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Boehringer Gains FDA Approval of COPD Treatment
Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.
Visterra Announces Partnership to Develop a Monoclonal Antibody
Visterra announces partnership with A*STAR to develop VIS513, a monoclonal antibody for the treatment of dengue fever.
“Cures” Debate Far From Over
The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.
Epirus Biopharmaceuticals and mAbxience Sign Agreement on Infliximab Biosimilar Distribution in Latin America
Epirus Biopharmaceuticals and mAbxience have entered into a development and future distribution deal for Epirus’ lead program, BOW015 (infliximab, reference biologic Remicade), for Latin American markets.
Medicago Plans Vaccine Facility In Quebec City
Medicago's new production facility will make plant-based vaccines and therapeutics.
House Committee Approves 21st Century Cures Legislation
The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.
CMC Biologics Expands Denmark Facility
The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.
Compounding Center to Pay $200 Million for Meningitis Outbreak
The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.
The Alliance for Health Reform Hosts Expert Panel on Biosimilars
Physician confidence in biosimilars and extrapolation of indications are two of the most important factors governing the acceptance and sustainability of biosimilars, say industry panelists.
Eagle Pharmaceuticals Wins Patent Approval for Rapid Infusion Method
The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.
Alexion Plans Biologics Facility in Ireland
Alexion will construct a biologics facility in Ireland that is its first outside the US.
Emergent BioSolutions Enters Agreement with ProMetic Life Sciences
Emergent gives ProMetic long-term access to its Winnipeg facility.
International Neonatal Consortium Launched
The Critical Path Institute launched a consortium to help develop therapies for newborns.
Endo Acquires Par for $8.05 Billion
The Irish company Endo International announced that it would acquire Par Pharmaceutical for $8.05 billion.
AstraZeneca Invests $285 Million in New Facility
AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.
FDA Approves First Spray-Dried Biologic
Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.
Circassia Invests $377 Million in Asthma Specialists
UK-based Circassia invests approximately $377 million on Aerocrine and Prosonix, two companies focused on asthma.
CPhI Worldwide Announces 2015 Expert Panel
CPhI Worldwide announces the 2015 Expert Panel, including 2014 panel veterans and three new members.
SAFC Expansions Address Significant Need for Enhanced Manufacturing Capabilities
SAFC’s new ADC wing in St. Louis, MO will feature commercial-scale manufacture of antibody-drug conjugates, and its Carlsbad, CA site will offer enhanced gene-therapy services.
Rx-360 Establishes Working Group in India
Supply chain consortium establishes a working group to address quality problems in India.
FDA Advisory Panel Questions Clinical Meaningfulness of Vertex’s Cystic Fibrosis Drug Combo
FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.
Pall to be Acquired by Danaher
Pall has agreed to be acquired by Danaher for $127.20 per share.
Juno Expands CAR T-cell Pipeline with $59 Million Acquisition
Juno Therapeutics announces that it will expand its cellular therapies pipeline with the acquisition of Stage Cell Therapeutics for €52.5 million.
Pluristem’s PLX Cells Satisfy Prerequisites for Fast-Track Approval in Japan
Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.
Baxter BioScience Expands Oncology Business
With acquisition of Oncaspar portfolio for leukemia from Sigma-Tau Finanziaria, Baxter BioScience adds an oncology infrastructure and biologic.
FDA Releases Q&A on Biosimilars
The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.
Vaccine Patch Could Eliminate Traditional Protocol for Vaccine Delivery
A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.
J&J Announces Compassionate Care Committee in Collaboration with NYU
Johnson & Johnson announces partnership with NYU School of Medicine to launch a compassionate care committee for individual patient requests of investigational drugs.
Court Blocks First FDA-Approved Biosimilar, for the Time Being
The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.
CPhI Worldwide Launches Charity Initiative with Global Angels
A range of packages is available for industry partners to implement charity giving.