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GSK seeks Japanese approval for eosinophilic asthma drug mepolizumab GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for mepolizumab, an anti IL-5 monoclonal antibody, as an add-on maintenance treatment for patients with severe eosinophilic asthma who experience exacerbations on standard treatment. Drug Research > Drug Delivery > News
Actavis confirms appeals Court Ruling requiring continued distribution of NAMENDA IR Actavis confirmed that a panel of the U.S. Court of Appeals for the Second Circuit has issued a ruling upholding a December 15, 2014 preliminary injunction requiring the Company to continue distribution of NAMENDA (memantine HCl) immediate-release tablets.
News Regeneron, Sanofi report positive topline results from Phase III trials with sarilumab in patients with rheumatoid arthritis Regeneron Pharmaceuticals, and Sanofi announced that a Phase 3 study of sarilumab, an investigational, fully human IL-6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis (RA) at 24 weeks and physical function at 12 weeks, compared to placebo.
News Cellular Biomedicine reports positive Phase I results from CAR-T CD30 immuno-oncology clinical development program Cellular Biomedicine Group, a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, announced encouraging clinical data from its Chimeric Antigen Receptor (CAR-T) CD30-positive Hodgkin's lymphoma immuno-oncology clinical development program.
News
Amgen to terminate participation in co-development and commercialization of brodalumab with AstraZeneca Amgen announced the Company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca.
News Amgen gets CHMP positive ppinion for Repatha to treat high cholesterol Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Repatha (evolocumab) recommending approval for use in certain patients with high cholesterol.
News Rhodes to launch ADHD treatment Aptensio XR this summer By PBR Staff Writer
Rhodes Pharmaceuticals will launch Aptensio XR, a once-daily central nervous system stimulant indicated to treat attention-deficit/hyperactivity disorder (ADHD) beginning this summer.
News

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Production & Manufacturing

Actavis confirms appeals Court Ruling requiring continued distribution of NAMENDA IR
Actavis confirmed that a panel of the U.S. Court of Appeals for the Second Circuit has issued a ruling upholding a December 15, 2014 preliminary injunction requiring the Company to continue distribution of NAMENDA (memantine HCl) immediate-release tablets.
News
Amgen gets CHMP positive ppinion for Repatha to treat high cholesterol
Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Repatha (evolocumab) recommending approval for use in certain patients with high cholesterol.
News

Drug Research

Regeneron, Sanofi report positive topline results from Phase III trials with sarilumab in patients with rheumatoid arthritis
Regeneron Pharmaceuticals, and Sanofi announced that a Phase 3 study of sarilumab, an investigational, fully human IL-6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis (RA) at 24 weeks and physical function at 12 weeks, compared to placebo.
News
Omeros' Omidria gets EMA committee positive opinion for cataract and IOL procedures
By PBR Staff Writer
US-based biopharmaceutical firm Omeros has received positive opinion from the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) for Omidria (phenylephrine and ketorolac injection) 1%/0.3%, for use during cataract surgery and other intraocular lens (IOL) replacement procedures.
News

Inward Investment

PPF Group acquires minority stake in Cytune Pharma
By PBR Staff Writer
PPF Group, in cooperation with SOTIO has completed acquisition of minority stake in French biotechnology firm Cytune Pharma.
News
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

Packaging

Catalent completes acquisition of Australia's Pharmapak
By PBR Staff Writer
US-based Catalent Pharma Solutions has strengthened its ability to provide integrated solutions to customers with the acquisition of Pharmapak Technologies, an Australian pharmaceutical packaging business.
News
MP Global Products introduces foam-free packaging for shipment of temperature sensitive pharmaceuticals
MP Global Thermal Packaging Products insulated protective mailers and box liners are specifically designed for temperature control and protection of mail order shipments of temperature sensitive pharma, pet meds, and natural and organic cosmetics.
News

Contract Research & Services

Cellular Biomedicine reports positive Phase I results from CAR-T CD30 immuno-oncology clinical development program
Cellular Biomedicine Group, a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, announced encouraging clinical data from its Chimeric Antigen Receptor (CAR-T) CD30-positive Hodgkin's lymphoma immuno-oncology clinical development program.
News
Amgen to terminate participation in co-development and commercialization of brodalumab with AstraZeneca
Amgen announced the Company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca.
News

Automation

Highland Therapeutics gets three US patents and one notice of allowance
Highland Therapeutics, a pharmaceutical company, announced that the US Patent and Trademark Office (USPTO) has issued three patents and one Notice of Allowance (NOA) for the Company’s lead products.
News
FDA accepts Tris Pharma's NDA for Dyanavel XR to treat ADHD
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review Tris Pharma's new drug application (NDA) for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension, for the treatment of attention deficit hyperactivity disorder (ADHD).
News

Regulatory Affairs

PlasmaTech's lead product candidates get FDA orphan drug and rare pediatric disease designations
PlasmaTech Biopharmaceuticals (PTBI), a biopharmaceutical company focused on gene therapy and plasma-based products for severe and life- threatening rare diseases announced that the US Food and Drug Administration (FDA) had granted both Orphan Drug Designation and Rare Pediatric Disease Designation for both of PlasmaTech Biopharmaceuticals' lead product candidates for the treatment of Sanfilippo Syndromes A and B.
News
Bristol-Myers gets amended FDA breakthrough therapy status for daclatasvir-based HCV regimen
By PBR Staff Writer
The US Food and Drug Administration (FDA) has amended a previously granted breakthrough therapy designation for Bristol-Myers Squibb's investigational daclatasvir and sofosbuvir combination to treat patients with hepatitis C (HCV).
News



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