BioSpace.com News

AB SCIEX Improves Food Safety With New Method to Identify Markers for Horse Meat and the Banned Veterinary Drug Residue Phenylbutazone

Thu, 23 May 2013 12:00:00 AM GMT

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FRAMINGHAM, Mass.--(BUSINESS WIRE)--AB SCIEX, a global leader in analytical technology, today announced that its scientists have developed a new method for detecting horse tissue present in meat samples. This...

A Boehringer Ingelheim Corporation Shake Up and an FDA Warning Letter Over Production Gaffes

Wed, 22 May 2013 12:00:00 AM GMT

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After a string of grave and embarrassing manufacturing problems, Boehringer Ingelheim is overhauling some of its management. Late last week, Boehringer Ingelheim quietly posted on its web site that Wolfram Carius...

Ranbaxy Laboratories Highlights Improved Business and Quality Assurance Standards

Wed, 22 May 2013 12:00:00 AM GMT

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GURGAON, India--(BUSINESS WIRE)--Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) (Ranbaxy) today highlighted some of the major specific actions the Company has been taking in recent years to address...

Lonza Inc. Issues Guidance on Infection Control and Global Influenza A (H7N9)

Wed, 22 May 2013 12:00:00 AM GMT

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Basel, Switzerland, 22 May 2013 As human infections with a new avian influenza A (H7N9) virus continue to be reported in China, Lonza is making information available about infection control.

Influenza...

IMPAX Laboratories, Inc. Board Steps in to Oversee Hayward Manufacturing Issues

Tue, 21 May 2013 12:00:00 AM GMT

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HAYWARD, Calif. -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that its Board of Directors has established a Compliance Committee composed of three independent directors to provide oversight for...

Biotrial Bioanalytical Services (Bbs) Proves Top-Quality Performance by Successfully Passing Another FDA Inspection

Mon, 13 May 2013 12:00:00 AM GMT

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May 13, 2013 -- Biotrial is pleased to announce that following an inspection of Biotrial Bioanalytical Services (BBS) located in Laval, Quebec by the Centre for Drug Evaluation and Research (CDER) division...

FDA Releases Alexion Pharmaceuticals Inc. Response to 483 Report

Thu, 09 May 2013 12:00:00 AM GMT

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In a rare move, the FDA has publically released Alexion Pharmaceuticals response to a Form 483 following inspection of its US site and the discovery of microbial contamination.

Help employers find...

Tekmira Pharmaceuticals Corporation Provides Update on U.S. Government Sponsored TKM-Ebola Program

Wed, 08 May 2013 12:00:00 AM GMT

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VANCOUVER, British Columbia, May 8, 2013 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced that its...

Clinovo Launches Its TechTraining on CDISC Standards

Wed, 08 May 2013 12:00:00 AM GMT

Sunnyvale, CA. May 06, 2013. Clinovo's new CDISC Standards: Theory and Application class is an 8-week training program starting in June 11th, 2013. The TechTrainings are technical hands-on classes for entry-level or experienced clinical trial professionals designed to help them reach the next step in their professional career. The class will be held in Palo Alto at Dentons Offices or remotely. ...

Another Biosimilar Legislative Defeat for Amgen & Genentech

Tue, 07 May 2013 12:00:00 AM GMT

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Once again, a state legislature has defeated a controversial push by some of the largest biotechs to establish new requirements for biosimilar substitution. The latest vote took place late last week in Florida...

Spectranetics Corporation Finalizes EXCITE ISR Adjunct Analysis Plan

Tue, 07 May 2013 12:00:00 AM GMT

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COLORADO SPRINGS, Colo., May 6, 2013 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced the Food and Drug Administration's (FDA) approval of its adjunct analysis plan associated...

Johnson & Johnson Licence Revoked Over Baby Powder Concerns

Mon, 06 May 2013 12:00:00 AM GMT

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Health officials have revoked Johnson & Johnson's license to make cosmetics at a plant outside Mumbai after they discovered the company had used an unauthorized process for sterilizing its baby powder...

Ajinomoto???s North Carolina Plant Receives ISO 9001 Certification

Mon, 06 May 2013 12:00:00 AM GMT

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RALEIGH, N.C.--(BUSINESS WIRE)--Ajinomoto North America, Inc. today announced it has received ISO 9001 certification at its North Carolina plant. ISO 9001 is an ISO (International Organization for Standardization...

