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31-45 of 2253 results
FDA takes key steps under new drug competition action plan
By PBR Staff Writer
The US Food and Drug Administration (FDA) is taking two new key steps to increase competition in the market for prescription drugs and support entry of lower-cost alternatives.
Production & Manufacturing > Manufacturing > News
Pfizer breaks ground on new R&D facility in Missouri
Pfizer has broke ground on a research and development (R&D) and process development facility at 875 W. Chesterfield Parkway, Chesterfield in the US state of Missouri.
Production & Manufacturing > Manufacturing > News
Eli Lilly completes $90m expansion of biotechnology center in San Diego
Eli Lilly and Company has completed the $90m expansion of its biotechnology center in San Diego, California, US.
Production & Manufacturing > Manufacturing > News
Bristol-Myers Squibb to divest Irish manufacturing facility to SK Biotek
Bristol-Myers Squibb has agreed to divest its small molecule active pharmaceutical ingredient manufacturing facility in Swords, Ireland, to South Korea based SK Biotek, a subsidiary of SK Holdings.
Production & Manufacturing > Manufacturing > News
JSR Life Sciences to buy cell line developer Selexis
By PBR Staff Writer
JSR Life Sciences (JLS) has agreed to acquire life sciences firm and mammalian cell-line generation technologies provider Selexis for an undisclosed sum.
Production & Manufacturing > Manufacturing > 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 > Manufacturing > News
AstraZeneca to divest Zomig migrane drug rights for $302m
By PBR Staff Writer
German firm Grünenthal Group has agreed to acquire global rights of migraine treatment, Zomig (Zolmitriptan), from AstraZeneca for around $302m.
Production & Manufacturing > Manufacturing > News
Bristol-Myers’ opdivo approved in Europe for urothelial carcinoma
Bristol-Myers Squibb’s Opdivo (nivolumab) has been approved by the European Commission (EC) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-based therapy.
Production & Manufacturing > Manufacturing > News
Roquette to acquire Brazilian pharmaceutical tablet maker Itacel
Plant-based ingredient manufacturer Roquette has agreed to buy Brazilian pharmaceutical tablet maker Itacel.
Production & Manufacturing > Manufacturing > 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 > Manufacturing > News
ReNeuron secures £1.8m grant to optimize cell therapy manufacturing processes
Innovate UK has awarded ReNeuron Group a £1.8m grant to further advance its next generation commercial cell therapy manufacturing capabilities.
Production & Manufacturing > Manufacturing > 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 > Manufacturing > News
Takeda’s Alunbrig granted accelerated approval for Metastatic NSCLC
Takeda Pharmaceutical’s Alunbrig (brigatinib) has secured accelerated approval from the US Food and Drug Administration (FDA) for the treatment of anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed on or are intolerant to crizotinib.
Production & Manufacturing > Manufacturing > News
FDA grants Pfizer’s Lorlatinib breakthrough designation for NSCLC
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer’s lorlatinib for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), who were earlier treated with one or more ALK inhibitors.
Production & Manufacturing > Manufacturing > News
uniQure’s gene therapy for severe hemophilia B gets PRIME designation in Europe
uniQure’s AMT-060 investigational gene therapy in patients with severe hemophilia B, has been granted PRIME designation by the European Medicines Agency (EMA).
Production & Manufacturing > Manufacturing > News
31-45 of 2253 results