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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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Business & Industry

  • Bayer opens new Research & Innovation Center in Boston-Cambridge demonstrating its commitment to precision oncology
  • New Novartis extension phase data show nearly 80% of RMS patients treated with Kesimpta® (ofatumumab) had no evidence of disease activity (NEDA-3)
  • Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against Omicron
  • GSK announces £1 billion R&D investment over ten years to get ahead of infectious diseases in lower-income countries
  • Novartis announces Nature Medicine publication of Zolgensma data demonstrating age-appropriate milestones when treating children with SMA presymptomatically

Research & Development

  • Researchers discover new leukemia-killing compounds
  • Oral antiviral drug effective against respiratory syncytial virus (RSV) identified by researchers
  • Biomarkers found that could be drug targets against a deadly form of brain cancer
  • COVID-19 rebound after taking Paxlovid likely due to insufficient drug exposure
  • Novel drug combo activates natural killer cell immunity to destroy cancer cells
  • Broadly neutralizing antibodies could provide immunity against SARS-CoV-2 variants
  • A new technology offers treatment for HIV infection through a single injection

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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