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Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > News
Axovant’s dementia drug granted FDA fast track designation
Axovant Sciences’ investigational drug nelotanserin has secured fast track designation from the US Food and Drug Administration (FDA) for the treatment of visual hallucinations disorder in dementia with Lewy bodies (DLB).
Production & Manufacturing > Process & Production > News
Omeros’ OMS721 kidney drug gets FDA breakthrough therapy status
By PBR Staff Writer
Omeros’ MASP-2 inhibitor OMS721 has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of Immunoglobulin A (IgA) nephropathy.
Production & Manufacturing > Process & Production > News
FDA accepts Synergy’s sNDA for Trulance to treat adults with IBS-C
The US Food and Drug Administration (FDA) has accepted Synergy Pharmaceuticals’ supplemental New Drug Application (sNDA) Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Production & Manufacturing > Process & Production > News
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
Sunovion receives complete response letter from FDA for SUN-101/eFlow for COPD
Sunovion Pharmaceuticals has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), such as chronic bronchitis and/or emphysema.
Production & Manufacturing > Process & Production > News
UK’s NICE recommends Novartis’ Afinitor to treat neuroendocrine tumours
By PBR Staff Writer
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Novartis’ Afinitor (everolimus) to treat unresectable or metastatic neuroendocrine tumours (NETs) in patients with progressive disease.
Production & Manufacturing > Process & Production > News
EMA's CHMP backs Novartis' Zykadia for first-line use in lung cancer
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis' Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Production & Manufacturing > Process & Production > News
Amgen submits BLA of migraine prevention drug to FDA
Amgen has submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for erenumab to prevent migraine.
Production & Manufacturing > Process & Production > News
Bayer lymphoma candidate secures FDA priority review designation
By PBR Staff Writer
Bayer has secured priority review designation from the US Food and Drug Administration (FDA) for its investigational anti-cancer compound copanlisib to treat follicular lymphoma (FL).
Production & Manufacturing > Process & Production > News
Russell Finex Specialized Vibrating Graders for the Pharmaceutical Industry
Customized vibrating separator increases productivity and product quality for pharmaceutical filler manufacturer
Production & Manufacturing > Process & Production > Press Releases
XyloCor’s cardiovascular gene therapy gets FDA fast track designation
The US Food and Drug Administration (FDA) has granted Fast Track designation to XyloCor Therapeutics’ lead product candidate XC001 (AdVEGF-All6A+), a cardiovascular angiogenic gene therapy.
Production & Manufacturing > Process & Production > News
FDA accepts to review Pfizer’s sNDA for XELJANZ to treat adult PsA patients
The US Food and Drug Administration (FDA) has accepted for review Pfizer's supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA).
Production & Manufacturing > Process & Production > News
AstraZeneca’s bladder cancer drug imfinzi gets accelerated approval from FDA
The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) for previously treated patients with advanced bladder cancer.
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
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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 2236 results