BioIndustry Association Meeting Highlights Benefits of the Patent Box to Life Science Companies

Thu, 02 May 2013 12:00:00 AM GMT

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2 May 2013 -- Fifty life science companies discussed how the recently-introduced Patent Box can benefit their businesses and drive future jobs and growth in the UK at the BioIndustry Association's (BIA...

Tauriga Sciences Inc. Enhances Its Corporate Governance Protocols Through the Establishment of Four Board Oversight Committees and Corporate Code of Ethics

Fri, 26 Apr 2013 12:00:00 AM GMT

NEW YORK, NY--(Marketwired - April 26, 2013) - Tauriga Sciences, Inc. (OTCQB: TAUG) ("the Company"), a life sciences holding company creating a diversified portfolio of medical technology assets, has today announced that the Company has taken meaningful steps to enhance its corporate governance protocols...

Immunotech Laboratories Begins Regulatory Process With FDA

Fri, 26 Apr 2013 12:00:00 AM GMT

MONROVIA, CA--(Marketwired - April 26, 2013) - Immunotech Laboratories, Inc. (PINKSHEETS: IMMB) today announced the company has initiated the Pre-IND and IND process with the US Food & Drug Administration (FDA). The successful submission of an Investigational New Drug (IND) to FDA will permit...

FDA Scolds Teva Pharmaceutical Industries Limited for an Unbalanced and Overblown Handout

Tue, 23 Apr 2013 12:00:00 AM GMT

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File this under how could they not know? Drugmakers are well aware of the requirements for readying promotional materials, steps that include submitting a form to spell out the messages to be conveyed...

Regulatory Affairs Professionals Society Virtual Program on Advertising, Promotion and Labeling for Drugs and Devices to Cover Federal Trade Commission and FDA Enforcement, Social Media, Sunshine Act and More

Tue, 23 Apr 2013 12:00:00 AM GMT

Rockville, MD, USAThe Regulatory Affairs Professionals Society (RAPS) will host a virtual workshop, Advertising, Promotion and Labeling: the US Regulated Environment, Monday, 29 April, 12:005:00 pm EDT. The program features regulators and regulatory experts on current communications guidelines and expectations for companies marketing regulated healthcare products in the US.

Among the program...

Biosearch Technologies Launches New GMP Production Facility and Successfully Certifies to ISO 13485:2003

Thu, 18 Apr 2013 12:00:00 AM GMT

NOVATO, CA (THURSDAY, APRIL 18, 2013) Biosearch Technologies, Inc. (Biosearch), a leader in the development and manufacture of GMP grade oligonucleotides, announced today the relocation of its GMP manufacturing process into a new, state-of-the-art GMP production facility in Novato, California. The 30,000 square foot facility was developed to further expand processes and controls relevant to medical...

La Jolla Pharmaceutical Company Receives Orphan Designation From FDA for LJPC-6417

Thu, 18 Apr 2013 12:00:00 AM GMT

SAN DIEGO, CA--(Marketwired - April 18, 2013) - La Jolla Pharmaceutical Company (OTCQB: LJPC) ("La Jolla"), a leader in the development of therapeutics targeting galectin proteins, announced today that the FDA Office of Orphan Products Development has granted an "Orphan...

Second ISPE-FDA Event Attracts Top Names, Features Release of Drug Shortage Survey Results

Wed, 17 Apr 2013 12:00:00 AM GMT

(TAMPA, FLORIDA, USA, 16 April 2013) ISPE announced today that it will hold its second annual Redefining the C in CGMP conference, 11 13 June in Baltimore, Maryland USA. Themed Ensuring a Reliable Supply of Quality Medicines, the event will feature strategic education on issues of interest to industry leaders and global regulatory officials focused on quality systems, processes and technology...

Omeros Corporation Files Orphan Drug Application for Treatment of Atypical Hemolytic Uremic Syndrome With OMS721

Wed, 17 Apr 2013 12:00:00 AM GMT

SEATTLE, April 17, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has filed an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 ...

