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Teva Announces the Launch of a Generic Version of Lialda in the United States
Teva Pharmaceutical Industries Ltd. announced the launch of a generic version of Lialda (mesalamine) delayed-release tablets, 1.2 g, in the U.S.
Mesalamine delayed-release tablets…
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Sandoz receives positive CHMP opinion for proposed biosimilar infliximab
Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of…
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FDA approves inclusion of data from safety outcomes trial in the Tresiba label
Novo Nordisk announced that the US Food and Drug Administration (FDA) approved updates to the prescribing information (PI) for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to…
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Pfizer Reports Top-Line Results from a Study of CHANTIX/CHAMPIX (varenicline) in Adolescent Smokers
Pfizer Inc. announced results from a Phase 4 study evaluating the efficacy and safety of CHANTIX/CHAMPIX (varenicline) for smoking cessation in nicotine dependent adolescents 12-19…
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3P Biopharmaceuticals and Intervacc complete manufacturing agreement
3P Biopharmaceuticals and Intervacc complete manufacturing agreement for new vaccine against equine strangles
3P Biopharmaceuticals and the Swedish company Intervacc have now…
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Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for Enfortumab Vedotin in…
Astellas Pharma and Seattle Genetics announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug…
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Shire and NanoMedSyn Enter Into Research Agreement for Potential Lysosomal Storage Disorder…
Shire plc and NanoMedSyn announced that the companies have entered into a preclinical research collaboration to evaluate a potential ERT using NanoMedSyn's proprietary synthetic…
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Teva Announces the Launch of a Generic Version of ALOXI in the United States
Teva Pharmaceutical Industries Ltd., announced the launch of a generic version of ALOXI®1 (palonosetron HCI) injection, 0.25 mg/5 mL, in the United States. Palonosetron hydrochloride…
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Regeneron and Alnylam to Discover New Treatments for Nonalcoholic Steatohepatitis
Regeneron Pharmaceuticals and Alnylam Pharmaceuticals announced a collaboration to identify RNAi therapeutics for the chronic liver disease nonalcoholic steatohepatitis (NASH) and…
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Seattle Genetics Announces FDA Approval of ADCETRIS (Brentuximab Vedotin)
Seattle Genetics announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) in combination with chemotherapy in adult patients with…
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Saladax Receives Approval to Sell a New Line of Psychiatry Tests on the European Market
Saladax Biomedical Inc., a diagnostics company providing kits to test drug levels for adherence and personalized dose management, announced that it has received CE mark (Conformité…
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FDA Approves Genentech’s Lucentis (ranibizumab injection) 0.3 mg Prefilled Syringe for Diabetic…
Genentech announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis® (ranibizumab injection) 0.3 mg prefilled syringe (PFS) as a new method of administering the…
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Aldevron Selects AES, Begins Construction of Cleanrooms in $30 Million GMP Plasmid Facility
Aldevron has selected AES Clean Technology to design modular cleanrooms for Aldevron’s $30 million, 70,000 square-foot manufacturing facility in Fargo, N.D. Cleanroom construction is…
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Thermo Fisher Scientific to invest in new Pharma Service Facility in Germany
Thermo Fisher Scientific announced that it is expanding its footprint in the European Union and investing $35 million in a state-of-the-art pharma services supply chain facility in…
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Mallinckrodt Completes Sale Of RECOTHROM And PREVELEAK To Baxter
Mallinckrodt plc announced it has closed the sale of RECOTHROM Thrombin topical (Recombinant) and PREVELEAK Surgical Sealant to Baxter International Inc.
"This action further…
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Mylan Adds to Growing Oncology Portfolio with Launch of Generic Mutamycin Injection
Global pharmaceutical company Mylan N.V. announced the U.S. launch of the oncology drug Mitomycin for Injection USP, 5 mg/vial, 20 mg/vial and 40 mg/vial Single Dose Vials, a generic…
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Sartorius Stedim Biotech Launches New ambr 250 High Throughput Bioreactor System for Perfusion…
Sartorius Stedim Biotech (SSB) announced the launch of the ambr 250 high throughput (ht) perfusion, a new automated parallel bioreactor system. It has been specially designed for rapid…
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MEDISCA Signs Out-Licensing Agreement with Torrey Hills Technologies for its ProMill Cleaning Tool
MEDISCA announced that an out-licensing agreement has been signed with California-based Torrey Hills Technologies Inc., for its innovative ointment mill cleaning tool for ProMill™. The…
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Ionis and Akcea Partner to Commercialize Inotersen for hATTR
Ionis Pharmaceuticals and Akcea Therapeutics announced an exclusive, worldwide license by Ionis to Akcea for inotersen and AKCEA-TTR-LRx, formerly IONIS-TTR-LRx, in a transaction…
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Recipharm completes Blow-fill-seal expansion at Kaysersberg facility
Recipharm, the contract development and manufacturing organisation (CDMO), announces its new Blow-fill-seal machinery is now operational following a substantial investment last year at…
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