Biopharmaceutical News and Research

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FDA accepts Navidea’s resubmitted NDA for Lymphoseek

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of the Company's October 30, 2012 resubmission of its New Drug Application (NDA) for Lymphoseek (Technetium Tc 99m Tilmanocept) Injection.

14 Nov 2012

Soligenix receives FDA Fast Track designation for SGX203 to treat pediatric Crohn's disease

Soligenix, Inc., a development stage biopharmaceutical company, announced today that its program for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the induction treatment of mild-to-moderate pediatric Crohn's disease has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA).

8 Nov 2012

Patient recruitment complete for immatics IMA901 Phase 3 trial for renal cell carcinoma

immatics biotechnologies GmbH, a biopharmaceutical company developing rationally designed therapeutic vaccines that are active against cancer, announced today that it has completed patient recruitment into the pivotal phase 3 trial evaluating its lead cancer vaccine IMA901 for renal cell carcinoma (RCC). The trial has completed patient inclusion and it is expected that around 345 patients will be randomized across 10 countries in the US and Europe.

8 Nov 2012

FDA grants Albireo's A4250 orphan-drug designation for treatment of PFIC and PBC

Albireo AB, a biopharmaceutical company specializing in gastroenterology, today announced that A4250 (an inhibitor of the ileal bile acid transporter, IBAT/ASBT) has been granted orphan-drug designation by the U.S Food and Drug Administration for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) and Primary Biliary Cirrhosis (PBC).

8 Nov 2012

EpiCept, Immune Pharmaceuticals enter definitive merger agreement

Immune Pharmaceuticals Ltd., a privately held Israeli company, and EpiCept Corporation today announced that they have entered into a definitive merger agreement. The transaction is anticipated to close during the first quarter of 2013 and is subject to satisfaction of certain customary closing conditions, including the approval of a majority of EpiCept shareholders.

8 Nov 2012

FDA grants Priority Review to ImmunoGen’s trastuzumab emtansine BLA

ImmunoGen, Inc., a biopharmaceutical company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today announced that Genentech, a member of the Roche Group, has disclosed that the U.S. Food and Drug Administration (FDA) has officially accepted the Biologics License Application (BLA) for trastuzumab emtansine and granted it Priority Review.

7 Nov 2012

Endo, Bioniche decide to end second Urocidin Phase III trial on non-muscle-invasive bladder cancer

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today announced that a second Phase III clinical trial with Urocidin in non-muscle-invasive bladder cancer is being discontinued.

5 Nov 2012

Integra Holdings, a biopharmaceutical holding company, announced by Yissum

Yissum Research and Development Company of the Hebrew University of Jerusalem, the technology transfer company of the Hebrew University, announced today the inception of its subsidiary, Integra Holdings, a holding company focusing on biopharmaceutical companies based on inventions of researchers from the Hebrew University.

31 Oct 2012

Top-line results from Neuraltus’ NP001 Phase 2 study on amyotrophic lateral sclerosis

Neuraltus Pharmaceuticals, a private biopharmaceutical company developing novel therapies for rare neurological disorders, announced today top-line results from the Company's Phase 2 clinical study of NP001 in patients with Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease).

30 Oct 2012

BioXpress, AET BioTech enter agreement to co-develop Adalimumab biosimilar

AET BioTech, the separate biosimilars business within the generic drug developer AET (Alfred E Tiefenbacher) Group and BioXpress Therapeutics SA, a Swiss-based biotechnology company developing monoclonal antibody (MAb) biosimilars have entered into an agreement for the co-development of a biosimilar version of the TNF inhibitor MAb Adalimumab.

30 Oct 2012

Array BioPharma first quarter 2013 revenue decreases to $15.8 million

Array BioPharma Inc. today reported results for the first quarter of its fiscal year ending June 30, 2013.

30 Oct 2012

Nonclinical data on Provectus PV-10 oncology drug presented at 27th SITC

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, presented nonclinical data on PV-10 at the Society for Immunotherapy of Cancer (SITC) 27th Annual Meeting on October 26 and 27, 2012 in North Bethesda, MD.

29 Oct 2012

Range of biopharma solutions from Malvern Instruments extended by distribution agreement with Affinity Biosensors

Materials characterization company Malvern Panalytical. (Malvern Panalytical, UK) has signed an exclusive distribution agreement with Affinity Biosensors LLC (Santa Barbara, CA, USA) which will extend the range of solutions that Malvern Panalytical offers to the biopharmaceutical sector.

