Production & Manufacturing
Process & Production

Process & Production News

View news from other Pharmaceutical sectors:
136-150 of 1882 results
SOBI003 receives EC orphan designation to treat mucopolysaccharidosis type IIIA
Swedish Orphan Biovitrum AB (Sobi) has secured orphan designation from the European Commission (EC) for its development product candidate SOBI003, a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome).
Production & Manufacturing > Process & Production > News
CHMP recommends marketing approval for Ferring's Rekovell for use in controlled ovarian stimulation
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Ferring Pharmaceuticals’ Rekovelle (follitropin delta) for controlled ovarian stimulation in women undergoing assisted reproductive technologies.
Production & Manufacturing > Process & Production > News
CHMP issues positive opinion for BMS’ Opdivo in Hodgkin lymphoma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the therapeutic indication of Bristol-Myers Squibb’s Opdivo to include the treatment of adult patients with relapsed or refractory classical Hodgkin's lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.
Production & Manufacturing > Process & Production > News
True North’s TNT009 gets FDA orphan drug status to treat autoimmune hemolytic anemia
True North Therapeutics has secured Orphan Drug Designation from the US Food and Drug Administration (FDA) for TNT009 to treat autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD).
Production & Manufacturing > Process & Production > News
FDA grants QIDP and fast track designations to Viamet’s VT-1161 to treat RVCC
Viamet Pharmaceuticals has secured Qualified Infectious Disease Product (QIDP) and Fast Track designations from the US Food and Drug Administration (FDA) for VT-1161 to treat recurrent vulvovaginal candidiasis (RVVC).
Production & Manufacturing > Process & Production > News
Regenicin schedules pre-IND meeting with FDA for new autologous cultured skin substitute
Biotechnology company Regenicin will have a Pre-IND Meeting via teleconference regarding its product NovaDerm with members of the FDA Office of Cellular, Tissue, and Gene Therapies (OCTGT) in the Center for Biologics Evaluation and Research (CBER) on 27 October.
Production & Manufacturing > Process & Production > News
FDA grants priority review to Genentech’s Lucentis' sBLA for Myopic Choroidal Neovascularization
The US Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application (sBLA) and granted Priority Review for Lucentis (ranibizumab injection) for the treatment of myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness.
Production & Manufacturing > Process & Production > News
FDA grants priority review for Genmab's Daratumumab in relapsed multiple myeloma
The US Food and Drug Administration (FDA) has granted Priority Review to Genmab's supplemental Biologics License Application (sBLA) for the use of daratumumab (DARZALEX) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, to treat patients with multiple myeloma who have received at least one prior therapy.
Production & Manufacturing > Process & Production > News
Roche’s Actemra/RoActemra gets FDA breakthrough therapy status for giant cell arteritis
By PBR Staff Writer
Roche and Chugai Pharmaceutical have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for Actemra/RoActemra (tocilizumab) for giant cell arteritis (GCA).
Production & Manufacturing > Process & Production > News
FDA grants breakthrough therapy status to AbbVie's investigational HCV regimen
By PBR Staff Writer
AbbVie has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) to treat patients with hepatitis C virus infection who failed previous direct-acting antiviral (DAA) therapy.
Production & Manufacturing > Process & Production > News
FDA grants rare pediatric disease designation to Summit Therapeutics’ DMD drug
By PBR Staff Writer
Summit Therapeutics has received second drug designation from the US Food and Drug Adminstration for ezutromid, a treatment for Duchenne Muscular Dystrophy (DMD).
Production & Manufacturing > Process & Production > News
Janssen Biotech files US regulatory application for Sirukumab in rheumatoid arthritis
By PBR Staff Writer
Janssen Biotech is seeking approval for sirukumab in the US to treat adults with moderately to severely active rheumatoid arthritis (RA).
Production & Manufacturing > Process & Production > News
EMA’s CHMP recommends approval for three new cancer drugs
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended three cancer drugs for approval.
Production & Manufacturing > Process & Production > News
GSK and Janssen seek European approval for sirukumab in rheumatoid arthritis
By PBR Staff Writer
GlaxoSmithKline (GSK) and Janssen-Cilag International have submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of sirukumab to treat moderately to severely active rheumatoid arthritis (RA) in adults.
Production & Manufacturing > Process & Production > News
FDA grants orphan drug status to Ovid’s OV101 for genetic neurologic disorder
By PBR Staff Writer
Ovid Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for OV101 to treat Angelman syndrome, a genetic disorder that causes developmental and neurologic disabilities.
Production & Manufacturing > Process & Production > News
136-150 of 1882 results