Merck Serono
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Merck Serono and Quintiles Announce Clinical Development Partnership
May 15, 2013 8:06 am | News | Comments
Merck Serono, a division of Merck, Darmstadt, Germany, and Quintiles, a provider of biopharmaceutical development and commercial outsourcing services, today announced a new, five-year clinical development agreement. This strategic collaboration is the first-of-its-kind between a biopharmaceutical company and a biopharmaceutical services provider.
Merck Serono and Quintiles Announce Clinical Development Partnership
May 15, 2013 8:06 am | News | Comments
Merck Serono, a division of Merck, Darmstadt, Germany, and Quintiles, a provider of...
Merck Serono and Quintiles Announce Clinical Development Partnership
May 15, 2013 8:06 am | News | Comments
Merck Serono, a division of Merck, Darmstadt, Germany, and Quintiles, a provider of...
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EMD Serono Expands Global Research & Development Hub in Massachusetts
April 18, 2013 10:43 am | News | CommentsEMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced today the continued expansion of the company’s presence in the United States, resulting in an estimated 20% increase in EMD Serono’s employee base from last July to the end of 2014.
Aeterna Zentaris Transfers Cetrotide Manufacturing Rights to Merck KGaA
April 17, 2013 7:57 am | News | CommentsAeterna Zentaris Inc. today announced that its German subsidiary has entered into binding agreements with various partners and licensees with respect to the manufacturing rights and obligations for its Cetrotide product. The principal effect of such agreements is to transfer manufacturing rights and to grant a manufacturing license for Cetrotide to a subsidiary of Merck KGaA of Darmstadt, Germany, in all jurisdictions.
Columbia Labs Extends Agreement with Merck Serono for CRINONE Through 2020
April 9, 2013 7:56 am | News | CommentsColumbia Laboratories, Inc. has amended its license and supply agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for CRINONE ® (progesterone gel) through May 2020, representing an extension of five years beyond the current term, which was due to expire in May 2015.
EMD Serono: Phase III Trial of Cilengitide Did Not Meet Primary Endpoint in Patients With Newly Diagnosed Glioblastoma
February 25, 2013 8:04 am | News | CommentsEMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced today that the Phase III CENTRIC a trial of the investigational integrin inhibitor cilengitide did not meet its primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy).
Dr. Reddy's Laboratories Ltd. and Merck Serono Announce Collaboration to Develop and Commercialize Biosimilars
June 6, 2012 4:02 am | News | CommentsDr. Reddy's Laboratories Ltd. and Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs). The partnership covers co-development, manufacturing and commercialization of the compounds around the globe, with some specific country exceptions.
Study: Use of Drug Following First Sign of Possible MS Reduces Likelihood of Progression to MS
April 20, 2012 4:23 am | News | CommentsPeople who received injections of the multiple sclerosis (MS) drug interferon beta-1a soon after their first signs of possible MS were less likely to progress to clinically definite MS than people who switched to interferon beta-1a from placebo, according to new phase three results of the three-year REFLEXION clinical trial.
Merck and Threshold to Co-Develop and Commercialize Hypoxia-Targeted Drug
February 3, 2012 3:36 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that a global agreement was signed with Threshold Pharmaceuticals, Inc., South San Francisco, to co-develop and commercialize TH-302, Threshold's small molecule hypoxia-targeted drug.
Ablynx and Merck Serono Expand Their Partnership Into Osteoarthritis
November 9, 2011 3:58 am | News | CommentsABLX today announced that it has further expanded its relationship with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and entered into a third agreement to co-discover and co-develop Nanobodies against two targets in osteoarthritis.
Merck Serono Returns Rights for Safinamide to Newron
October 21, 2011 4:22 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it has decided to return all rights for safinamide to Newron Pharmaceuticals S.p.A.
Merck Serono and Ono Pharmaceutical Form Collaborations to Develop Oral Multiple Sclerosis Drug and Cancer Immunotherapy
October 4, 2011 4:05 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced the signature of two separate agreements with Ono Pharmaceutical Co., Ltd., Osaka, Japan to strengthen its multiple sclerosis and cancer franchises.
