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United Therapeutics Corporation announced today that it has withdrawn its Marketing Authorization Application (MAA) for Tyvaso (treprostinil sodium) 0.6 mg/ml nebuliser solution for the treatment of pulmonary arterial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

New Jersey Superior Court links Roche's Accutane to IBD

In another major courtroom verdict linking powerful acne medication Accutane with long-term inflammatory bowel disease (IBD), a nine-person New Jersey jury has found that pharmaceutical maker Hoffman-La Roche Inc. failed to provide an adequate warning of the possible condition to Andrew McCarrell's prescribing physician, which then led to his development of chronic IBD. Mr. McCarrell, who was 23 at the time he took Accutane, developed a severe case of IBD and thereafter had his colon removed. The jury awarded compensatory damages of $25.16 million to Andy, now in his thirties.

19 Feb 2010

DSM Pharmaceutical Products wins Profiles in Sustainability award

DSM Pharmaceutical Products, based in Parsippany, NJ, today announced that it has received a Profiles in Sustainability award from United Business Media and ICIS Chemical Business. United Business Media Limited is a leading global business media company and parent of InformexUSA, where the award was announced today in San Francisco.

19 Feb 2010

Proven strategies mastered by best-in-class biopharma companies

Companies invest hundreds of millions – and occasionally billions – of dollars overall in developing new drugs and face countless hurdles in bringing these new products to market. To make good on these vast investments, successful companies must maximize product uptake across all customer groups: not only among patients and physicians, but also among government and private payers to win formulary access and improve product placement.

19 Feb 2010

FDA approves 53 new cancer indications between July 2005 and end of 2007

The U.S. Food and Drug Administration's Office of Oncology Drug Products approved more than 50 new indications for the use of oncology and hematology drugs and biologics between July 2005, when the office began reviewing marketing applications, and the end of 2007, according to a new agency study.

19 Feb 2010

UBC researcher finds improved uptake of highly active antiretroviral therapy

A comprehensive population-based study, conducted by the BC Centre for Excellence in HIV/AIDS (BC-CfE) and presented at the 17th Conference on Retroviruses and Opportunistic Infections in San Francisco, shows that expanded highly active antiretroviral therapy (HAART) coverage was associated with a 50% decrease in new yearly HIV infections among injection drug users.

19 Feb 2010

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

Novartis announced today that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

19 Feb 2010

Researchers develop technology to preserve vaccines in tropical temperatures

A team of British researchers have developed a simple, low-cost method to preserve vaccines in tropical climates, which they say could help to revolutionalize vaccination campaigns in developing countries, Reuters reports.

19 Feb 2010

Pharmaceutical and biotechnology companies working on nearly 200 new medicines to treat diabetes

A Stratton Spotlight article recently highlighted a Centers for Disease Control and Prevention (CDC) survey that showed a dramatic rise in the number of diabetes cases during the last 10 years and noted that pharmaceutical research and biotechnology companies are working on nearly 200 new medicines to treat this debilitating disease.

19 Feb 2010

GSK decides to remove potentially hazardous zinc from denture adhesive products

GlaxoSmithKline, the maker of popular denture adhesives Poligrip and Super Poligrip, announced today that it will remove zinc from all of its denture adhesive products. The pharmaceutical giant has added the potentially hazardous mineral to its adhesives for decades, despite overwhelming evidence that consuming large quantities of zinc over an extended period of time can cause serious neurological damage.

19 Feb 2010

Pharmaceutical News

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

New Jersey Superior Court links Roche's Accutane to IBD

DSM Pharmaceutical Products wins Profiles in Sustainability award

Proven strategies mastered by best-in-class biopharma companies

FDA approves 53 new cancer indications between July 2005 and end of 2007

UBC researcher finds improved uptake of highly active antiretroviral therapy

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

Researchers develop technology to preserve vaccines in tropical temperatures

Pharmaceutical and biotechnology companies working on nearly 200 new medicines to treat diabetes

GSK decides to remove potentially hazardous zinc from denture adhesive products

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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