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EMA to Relocate to New HQ in Amsterdam in Wake of Brexit
Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.
Avista Doubles API Manufacturing Capacity at Colorado Facility
Avista Pharma Solutions facility and equipment upgrades at its Longmont, Colorado facility support processing of potent compounds.
Boehringer Ingelheim Launches Open-Access Platform of Selected Preclinical Molecules
The opnME.com platform offers scientists access to best-in-class molecules supported by comprehensive data packages.
Samsung Bioepis Receives Approval for First Trastuzumab Biosimilar, Ontruzant, in Europe
Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.
Design Solution for Single-Use Technology Applications
SciLog Select Go Single-Use Assemblies from Parker Hannifin uses an assortment of validated parts and assemblies to build needed devices for biopharmaceutical manufacturing.
FDA Approves Roche’s Hemophilia A Biologic and Expands Indication for Leukemia Drug
The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.
Integrated Analytical Software Solutions for Clinical and Regulatory Processes
MasterControl has added three new cloud-based analytical solutions to its MasterControl Version 11.7 software for clinical managers and regulatory/submissions professionals.
FDA’s Policy on Regenerative Medicine Therapies
Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.
Record Attendance at CPhI Worldwide Reflects Pharma’s Strength
Germany tops quality ranking in the inaugural CPhI Global Pharma Index.
CPhI Global Pharma Index Shows India’s Reputation Improving
India was ranked by international pharmaceutical companies as the third most competitive nation globally.
J&J and Zymeworks in Bispecific Antibody Pact Worth Nearly $1.5 Billion
As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.
Novartis, ASCP, and ACS Partner for African Cancer Initiative
The entities announced that they will partner to improve access to cancer treatments and diagnostics in Ethiopia, Uganda, and Tanzania.
Bayer in $1.5-Billion Deal with Loxo Oncology for Anti-Cancer Drugs
Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.
Pall Debuts New Inline Diafiltration Modules for Continuous Bioprocessing
The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.
Spectrum Chemical and BASF Enter Catalyst Agreement
Spectrum Chemical will provide BASF precious-metal-containing powder catalysts in research quantities for early product development.
Baxter Recalls NEXTERONE
The company is voluntarily recalling one lot of NEXTERONE 150 mg/100 mL Premixed Injection because of particulate matter found in the solution.
FDA Warns Against Using Kratom Products for Opioid Treatment
Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.
FDA Approves Digital Pill
The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.
ADC Targets Fail Because of Aggregation Problems
ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.
Bormioli Rocco Pharma Introduces Packaging Innovations
Bormioli Rocco Pharma offers new packaging solutions for powdered oral drugs, parenteral drugs, pediatric syrups, and protein-based drugs.
Cambrex Expands Small-Scale Capacity at Iowa Facility
The company has completed a small-scale capacity expansion at its site in Charles City, IA.
Pfizer Appoints New COO
The company has appointed Albert Bourla, PhD, as its new COO.
Nitto Avecia Completes Large-Scale Synthesis of Oligonucleotide
Company completes first successful run of what is believed to be the largest synthesis-scale done for oligonucleotide APIs.
WuXi and Pall Establish Continuous MAb Manufacture
The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.
Alcami in API Manufacturing Pact with Solasia
Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.
EMA Recommends Ten Drugs for Approval
Two of the medicines recommended for approval are orphan drugs.
QuintilesIMS Changes Name to IQVIA
QuintilesIMS has changed its name to IQVIA to reflect its October 2016 merger with IMS Health.
AstraZeneca Gets Positive EMA Opinion on Respiratory Biologic
The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
Dynavax Wins FDA Approval for Hep B Vaccine
The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.
Recipharm Reveals Plans to Discontinue Operations in Two Swedish Facilities
As part of Recipharm’s ongoing initiative to improve profitability and competitiveness, a decision has been made to end operations in Stockholm and Höganäs.
