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VAC-3S immunotherapeutic vaccine for HIV completes first clinical development phase

InnaVirVax, a biopharmaceutical company specialized in research and development on therapeutic and diagnostic solutions for diseases linked to immune dysregulation, has just announced successful completion of the first clinical development phase for VAC-3S immunotherapy in the treatment of HIV infections.

30 Nov 2012

U.K. NICE issues final draft guidance on Alimera Sciences’ ILUVIEN

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance indicating that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

30 Nov 2012

Epizyme to present data from DOT1L and EZH2 inhibitor programs at 54th ASH annual meeting

Epizyme, Inc., a biopharmaceutical company leading the creation of personalized therapeutics to treat patients with genetically defined cancers, today announced the presentation of data evaluating the preclinical safety and efficacy of two of the Company's novel, potent and selective small molecule inhibitors. These inhibitors individually target DOT1L and EZH2, members of a class of epigenic enzymes called histone methyltransferases (HMTs).

30 Nov 2012

UCB to sponsor key sets of VIMPAT C-V data at 66th American Epilepsy Society annual meeting

UCB, a global biopharmaceutical company focusing on CNS and immunology treatment and research, is sponsoring key sets of VIMPAT® (lacosamide) C-V data at the 66th Annual Meeting of the American Epilepsy Society (AES) in San Diego, Calif., November 30 - December 4.

29 Nov 2012

National Taiwan University Hospital, PAREXEL establish alliance

PAREXEL International Corporation a leading global biopharmaceutical services provider, and the National Taiwan University Hospital (NTUH) announced today that they have established an alliance. Under the agreement, PAREXEL and NTUH will collaborate to provide drug development services in Taiwan.

From Parexel 27 Nov 2012

XTL Biopharmaceuticals purchases 4,620,356 shares of Proteologics from Teva

XTL Biopharmaceuticals Ltd., a biopharmaceutical development company, announced on November 21st that it has acquired 4,620,356 shares, of Proteologics Ltd., from Teva Pharmaceutical Industries Ltd. in consideration for an amount of approximately NIS 6.5 million, which represents an amount of NIS 1.405 per Share (approximately 22% premium).

27 Nov 2012

mRNA vaccines offer protection against influenza A virus infections in various animal models

CureVac GmbH, a clinical stage biopharmaceutical company developing a new class of therapies and vaccines based on mRNA, and the German Federal Research Institute for Animal Health, Friedrich-Loeffler-Institute (FLI), Germany, today announced that mRNA vaccines (RNActive) based on the company's RNA technology platform have the potential to provide effective protection against infectious diseases.

26 Nov 2012

Single dose of Medicago's vaccine could offer cross-protection against flu

Researchers recently found that a single dose of a vaccine being developed by Medicago, Inc., a publicly traded biopharmaceutical company, could protect against not only the avian influenza (H5N1) strain it was designed for, but also another H5N1 strain and a strain of a different flu subtype, called H2N2.

22 Nov 2012

UBC microbiologist receives Prix Galien 2012 Research Award

UBC microbiologist Robert E.W. Hancock has received the Prix Galien 2012 Research Award, widely considered the most prestigious honour in Canadian pharmaceutical research and innovation. Hancock is being recognized for pioneering work unravelling the complex interactions between antibiotics and bacteria.

20 Nov 2012

KemPharm announces successful Type B meeting with FDA for KP201

KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today a successful Type B meeting with the Food and Drug Administration (FDA) for its lead pain candidate, KP201.

19 Nov 2012

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

Biopharmaceutical News and Research

VAC-3S immunotherapeutic vaccine for HIV completes first clinical development phase

U.K. NICE issues final draft guidance on Alimera Sciences’ ILUVIEN

Epizyme to present data from DOT1L and EZH2 inhibitor programs at 54th ASH annual meeting

UCB to sponsor key sets of VIMPAT C-V data at 66th American Epilepsy Society annual meeting

National Taiwan University Hospital, PAREXEL establish alliance

XTL Biopharmaceuticals purchases 4,620,356 shares of Proteologics from Teva

mRNA vaccines offer protection against influenza A virus infections in various animal models

Single dose of Medicago's vaccine could offer cross-protection against flu

UBC microbiologist receives Prix Galien 2012 Research Award

KemPharm announces successful Type B meeting with FDA for KP201

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

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