Merck Serono Acquires Rights to PI-2301 Program for Multiple Sclerosis
September 19, 2011 4:10 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that it has acquired worldwide exclusive rights to PI-2301, an experimental drug for multiple sclerosis, previously developed by Peptimmune Inc. PI-2301 has completed Phase 1b in multiple sclerosis and is ready to initiate phase 2 clinical trials.
EMD Serono Appoints New President
July 14, 2011 6:07 am | News | CommentsEMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that James Hoyes has been appointed President.
Merck Serono Receives European Approval for Three Pre-filled, Ready-To-Use Pen Injectors for Fertility Treatment
July 5, 2011 4:32 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, has announced that the European Commission (EC) has granted an approval for three pre-filled, ready-to-use pen injectors for fertility treatment.
EMD Serono’s Massachusetts Facility Receives Gold LEED® Rating
April 26, 2011 7:36 am | News | CommentsEMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, today announced that the company's state-of-the-art research center in Billerica, MA, is LEED® Gold certified under the U.S. Green Building Council and verified by the Green Building Certification Institute (GBCI).
Merck Serono Receives Complete Response Letter from FDA on Cladribine Tablets NDA
March 2, 2011 3:49 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on the new drug application (NDA) for Cladribine Tablets, Merck Serono’s proprietary investigational oral formulation of cladribine, as a therapy for relapsing-remitting multiple sclerosis (MS).
EMD Serono Opens State-of-the-Art Research Center in Billerica, MA
February 10, 2011 3:44 am | News | CommentsEMD Serono, Inc. has opened a state-of-the-art research center in Billerica, MA, establishing it as a "hub" within the Merck KGaA research organization.
Merck Serono and Domain Therapeutics to Develop Drugs for Parkinson's Disease
January 17, 2011 3:21 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that an exclusive development and licensing agreement with Domain Therapeutics, Strasbourg, France, was signed to develop metabotropic glutamate receptor 4 (mGluR4) Positive Allosteric Modulator (PAM) drugs targeting Parkinson's disease and other neurodegenerative diseases.
Merck and sanofi-aventis to Jointly Investigate Novel Combinations Against Cancer
December 17, 2010 3:37 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that Merck, has signed a worldwide research and development agreement with sanofi-aventis U.S. Inc., under which Merck Serono and sanofi-aventis U.S. Inc. will collaboratively investigate novel experimental combinations of agents that could block specific pathways in cancer cells.
Ready-to-Use Formulation of Recombinant Growth Hormone Saizen Recommended for Approval in Europe
November 15, 2010 3:33 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it has successfully completed the Decentralized Procedure (DCP) allowing for approval of Saizen(R) Solution For Injection (somatropin) in the 18 participating Member States
EMA Issues Negative Opinion Regarding Merck's MS Treatment
September 24, 2010 4:53 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion regarding the marketing authorization application (MAA) for Cladribine Tablets as a treatment for relapsing-remitting multiple sclerosis (MS).
FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of MS
July 28, 2010 4:26 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the FDA has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS).
Merck Serono's Cladribine Tablets for MS Approved in Russia
July 12, 2010 4:25 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the Russian Federal Service on Surveillance in Healthcare and Social Development has become the first government agency to grant marketing approval to Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Cladribine Tablets will be available in Russia under the trade name Movectro(R).
FDA Lifts Clinical Hold on EMD Serono's Stimuvax Program
June 17, 2010 4:41 am | News | CommentsEMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, today announced that they are resuming their Stimuvax(R) (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, STARTa and INSPIREb. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.
Merck Serono Resubmits U.S. Application for Cladribine Tablets as a Potential MS Therapy
June 8, 2010 4:08 am | News | CommentsMerck Serono, a division of Merck KGaA, Darmstadt, Germany, announced the submission of a New Drug Application (NDA) to the U.S. FDA for Cladribine Tablets as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).
Columbia Laboratories Renews Agreement with Merck Serono for CRINONE in Foreign Markets
May 18, 2010 4:39 am | News | CommentsColumbia Laboratories, Inc. has renewed its license and supply agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for CRINONE(R) (progesterone gel) for an additional five-year term.
