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FDA Grants QIDP to Morphochem’s intravenous antibacterial to treat C. difficile infections
By PBR Staff Writer
Morphochem, a clinical-stage pharmaceutical company, announced that the US Food and Drug Administration (FDA) has designated Morphochem’s intravenous (IV) antibacterial product candidate MCB3837 as a Qualified Infectious Disease Product (QIDP) for the treatment of Clostridium difficile infection (CDI).
News
Puma submits NDA for PB272 to FDA for extended adjuvant treatment of HER2-Positive early stage breast cancer
Puma Biotechnology has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy.
Drug Research > Drug Delivery > News
Citron Pharma launches Rosuvastatin calcium tablets
Citron Pharma confirmed that its licensing partner received final approval from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Application (ANDA) for Rosuvastatin Calcium 5, 10, 20 and 40 mg tablets, the generic version of AstraZeneca's CRESTOR (rosuvastatin calcium) tablets.
Drug Research > Drug Delivery > News
Synaffix achieves improved therapeutic index compared to both FDA-approved ADCs
Synaffix has completed a new set of preclinical studies that further supports the potential for its technology to enable safer and more effective targeted cancer therapeutics.
Automation > IT & Software > News
Gilead’s Odefsey (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) meets primary objective in two phase 3b studies
Gilead Sciences announced that two Phase 3b switch studies evaluating Odefsey® (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) for the treatment of HIV-1 infection met their primary objectives.
Contract Research & Services > Clinical Trials > News
InflaRx raises $34m for phase II development of IFX-1 anti-complement C5a antibody
By PBR Staff Writer
German Biopharmaceutical firm InflaRx has raised $34m in a Series C financing round to advance clinical phase II development of the lead drug candidate IFX-1.
Drug Research > Drug Discovery & Development > News
Amgen and Allergan study finds biosimilar comparable to Roche’s Herceptin breast cancer drug
By PBR Staff Writer
Amgen and Allergan have said that a late-stage trial of their treatment being developed as a biosimilar to Roche’s breast cancer drug trastuzumab (Herceptin) met its primary endpoint.
Contract Research & Services > Clinical Trials > News
Merck provides regulatory update on bezlotoxumab biologics licensing application
Merck said that the US Food and Drug Administration (FDA) has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab, an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence.
Production & Manufacturing > Process & Production > News
Transgene to continue phase 1/1b study with TG1050 in Chronic Hepatitis B patients
The Safety Review Committee of the Phase 1/1b trial with TG1050, Transgene’s immunotherapy product candidate for the treatment of chronic hepatitis B virus (HBV) infection, has recommended that the study should continue.
Contract Research & Services > Clinical Trials > News
Chugai, Galderma sign license deal for nemolizumab
Chugai Pharmaceutical and Galderma Pharma have entered into a global license agreement for “nemolizumab” (CIM331) the anti-IL-31 receptor A humanized monoclonal antibody created by Chugai, which is currently under development for atopic dermatitis and pruritus in hemodialysis patients.
Contract Research & Services > Contract Services > News
Scancell appoints Eurogentec SCIB1 material manufacturer
Scancell has signed an agreement with Eurogentec for the manufacture of new supplies of Scancell’s SCIB1 ImmunoBody vaccine for use in the US clinical study of SCIB1 in combination with a checkpoint inhibitor, expected to commence in 2017.
Production & Manufacturing > Manufacturing > News
AstraZeneca’s Zavicefta meets main goals in phase III trial to treat hospital-acquired pneumonia
By PBR Staff Writer
AstraZeneca has unveiled positive results from a phase III trial of its Zavicefta antibiotic, a fixed dose combination of two active substances, ceftazidime and avibactam.
Contract Research & Services > Clinical Trials > News
FDA accepts ApeX Therapeutics’ IND for clinical testing of APX3330 in pancreatic cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted ApeX Therapeutics’ investigational new drug (IND) application for clinical testing of APX3330 in pancreatic cancer.
Production & Manufacturing > Process & Production > News
Synthorx raises $10m to develop and scale novel protein therapeutics
Synthorx has completed a $10m Series B financing, led by RA Capital Management and joined by Series A investors Avalon Ventures and Correlation Ventures.
Drug Research > Drug Discovery & Development > News
Sapience Therapeutics signs license deal with Columbia University for novel cancer treatment
Sapience Therapeutics has entered into an exclusive license agreement with Columbia University to develop a first-in-class cancer treatment, which the Company refers to as ST-36.
Contract Research & Services > Contract Services > News
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