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European Commission Approval for biosimilar epoetin alfa

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04 September 2007
Sandoz has become the first company to develop and receive European Commission approval for its biosimilar epoetin alfa, achieving another important milestone in its efforts to bring high quality, cost-effective biological medicines to patients. The European Commission's decision to grant this approval followed a positive opinion in June from the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP), which reviews medicines scientifically for the Commission.
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Results Were Consistent in Patients Switched to Angiox from Other Antithrombin Therapy

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03 September 2007
The Medicines CompanyPatients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), or angioplasty, experienced nearly 50 percent less bleeding at 30 days and comparable mortality at one-year when treated with Angiox(R) (bivalirudin) alone compared to unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor (GPI), according to data from the ACUITY trial.
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Award for Bilobil in Poland

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Product
01 September 2007
The first place in the national competition "Consumer's Laurel 2007" in the category "Drugs for memory improvement" has been won by Krka's Bilobil. As in the last year, also this year Bilobil won the first place in its category.
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Recommendation of Approval for the Merz Botulinum Neurotoxin Typ A in European Countries

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20 July 2007
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in London recommended the approval of the Merz- developed product Botulinum neurotoxin Type A. Merz is expecting approval in ten European countries within the next few months. The company already received approval in Denmark and Sweden.
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The U.S. Launch of Neupro® for the Treatment of Early-Stage Parkinson's Disease

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Product
16 July 2007
UCB and SCHWARZ PHARMA announced today that Neupro® (Rotigotine Transdermal System), a new once-daily transdermal dopamine agonist approved for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, is now commercially available in retail pharmacies throughout the United States. Neupro® will be co-promoted by UCB and SCHWARZ PHARMA. These companies have dedicated sales forces that will immediately begin reaching out to physicians who treat Parkinson's disease nationwide.
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Business & Industry

  • Pfizer to acquire Global Blood Therapeutics for $5.4 billion to enhance presence in rare hematology
  • Roche's subcutaneous formulation of Tecentriq demonstrates positive Phase III results
  • Bayer Consumer Health leaders propose new principles for science-led self-care
  • GSK signs agreement to support pandemic preparedness in Europe
  • Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate based on enhanced spike protein design

Research & Development

  • New method of nasal vaccine delivery could lead to better vaccines for HIV and COVID-19
  • Research identifies, exploits vulnerability in certain high-risk cancers
  • Scientists create long-acting injectable drug delivery system for tuberculosis
  • Treating cancer by sticking cells in place
  • Vitamin K prevents cell death: a new function for a long-known molecule
  • Disparities in United States COVID-19 vaccine distribution
  • New needle-free nasal vaccine shows promise for COVID-19

Conferences & Events

  • New approach to treatment of deadly kidney cancer
  • SAE Media Group proudly presents the 2nd Annual Aseptic Processing Conference
  • Pharma join together to achieve new standards in digital and patient innovation for clinical transformation
  • SMi's 22nd Annual Pain Therapeutics Conference
  • SMi Group Introduces the 4th Annual Injectable Drug Delivery Conference 2022
  • SMi's 5th Annual Pharmaceutical Microbiology East Coast Conference
  • SMi's 3rd Annual AI in Drug Discovery Conference

Regulatory Affairs

  • FDA approves first systemic treatment for alopecia areata
  • FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain
  • FDA limits use of Janssen COVID-19 vaccine to certain individuals
  • EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
  • FDA approves first generic of Symbicort to treat asthma and COPD
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