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Pharmaceutical Business Review

Bristol-Myers' Evotaz gets FDA approval for HIV-1 treatment in adults The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's Evotaz tablets in combination with other antiretroviral agents to treat HIV-1 infection in adults. Regulatory Affairs > News
AstraZeneca to use CRISPR genome editing technology for key therapeutic areas By PBR Staff Writer
AstraZeneca has entered into four research collaborations to use clustered regularly interspaced short palindromic repeats (CRISPR) technology for genome editing across its discovery platform in key therapeutic areas.
News Reata enrolls first patient in Phase II/III MOXIe study of RTA 408 in friedreich's ataxia patients Reata announces enrollment of the first patient in a Phase 2 dose-ranging study examining the safety, tolerability, and efficacy of RTA 408 Oral Capsules versus placebo for the treatment of patients with Friedreich's ataxia.
News USPTO issues patent for VG Life Sciences covering treatment of IBD with CLIP-Inducing agent VG Life Sciences, a biotechnology company developing therapies for autoimmune and infectious diseases, announced the US Patent and Trademark Office (USPTO) has issued U.S. Patent No. 8906846, covering a method of treating inflammatory bowel disease (IBD) through the administration of a CLIP-inducing agent.
News
Janssen's PREZCOBIX gets FDA approval to treat adults living with HIV-1 Janssen Therapeutics, Division of Janssen Products, LP (Janssen), announced the U.S. Food and Drug Administration (FDA) has approved PREZCOBIX (darunavir 800 mg/cobicistat 150 mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, for the treatment of human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for treatment-naive and treatment-experienced adults with no darunavir resistance-associated substitutions.
News Intercept gets FDA breakthrough therapy status for Obeticholic acid to treat NASH with liver fibrosis Intercept Pharmaceuticals, announced that its investigational product obeticholic acid (OCA) has received "breakthrough therapy designation" from the U.S. Food and Drug Administration (FDA) for the treatment of patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.
News MediciNova gets new patent covering MN-029 (denibulin) di-hydrochloride in Japan MediciNova, a biopharmaceutical company, announced that it has received a new patent from the Japanese Patent Office which covers MN-029 (denibulin) di-hydrochloride.
News

Latest News and Insight by Sector

Production & Manufacturing

USPTO issues patent for VG Life Sciences covering treatment of IBD with CLIP-Inducing agent
VG Life Sciences, a biotechnology company developing therapies for autoimmune and infectious diseases, announced the US Patent and Trademark Office (USPTO) has issued U.S. Patent No. 8906846, covering a method of treating inflammatory bowel disease (IBD) through the administration of a CLIP-inducing agent.
News
Janssen's PREZCOBIX gets FDA approval to treat adults living with HIV-1
Janssen Therapeutics, Division of Janssen Products, LP (Janssen), announced the U.S. Food and Drug Administration (FDA) has approved PREZCOBIX (darunavir 800 mg/cobicistat 150 mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, for the treatment of human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for treatment-naive and treatment-experienced adults with no darunavir resistance-associated substitutions.
News

Drug Research

Intercept gets FDA breakthrough therapy status for Obeticholic acid to treat NASH with liver fibrosis
Intercept Pharmaceuticals, announced that its investigational product obeticholic acid (OCA) has received "breakthrough therapy designation" from the U.S. Food and Drug Administration (FDA) for the treatment of patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.
News
Sumitomo Chemical develops SumiLarv 2 MR to prevent dengue fever
Sumitomo Chemical is pleased to announce that it has developed SumiLarv 2 MR, a novel, long - lasting larvicide formulation that is effective in preventing dengue fever.
News

Inward Investment

Merck in talks to acquire Cubist Pharmaceuticals for nearly $8bn
By PBR Staff Writer
New Jersey-based drug giant Merck & Co is, reportedly, in talks over a potential acquisition of antibiotics maker Cubist Pharmaceuticals for more than $8bn.
News
Endo International to buy Auxilium Pharmaceuticals for $2.6bn
By PBR Staff Writer
Ireland-based Endo International has signed an agreement to acquire Auxilium Pharmaceuticals, in a deal that is worth nearly $2.6bn.
News

Packaging

Bosch expands CPS portfolio for serialization of pharmaceutical packaging
Bosch Packaging Technology, a leading supplier of process and packaging technology, has expanded its portfolio for the serialization of pharmaceutical packaging. In the fight against counterfeit drugs, many countries are about to implement legislation changes for a stricter labelling of pharmaceuticals. Consequently, drug manufacturers require safer and more flexible solutions.
News
UPS announces acquisition of Poltraf
By PBR Staff Writer
Atlanta-based UPS that offers a range of solutions for transporting packages and freight will be acquiring the pharmaceutical logistics company of Poland-based investment fund Ortie, Poltraf for an undisclosed amount.
News

Contract Research & Services

Reata enrolls first patient in Phase II/III MOXIe study of RTA 408 in friedreich's ataxia patients
Reata announces enrollment of the first patient in a Phase 2 dose-ranging study examining the safety, tolerability, and efficacy of RTA 408 Oral Capsules versus placebo for the treatment of patients with Friedreich's ataxia.
News
Astellas to develop Immunomic's JRC2-LAMP-vax to treat Japanese red cedar pollinosis
By PBR Staff Writer
Astellas Pharma has entered into an exclusive license agreement with US-based biotechnology firm Immunomic Therapeutics to develop a vaccine that could relieve a common allergy that affects millions of people in Japan.
News

Automation

AstraZeneca to use CRISPR genome editing technology for key therapeutic areas
By PBR Staff Writer
AstraZeneca has entered into four research collaborations to use clustered regularly interspaced short palindromic repeats (CRISPR) technology for genome editing across its discovery platform in key therapeutic areas.
News
Sorrento completes patient enrollment in Cynviloq TRIBECA registrational trial
By PBR Staff Writer
US-based Sorrento Therapeutics has completed patient enrollment in its ongoing TRIBECA (TRIal establishing bioequivalence [BE] between Cynviloq and Albumin-bound paclitaxel) registrational trial.
News

Regulatory Affairs

FDA approves Pharmacyclics and Janssen' Imbruvica to treat Waldenstrom's macroglobulinemia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Imbruvica (ibrutinib) capsules as the first therapy indicated specifically to treat patients with Waldenström's macroglobulinemia (WM), a rare, indolent type of B-cell lymphoma.
News
Bristol-Myers' Evotaz gets FDA approval for HIV-1 treatment in adults
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's Evotaz tablets in combination with other antiretroviral agents to treat HIV-1 infection in adults.
News

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