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Pharmaceutical Business Review

FDA approves Avanir's Phase II trial of MDD candidate AVP-786 The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals' investigational new drug (IND) application for a Phase II trial evaluating the safety and efficacy of its next generation compound AVP-786. Production & Manufacturing > Process & Production > News
Dipexium enrols first patient in Phase III trials of Locilex By PBR Staff Writer
Dipexium Pharmaceuticals has enrolled first patient in the second of two pivotal Phase III clinical trials, called OneStep-1 and OneStep-2, evaluating its new, broad-spectrum, topical antibiotic peptide, Locilex (pexiganan cream 0.8%), to treat patients mild infections of diabetic foot ulcers, or Mild DFI.
Contract Research & Services > Clinical Trials > News Advanced BioScience Laboratories acquires majority stake in Platine Advanced BioScience Laboratories (ABL), a US-based biomedical contract research and manufacturing organization, has acquired majority stake in Platine Pharma Services (Platine), a specialist in immunomonitoring and immunogenicity services.
Contract Research & Services > Contract Research > News Anavex receives cGMP manufacturing for drug candidate trial supplies By PBR Staff Writer
US-based biopharmaceutical firm Anavex Life Sciences has received cGMP manufacturing of ANAVEX 2-73 for its drug candidate trial supplies.
Production & Manufacturing > Manufacturing > News
Arena subsidiary inks marketing, supply deal with Abic for BELVIQ in Israel By PBR Staff Writer
Arena Pharmaceuticals' subsidiary has entered into an exclusive marketing and supply agreement for BELVIQ (lorcaserin HCl) with Teva Pharmaceutical Industries' Israeli subsidiary, Abic Marketing Limited.
Contract Research & Services > Contract Services > News Regulus gets FDA orphan drug status for RG-012 to treat Alport Syndrome By PBR Staff Writer
US-based biopharmaceutical firm Regulus Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for RG-012, a single stranded, chemically modified oligonucleotide.
Regulatory Affairs > News Anacor Pharmaceuticals, Sandoz ink deal to commercialize KERYDIN in US Anacor Pharmaceuticals has entered into an exclusive agreement with Sandoz, a Novartis company, pursuant to which Sandoz will distribute and commercialize Anacor’s drug KERYDIN (tavaborole) topical solution, 5% in the United States.
Contract Research & Services > Contract Services > News

Latest News and Insight by Sector

Production & Manufacturing

Anavex receives cGMP manufacturing for drug candidate trial supplies
By PBR Staff Writer
US-based biopharmaceutical firm Anavex Life Sciences has received cGMP manufacturing of ANAVEX 2-73 for its drug candidate trial supplies.
Production & Manufacturing > Manufacturing > News
FDA approves Avanir's Phase II trial of MDD candidate AVP-786
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals' investigational new drug (IND) application for a Phase II trial evaluating the safety and efficacy of its next generation compound AVP-786.
Production & Manufacturing > Process & Production > News

Drug Research

Regeneron, Bayer release positive Phase III trial results of EYLEA to treat DME
By PBR Staff Writer
Regeneron Pharmaceuticals and Bayer HealthCare have released positive results from the Phase III VIVID-DME trial of EYLEA (aflibercept) Injection indicated to treat diabetic macular edema (DME).
Drug Research > Drug Delivery > News
Durata Therapeutics launches DALVANCE for injection in US
By PBR Staff Writer
Durata Therapeutics has launched DALVANCE (dalbavancin) for injection in the US to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI).
Drug Research > Drug Delivery > News

Inward Investment

Amgen to buy Onyx Pharmaceuticals for $10.4bn
By PBR Staff Writer
Biotechnology company Amgen has reached a deal to buy all outstanding shares of California-based Onyx Pharmaceuticals for $125 per share in cash.
Inward Investment > News
Johnson & Johnson completes purchase of Aragon Pharmaceuticals
By PBR Staff Writer
Johnson & Johnson has completed the acquisition of Aragon Pharmaceuticals, a pharmaceutical discovery and development company focused on drugs to hormonally-driven cancers.
Inward Investment > News

Packaging

Biologics adds frozen storage capabilities to clinical research services
By PBR Staff Writer
Biologics’ Clinical Research Services has announced the addition of frozen storage capabilities to its state-of-the-art facilities and cold-chain packaging and distribution.
Packaging > News
ATMI, D-Lab launch new Sterile Pyrofree vials
By PBR Staff Writer
US-based technology firm ATMI in partnership with Disposable Lab (D-Lab), a French contract-manufacturing company, has launched a line of pyrogen-free vials in order to meet biopharmaceutical filling and final packaging needs.
Packaging > News

Contract Research & Services

Dipexium enrols first patient in Phase III trials of Locilex
By PBR Staff Writer
Dipexium Pharmaceuticals has enrolled first patient in the second of two pivotal Phase III clinical trials, called OneStep-1 and OneStep-2, evaluating its new, broad-spectrum, topical antibiotic peptide, Locilex (pexiganan cream 0.8%), to treat patients mild infections of diabetic foot ulcers, or Mild DFI.
Contract Research & Services > Clinical Trials > News
Advanced BioScience Laboratories acquires majority stake in Platine
Advanced BioScience Laboratories (ABL), a US-based biomedical contract research and manufacturing organization, has acquired majority stake in Platine Pharma Services (Platine), a specialist in immunomonitoring and immunogenicity services.
Contract Research & Services > Contract Research > News

Automation

Harvard Medical School, Phelan-McDermid Syndrome Foundation Contract leverages the tranSMART open-source knowledge management platform
The tranSMART Foundation has announced that the Phelan-McDermid Syndrome Foundation and the Center of Biomedical Informatics at Harvard Medical School were awarded a nearly $1 million contract from the Patient-Centered Outcomes Research Institute (PCORI) to undertake an exciting research endeavor that will leverage the tranSMART platform.
Automation > IT & Software > News
MorphoSys gets additional patents on Ylanthia in US and first patent in China
MorphoSys has announced that the US Patent and Trademark Office (USPTO) and the State Intellectual Property Office of China have granted additional patents covering the Company's latest antibody platform Ylanthia.
Automation > IT & Software > News

Regulatory Affairs

Regulus gets FDA orphan drug status for RG-012 to treat Alport Syndrome
By PBR Staff Writer
US-based biopharmaceutical firm Regulus Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for RG-012, a single stranded, chemically modified oligonucleotide.
Regulatory Affairs > News
CTI BioPharma expands access to PIXUVRI with approval in Israel
BioPharma has received approval from the Israeli Ministry of Health (MOH) for PIXUVRI (pixantrone).
Regulatory Affairs > News

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