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Process & Production

Exelixis Announces First Regulatory Approval of Cobimetinib in Switzerland Exelixis announced that Swissmedic, the Swiss licensing and supervisory authority of Switzerland, has approved cobimetinib for use in combination with vemurafenib as a treatment for patients with advanced melanoma.
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FDA approves new indication for Sunovion's Aptiom as monotherapy for partial-onset seizures By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Sunovion Pharmaceuticals' supplemental new drug application (sNDA) for Aptiom (eslicarbazepine acetate) as monotherapy to treat partial-onset seizures.
Production & Manufacturing > Process & Production > News Telesta secures BLA filing notification and priority review designation from FDA for MCNA By PBR Staff Writer
Canadian biopharmaceutical firm Telesta Therapeutics has received its Biologics License Application (BLA) filing notification for MCNA from the US Food and Drug Administration (FDA).
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Horizon Pharma gets USPTO issuance of additional notice of allowance with claims covering Pennsaid 2%
Horizon Pharma received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for US patent application number 14/705,636 (US publication number 2015-0231263), entitled 'Diclofenac Topical Formulation' that covers Horizon's US approved product PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%).
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FDA approves Boehringer and Lilly's Synjardy to treat type 2 diabetes in adults
By PBR Staff Writer
Boehringer Ingelheim Pharmaceuticals (BIPI) and Eli Lilly and Company have received approval from the US Food and Drug Administration (FDA) for their Synjardy (empagliflozin and metformin hydrochloride) tablets to treat adults with type 2 diabetes (T2D).
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CSL Behring gets marketing authorization for Respreeza in Europe
CSL Behring announced that the European Commission (EC) has granted marketing authorization in all European Union (EU) member states for Respreeza to treat patients with Alpha-1 antitrypsin deficiency (AATD).
Production & Manufacturing > Process & Production > News
Custom Powder Systems: Our Employees
Everyone is very willing to support each other. It's a tight-knit bunch. Everyone knows everyone, and everyone has an appreciation for their roles in terms of the collective good. One of the nice things about a smaller company is they're not as compartmentalized. Everyone understands they have a role in a bigger picture.
Production & Manufacturing > Process & Production > Press Releases
Custom Powder Systems: Working as a Team
We've got a particular product for a customer and it's a compact blender that is pneumatically actuated. We've been going through some design bugs in the process of putting this thing together -- a lot of new learning. And as we've worked through the bugs that's another impressive thing about Custom Powder Systems -- you're manufacturing with your sales with your engineering people all work very closely as one team. Even when we get into problems we're very quick to get together, understand what the situation is and come up with solutions.
Production & Manufacturing > Process & Production > Press Releases
MTG Biotherapeutics gets FDA orphan drug status for MTG-201 to treat malignant mesothelioma
By PBR Staff Writer
MTG Biotherapeutics has received orphan drug designation from the US Food and Drug Administration for MTG-201, an advanced biologic therapy targeting Dickkopf-3 gene defects in various cancers, to treat malignant mesothelioma, a rare, aggressive cancer.
Production & Manufacturing > Process & Production > News
EMA accepts Takeda's MAA for ixazomib to treat relapsed/refractory multiple myeloma
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted Takeda Pharmaceutical's marketing authorization application (MAA) for ixazomib, an investigational oral proteasome inhibitor, to treat patients with relapsed and/or refractory multiple myeloma.
Production & Manufacturing > Process & Production > News
FDA grants rare pediatric disease designation for Sarepta's eteplirsen to treat DMD
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted rare pediatric disease designation for Sarepta Therapeutics' lead drug candidate eteplirsen, a potential treatment for patients with duchenne muscular dystrophy (DMD) who are amenable to skipping exon 51.
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FDA accepts Allergan's Botox resubmission to treat lower limb spasticity in adults
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Allergan's resubmission of its supplemental biologics license application (sBLA) for Botox (onabotulinumtoxinA) to treat lower limb (involving ankle and toe muscles) spasticity in adults.
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Novartis' Odomzo gets approval in Europe to treat locally advanced basal cell carcinoma
By PBR Staff Writer
Swiss drug maker Novartis has received approval from the European Commission for Odomzo (sonidegib, formerly LDE225) 200mg capsules to treat adults with locally advanced basal cell carcinoma (laBCC) who are not amenable to curative surgery or radiation therapy.
Production & Manufacturing > Process & Production > News
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