Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos
Production & Manufacturing
Process & Production
Return to: PBR Home | Production & Manufacturing | Process & Production
Search Refinements
Search Results: Process & Production
1-15 of 2255 results
Seattle Genetics gets FDA priority review for Adcetris in Cutaneous T-Cell Lymphoma
Seattle Genetics reported that the US Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).
Production & Manufacturing > Process & Production > News
H3 Biomedicine gets FDAorphan drug status for acute myelogenous leukemia treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation for H3 Biomedicine's H3B-8800, its lead clinical compound for the treatment of patients with Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML).
Production & Manufacturing > Process & Production > News
Gilead gets FDA priority review for bictegravir regimen for HIV treatment
The US Food and Drug Administration (FDA) has granted priority review for Gilead Sciences’ New Drug Application (NDA) for its investigational, fixed-dose combination of bictegravir (50mg) (BIC) and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) for the treatment of HIV-1 infection.
Production & Manufacturing > Process & Production > News
InDex secures FDA orphan-drug designation for cobitolimod
InDex Pharmaceuticals has secured the orphan-drug designation for the drug candidate cobitolimod from the US Food and Drug Administration (FDA) for treatment of ulcerative colitis in pediatric patients.
Production & Manufacturing > Process & Production > News
Genentech gets FDA priority review for Zelboraf in Erdheim-Chester Disease
The US Food and Drug Administration (FDA) has accepted Genentech's supplemental New Drug Application (sNDA) and granted Priority Review for Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation.
Production & Manufacturing > Process & Production > News
Janssen’s RA drug sirukumab fails to get FDA Advisory Committee nod
By PBR Staff Writer
Janssen Biotech has received a setback for its rheumatoid arthritis (RA) drug sirukumab after the Arthritis Advisory Committee of the US Food and Drug Administration (FDA) decided not to recommend its approval.
Production & Manufacturing > Process & Production > News
AstraZeneca's Acalabrutinib gets priority review from FDA for mantle cell lymphoma
AstraZeneca reported that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for its Bruton tyrosine kinase (BTK) inhibitor, acalabrutinib.
Production & Manufacturing > Process & Production > News
UK’s NICE invites Roche to submit CDF proposal for urothelial cancer drug
By PBR Staff Writer
The National Institute for Health and Care Excellence (NICE) has turned down Roche’s urothelial cancer drug atezolizumab citing the need for stronger evidence in clinical and cost effectiveness.
Production & Manufacturing > Process & Production > News
Amgen, Allergan submit BLA to FDA for biosimilar candidate to Herceptin
Amgen and Allergan have submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for ABP 980, a biosimilar candidate to Herceptin (trastuzumab).
Production & Manufacturing > Process & Production > News
Galera gets Promising Innovative Medicines Designation for GC4419 in UK
Galera Therapeutics' GC4419 has secured a Promising Innovative Medicines (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the reduction of the duration or incidence of radiation and chemotherapy induced severe oral mucositis in head and neck cancer patients.
Production & Manufacturing > Process & Production > News
Kite Pharma seeks European approval for Axicabtagene Ciloleucel
Kite Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are not eligible for autologous stem cell transplant.
Production & Manufacturing > Process & Production > News
Eagle gets complete response letter from FDA on exertional heat stroke drug RYANODEX
Eagle Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application for RYANODEX (dantrolene sodium) for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods.
Production & Manufacturing > Process & Production > News
CHMP issues positive opinion for Daiichi Sankyo's LIXIANA label update
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label update for Daiichi Sankyo Europe's LIXIANA, to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion.
Production & Manufacturing > Process & Production > News
FDA advisory panel recommends Pfizer’s Mylotarg for acute myeloid leukemia
By PBR Staff Writer
Pfizer’s Mylotarg (gemtuzumab ozogamicin) has been recommended for approval by the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) to treat acute myeloid leukemia (AML).
Production & Manufacturing > Process & Production > News
Amicus plans to submit NDA to FDA for migalastat for fabry disease
Amicus Therapeutics has revealed its plans to file a new drug application (NDA) with the US FDA for the oral precision medicine migalastat for Fabry disease in the fourth quarter of the year.
Production & Manufacturing > Process & Production > News

PBR Supplier Recommendations

Russell Finex - Fine Mesh Separation Technology
Russell Finex are worldwide leaders in fine mesh separation technology, designing and manufacturing vibratory sieves, separators, self-cleaning in-line filters and ultrasonic systems.... Production & Manufacturing > Process & Production > Suppliers
Vaisala - Supplier of Continuous Monitoring Systems for Controlled Life Science Environments
Vaisala is a world leader in environmental and industrial measurement systems and instrumentation. We offer measurement instrumentation, continuous monitoring systems and validation systems to measure and supervise environmental conditions, within regulated or controlled life science environments.... Production & Manufacturing > Process & Production > Suppliers
Munters - Your Perfect Climate
Munters is the global leader in energy efficient climate control. Munters provide temperature and humidity climate solutions to assist manufacture and storage of products and create comfortable indoor environments. The company was established over 65 years ago and with over 3,000 employees in 30 offices worldwide.... Production & Manufacturing > Process & Production > Suppliers
Bürkert Fluid Control Systems - Manufacturer of Measuring, Control and Regulation Systems for Liquids and Gases
The company group Bürkert Fluid Control Systems, founded in 1946 by Christian Bürkert, is a manufacturer of measuring, control and regulation systems for liquids and gases, with headquarters in the southern German town of Ingelfingen. The company which has been family owned since its foundation has got an export ratio of 80%.... Production & Manufacturing > Process & Production > Suppliers
3R PHARMA CONSULTING - Reducing Regulatory Risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to registration filings and challenges in pharmaceutical development strategies across Europe, the US and the rest of world. ... Production & Manufacturing > Process & Production > Suppliers
See more

PBR White Paper Recommendations

SYSTAG: The use of FlexyPAT-HFC for calorimetric measurements By SYSTAG
FlexyPAT is a modular Process Automation Technology that enables automated customer-specific lab reactor systems to be implemented in a very cost-effective manner, including with the integration of existing devices.... Production & Manufacturing > Process & Production > White Papers SYSTAG: Efficient synthesis development By SYSTAG
Efficient synthesis development using the example of determi-nation of the metastable zone.... Production & Manufacturing > Process & Production > White Papers FlexyPlant – Scale-Up Application Example from the Pharmaceutical Industry By SYSTAG
Scale-up by a factor of 300; from 70ml reactor into 25lt pilot plant. A scale-up step by factor 300 takes place in different laboratories, in fully diversified plants mostly. A great deal of information may be lost, and the knowledge of development Chemists can not be implemented optimally.... Production & Manufacturing > Process & Production > White Papers Optimizing Development Resources for Efficient Product Development By SYSTAG
Nowadays, efficient process research and development are, more than ever, an absolute must for contract manufacturers and API manufacturers. New products/processes need to be pushed through to market readiness faster and faster.... Production & Manufacturing > Process & Production > White Papers Reliable, Long-range Wireless Sensors for Environmental Monitoring By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.... Production & Manufacturing > Process & Production > White Papers See more
1-15 of 2255 results