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Lannett, Celgene sign settlement and license agreement related to Thalomid
Lannett has entered into a settlement and license agreement with Celgene, which resolves patent infringement litigation in the US related to Celgene's Thalomid.
Production & Manufacturing > Manufacturing > News
Novartis to buy nuclear medicine firm Advanced Accelerator Applications for $3.9bn
By PBR Staff Writer
Novartis has agreed to acquire French radiopharmaceutical company Advanced Accelerator Applications (AAA) for $3.9bn to strengthen its oncology presence.
Production & Manufacturing > Manufacturing > News
AbbVie’s psoriasis drug meets co-primary endpoints in three phase 3 trials
By PBR Staff Writer
AbbVie’s psoriasis drug risankizumab has met all co-primary and ranked secondary points in three pivotal phase 3 clinical trials.
Contract Research & Services > Clinical Trials > News
Novartis pediatric multiple sclerosis drug Gilenya shows significant effect in phase III trial
Novartis has announced full results from the phase III PARADIGMS study, investigating the safety and efficacy of Gilenya (fingolimod) versus interferon beta-1a, in children and adolescents (ages 10 to 17) with multiple sclerosis (MS).
Contract Research & Services > Clinical Trials > News
Merck withdraws European application for Keytruda in first-line NSCLC
By PBR Staff Writer
Merck has withdrawn its European application seeking approval of its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and carboplatin (pem/carbo) in Europe as a first-line treatment for metastatic nonsquamous non-small cell lung cancer (NSCLC).
Production & Manufacturing > Process & Production > News
FDA accepts Roche’s sBLA for Avastin to treat women with advanced ovarian cancer
Roche has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA) for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer.
Regulatory Affairs > News
OncoQuest to collaborate with Tesaro in recurrent ovarian cancer setting
OncoQuest has entered into collaboration with Tesaro to conduct a proof-of-concept clinical trial evaluating the combination of oregovomab with ZEJULA (niraparib) in the recurrent ovarian cancer setting.
Contract Research & Services > Clinical Trials > News
Teva loses Copaxone patent dispute case to Mylan in UK
By PBR Staff Writer
The UK High Court of Justice has given a decision in favor of Mylan and Synthon over their dispute concerning the patent of Teva Phamaceutical Industries’ multiple sclerosis (MS) treatment Copaxone which was ruled to be invalid due to obviousness.
Regulatory Affairs > News
Regeneron Pharmaceuticals to invest $100m in Irish facility
By PBR Staff Writer
US-based Regeneron Pharmaceuticals will invest an additional $100m to expand its bioprocessing campus in Limerick, Ireland, to increase its drug substance production capacity.
Production & Manufacturing > Manufacturing > News
Study uses genomics to make treatment recommendations for recurrent glioblastoma patients
A study led by the Translational Genomics Research Institute (TGen), UC San Francisco (UCSF) and the Ivy Foundation Early Phase Clinical Trials Consortium has used genomics to make treatment recommendations for recurrent glioblastoma patients.
Contract Research & Services > Clinical Trials > News
Researchers identify new genetic variants for breast cancer risk
A major international collaboration involving hundreds of researchers worldwide has identified seventy-two new genetic variants that contribute to the risk of developing breast cancer.
Drug Research > Drug Discovery & Development > News
Incyte, MacroGenics sign licensing agreement for anti-PD-1 monoclonal antibody MGA012
Incyte and MacroGenics have entered into an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1).
Drug Research > Drug Discovery & Development > News
FDA rejects PTC Therapeutics' application for Duchenne drug
By PBR Staff Writer
PTC Therapeutics has failed to secure the approval from the US Food and Drug Administration (FDA) for its experimental drug Ataluren (Translarna) to treat nonsense mutation Duchenne muscular dystrophy (nmDMD).
Regulatory Affairs > News
Synlogic gets orphan drug status for SYNB1618 to treat phenylketonuri
Synlogic has secured orphan drug status from the US Food and Drug Administration (FDA) for o SYNB1618 preclinical-stage drug candidate for the treatment of phenylketonuria (PKU).
Regulatory Affairs > News
Gilead Sciences' GS-0976 shows positive effect in phase 2 NASH study
Gilead Sciences announced results from a Phase 2, randomized, placebo-controlled trial evaluating two doses of GS-0976, an oral, investigational inhibitor of Acetyl-CoA carboxylase (ACC), in patients with nonalcoholic steatohepatitis (NASH).
Contract Research & Services > Clinical Trials > News
121-135 of 50849 results