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U.S. FDA Approves CSL Behring's AFSTYL for adults and children with haemophilia A

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CSL announced that the US Food and Drug Administration (FDA) has approved AFSTYLA® , CSL Behring’s novel long-lasting recombinant factor VIII single-chain therapy for adults and children with haemophilia A.

Novartis highlights its strong foundation for long-term, sustainable growth at the third Meet Novartis Management event

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  • Outlines actions underway to accelerate launch of Entresto®, including further expansion of US primary care field force, and reinforce strong uptake of Cosentyx®
  • Highlights leading pipeline of second generation immuno-oncology assets
  • Confirms Sandoz on track for 10 biosimilar filings by 2017
  • Shows progress on implementation of Alcon growth acceleration plan

FDA Recommends Approval Of Sanofi Treatment For Adults With Type 2 Diabetes

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Sanofi announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. FDA recommended the approval of the NDA for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. The 15-member panel  voted 12 to 2 (1 panelist did not vote due to travel) to approve the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide.

GSK, Fondazione Telethon and Ospedale San Raffaele announce publication of pivotal safety and efficacy of gene therapy for children with ADA-SCID

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GSK, Fondazione Telethon and Ospedale San Raffaeletoday announced the publication in BLOOD of the long-term safety and efficacy data from an analysis of 18 children with ADA-SCID treated with hematopoietic stem cell gene therapy between 2000 and 2010 at the San Raffaele Telethon Institute for Gene Therapy (SR-Tiget). Children with ADA-SCID, a very rare inherited disorder caused by a faulty gene, do not develop a healthy immune system which often proves fatal within the child’s first year of life.

Daiichi Sankyo Launches Antiplatelet Agent Efient® Tablets 20mg

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Daiichi Sankyo Company, Limited announced that it has launched the antiplatelet agent Efient® Tablets 20mg  (JAN: Prasugrel Hydrochloride; approval to market: January 20, 2016; NHI drug price listing: May 25, 2016) in Japan.

EISAI To Launch In-House Developed Antiepileptic Drug Fycompa (Perampanel Hydrate) As Adjunctive Therapy For Partial-Onset And Generalized Tonic-Clonic Seizures In Japan

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Eisai Co Ltd announced that it will launch its in-house-discovered antiepileptic drug (AED) Fycompa® Tablets 2 mg and 4 mg (perampanel hydrate) as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures) or primary generalized tonic-clonic seizures in patients with epilepsy showing inadequate response to other AEDs in Japan on May 26, 2016. Eisai received marketing and manufacturing approval for this formulation on March 28, 2016.

Rituximab regulatory submission accepted by European Medicines

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  • Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year
  • Sandoz is seeking approval for all indications included in the reference product's label
  • Sandoz' submission includes data from multiple clinical trials with over 800 patients

FDA Expands Invokamet Label to Include First-Line Treatment of with type 2 diabetes

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Janssen Pharmaceuticals, Inc announced the U.S. FDA has approved INVOKAMET®, a fixed-dose combination therapy of INVOKANA® (canagliflozin) and metformin hydrochloride, for first-line treatment of adults with type 2 diabetes. With this new approval, INVOKAMET® may now be prescribed in adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy.1

Bayer Comments on Monsanto’s Statement Regarding Proposed Transaction

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Bayer announced that it looks forward to engaging in constructive discussions with Monsanto regarding the proposed transaction. Bayer reiterated that its USD 122 per share all-cash proposal provides full and certain value for Monsanto shareholders.

Novo Nordisk IDegLira receives positive 16-0 vote in favour of approval from FDA

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Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. IDegLira is a once-daily, single injection fixed combination of insulin degludec (Tresiba®) and liraglutide (Victoza®) for the treatment of adults with type 2 diabetes.

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