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FDA Issues Approvable Letter for Nebivolol for the Treatment of Hypertension

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03 December 2007
Forest Laboratories, Inc.Forest Laboratories, Inc. (NYSE: FRX) and Mylan Inc. (NYSE: MYL) announced that Mylan has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for nebivolol (proposed brand name Bystolic(TM)), a novel beta blocker under review for the treatment of hypertension.
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Nebivolol Lowers Blood Pressure in African Americans With Stage I-II Hypertension

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01 November 2007
Forest Laboratories, Inc.Forest Laboratories, Inc. (NYSE: FRX) today announced the results of a double-blind, randomized, placebo-controlled clinical trial, published in the November 2007 issue of the Journal of Clinical Hypertension, which demonstrated that nebivolol significantly reduced sitting diastolic and systolic blood pressure used as monotherapy among African-American patients with stage I-II hypertension.
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Teva Announces Approval of Generic Actonel®

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11 October 2007
Teva Pharmaceutical Industries Ltd.Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Procter and Gamble Actonel® (Risedronate Sodium) Tablets, 5 mg, 30 mg and 35 mg.
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FDA Accepts sNDA for Expanded Use of Angiomax®

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26 September 2007
The Medicines CompanyThe Medicines Company (NASDAQ: MDCO) announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's supplemental new drug application (sNDA) for a modified dosing regimen of Angiomax® (bivalirudin) for the treatment of acute coronary syndromes (ACS), specifically in patients with unstable angina or non-segment elevation myocardial infarction (NSTEMI).
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Protherics licenses its Covaccine HT adjuvant to Nobilon for influenza vaccine indications

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26 September 2007
ProthericsProtherics PLC, the international biopharmaceutical company focused on critical care and cancer, and Nobilon International B.V., part of Organon, the human health care business unit of Akzo Nobel, today announced that Nobilon has licensed Protherics' CoVaccine HT™ adjuvant for use in pandemic influenza vaccines and seasonal influenza vaccines in elderly people.
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Invega® receives marketing authorisation in European Union for treatment of schizophrenia

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15 September 2007
Janssen-CilagThe European Commission, on 25 June 2007, granted marketing authorisation for INVEGA® (paliperidone prolonged-release tablets), a new atypical antipsychotic medication for the treatment of schizophrenia. This once daily medication is specifically designed to deliver paliperidone - the active ingredient in INVEGA® - through the innovative osmotic delivery system (OROS®) resulting in strong efficacy, a proven safety and tolerability profile and improved patient functioning.
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FDA Accepts NDA Filing for Cleviprex(TM) for the Treatment of Acute Hypertension

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14 September 2007
The Medicines CompanyThe Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's new drug application (NDA) for Cleviprex(TM) (clevidipine butyrate injectable emulsion) for the treatment of acute hypertension. If approved, Cleviprex will be the first new treatment for acute hypertension in more than 10 years.
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More Pharma News ...

  1. European Commission Approval for biosimilar epoetin alfa
  2. Results Were Consistent in Patients Switched to Angiox from Other Antithrombin Therapy
  3. Award for Bilobil in Poland
  4. Recommendation of Approval for the Merz Botulinum Neurotoxin Typ A in European Countries
  5. The U.S. Launch of Neupro® for the Treatment of Early-Stage Parkinson's Disease
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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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