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Pfizer to Begin Shipping Inflectra in US
The company announced plans to begin shipping Inflectra to the US market in late November 2016.
FDA Releases ANDA Submission Guidance
The guidance assists applicants in preparing prior approval supplements for abbreviated new drug applications.
EMA Recommends Conditional Authorization of Ocaliva
The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.
FDA Awards Grants for Treatments of Rare Diseases
The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.
US and Europe Collaborate on Patient Treatments
FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.
Recipharm to Open New GLP Bioanalysis Laboratory in Sweden
Recipharm announced that it has invested 5 million SEK in a new GLP bioanalysis laboratory in Uppsala.
CordenPharma Completes API Process Bay
CordenPharma announced the completion of a new highly potent process bay for APIs at the company’s Colorado facility.
Catalent Collaborates with Moderna
The companies will collaborate the manufacture of personalized cancer vaccines.
FDA Warns Swiss Company
Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
Scottish Company Receives USFDA Warning Letter
Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.
Recipharm Launches Serialization Showcase Line
Recipharm launched a showcase line to demonstrate the company’s new serialization solutions.
Study Demonstrates Potential Method for Treating Congenital Diseases In Utero
A new study proposes a new way to potentially treat congenital diseases in utero.
Pfizer Comes Up Short in Lyrica Patent Battle
A UK appeals court ruled against Pfizer, saying generic-drug makers did not infringe on Lyrica’s pain patent.
Piramal to Acquire Five Janssen Injectables
Piramal entered into an agreement with Janssen Pharmaceuticals to acquire five of the company’s injectable products.
FDA Officials Issue Warning Letter to Japanese API Manufacturer
FDA warned Nippon Fine Chemical Co. for refusing to allow FDA investigators to inspect sections of the company’s laboratory and equipment.
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.
Gamida Cell Receives Breakthrough Therapy Designation For NiCord
Gamida Cell was granted FDA Breakthrough Therapy Designation for NiCord, a novel graft modality for bone marrow transplantation.
Industry Honored at CPhI Pharma Awards
PharmTech's Editorial Director, Rita Peters, addresses the CPhI Pharma Awards' finalists at this year's CPhI Awards Gala.
Ashland Reveals New Corporate Identity
The company revealed its new Always Solving corporate identity following its eventual separation from Valvoline.
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.
Mylan Reaches Settlement with Department of Justice
Mylan reached a $485-million settlement with the Department of Justice over questioned raised about the Medicaid rebate classification of EpiPen.
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.
Cambrex Takes API Development Prize at the CPhI Pharma Awards
Cambrex’s novel synthesis of Dronederone intermediate was recognized for its excellence in API development.
Manufacturing Technology and Equipment Prize Goes to GEA Group
GEA’s ConsiGma, which is a multipurpose continuous manufacturing platform, won the award for excellence in manufacturing technology and equipment at the 2016 CPhI Pharma Awards.
Capsugel and Merck KGaA Named Winners of the Formulation and Excipients Category of the CPhI Pharma Awards
Capsugel’s intrinsically enteric capsule technology provides enteric protection and delayed release without a functional coating. Merck’s Parteck SRP 80 sustained-release excipient is well suited for direct compression.
