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China SFDA approves China Biologic's Human Coagulation Factor VIII

China Biologic Products, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, today announced that its indirectly owned subsidiary, Shandong Taibang Biological Products Co., Ltd. has received a manufacturing approval certificate from the China State Food and Drug Administration for Human Coagulation Factor VIII ("FVIII").

25 Jun 2012

Researchers unlock structure of STING protein

Researchers at Weill Cornell Medical College have unlocked the structure of a key protein that, when sensing certain viruses and bacteria, triggers the body's immediate immune response.

20 Jun 2012

CMC Biologics' Bothell manufacturing and testing facilities receive cGMP compliance

CMC Biologics, a leading contract manufacturing organization (CMO) known for its technical excellence in process development and cGMP manufacture, has received a Certificate of Good Manufacturing Practice (GMP) Compliance for commercial manufacturing issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

18 Jun 2012

Arrowhead initiates final IND-enabling steps for ARC-520 to treat HBV

Arrowhead Research Corporation, a targeted therapeutics company, today announced that its hepatitis B virus (HBV) program has completed all internal preclinical requirements and has named a clinical candidate.

7 Jun 2012

Arte, ProJect Pharmaceutics partner to develop Lyo-DCPS

Arte Corporation and ProJect Pharmaceutics have been working closely on the development of a new type of dual chamber prefillable syringe for freeze-dried pharmaceuticals. The two companies have joined together with the objective to provide innovative dual chamber syringes for the global pharmaceutical market.

6 Jun 2012

Sinovac first quarter sales increase 30.3% to $6.0M

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today its unaudited first quarter financial results for the period ended March 31, 2012.

15 May 2012

Ono, Scil Proteins partner to discover and develop new Affilin therapeutics

Scil Proteins GmbH, a private biotech company specializing in the research, development and production of recombinant proteins, today announced that it has signed a collaboration agreement with Ono Pharmaceutical Co., Ltd., for the joint discovery and development of new Affilin therapeutics to treat various diseases.

15 May 2012

Monteris secures financing to commercialize NeuroBlate System

Monteris Medical Inc., a privately held medical device company dedicated to the development of innovative MRI guided, laser-based cancer treatments announced today it has secured $9 million in financing to support the continued commercialization of the company's NeuroBlate System (formerly AutoLITT) within the North American neurosurgery market.

7 May 2012

Xcellerex introduces XDUO Quad single-use mixing system for biomanufacturing

Xcellerex, Inc., a provider of turnkey biomanufacturing solutions, has launched its XDUO Quad single-use mixing system supporting single-use biomanufacturing in upstream and downstream mixing applications and unit operations.

3 May 2012

Report identifies strategies necessary to improve marketplace for LLINs

The universal coverage campaign for bed nets succeeded in dramatically extending access to these life-saving products, though recent gains may be in jeopardy unless rapid action is taken. Over 560 million long-lasting insecticide-treated nets (LLINs) are required through 2015 alone to achieve and maintain universal coverage in Africa, at a total global cost of $2.4 billion.

26 Apr 2012

Novasep’s outstanding results in scale-up and biomanufacturing of Apo-A1 acknowledged by Cerenis at BioProcess International Conference

Novasep, a provider of purification-based manufacturing solutions for lifescience molecules, has announced that Cerenis Therapeutics has been invited by BioProcess International to present its major project CER – 001 ApoA1 - HDL mimetic drug candidate, and describe how Novasep played a critical role in the project by successfully achieving the transfer and scale up of Apo-A1 production.

16 Apr 2012

C3BS' new production facilities in Mont-Saint-Guibert granted GMP Certification

The Belgian biotechnology company Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases, today announces that it has been granted Good Manufacturing Practice (GMP) Certification for its new production facilities in Mont-Saint-Guibert.

12 Apr 2012

USPTO issues Notice of Allowance for Sunshine Biopharma's anti-tumor compound patent application

Sunshine Biopharma Inc. is pleased to announce that it has recently received notification that the United States Patent and Trademark Office has issued a "Notice of Allowance" for the patent application covering its lead anti-tumor compound, Adva-27a. The allowed claims protect Adva-27a and extensively cover various formulations, derivatives and cancer applications.

9 Apr 2012

GE-BAC partner to launch LambdaFabSelect bioprocess affinity resin

GE Healthcare, the healthcare business of GE and BAC BV, the leading provider of antibody-based affinity purification technology, announced today that, following a successful collaboration between the two companies, GE Healthcare Life Sciences has added a new and innovative affinity resin to its portfolio of technologies for the purification of antibody-based fragments.

19 Mar 2012

PaxVax announces FDA acceptance of IND for PXVX-0200 cholera vaccine

PaxVax Corporation, developer of innovative and socially responsible oral vaccines against infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for its single-dose oral cholera vaccine, clearing the way to begin clinical trials. The company intends to begin Phase 3 trials later this year.

19 Mar 2012

MTPC, Medicago partner to develop and commercialize three new vaccines

Medicago Inc., a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced the establishment of a strategic alliance with Mitsubishi Tanabe Pharma Corporation (MTPC) through the execution of a Master Research Collaboration Agreement.

6 Mar 2012

Baxter commences CD34+ stem cell phase III trial in CMI

Baxter International Inc. announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual's own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).

From Baxter International Inc. 28 Feb 2012

TRANSFUSION publishes positive results from CryoStor collaborative research

BioLife Solutions, Inc., a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, today announced that TRANSFUSION, the foremost publication in the world for new information regarding transfusion medicine, has published a peer-reviewed journal article reporting positive results of collaborative research on CryoStor, BioLife's serum-free, protein-free cryopreservation freeze media.

18 Feb 2012

Paragon receives JVAP-CBMS contract from DoD

Paragon Bioservices, Inc., a Baltimore-based CMO focused on the process development and manufacturing of biologics, announced today that it has been awarded a JVAP-CBMS contract from the Department of Defense (DoD) for the vaccine development and subsequent GMP manufacturing of the "VEE Replicon Particle Trivalent Filovirus Vaccine."

18 Jan 2012

Selcia completes 14C radiolabelled API projects for clients

Selcia has successfully completed 14C radiolabelled API projects on behalf of a diverse range of clients for phase 1 human trials, following MHRA GMP Certification in September 2010. In response to a sharp increase in demand for this specialist service, Selcia has invested to double its capacity for handling GMP radiolabelling projects.

29 Nov 2011