Waiter, There's Cardboard in My Sample: FDA Warns Pfizer Inc. Over Manufacturing Gaffes

Fri, 12 Apr 2013 12:00:00 AM GMT

In its latest bid to clamp down on wayward drug manufacturing, the FDA cited a Pfizer plant in Italy for violating some fairly basic procedures. The first involved problems with testing samples of batches of a diluting agent for its Torisel kidney cancer drug and claiming false positives were caused by interference from cardboard packaging. Yes, cardboard. The drugmaker, however, failed to offer any...

FDA Requests $4.7 Million for China Drug Maker Inspections

Fri, 12 Apr 2013 12:00:00 AM GMT

by Richard Daverman, PhD

April 11, 2013 -- In President Obamas new 2014 budget request, the FDA asked for $4.7 million to carry out inspections of China pharmas that export products to the US during the fiscal year 2014. The request includes funding for nine full-time equivalent employees. In previous years, the agency did not break out separate line items for China drug safety inspections...

Regulatory Affairs Professionals Society Webcast to Examine China SFDA Device Registration Process

Tue, 09 Apr 2013 12:00:00 AM GMT

9 April 2013 -- The Regulatory Affairs Professionals Society (RAPS) will host a webcast, 10 April at 11:00 am EDT, examining and clarifying the China Food and Drug Administrations (CFDA) medical device registration process.

John Beasley, founder and senior consultant, MedTech Review LLC, and Daniel Huang, regulatory affairs officer, Celestica (Suzhou) Technology Co. Ltd, will examine real...

ISPE Releases New Guidance for Standardizing Use of Booklet Labels in Global Clinical Trials

Thu, 04 Apr 2013 12:00:00 AM GMT

(TAMPA, FLORIDA, USA, 03 April 2013) ISPE, a leading authority on best practices for the pharmaceutical industry, announced today that it has issued the industrys first-ever guidance to help companies conducting clinical trials in multiple countries standardize their use of booklet labels. The Guide provides templates, guidelines and tools to make it easier for companies to use booklet labels consistently...

Alliance Life Sciences Empowers International Reference Pricing for Pharmaceutical Manufacturers Worldwide With PRICENTRIC™ - Global Pricing Data and Advanced Analytics

Thu, 04 Apr 2013 12:00:00 AM GMT

SOMERSET, N.J.--(BUSINESS WIRE)--Alliance Life Sciences Consulting Group (ALSCG), an innovative management and technology consultancy, announces its competitive pricing data offering, PRICENTRICTM, designed for the international pharmaceutical marketplace. With the release of its White Paper: Global Pricing Data and Advanced Analytics for Better Decisions and Competitor Edge, ALSCG empowers pharmaceutical...

Bioheart, Inc. Completes FDA Registration for Tissue Bank Establishment

Tue, 02 Apr 2013 12:00:00 AM GMT

SUNRISE, FL--(Marketwired - April 02, 2013) - Bioheart, Inc. (OTCQB: BHRT) announced today that it has completed the FDA tissue bank registration process. Bioheart is offering stem cell storage for patients enrolled in the studies at the centers of excellence outside the US. Patients can store additional...

China Cord Blood Corporation Received AABB Accreditation

Tue, 02 Apr 2013 12:00:00 AM GMT

HONG KONG, April 2, 2013 /PRNewswire-FirstCall/ -- China Cord Blood Corporation (NYSE:CO) ("CCBC" or the "Company"), the first and largest cord blood banking operator in China, today announced that the cord blood bank operated by its Beijing subsidiary...

FDA Lifts Import Alert on Aurobindo Pharma's Hyderabad Facility

Thu, 28 Mar 2013 12:00:00 AM GMT

Aurobindo Pharma today said the US health regulator has lifted the import alert on its Hyderabad-based antibiotics facility, thereby allowing the company to export 9 products from this plant to the US market. US Food and Drug Administration (USFDA) has lifted the import alert for non-sterile products manufactured at Unit-VI cephalosporin facility based in Hyderabad, thereby, paving the way for resumption...

AIBioTech Receives Laboratory Permit From the to Perform Clinical Testing

Thu, 28 Mar 2013 12:00:00 AM GMT

Richmond, VAAIBioTech has received a clinical laboratory permit from the Clinical Laboratory Evaluation Program (CLEP) of the New York State Department of Health to perform clinical testing on samples collected in the state. This includes its comprehensive pharmacogenetic testing panel.

