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Waters Introduces Ion Mobility-Enhanced Research Mass Spectrometer
Waters Corporation introduced the Waters SYNAPT G2-Si Mass Spectrometer, which integrates a third dimension of resolution and separation power.
Mass Spec Software Optimizes Biopharmaceutical Characterization
Agilent Technologies Inc. introduced the MassHunter BioConfirm application, which allows users to rapidly create targeted screening methods.
Bruker Offers LC Triple Quadrupole Mass Spectrometers
Bruker Chemical and Applied Markets offers three LC-triple quadrupole (LC-TQ) mass spectrometers, the EVOQ Qube, the EVOQ Elite, and the EVOQ Elite ER.
FDA Takes Action Against Illegal Online Pharmacies
The US Food and Drug Administration took action against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers.
Thermo Fisher Scientific Launches Tribrid LC-MS
Thermo Fisher Scientific Inc. introduced the Thermo Scientific Orbitrap Fusion Tribrid liquid chromatography-mass spectrometry (LC-MS) system, which combines three mass analyzers.
FDA Grants Breakthrough Status to Novartis Investigational Drug
Serelaxin, to treat acute heart failure, is the second Novartis drug to get new designation from FDA.
CHMP Recommends Approval of First Two mAb Biosimilars
The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.
PhRMA, BIO Join Newly Formed Coalition Advocating for Fair Trade with India
The Alliance for Fair Trade with India is seeking action to resolve discriminatory trade practices and improved protection of intellectual property rights.
Sandoz Launches Phase III Clinical Trial for Biosimilar Etanercept
Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.
National Institutes of Health Funds Projects to Identify New Uses for Existing Compounds
NIH awards $12.7 million for collaborations between nine academic research groups and pharmaceutical industry partners to explore new treatments.
J&J to Acquire Aragon Pharmaceuticals
The billion-dollar deal strengthens J&J's oncology portfolio.
Pfizer Wins Multibillion-Dollar Settlement from Teva and Sun for Infringement of Protonix Patent
The settlement comes after a nearly 10-year legal battle in which Pfizer and Nycomed (now part of Takeda) sought to enforce the patent for its blockbuster acid reflux medicine.
RAME-HART Technology Helps Boost Vaccine Production in Emerging Markets
Semi-automatic technology aids egg-based influenza vaccine production in smaller facility footprints.
Lonza Introduces Risk Assessment Platform for Biopharmaceuticals
The Developability Assessment Platform evaluates manufacturability and safety in discovery and early-stage biological drug development.
AstraZeneca Selects Cambridge, UK for New Global R&D Center and Corporate HQ
The multimillion investment in a facility in Cambridge is part of the company’s move to create strategic global R&D centers in the UK, US and Sweden.
GSK Receives Offer for its Thrombosis Brands and Related Manufacturing Site
A proposed deal with Aspen includes the company’s site in Notre-Dame-de-Bondeville, France.
Elan Proceeds with Formal Sale Process of Company; Royalty Pharma Drops Bid
The move follows rejection of Elan shareholders of certain key deals and withdrawal of Royalty Pharma bid.
Cobra Biologics Announces Development Projects
Cobra Biologics announced several product development projects with Novolytics, Recopharma, and Vaccibody.
Supreme Court: Human Genes Are Not Patentable
The US Supreme Court ruled that naturally occurring isolated biological material is not patentable, but a synthetic version of gene material may be patented.
ISPE Study Reports on Root Causes for Drug Shortages
ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.
EMA Revises Biosimilars Guideline
EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.
GlaxoSmithKline Acknowledges Misrepresentation in Scientific Article
One employee is dismissed, another has resigned, and three others are put on administrative leave.
Pfizer Partners with CytomX for Antibody Drug Conjugates
The multimillion deal focuses on oncology.
Elan Board Rejects Multibillion Takeover Bid from Royalty Pharma
Elan urges its shareholders to reject bid in an upcoming meeting on June 17.
USP Forms Elemental Impurities Advisory Group
USP appoints regulatory experts to elemental impurities implementation advisory group.
FDA Issues Warning Letter to Baxter Healthcare
FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.
AstraZeneca to Acquire Pearl Therapeutics
Acquisition will strengthen AstraZeneca?s respiratory portfolio with a potential new treatment for chronic obstructive pulmonary disease.
Janssen and Second Genome Partner on Microbiome Drug Discovery
Agreement seeks to advance novel drug targets and focus on therapies for ulcerative colitis.
Boehringer Ingelheim Plans Biopharmaceuticals Facility in China
Facility will use mammalian cell-culture technology and be ready for operations by 2016.
FDA Discovers Microbial Contamination in Compound Pharmacy Products