Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos
Pharmaceutical Business Review
Return to: PBR Home
Top Headlines

Pharmaceutical Business Review

AstraZeneca’s Zavicefta meets main goals in phase III trial to treat hospital-acquired pneumonia 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
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

Latest News and Insight by Sector

Production & Manufacturing

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
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

Drug Research

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

Inward Investment

New WuXi Life Science to acquire WuXi PharmaTech for $3.3bn
Shanghai-based WuXi PharmaTech has entered into a merger agreement with New WuXi Life Science and its wholly owned subsidiary WuXi Merger, worth a total cash consideration of $3.3bn.
Inward Investment > News
PPF Group acquires minority stake in Cytune Pharma
By PBR Staff Writer
PPF Group, in cooperation with SOTIO has completed acquisition of minority stake in French biotechnology firm Cytune Pharma.
Inward Investment > News

Packaging

Catalent completes acquisition of Australia's Pharmapak
By PBR Staff Writer
US-based Catalent Pharma Solutions has strengthened its ability to provide integrated solutions to customers with the acquisition of Pharmapak Technologies, an Australian pharmaceutical packaging business.
Production & Manufacturing > OTC > News
MP Global Products introduces foam-free packaging for shipment of temperature sensitive pharmaceuticals
MP Global Thermal Packaging Products insulated protective mailers and box liners are specifically designed for temperature control and protection of mail order shipments of temperature sensitive pharma, pet meds, and natural and organic cosmetics.
Packaging > News

Contract Research & Services

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
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

Automation

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
PeptiDream licenses PDPS technology to Genentech
PeptiDream has entered into a Technology License Agreement with US-based Genentech, a member of the Roche Group, to non exclusively license its Peptide Discovery Platform System (PDPS) technology.
Automation > IT & Software > News

Regulatory Affairs

FDA approves Relistor tablets to treat OIC in chronic non-cancer pain adults
By PBR Staff Writer
The US Food and Drug Administration has approved Relistor (methylnaltrexone bromide) tablets to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
Regulatory Affairs > News
FDA approves expanded label for NAMZARIC to treat moderate to severe Alzheimer's disease
Allergan and Adamas Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a new, expanded label for NAMZARIC (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI).
Regulatory Affairs > News



Data-Label.co.uk DataLabel have been supplying
the medical industry with labels
for over 10 years

Manufactures of
healthcare packaging
machinery