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Amgen drug appears 'highly similar' to Humira: FDA staff
Saturday, July 09, 2016Amgen Incs version of AbbVie Incs Humira arthritis drug the worlds topselling medicine appears similar in potency and safety to the original product US Food and Drug Administration staff members said on Friday The assessment precedes an allday meeti...
Funds advised by Apax Partners to acquire Neuraxpharm
Saturday, July 09, 2016Funds advised by Apax Partners today announced that an entity controlled by them has entered into a definitive agreement to acquire neuraxpharm Arzneimittel GmbH a leading German pharmaceutical company from ATAX GmbH and Neuraxpharm Holding The tran...
Pfizer, Germany's Merck begin large ovarian cancer trial
Friday, July 08, 2016Pfizer Inc and German drugmaker Merck KGaA on Wednesday said they had begun a latestage trial of their immunooncology drug avelumab in combination with standard treatment for ovarian cancer The patient study will enroll patients with advanced ovaria...
Fosun independent research and development of new drugs in clinical trials eligible for drug approval
Friday, July 08, 2016Shanghai Fosun Pharmaceutical Co Ltd announcement called Star Thai subsidiary of Shanghai Pharmaceutical Co Ltd Guilin pharmaceutical Co Ltd received the State food and drug administration of the recently agreed on ex miscellaneous Lu amine soft caps...
France's Valneva says has generated possible Zika vaccine
Friday, July 08, 2016French biotech firm Valneva said on Thursday it has produced a possible vaccine against the mosquitoborne Zika virus Valneva said its facility in Lyon central France had succeeded in generating a highly purified inactivated vaccine candidate using t...
Japan's Eisai weighs legal action in UK cancer drug row
Friday, July 08, 2016Japans Eisai said on Friday it would consider all options including possible legal action to fight delays in Britains healthcare system that prevent patients from accessing one of its drugs to treat a rare form of cancer The move highlights frustrat...
Hamlet Pharma signs agreement with Liansa Pharma Consulting
Wednesday, July 06, 2016Hamlet Pharma AB Agreement with Liansa Pharma Consulting as partner for Regulatory Services Says has signed agreement with Liansa Pharma Consulting AB company focusing on regulatory strategies and communication with regulatory agencies Sou
Cempra Announces FDA Acceptance of Solithera™ New Drug Applications
Wednesday, July 06, 2016Cempra Inc a clinicalstage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases today announced that its New Drug Applications NDAs for the approval of SolitheraTM s...
Alembic Pharma gets tentative nod from USFDA for Febuxostat
Wednesday, July 06, 2016Alembic Pharmaceuticals has received tentative approval from the US health regulator for Febuxostat tablets used for treatment of hyperuricemia in patients of gout The company has received tentative approval from the US Food and Drug Administration...
France's Sanofi signs Zika vaccine research deal with Pentagon
Wednesday, July 06, 2016French drugmaker Sanofi said on Wednesday it had struck a research and development agreement with the Walter Reed Army Institute of Research WRAIR in the United States to develop a Zika vaccine candidate Sanofi said the WRAIR a biomedical research f...