced that its lead product, PRT-201, has received orphan drug designation in the European Union for the prevention of arteriovenous access dysfunction in hemodialysis patients.

9 Jan 2014

Rexahn Pharmaceuticals initiates RX-3117 Phase Ib trial in cancer patients with solid tumors

Rexahn Pharmaceuticals, Inc. a clinical stage biopharmaceutical company, announced today the initiation of a Phase Ib clinical trial to study the safety and efficacy of RX-3117 in cancer patients with solid tumors.

9 Jan 2014

Emmaus completes all patient visits for Phase 3 trial of L-glutamine for treatment of sickle cell disease

Emmaus Medical, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of innovative and cost-effective treatments and therapies primarily for rare and orphan diseases, today announced it has completed all patient visits for its Phase 3 clinical trial for the treatment of sickle cell disease. Emmaus expects top-line data from the Phase 3 clinical trial to be available in the first quarter of 2014.

8 Jan 2014

OxThera announces initiation of Oxabact clinical study in Primary Hyperoxaluria

OxThera AB, a Stockholm-based privately-held biopharmaceutical company, today announced that it has initiated a clinical study in Primary Hyperoxaluria. This announcement bolsters the Company's position as a leader in developing therapies for hyperoxaluria, a debilitating condition that, if untreated, leads to kidney damage and end-stage renal disease.

8 Jan 2014

FDA accepts NPS Pharmaceuticals' Natpara BLA for review

NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the U.S. Food and Drug Administration has accepted and filed for review the company's Biologics License Application for Natpara (recombinant human parathyroid hormone 1-84, (rhPTH[1-84])) for the treatment of hypoparathyroidism.

7 Jan 2014

Memorial Sloan-Kettering to use Sutro's cell-free protein synthesis technology to produce bispecific antibodies

Sutro Biopharma, a biopharmaceutical company developing a new generation of protein therapeutics, including next-generation antibody drug conjugates and bispecific antibodies, today announced that it has entered into a collaboration agreement with Memorial Sloan-Kettering Cancer Center to use Sutro's proprietary cell-free protein synthesis technology to produce bispecific antibodies that were discovered by Memorial Sloan-Kettering for the treatment of neuroblastoma in children.

7 Jan 2014

Navidea Biopharmaceuticals, GMST sign distribution agreement for Lymphoseek Injection in Taiwan

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today it has entered into a distribution agreement for Lymphoseek (technetium Tc 99m tilmanocept) Injection in Taiwan with Global Medical Solutions Taiwan, Ltd., a leading in-country distributor of nuclear medicine and diagnostic imaging products.

7 Jan 2014

Biopharmaceutical News and Research

AbbVie's global sales reduce 1.8% to $5.111B in fourth quarter 2013

Biogen Idec, UCB sign agreements to commercialize treatment of MS and hemophilia in Asia

New pre-clinical data shows potential protective effects of GFT505 in different types of cancer

Intelsius introduces revisions to PharmaTherm line of solutions

FDA meeting streamlines pathway to initial U.S. approval of Provectus's PV-10 oncology drug

ResearchDx expands operations to focus on Middle East clinical laboratory and diagnostics markets

Hols conveys product’s safety and cost effectiveness to managed care groups

CytRx initiates aldoxorubicin Phase 2 trial in HIV-infected patients with Kaposi's sarcoma

BioLineRx's BL-8040 gets FDA Orphan Drug Designation for stem cell mobilization treatment

CytRx receives FDA approval to continue dosing aldoxorubicin for patients with soft tissue sarcomas

Kolltan Pharmaceuticals announces treatment of first cancer patient with KTN3379

BioLineRx gets approval to begin CE Mark registration trial of BL-5010P for skin lesion treatment

Auxilium Pharmaceuticals reports interim data from XIAFLEX Phase 4 study in patients with DC

Proteon's PRT-201 gets orphan drug designation for prevention of arteriovenous access dysfunction

Rexahn Pharmaceuticals initiates RX-3117 Phase Ib trial in cancer patients with solid tumors

Emmaus completes all patient visits for Phase 3 trial of L-glutamine for treatment of sickle cell disease

OxThera announces initiation of Oxabact clinical study in Primary Hyperoxaluria

FDA accepts NPS Pharmaceuticals' Natpara BLA for review

Memorial Sloan-Kettering to use Sutro's cell-free protein synthesis technology to produce bispecific antibodies

Navidea Biopharmaceuticals, GMST sign distribution agreement for Lymphoseek Injection in Taiwan

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How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

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