From Malvern Panalytical 29 Oct 2012

Exploring the New Biopharmaceutical Contract Manufacturing Offering from Olympus

In this interview, News-Medical talks to Peter Gariepy, to find out about the new Contract Manufacturing Offering (CMO) from Olympus Life Science Solutions.

From Evident Corporation - Life Sciences 25 Oct 2012

BioLineRx intends to conduct interim analysis of BL-1020 Phase II/III trial for schizophrenia

BioLineRx, a biopharmaceutical development company, announced today that it intends to conduct an interim analysis of the Phase II/III CLARITY trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia.

25 Oct 2012

PLoS ONE publishes review of AntiViral-HyperActivation Limiting Therapeutics clinical trial

ViroStatics, a private Italian/American biopharmaceutical company developing novel therapeutics for viral and other chronic diseases, announced that a review of the first human clinical trial to test a new class of anti-HIV medications known as AntiViral-HyperActivation Limiting Therapeutics (AV-HALTs) has been published in the peer-reviewed journal PLoS ONE.

22 Oct 2012

BioLineRx completes pre-clinical development of BL-8020 for HCV

BioLineRx, a biopharmaceutical development company, announced today that it has successfully completed the pre-clinical development of BL-8020, an orally available, interferon-free treatment for the Hepatitis C virus (HCV), and plans to commence a Phase I/II safety and efficacy study for BL-8020 in Europe during the first quarter of 2013.

17 Oct 2012

AAPS recognizes top scientists in pharmaceutical sciences

During the Opening Session of the 2012 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition, AAPS President David Y. Mitchell, Ph.D., presented the following ground-breaking researchers with awards commemorating their contributions to the pharmaceutical sciences:

15 Oct 2012

Johns Hopkins joins API’s Actimab-A Phase I/II trial in acute myeloid leukemia

Actinium Pharmaceuticals, Inc. (API), a biopharmaceutical company that develops innovative targeted payload immunotherapeutics, announced that Johns Hopkins University School of Medicine in Baltimore, MD has joined the Company's ongoing Phase I/II trial in newly diagnosed elderly patients with acute myeloid leukemia (AML).

9 Oct 2012

Soluble Therapeutics to introduce high-throughput second viral coefficient determination system

Birmingham-based Soluble Therapeutics, Inc, today announced the official launch of its high-throughput second viral coefficient determination system, HSC Technology, at the IBC BioProcess International Conference in Providence, RI October 8-12.

9 Oct 2012

Biopharmaceutical News and Research

FDA accepts Navidea’s resubmitted NDA for Lymphoseek

Soligenix receives FDA Fast Track designation for SGX203 to treat pediatric Crohn's disease

Patient recruitment complete for immatics IMA901 Phase 3 trial for renal cell carcinoma

FDA grants Albireo's A4250 orphan-drug designation for treatment of PFIC and PBC

EpiCept, Immune Pharmaceuticals enter definitive merger agreement

FDA grants Priority Review to ImmunoGen’s trastuzumab emtansine BLA

Endo, Bioniche decide to end second Urocidin Phase III trial on non-muscle-invasive bladder cancer

Integra Holdings, a biopharmaceutical holding company, announced by Yissum

Top-line results from Neuraltus’ NP001 Phase 2 study on amyotrophic lateral sclerosis

BioXpress, AET BioTech enter agreement to co-develop Adalimumab biosimilar

Array BioPharma first quarter 2013 revenue decreases to $15.8 million

Nonclinical data on Provectus PV-10 oncology drug presented at 27th SITC

Range of biopharma solutions from Malvern Instruments extended by distribution agreement with Affinity Biosensors

Exploring the New Biopharmaceutical Contract Manufacturing Offering from Olympus

BioLineRx intends to conduct interim analysis of BL-1020 Phase II/III trial for schizophrenia

PLoS ONE publishes review of AntiViral-HyperActivation Limiting Therapeutics clinical trial

BioLineRx completes pre-clinical development of BL-8020 for HCV

AAPS recognizes top scientists in pharmaceutical sciences

Johns Hopkins joins API’s Actimab-A Phase I/II trial in acute myeloid leukemia

Soluble Therapeutics to introduce high-throughput second viral coefficient determination system

Event guide: World ADC Asia eBook

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The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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