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136-150 of 44611 results
FDA accepts to review Teva's NDA for Albuterol MDPI
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Teva Pharmaceuticals' new drug application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI), an investigational breath-actuated dry-powder inhaler to treat or prevent bronchospasm in patients 12 years of age and older with reversible obstructive airway disease.
Production & Manufacturing > Process & Production > News
FDA approves Salix’s RELISTOR subcutaneous injection sNDA
Salix Pharmaceuticals and Progenics Pharmaceuticals have announced that the Food and Drug Administration (FDA or Agency) has informed Salix that RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, 20 mg/ml, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain can be approved on the data submitted in the sNDA.
Drug Research > Drug Delivery > News
Hemispherx Biopharma, Bioclones join forces on novel therapeutic cancer vaccine
Hemispherx Biopharma announced a strategic alliance to develop multiple projects with Bioclones, a leading South African biotechnology company.
Drug Research > Drug Delivery > News
Targacept Phase IIb trial in Alzheimer’s disease fails to show superiority of TC-1734 over Donepezil
Targacept, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, has announced top-line results from a Phase 2b monotherapy clinical trial of TC-1734 as a treatment for mild to moderate Alzheimer’s disease.
Contract Research & Services > Clinical Trials > News
Anthera acquires Sollpura for exocrine pancreatic insufficiency from Eli Lilly
Anthera Pharmaceuticals announced that it has acquired Sollpura (liprotamase), a novel investigational Pancreatic Enzyme Replacement Therapy ("PERT") from Eli Lilly and Company.
Production & Manufacturing > Manufacturing > News
Genmab to receive milestone payment in DuoBody platform collaboration with Janssen
Genmab announced it has reached a milestone in its DuoBody technology platform collaboration with Janssen Biotech (Janssen), triggering a $3 million milestone payment.
Automation > IT & Software > News
Upsher-Smith launches generic equivalent to Qudexy XR extended-release capsules
Upsher-Smith Laboratories (Upsher-Smith), has announced the launch of Topiramate Extended-Release Capsules, the authorized generic of the recently Food and Drug Administration (FDA) approved Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.
Production & Manufacturing > OTC > News
Trevi Therapeutics starts pivotal study of Nalbuphine ER in hemodialysis patients
By PBR Staff Writer
US-based Trevi Therapeutics has enrolled first patient in a major study of Nalbuphine ER in hemodialysis patients with uremic pruritus.
Contract Research & Services > Clinical Trials > News
Codexis, GSK enter into technology collaboration, license agreement
By PBR Staff Writer
Codexis, a US-based developer of biocatalysts for the pharmaceutical and fine chemical industries, has signed a platform technology license agreement with British drug-maker GlaxoSmithKline (GSK).
Automation > IT & Software > News
Medac gets FDA approval for Rasuvo injection to treat rheumatoid arthritis, pJIA and psoriasis
By PBR Staff Writer
US-based Medac Pharma has received approval from the US Food and Drug Administration (FDA) for Rasuvo, a subcutaneous injectable methotrexate (MTX) therapy delivered in an auto-injector for rheumatoid arthritis (RA), polyarticular-course juvenile idiopathic arthritis (pJIA) and psoriasis.
Drug Research > Drug Delivery > News
Mylan agrees to buy non-US specialty, branded generics assets from Abbott for $5.3bn
By PBR Staff Writer
Generic drug-maker Mylan has entered into a definitive agreement to acquire Abbott's non-US developed markets specialty and branded generics business in an all-stock transaction of $5.3bn.
Production & Manufacturing > Manufacturing > News
Roche's Phase III trial of melanoma combination therapy meets primary endpoint
By PBR Staff Writer
Roche has released positive results from the Phase III coBRIM trial of an investigational MEK inhibitor cobimetinib, used in combination with its BRAF inhibitor Zelboraf, to treat patients with previously untreated BRAF V600 mutation-positive advanced melanoma.
Drug Research > Drug Discovery & Development > News
Genticel's Phase II study with ProCervix passes the halfway mark for patient recruitment
Genticel, a French biotechnology company and leading developer of therapeutic vaccines, has announced that the enrollment of the Phase II RHEIA-VAC study has reached the halfway mark of its recruitment target.
Contract Research & Services > Clinical Trials > News
Sanofi Pasteur releases positive results from Phase III dengue vaccine trial
By PBR Staff Writer
Sanofi Pasteur has released positive results of its first Phase III dengue vaccine efficacy trial carried out in five countries in Asia.
Contract Research & Services > Clinical Trials > News
ProStrakan agrees to acquire Archimedes Pharma
By PBR Staff Writer
UK-based ProStrakan, a subsidiary of Japanese firm Kyowa Hakko Kirin, has entered into an agreement with Denmark-based Novo to acquire the entire share capital of Archimedes Pharma for a consideration of GBP230m in cash.
Production & Manufacturing > Manufacturing > News
136-150 of 44611 results