Under the terms of the agreement, Amerigen and Menovo will jointly develop products for Amerigen to commercialize in the United States. Menovo will be responsible for manufacturing API and finished product whereas Amerigen will be responsible for clinical, regulatory and commercial activities in the United States.
The alliance is intended to encompass a long-term supply agreement in which EMD Millipore will...
Due to the special containment requirements for manufacturing highly potent active...
Pfizer and Merck announced today that they have entered into an agreement to explore the...
EMD Millipore Expands Biomanufacturing Sciences and Training Center in Japan and Opens New Location in TokyoAugust 26, 2014 8:14 am | News | Comments
EMD Millipore today announced the opening of a new Biomanufacturing Sciences Training Center (BSTC) facility in Tokyo. The facility is designed to help biopharmaceutical companies develop manufacturing processes and find solutions to processing challenges in collaboration with engineers from EMD Millipore.
Scaling up can be a challenge; know the processes and tools for a successful transition.
Eli Lilly and Co. says it will close its Elanco animal enzyme plant in Terre Haute by early 2016 as part of a consolidation push. Lilly spokesman Ed Sagebiel tells the Tribune-Star the Indianapolis-based company is consolidating all of its animal enzyme manufacturing to a site in Great Britain.
Rigel Pharmaceuticals today announced that R348, its ophthalmic JAK/SYK inhibitor, did not meet the primary or secondary endpoints in a recently completed Phase 2 clinical study in patients with dry eye disease. The endpoints were measured by changes in corneal fluorescein staining, conjunctival staining, tear production and dry eye symptom scores from baseline over 12 weeks of treatment versus placebo.
Pfizer is teaming up with DNA testing company 23andMe to study the possible genetic underpinnings of inflammatory bowel disease, a hard-to-treat ailment that affects an estimated 1.4 million Americans. Under the agreement, Silicon Valley-based 23andMe will map the DNA of 10,000 patients who have forms of the disease, which include Crohn's disease and ulcerative colitis.
In 2005 I had raised a question about Batch or a Continuous Process: A Choice. At that time it seemed like a logical question and still is. However, I left part of the question unanswered. Missing was the discussion of components of pharma manufacturing, API manufacture and their formulations.
Impax Laboratories today announced FDA performed a re-inspection of the company's Hayward, California manufacturing facility and issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations.
Allied Minds and Bristol-Myers Squibb Company today announced the formation of Allied-Bristol Life Sciences LLC, a new jointly owned enterprise created to identify and foster research and pre-clinical development of biopharmaceutical innovations from leading university research institutions across the U.S.
NanoViricides, Inc. reports that it is restarting its drug development program to combat Ebola virus infections. Currently, there are no licensed drugs or vaccines for Ebola, although some vaccines as well as some drug candidates have entered clinical trials.
Pluristem Therapeutics has announced that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa.
The Galien Foundation today announced the 2014 nominees for the eighth annual Prix Galien USA. Awards. The Prix Galien Award is considered the biomedical industry's highest accolade and recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines and devices.
AstraZeneca today announced that it has entered into a clinical study collaboration with Kyowa Hakko Kirin for a Phase I/Ib immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumours.
Packaging Coordinators has reached a definitive agreement to acquire Penn Pharmaceutical Services Limited. Penn Pharma is headquartered in Tredegar, Wales in the United Kingdom and operates regional offices in New Hope, Pennsylvania and Tokyo, Japan.
Ortho-Clinical Diagnostics has entered into a strategic partnership with Astute Medical, under which OCD will become the exclusive commercial partner for the distribution of Astute’s NEPHROCHECK ® Test and ASTUTE140 ® Meter in certain markets in Europe and, pending FDA clearance, the United States.
AstraZeneca and QIAGEN to Develop Diagnostic Test for Lung Cancer Patients Suitable for Treatment with IRESSAJuly 28, 2014 8:49 am | News | Comments
AstraZeneca today announced that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with IRESSA®.
AstraZeneca today announced it has entered into collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small-cell lung cancer (NSCLC).
Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).
Oncology drug developer, CanTx Inc., and its parent company, Novogen Ltd., today announced that they have named two key contract manufacturing organizations (CMOs) to produce clinical batches of the experimental anti-cancer drug, Cantrixil.
They've got money, connections and hordes of eager college students. Ten U.S. cities head a new list of best places to develop and distribute drugs...of the legal kind, that is. The 2014 JLL Global Life Sciences Cluster Report analyzes the top cities where science and pharmaceutical innovation converge.
GSK CEO Sir Andrew Witty and CFO Simon Dingemans on the group’s Q2 2014 results and strategy update.
Shire and ArmaGen announced a worldwide licensing and collaboration agreement for AGT-182, an investigational enzyme replacement therapy (ERT) for the potential treatment of both the central nervous system (CNS) and somatic manifestations in patients with Hunter syndrome (MPS II).
AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a clinical trial collaboration with Advaxis, Inc., a US-based biotechnology company developing cancer immunotherapies.
Merz North America will establish its headquarters in Raleigh, North Carolina, officials announced today at a press conference with Gov. Pat McCrory. The global pharmaceutical company – part of the Merz Pharma Group, with affiliates in 18 countries around the world – will move operations from current headquarters in Greensboro and from elsewhere in the U.S.
Some things just seem to naturally go together – peanut butter and chocolate is one of those combinations – especially in the form of peanut butter cups. Bacon and eggs is another, as is peanut butter and jelly, pizza and beer and numerous other tasty combinations.
Aptuit Names Executive VP, Business Development & Marketing; Enhances Sterile Drug Product CapabilitiesJuly 16, 2014 11:33 am | News | Comments
Aptuit LLC has appointed Paul D. Overton, Ph.D., as Executive Vice President, Business Development and Marketing, making him responsible for all of Aptuit’s sales and marketing activities.
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