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Manufacturing

Manufacturing News

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46-60 of 2334 results
Impax to sell Taiwan manufacturing facility to Bora Pharmaceuticals
Impax Laboratories has agreed to divest its manufacturing facility in Taiwan (Impax Taiwan) to Bora Pharmaceuticals.
Production & Manufacturing > Manufacturing > News
FDA proposes risk-based enforcement approach to homeopathic drugs
By PBR Staff Writer
The US Food and Drug Administration (FDA) is proposing new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs.
Production & Manufacturing > Manufacturing > News
CHMP recommends approval of darvadstrocel to treat complex perianal fistulas in Crohn’s disease
Takeda Pharmaceutical and TiGenix reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel).
Production & Manufacturing > Manufacturing > News
FDA approves Pfizer’s Xeljanz and Xeljanz XR to treat active psoriatic arthritis
The US Food and Drug Administration (FDA) has approved Pfizer’s Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
Production & Manufacturing > Manufacturing > News
Drugmaker Teva to cut 14,000 jobs globally
By PBR Staff Writer
Teva Pharmaceutical Industries said it will lay off 14,000 jobs globally as part of a two-year restructuring plan, aimed at boosting its business and financial performance.
Production & Manufacturing > Manufacturing > News
Flexion Therapeutics to acquire novel and non-opioid asset for osteoarthritis of knee
Flexion Therapeutics has entered into a definitive agreement with GeneQuine Biotherapeutics GmbH to acquire the global rights to GQ-203.
Production & Manufacturing > Manufacturing > News
Pfizer's biosimilar of J&J's Remicade secures FDA approval
By PBR Staff Writer
Pfizer’s IXIFI (PF-06438179, infliximab-qbtx), a biosimilar to Johnson & Johnson’s rheumatoid arthritis drug Remicade (infliximab), has been approved by the US Food and Drug Administration (FDA) for all indications of the reference product.
Production & Manufacturing > Manufacturing > News
Allergan acquires Repros Therapeutics
Repros Therapeutics has entered into a definitive agreement under which Allergan, through a subsidiary, will acquire Repros for a cash payment of $0.67 per share.
Production & Manufacturing > Manufacturing > News
Ardelyx signs license agreement with Fosun Pharma for tenapanor in China
Ardelyx has entered into a license agreement with Shanghai Fosun Pharmaceutical Industrial Development Company (Fosun Pharma) for tenapanor.
Production & Manufacturing > Manufacturing > News
Arena, Everest Medicines partner for Ralinepag and Etrasimod in China
Arena Pharmaceuticals and Everest Medicines have entered into a development and commercialization partnership for ralinepag and etrasimod in mainland China, Taiwan, Hong Kong, Macau, and South Korea (the "Territories").
Production & Manufacturing > Manufacturing > News
Indivior's Sublocade secures FDA approval to treat opioid use disorder
By PBR Staff Writer
Indivior’s Sublocade (buprenorphine extended- release) injection has been approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder (OUD).
Production & Manufacturing > Manufacturing > News
Melinta Therapeutics to buy The Medicines Company's infectious disease business
Melinta Therapeutics has agreed to acquire the infectious disease business from The Medicines Company.
Production & Manufacturing > Manufacturing > News
Titan to grant European marketing rights of Probuphine to Molteni
Titan Pharmaceuticals has agreed to grant L. Molteni & C. dei F.lli Alitti Società di Esercizio (Molteni) an exclusive license to commercialize Probuphine in the European Union, Switzerland, Norway, Iceland, Liechtenstein, Bosnia, Serbia, Montenegro, Macedonia and Albania.
Production & Manufacturing > Manufacturing > News
Microbial contamination forces Sun Pharma to recall two lots of diabetes drug in US
By PBR Staff Writer
Sun Pharmaceutical Industries is voluntarily recalling two lots of diabetes drug Riomet in the US due to microbial contamination.
Production & Manufacturing > Manufacturing > News
Midatech secures manufacturing certification from Spanish regulatory authority
Midatech Pharma has received manufacturing certification from Spanish regulatory authority AEMPS.
Production & Manufacturing > Manufacturing > News
46-60 of 2334 results