AIBioTechs pharmacogenetic panel can provide vital information to physicians to determine the therapeutic...

Vetter's Newest Facility Successfully Completes FDA Inspection

Thu, 28 Mar 2013 12:00:00 AM GMT

RAVENSBURG, Germany--(BUSINESS WIRE)--Vetter, a leading contract development and manufacturing organization (CDMO), announced today that its new center for visual inspection and logistics passed its first GMP inspection by the U.S. Food and Drug Administration (FDA). The inspection was conducted March 11 through 14 to ensure the facility is in compliance with good manufacturing practices. The facility...

Bioheart, Inc.'s Appeals to the FDA for Compassionate Use Designation to Save Lives

Wed, 27 Mar 2013 12:00:00 AM GMT

SUNRISE, FL--(Marketwire - March 27, 2013) - Bioheart, Inc. (OTCQB: BHRT) today announced that the Company is preparing to request of the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) permission to allow access to investigational drugs outside of a clinical...

Vetter's Newest Facility Successfully Completes FDA Inspection

Wed, 27 Mar 2013 12:00:00 AM GMT

Ravensburg, Germany, March 27, 2013 / B3C newswire / Vetter, a leading contract development and manufacturing organization (CDMO), announced today that its new center for visual inspection and logistics passed its first GMP inspection by the U.S. Food and Drug Administration (FDA). The inspection was conducted March 11 through 14 to ensure the facility is in compliance with good manufacturing practices...

Recipharm AB Site in France Approved for Supply of Manufactured Products to Japan

Tue, 26 Mar 2013 12:00:00 AM GMT

26 March 2013: Recipharms solid dose facility located in Fontaine, France, has been approved for supply of manufactured products to the Japans pharmaceuticals market following a recent inspection by the PMDA, the Japanese drug agency.

The product dossier was presented by an existing contract manufacturing customer, also securing regulatory approval for its supply to Japan.

The...

Translational Genomics Research Institute (TGen) Establishes Secure Link to 2nd Supercomputer With "Obsidian Longbow™" Technology

Tue, 26 Mar 2013 12:00:00 AM GMT

PHOENIX--(BUSINESS WIRE)--The Translational Genomics Research Institute (TGen) is testing a secure connection to its second supercomputer using Obsidian Strategics Longbow technology, which features National Security Administration (NSA) approved hardware-based encryption and authentication. TGens new 19-teraflop supercomputer (19 trillion operations per second), located at Phoenix NAP, positions...

Isis Pharmaceuticals, Inc. Provides Update on CHMP Opinion on KYNAMRO™ (Mipomersen)

Mon, 25 Mar 2013 12:00:00 AM GMT

CARLSBAD, Calif., March 22, 2013 /PRNewswire/ -- Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that following Genzyme's request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its previous position and has maintained...

Cook Pharmica LLC Receives an Additional Commercial Approval From FDA

Mon, 25 Mar 2013 12:00:00 AM GMT

BLOOMINGTON, Ind.--(BUSINESS WIRE)--Cook Pharmica, which develops and manufactures pharmaceutical and biopharmaceutical products on a contract basis, recently received more good news from the Food and Drug Administration (FDA). The company earned another commercial approval from the FDA and did so with the FDA waiving the otherwise required pre-approval inspection. We are grateful for the confidence...

PPD, Inc.'s Bioanalytical Labs Certified as a Center of Bioavailability/Bioequivalence of Medicines by Brazil's National Health Surveillance Agency

Fri, 22 Mar 2013 12:00:00 AM GMT

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD) today announced its bioanalytical operation has been certified by Brazils Agencia Nacional de Vigilancia Sanitaria (ANVISA), validating that PPD meets the agencys stringent biopharmaceutical safety guidelines and allowing the company to conduct bioanalytical work on its clients compounds that will be marketed in Brazil...

