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FDA approves Amgen's BLINCYTO to treat relapsed or refractory B-Cell precursor ALL
By PBR Staff Writer
Amgen has announced that the US Food and Drug Administration (FDA) has granted approval of BLINCYTO™ (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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BMS awards nine new grants to fight against hepatitis B and C in China and India
By PBR Staff Writer
Bristol-Myers Squibb (BMS) Foundation has awarded nine new grants for the projects in China and India, in a bid to combat Hepatitis B and C infection in both the countries.
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Catalent and Valerion partner to bring new treatments for orphan genetic disorders to market
Catalent Pharma Solutions is set to collaborate with Valerion Therapeutics, an emerging science-driven company, focused on the development of bio-therapeutics for orphan genetic diseases, to develop Valerion’s two lead product candidates.
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Unilife to use Depot-ject delivery system with approved ocular injection drug
Unilife Corporation, a developer and supplier of injectable drug delivery systems, has signed ten year deal with a global pharmaceutical company for the use of the Depot-ject delivery system with an approved ocular injection therapy.
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First MS patients treated with Genzyme’s Lemtrada in US
By PBR Staff Writer
Genzyme has announced that the first patient with relapsing forms of multiple sclerosis (MS) has been treated with Lemtrada (alemtuzumab).
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Jazz starts enrolling patients in Phase III Xyrem Pediatric Narcolepsy trial
By PBR Staff Writer
Jazz Pharmaceuticals has commenced patient enrollment in a Phase III clinical trial designed to evaluate the safety, efficacy and pharmacokinetics of Xyrem (sodium oxybate) in children and adolescents aged seven to 17 who have narcolepsy with cataplexy.
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BioPharmX submits pre-IND meeting request to FDA for its topical acne solution
By PBR Staff Writer
BioPharmX Corporation has submitted a request for a pre-Investigational New Drug (IND) meeting to the US Food and Drug Administration (FDA) for the company's topical antibiotic acne compound currently under development.
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Zosano and Lilly agree to develop ZP-PTH product candidate for osteoporosis
By PBR Staff Writer
Zosano Pharma and Eli Lilly have entered into an exclusive agreement to develop the former's proprietary formulation of parathyroid hormone 1-34 (PTH) ZP-PTH using microneedle patch system to treat patients with osteoporosis.
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FDA approves Sanofi's Priftin to treat latent tuberculosis infection
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Sanofi's Priftin (rifapentine), an antimycobacterial, in combination with isoniazid (INH) for a new indication to treat latent tuberculosis infection (LTBI) in patients two years of age and older at high risk of progression to tuberculosis (TB) disease.
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TESARO, AnaptysBio expand immuno-oncology collaboration for new bispecific antibody candidate
TESARO, an oncology-focused biopharmaceutical company, and AnaptysBio, a privately-held therapeutic antibody company, announced an expansion of their immuno-oncology collaboration and exclusive license agreement to include development of a novel bispecific antibody candidate designed to target two undisclosed immune checkpoints.
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Foundation Medicine and Flatiron Health to develop data platform to accelerate Precision Medicine for Cancer
Foundation Medicine, and Flatiron Health announced a strategic collaboration to develop a unique, proprietary cloud-based information platform combining genomic and clinical treatment and outcomes data to significantly advance the field of precision medicine for cancer.
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Meridian Life Science gets SBIR II by CDC to develop rotavirus vaccine
Meridian Life Science, of Memphis, Tennessee, a wholly-owned subsidiary of Meridian Bioscience, is proud to announce they have been selected by the Centers for Disease Control and Prevention (CDC) to develop a process for manufacture of a rotavirus vaccine.
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Qualitas Health meets major commercial milestone with Almega PL
Qualitas Health announced the launch of the first consumer products based upon Almega PL, marking the company's transition from research and development into successful commercialization of the company's premium algal omega-3 oil.
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FDA orders new warnings on OTC Acetaminophen Drugs
A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious skin reactions.
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European Commission approves Astellas' prostate cancer drug enzalutamide
By PBR Staff Writer
The European Commission (EC) has granted a variation to amend the marketing authorization for Astellas Pharma's enzalutamide (XTANDI) to treat men with metastatic castration-resistant prostate cancer (mCRPC).
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