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

Process & Production

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
See more Process & Production news

Latest Process & Production News and Insight

View all Process & Production news or find news targeted to your interests
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
View all Process & Production news or find news targeted to your interests