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Chiltern International and Charles River Laboratories to study radiolabelled drug products

Chiltern International Limited, a global contract research organization (CRO), announced its latest collaboration with Charles River Laboratories, Inc. As part of this collaboration, Chiltern Early Phase will partner with Charles River to conduct and support early phase radiolabelled studies.

22 Feb 2010

Ritter Pharmaceuticals to discuss lactose intolerance and associated health risks at NIH Conference

Ritter Pharmaceuticals, a company dedicated to helping individuals live a healthier and happier life style through improved digestion, announced today that it will join the leading lactose intolerance experts around the country at the NIH Consensus Development Conference for Lactose Intolerance and Health in Bethesda, Maryland from February 22-24.

22 Feb 2010

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

BioSante Pharmaceuticals, Inc., today announced additional positive safety data in its ongoing LibiGel Phase III clinical development program. For the second time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review, the DMC once again unanimously recommended continuation of the study as described in the FDA-agreed LibiGel safety study protocol, with no modifications.

22 Feb 2010

Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

The U.S. Food and Drug Administration approved an important new inhaled antibiotic called Cayston® (aztreonam for inhalation solution) today for the treatment of cystic fibrosis. The drug was made possible by significant support from the Cystic Fibrosis Foundation, including a $1 million investment by a Foundation subsidiary to help develop the therapy.

22 Feb 2010

Boehringer Ingelheim Pharmaceuticals receives FDA approval for Mirapex ER in treatment of early PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex ER® (pramipexole dihydrochloride) extended-release tablets, a new once-daily treatment option for the signs and symptoms of early idiopathic Parkinson's disease (PD). MIRAPEX ER is not indicated in advanced PD. Parkinson's disease is a chronic, slowly progressive and potentially debilitating neurological condition affecting nearly one million people in the U.S., with one person newly diagnosed every nine minutes.

22 Feb 2010

Genetics associated with DILI and SSR: FDA and SAEC complete third release of data

The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) today announced the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs).

22 Feb 2010

Cancer pain patients: European regulations restricting access to opioid-based drugs

Many cancer patients in Europe are being denied access to adequate pain relief because of over-zealous regulations restricting the availability and accessibility of opioid-based drugs such as morphine.

22 Feb 2010

Missing prescription drugs: Cardinal Health Pharmacy Services to pay $1M penalty

U.S. Attorney Thomas Scott Woodward announced today that Cardinal Health Pharmacy Services, LLC, a company engaged in providing hospital pharmacy management services, has agreed to pay a civil penalty in the amount of $1 million for failing to account for large amounts of missing prescription drugs.

20 Feb 2010

News outlets examine HIV vaccine research, cervical cancer screening data presented at conference

Several news outlets examine the latest reports out of this week's Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.

20 Feb 2010

Amgen's Prolia Complete Response submission: FDA classifies and sets PDUFA date

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia™ (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.

20 Feb 2010

Janssen-Cilag International's European MAA for ZEFTERA: CHMP adopts negative opinion

Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion on its Marketing Authorisation Application (MAA) for the antibiotic ZEFTERA(TM) (ceftobiprole medocaril), for the treatment of complicated skin and soft tissue infections.

19 Feb 2010

Passage of DSSA will restrict Americans’ access to nutritional supplements, says Hotze Enterprises

On Feb. 4, Senators John McCain and Byron Dorgan introduced the Dietary Supplement Safety Act of 2010 (DSSA), that if passed, will restrict Americans’ access to nutritional supplements. Hotze Enterprises, a world leader in the alternative health care industry, is strongly opposed to this legislation being passed, and encourages consumers to take action.

19 Feb 2010

GenVec announces new contract with DHS to develop adenovector-based vaccines against FMD

Today GenVec, Inc. announced a new contract with the Department of Homeland Security to continue the development of adenovector-based vaccines against foot-and-mouth disease (FMD) based on research and development done in collaboration with USDA-ARS and DHS S&T scientists at the Plum Island Animal Disease Center.

