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Pharmaceutical Business Review

FDA approves Eliquis for DVT and PE treatment The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb and Pfizer’s supplemental new drug application (sNDA) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). News
BioLineRx Receives Notice of Allowance for US Patent on BL-7010 for Gluten Toxicity By PBR Staff Writer
BioLineRx Ltd., a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent claiming the use of BL-7010, a novel polymer in preventing or decreasing gluten’s deleterious effects on the gastrointestinal mucosa.
Production & Manufacturing > Process & Production > News Auxilium Pharmaceuticals achieves positive results from phase 2a study of CCH in patients with cellulite By PBR Staff Writer
Auxilium Pharmaceuticals announced positive results from a randomized, double-blind Phase 2a study of collagenase clostridium histolyticum (or CCH) for the treatment of edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite.
Contract Research & Services > Clinical Trials > News Dicerna issues multiple patents covering claims for dicer substrate siRNAs By PBR Staff Writer
Dicerna Pharmaceuticals announced a series of recently issued patents providing broad composition and method of use claims covering double stranded RNA molecules, called dicer substrate siRNAs (DsiRNAs).
Production & Manufacturing > Process & Production > News
Sucampo signs exclusive global manufacturing and supply deal for lubiprostone By PBR Staff Writer
Sucampo Pharmaceuticals announced that its subsidiary, Sucampo, has signed an exclusive global manufacturing and supply agreement (EMSA) with its manufacturing and development partner, R-Tech Ueno (R-Tech), for clinical and commercial supplies of AMITIZA (lubiprostone) in most global markets.
Production & Manufacturing > Manufacturing > News Pfizer initiates EAP for palbociclib in US By PBR Staff Writer
Pfizer Inc. announced that the company has initiated a multi-center, open-label expanded access program (EAP) in the United States for the investigational CDK 4/6 inhibitor, palbociclib.
Contract Research & Services > Clinical Trials > News Lilly's Ixekizumab proves superior in Phase 3 Psoriasis studies By PBR Staff Writer
Eli Lilly and Company's investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase 3 studies, the company said in disclosing top-line results from its pivotal UNCOVER studies in moderate-to-severe plaque psoriasis.
Contract Research & Services > Clinical Trials > News

Latest News and Insight by Sector

Production & Manufacturing

BioLineRx Receives Notice of Allowance for US Patent on BL-7010 for Gluten Toxicity
By PBR Staff Writer
BioLineRx Ltd., a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent claiming the use of BL-7010, a novel polymer in preventing or decreasing gluten’s deleterious effects on the gastrointestinal mucosa.
Production & Manufacturing > Process & Production > News
Dicerna issues multiple patents covering claims for dicer substrate siRNAs
By PBR Staff Writer
Dicerna Pharmaceuticals announced a series of recently issued patents providing broad composition and method of use claims covering double stranded RNA molecules, called dicer substrate siRNAs (DsiRNAs).
Production & Manufacturing > Process & Production > News

Drug Research

Glenmark starts IND-enabling studies of new bispecific antibody
By PBR Staff Writer
Glenmark Pharmaceuticals has started the investigational new drug (IND)-enabling studies of a new bispecific antibody.
Drug Research > Drug Discovery & Development > News
Mitsubishi Tanabe Pharma, Astrazeneca partner on diabetic nephropathy research
By PBR Staff Writer
Japan-based Mitsubishi Thnabe Pharma (MTPC) has collaborated with AstraZeneca to carry out research on diabetic nephropathy.
Drug Research > Drug Discovery & Development > News

Inward Investment

Recipharm to buy Corvette Pharmaceutical Services for $160m
By PBR Staff Writer
Swedish contract development and manufacturing organisation Recipharm has agreed to purchase Milan based Corvette Pharmaceutical Services Group (Corvette) from Italian private equity group LBO Italia Investimenti.
Contract Research & Services > Contract Research > News
Novartis agrees to acquire 15% stake in Gamida Cell
By PBR Staff Writer
Swiss drugmaker Novartis Pharma has signed an agreement to acquire 15% stake in Gamida Cell for $35m.
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

Auxilium Pharmaceuticals achieves positive results from phase 2a study of CCH in patients with cellulite
By PBR Staff Writer
Auxilium Pharmaceuticals announced positive results from a randomized, double-blind Phase 2a study of collagenase clostridium histolyticum (or CCH) for the treatment of edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite.
Contract Research & Services > Clinical Trials > News
Pfizer initiates EAP for palbociclib in US
By PBR Staff Writer
Pfizer Inc. announced that the company has initiated a multi-center, open-label expanded access program (EAP) in the United States for the investigational CDK 4/6 inhibitor, palbociclib.
Contract Research & Services > Clinical Trials > News

Automation

Novan’s Nitricil technology demonstrates efficacy against multi-drug resistant pathogens
By PBR Staff Writer
Novan Therapeutics’ Nitricil platform technology has proven to be effective against most of the multi-drug resistant pathogens infecting civilian and military health care providers worldwide.
Automation > IT & Software > News
EastGate augments sub-micron self-nanoemulsifying platform technology
By PBR Staff Writer
US-based pharmaceutical firm EastGate Acquisitions is augmenting its self-emulsifying sub-micron platform technology to include a broad spectrum of delivery options, which are directed towards improving patient compliance.
Automation > IT & Software > News

Regulatory Affairs

EMA agrees to review Basilea’s isavuconazole marketing authorization application
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted to review Basilea Pharmaceutica’s isavuconazole marketing authorization application (MAA) for the treatment of invasive aspergillosis and mucormycosis (zygomycosis) in adults.
Regulatory Affairs > News
US DEA tightens restrictions on painkiller prescriptions
By PBR Staff Writer
The US Department of Drug Enforcement Administration (DEA) is all set to roll out new restrictions on several products blended with hydrocodone, which has turned out to be a highly prescribed and addictive painkiller in America.
Regulatory Affairs > News

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