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91-105 of 1839 results
Portola seeks US approval for Betrixaban for extended duration prophylaxis of VTE in acute medically ill patients
Portola Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
Production & Manufacturing > Process & Production > News
GlaxoSmithKline seeks US approval for shingles vaccine Shingrix
By PBR Staff Writer
GlaxoSmithKline (GSK) is seeking regulatory approval in the US for its experimental shingles vaccine, Shingrix.
Production & Manufacturing > Process & Production > News
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
91-105 of 1839 results