The lawsuit alleges EnzymeWorks and its founder engaged in willful patent infringement, misappropriation of trade secrets, and breach of confidence, in addition to other claims.
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Sandoz filed a petition with the US Supreme Court to review a Federal Circuit Court’s July 2015 judgment of the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical company filed the writ of certiorari with the court on Feb.
Researchers discovered more than 300 antibodies that reacted with the Ebola virus’s surface glycoprotein and could be used to neutralize many strains of the virus.
The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.
The company issues a voluntary recall of a lot of 0.9% sodium chloride solution due to particulate matter.
The directorate is looking for experts to join the European Pharmacopoeia network.
The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.
Growth in finished dosage formulations triggers a new CPhI Worldwide event.
GRAM completed a fourth FDA inspection of its parenteral manufacturing facility with no Form 483 observation issues.
Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.
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There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.
Metrohm USA awards the 2016 Young Chemist Award to PhD candidate developing wearable sensors that can non-invasively monitor physiologically relevant chemicals.
3M Drug Delivery Systems, Ei Solutionworks, IDT Biologika join CMO/CDMO association
The agency prepares a plan to implement new packaging safety features.
FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.
Barvarian Nordic, Evaxion Biotech, and the Technical University of Denmark announced plans to collaborate on the development of a vaccine for MRSA.
In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.
Several biopharmaceutical companies announce plans to launch R&D into Zika vaccine candidates.
The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.
The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.
Pfizer and Bristol-Myers Squibb enter into agreement with Portola to develop and commercialize andexanet alfa in Japan.
CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.
The body’s over-editing of synaptic interactions is recognized as a probable cause of schizophrenia in a landmark study.
Novartis announced the companies plan to boost growth at Alcon, the company’s vision care division.
Amgen announces FDA will review the company’s BLA for ABP 501.
The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.
NICE announces plans to back biosimilar alternatives to Merck’s Remicade.
The partnership will focus on the identification and analysis of host-cell proteins in biologics.
Novartis announced on Jan. 5, 2016 that the company is collaborating with Qualcomm to develop cloud-based technology for COPD patients.
GS1 US announces the expansion of its advisory services program to address industry needs.
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