19 Feb 2010

United Therapeutics announces withdrawal of Tyvaso European MAA for treatment of PAH

United Therapeutics Corporation announced today that it has withdrawn its Marketing Authorization Application (MAA) for Tyvaso (treprostinil sodium) 0.6 mg/ml nebuliser solution for the treatment of pulmonary arterial hypertension (PAH) in the European Union.

19 Feb 2010

Depomed receives final meeting minutes from FDA for pre-NDA meeting on DM-1796 for PHN

Depomed, Inc. today announced that it has received final meeting minutes from the FDA for a pre-NDA meeting related to DM-1796 for postherpetic neuralgia (PHN) held in December 2009. Depomed also commented on recent public disclosures related to the Complete Response letter from the U.S. Food and Drug Administration regarding the New Drug Application (NDA) for Horizant™ (gabapentin enacarbil) Extended-Release Tablets.

19 Feb 2010

BioTrends' Stelara second wave report finds increase in prescribing among dermatologists

BioTrends published the second wave of LaunchTrends®: Stelara, highlighting dermatology market trends at three months post launch. The report is based on 76 survey responses and 20 qualitative phone interviews with U.S. dermatologists.

19 Feb 2010

Parker Waichman Alonso applauds GSK for deciding to stop manufacturing denture adhesive products made with zinc

The attorneys of Parker Waichman Alonso LLP applaud GlaxoSmithKline for its decision to voluntarily stop the manufacture, distribution and advertising of all Super PoliGrip denture adhesive products made with zinc.

19 Feb 2010

State policy developments: Wisconsin's new 'public option,' Iowa's medical marijuana vote, and more

New Hampshire Public Radio: A bill in the state legislature would create an annual public report that details the causes of rising health spending by analyzing now-private information that doctors, hospitals and other health organizations would have to provide to the state's Department of Insurance. The move is partly in response to conflicting narratives: The state's health spending continues to rise, yet hospitals and doctors say they are struggling (Grant, 2/17).

19 Feb 2010

Cancer patients frequently face barriers to accessing oral drugs: Study

A comprehensive study of oral oncolytic (anti-cancer) drug treatments revealed that while their use is increasingly common, cancer patients frequently face barriers to accessing oral drugs compared to those delivered intravenously in oncology practice settings.

19 Feb 2010

Delay in Vibativ's approval for nosocomial pneumonia to reduce previously forecasted commercial impact

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that delays in the U.S. approval and launch of Theravance/Astellas's Vibativ (telavancin) for the treatment of nosocomial pneumonia will reduce by more than half the commercial impact that it was previously forecasted to garner in the methicillin-resistant Staphylococcus aureus (MRSA) drug market.

19 Feb 2010

Pharmaceutical News

Chiltern International and Charles River Laboratories to study radiolabelled drug products

Ritter Pharmaceuticals to discuss lactose intolerance and associated health risks at NIH Conference

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

Boehringer Ingelheim Pharmaceuticals receives FDA approval for Mirapex ER in treatment of early PD

Genetics associated with DILI and SSR: FDA and SAEC complete third release of data

Cancer pain patients: European regulations restricting access to opioid-based drugs

Missing prescription drugs: Cardinal Health Pharmacy Services to pay $1M penalty

News outlets examine HIV vaccine research, cervical cancer screening data presented at conference

Amgen's Prolia Complete Response submission: FDA classifies and sets PDUFA date

Janssen-Cilag International's European MAA for ZEFTERA: CHMP adopts negative opinion

Passage of DSSA will restrict Americans’ access to nutritional supplements, says Hotze Enterprises

GenVec announces new contract with DHS to develop adenovector-based vaccines against FMD

United Therapeutics announces withdrawal of Tyvaso European MAA for treatment of PAH

Depomed receives final meeting minutes from FDA for pre-NDA meeting on DM-1796 for PHN

BioTrends' Stelara second wave report finds increase in prescribing among dermatologists

Parker Waichman Alonso applauds GSK for deciding to stop manufacturing denture adhesive products made with zinc

State policy developments: Wisconsin's new 'public option,' Iowa's medical marijuana vote, and more

Cancer patients frequently face barriers to accessing oral drugs: Study

Delay in Vibativ's approval for nosocomial pneumonia to reduce previously forecasted commercial impact

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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