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Ranbaxy announces launch of Atorvastatin, generic Lipitor®, in the U.S.

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01 December 2011
Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) ("Ranbaxy"), today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market Atorvastatin and has launched the product in the U.S. market.
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Forest Laboratories and Nycomed Receive Complete Response Letter for Roflumilast

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19 May 2010
Forest Laboratories, Inc.Forest Laboratories, Inc. (NYSE: FRX) and Nycomed announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roflumilast.
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Saudi Food and Drug Authority Suspends The Authorisation of Rosiglitazone (Avandia®)

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23 March 2010
The Saudi food and Drug Authority has reviewed the safety of Rosiglitazone (Avandia®) which used in treatment of type 2 diabetes mellitus and marketed in Saudi Arabia as Avandia®.
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Novel Drug for Chronic Management of Hyperuricemia in Gout Patients

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10 March 2010
Teijin Pharma Limited announced the European launch of TMX-67 (febuxostat), a novel drug discovered by Teijin Pharma for the treatment of hyperuricemia in patients with gout. Ipsen, a global biotechnology specialty care group and the TMX-67 licensee in Europe, and its sublicensee the Menarini Group, the first Italian pharmaceutical group in the world, have began marketing the product in Europe under the brand name ADENURIC(r).
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FDA Grants IBsolvMIR Orphan Drug designation in the treatment of diabetes patients in the U.S.

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25 November 2009
TikoMed AB, a biotechnology company focused on development and commercialization of innovative treatments for immune diseases and cell therapies, today announced that IBsolvMIR® has been granted orphan drug designation for the prevention of graft rejection of pancreatic islet transplantation by the U.S. Food and Drug Administration (FDA).
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Orphan Drug Designation for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS)

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18 August 2009
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced today that Soliris(R) (eculizumab), its first-in-class complement inhibitor, has been granted Orphan Medicinal Product Designation by the European Commission for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS).
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Schering-Plough Announces European Filing of SYCREST(R) (asenapine)

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04 June 2009
Schering-Plough CorporationSchering-Plough Corporation (NYSE: SGP) announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for SYCREST(R) (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder.
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More Pharma News ...

  1. HemCon Announces Further Successful Results from Live Nail Infection Anti-Fungal Study
  2. New Non-Drowsy CLARITIN(R) Liqui-Gels(R) Now Available
  3. U.S. FDA Issues Complete Response Letter for SAPHRIS(TM)
  4. Forest Laboratories, Inc. Announces Amendment to Bystolic(TM) (nebivolol) Agreement
  5. Trasylol® - One Thousand Lives A Month
  6. Pharmion and MethylGene Announce U.S. Orphan Drug Designation
  7. Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R)
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Tahmeena

Business & Industry

  • Pfizer reports record full-year 2022 results
  • AMJEVITA™ (adalimumab-atto), first biosimilar to Humira® now available in the United States
  • CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
  • Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
  • Pfizer expands 'An Accord for a Healthier World' product offering to include full portfolio for greater benefit to 1.2 billion people in 45 lower-income countries

Research & Development

  • Scientists pinpoint protein that helps cancer-causing viruses evade immune response
  • Transforming the way cancer vaccines are designed and made
  • Antidepressants used for chronic pain on the rise, but are they effective?
  • Keys to making immunotherapy work against pancreatic cancer found in tumor microenvironment
  • Discovery of anti-cancer chemistry makes skullcap fit for modern medicine
  • Coordination of COVID-19 vaccine clinical trials produces a 'treasure trove' of data and a model for the future
  • Power of cancer drugs may see boost by targeting newly ID'd pathway

Conferences & Events

  • SAE Media Group proudly presents the 4th Annual AI in Drug Discovery Conference
  • SAE Media Group's 6th annual 3D Cell Culture Conference
  • CPHI Frankfurt returns to pre-pandemic strength as pharma industry booms again
  • 14th Annual RNA Therapeutics: Investigating the next generation of genetic medicine through RNA based therapies
  • CPHI Excellence in Pharma Award Winners 2022
  • CPHI Frankfurt Report predicts huge funding overhang to drive contract services growth
  • CPHI Frankfurt 2022: Global pharma confidence hits record high in the annual CPHI Pharma Index

Regulatory Affairs

  • FDA grants Accelerated Approval for Alzheimer's disease treatment
  • FDA approves new HIV drug for adults with limited treatment options
  • FDA approves first gene therapy for the treatment of high-risk, non-muscle-invasive bladder cancer
  • FDA approves first gene therapy to treat adults with Hemophilia B
  • FDA approves first treatment for Acid Sphingomyelinase Deficiency, a rare genetic disease
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