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HHS Sponsors Commercial Manufacturing Tests for Ebola Vaccine
HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.
Marken Announces New Depot and Operations Center in Argentina
Marken announced the opening of a new depot and logistics operations center in Argentina.
Crescendo and Takeda Collaborate on Humabody Therapeutics
The companies entered into a collaboration and license agreement for Crescendo’s Humabody-based therapeutics.
FDA Completes 20 Meetings on Patient Involvement in Drug Development
The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.
WuXi AppTec Unveils Manufacturing Center for Cell and Gene Therapies
WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.
Darzalex Combination Shows Promise as Multiple Myeloma Treatment
Results from the Phase III POLLUX trial with Janssen’s Darzalex showed that the drug was effective at reducing disease progression in patients with relapsed or refractory multiple myeloma.
Teva and Celltrion Partner on Biosimilar Commercialization
The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.
EUIPO Report Says Counterfeit Medicines Cost EU €10.2 Billion a Year
A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.
PDA’s First Aging Facilities Survey Sees Regulatory Obstacles to Modernization
The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.
Multisorb to Build New Manufacturing Facility in India
The company announced that it will build a new manufacturing facility at the GMR Aerospace Park at the Rajiv Gandhi International Airport in India.
Constantia Flexibles Acquires Flexible Packaging Business
Constantia Flexibles acquired a flexible packaging business from Lamp San Prospero SPA.
Drug Value Assessment Here to Stay
Value assessment initiatives are expected to have a major impact on drug use and reimbursement.
Xellia Pharmaceuticals Expands R&D in Croatia
Xellia added laboratory space and personnel in Zagreb, Croatia to work on anti-infective products that combat the antimicrobial resistance problem.
Cation Exchange Resin Achieves Higher Dynamic Binding Capacity
Tosoh Bioscience adds TOYOPEARL Sulfate-650F, a strong cation exchange resin that exhibits high salt tolerance, to its process media product line.
Integrated Membrane for Single-Use Filtration Assemblies Saves Set-Up and Validation Time
A PESU membrane is now available for Sartorius Stedim Biotech Sartocon benchtop and production-scale filtration assemblies.
Immobilized Metal Affinity Chromatography Resin
Bio-Rad Laboratories’ Nuvia IMAC Resin, an immobilized metal affinity chromatography resin, is optimized for use from laboratory-scale through pilot studies to process-scale manufacturing.
Allergan Enters into Licensing Agreement with AstraZeneca
Allergan entered into a licensing agreement with AstraZeneca for MEDI2070, an anti-IL-23 monoclonal antibody in phase IIB development for the treatment of patients with moderate-to-severe Crohn’s disease.
Carrick Therapeutics Launches in Europe
The new company will focus on R&D of cancer treatments.
Guselkumab Superior to Humira in Phase III Trial
The Phase III trial examined guselkumab compared with a placebo and Humira at treating moderate-to-severe plaque psoriasis.
Children’s Hospital of Pittsburgh of UPMC Receives Grant to Join Vaccine Surveillance Network
The hospital received a five-year $5 million grant from CDC to survey for communicable diseases in children and evaluate vaccine effectiveness.
SGS Invests in New cGMP Facility
The company invested in a new cGMP facility located in Berlin, Germany.
Boehringer Ingelheim and ViraTherapeutics Collaborate on Oncolytic Virus Therapies
ViraTherapeutics will develop its VSV-GP therapy alone and in combination with other therapies.
CDER Publishes Drug Safety Priorities
FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.
Europe Strengthens Collaborations with Japanese Pharmacopoeia
EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.
Baxter Recalls Micron Filters
The company is voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters.
PaizaBio Receives CFDA Approval for Expansion
PaizaBio will add aseptic injectable production capacity in Hangzhou, China.
FDA Releases Q7 GMP for API Guidance
he guidance addresses the good manufacturing practice for managing quality in APIs.
Issuing Pharma Report Cards
Could grading finished-drug manufacturers on their quality and efficiency lead to greater transparency, improve quality and reduce drug shortages?
Outlook for Biosimilars in 2020
Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.
Onset Expands Product Line for Cold-Chain Monitoring
Onset expanded its product line for pharmaceutical cold-chain management with the launch two new products.