NDIS Approval of Promega Corporation PowerPlex® Fusion System Assists Laboratories in Meeting Evolving Standards

Fri, 22 Mar 2013 12:00:00 AM GMT

MADISON, Wis.--(BUSINESS WIRE)--Promega Corporations PowerPlex Fusion System is now approved for use in laboratories that generate DNA records for the National DNA Index System (NDIS). NDIS is the U.S. national database containing over ten million offender profiles used to help authorities in solving criminal investigations nationwide, using the FBIs CODIS system. This approval of PowerPlex Fusion...

Baxter International, Inc. and Halozyme Therapeutics, Inc. Announce Positive Opinion for HyQvia for Treatment of Primary and Secondary Immunodeficiencies in the European Union

Fri, 22 Mar 2013 12:00:00 AM GMT

LONDON, March 22, 2013 /PRNewswire/ -- Baxter International Inc. (NYSE: BAX) and Halozyme Therapeutics, Inc., (NASDAQ: HALO) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter<...

GENEWIZ, Inc. Receives CAP Accreditation

Thu, 21 Mar 2013 12:00:00 AM GMT

SOUTH PLAINFIELD, NJ--(Marketwire - March 21, 2013) - Leading global genomics service company, GENEWIZ, Inc., announced accreditation from the College of American Pathologists (CAP). With this accreditation, the GENEWIZ, Inc. Global Headquarters joined the elite...

FDA Advisory Committee Votes Favorably on Abbott Laboratories's Minimally Invasive MitraClip® Device for Patients with Significant Mitral Regurgitation Who are Too High Risk for Surgery

Thu, 21 Mar 2013 12:00:00 AM GMT

ABBOTT PARK, Ill., March 20, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits of treatment with the MitraClip device outweigh its risks...

Link Technologies Ltd Release: New Cyanine Dyes Reduce Time and Cost of Oligo Labelling

Wed, 20 Mar 2013 12:00:00 AM GMT

BELLSHILL, SCOTLAND, 21 March 2013: Link Technologies Ltd, an ISO 9001:2008 certified specialist oligonucleotide reagent manufacturer, has launched a range of high quality cyanine dye products to support the continued increase in demand for fluorescent labelling in biological imaging and molecular diagnostics. As well as introducing a new range of 3-CPG solid supports modified with Cyanine 540 and...

Hospira, Inc. Obtains Six Months U.S. Pediatric Exclusivity for Precedex™ (dexmedetomidine HCl) Injection

Tue, 19 Mar 2013 12:00:00 AM GMT

LAKE FOREST, Ill., March 18, 2013 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for...

Butamax??? Advanced Biofuels LLC. Announces Immediate Appeal of Court Decisions on Claim Construction and Summary Judgment

Tue, 19 Mar 2013 12:00:00 AM GMT

WILMINGTON, Del., March 20, 2013 - Butamax Advanced Biofuels, LLC, the leading biobutanol technology company, announced today it would appeal the Courts claim construction and decisions on certain motions before the Court in Butamaxs litigation against Gevo.

Paul Beckwith, Butamax Chief Executive Officer, stated, Butamax has decided to appeal this case immediately. Butamax strongly...

Cytomedix Inc. Announces Centers for Medicare & Medicaid Services Issuance of Reimbursement Coding for Autologous PRP in Chronic Non-Healing Wounds

Mon, 18 Mar 2013 12:00:00 AM GMT

GAITHERSBURG, MD--(Marketwire - March 18, 2013) - Cytomedix, Inc. (OTCQX: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that the Center for Medicare & Medicaid Services (CMS) has issued...

Echo Therapeutics Achieves ISO 13485 Certification

Fri, 15 Mar 2013 12:00:00 AM GMT

PHILADELPHIA, March 15, 2013 /PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony CGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system, today announced that it has been granted International Standards Organization...

Masy Systems, Inc. Now NVLAP Accredited to Perform RH Calibrations

Fri, 15 Mar 2013 12:00:00 AM GMT

Pepperell, MA - March 7, 2013 - Masy Systems, Inc., a leader in validation, calibration, GMP storage and validation equipment rentals for the biotech, pharmaceutical and life sciences industries has expanded its scope of accreditation by NVLAP (National Voluntary Laboratory Accreditation Program) to include RH Calibrations.

Achieving and maintaining NVLAP Accreditation requires ongoing quality...

Pfizer Inc. Criticizes India's Intellectual Property Policies