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Pharmaceutical Business Review

Novartis reports positive results from two Phase III trials of secukinumab in ankylosing spondylitis Novartis has reported positive results from its Phase III trials MEASURE 1 and MEASURE 2 of its investigational medicine AIN457 (secukinumab) in patients with ankylosing spondylitis (AS). Contract Research & Services > Clinical Trials > News
EMA committee recommends AstraZeneca's ovarian cancer drug Lynparza By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending AstraZeneca's marketing authorization of ovarian cancer drug Lynparza (olaparib) as monotherapy.
News Cytori gets FDA nod to resume enrolment in ATHENA cardiovascular trial By PBR Staff Writer
Cytori Therapeutics has received notification from the US Food and Drug Administration (FDA) that the company has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials.
News Relypsa submits NDA for FDA clearance of hyperkalemia treatment Patiromer FOS By PBR Staff Writer
Biopharmaceutical firm Relypsa has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking clearance to market Patiromer for Oral Suspension (Patiromer FOS) to treat hyperkalemia.
News
NICE recommends Bayer's rivaroxaban as option for secondary prevention in ACS By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued its Appraisal Consultation Document (ACD) recommending Bayer HealthCare's Xarelto (rivaroxaban) 2.5mg twice daily as an option for secondary prevention in acute coronary syndrome (ACS).
News Islet and BHV report two Phase IIb clinical trials of remogliflozin etabonate to treat type 2 diabetes Islet Sciences has announced the publication of two peer-reviewed articles highlighting clinical results from completed 12-week Phase 2b studies of remogliflozin etabonate, a selective sodium glucose transporter 2 (SGLT2) inhibitor currently being developed by Brighthaven Ventures for type 2 diabetes and nonalcoholic steatohepatitis (NASH).
News Vaxart accelerates Ebola tablet vaccine development Vaxart, a privately held company developing vaccines that are administered by tablet rather than by injection, has announced that the company is accelerating its Ebola tablet vaccine program.
News

Latest News and Insight by Sector

Production & Manufacturing

Relypsa submits NDA for FDA clearance of hyperkalemia treatment Patiromer FOS
By PBR Staff Writer
Biopharmaceutical firm Relypsa has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking clearance to market Patiromer for Oral Suspension (Patiromer FOS) to treat hyperkalemia.
News
USPTO grants Epizyme with notices of allowance for patent applications covering PRMT5 inhibitors
Epizyme, a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, has announced that the US Patent and Trademark Office has granted Notices of Allowance for US Patent Applications, Nos. 14/136,551 and 14/136,738, both entitled “PRMT5 Inhibitors and Uses Thereof.”
News

Drug Research

Vaxart accelerates Ebola tablet vaccine development
Vaxart, a privately held company developing vaccines that are administered by tablet rather than by injection, has announced that the company is accelerating its Ebola tablet vaccine program.
News
Johnson & Johnson announces major commitment to expedite ebola vaccine development
Johnson & Johnson (JNJ) has made a commitment of up to $200m to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies.
News

Inward Investment

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
Endo offers $2.2bn to acquire Auxilium
By PBR Staff Writer
Irish pain drugmaker Endo International has proposed $2.2bn offer to acquire biopharmaceutical company Auxilium Pharmaceuticals.
News

Packaging

Packaging Coordinators completes acquisition of Biotec
By PBR Staff Writer
Packaging services provider Packaging Coordinators (PCI) has completed the acquisition of UK-based pharmaceutical services provider Biotec for an undisclosed amount.
News
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.
News

Contract Research & Services

Cytori gets FDA nod to resume enrolment in ATHENA cardiovascular trial
By PBR Staff Writer
Cytori Therapeutics has received notification from the US Food and Drug Administration (FDA) that the company has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials.
News
Islet and BHV report two Phase IIb clinical trials of remogliflozin etabonate to treat type 2 diabetes
Islet Sciences has announced the publication of two peer-reviewed articles highlighting clinical results from completed 12-week Phase 2b studies of remogliflozin etabonate, a selective sodium glucose transporter 2 (SGLT2) inhibitor currently being developed by Brighthaven Ventures for type 2 diabetes and nonalcoholic steatohepatitis (NASH).
News

Automation

Zymeworks, Lilly extend deal for new bi-specific immunotherapies on Azymetric platform
By PBR Staff Writer
Zymeworks and Eli Lilly and Company have extended their existing licensing and collaboration agreement for development of an undisclosed number of new bi-specific antibody therapeutics using Zymeworks’ Azymetric platform.
News
iBio expands exclusive product collaboration with Novici Biotech
iBio, a provider of plant-based biotechnology for developing and manufacturing biological products, and Novici Biotech (Novici) have agreed to broaden their commercial collaboration, currently focused on antibodies and certain vaccine products, to include iBio's proprietary IBIO-CFB03 product for idiopathic pulmonary fibrosis, systemic sclerosis and other fibrotic diseases.
News

Regulatory Affairs

EMA committee recommends AstraZeneca's ovarian cancer drug Lynparza
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending AstraZeneca's marketing authorization of ovarian cancer drug Lynparza (olaparib) as monotherapy.
News
NICE recommends Bayer's rivaroxaban as option for secondary prevention in ACS
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued its Appraisal Consultation Document (ACD) recommending Bayer HealthCare's Xarelto (rivaroxaban) 2.5mg twice daily as an option for secondary prevention in acute coronary syndrome (ACS).
News

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