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FDA Warning Letter for Deconsal: Cornerstone Therapeutics preparing a response

Cornerstone Therapeutics Inc., a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today reported that it had received a Warning Letter from the Food and Drug Administration ("FDA") alleging that its Deconsal CT chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg) and Deconsal DM chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg, Dextromothorphan HBr 15 mg) are new drugs lacking an approved application and as such should not be introduced into interstate commerce.

20 Nov 2009

Evidence does not connect H1N1 vaccine to patient deaths, WHO says

The deaths of 41 people from six countries who had received the H1N1 (swine flu) vaccine were not directly linked to the vaccine, the WHO said Thursday, the Associated Press/MSNBC reports (11/19).

20 Nov 2009

Antibiotic resistance a growing problem, particularly in southern, eastern Europe

Antibiotic resistance is increasing throughout the world because of excessive use, Agence France-Press reports. The news service writes, "Experts at the 2nd annual European antibiotics awareness day held by the Stockholm-based European Centre for Diseases Prevention and Control (ECDC) said new, hyper-resistant bacteria were emerging, threatening the pillars of global health."

20 Nov 2009

News outlets examine malaria drug resistance, hope for malaria eradication in Africa

Experts at an American Society of Tropical Medicine and Hygiene meeting this week said that resistance to the best available drug to treat malaria "is more widespread in Southeast Asia than previously reported," Science News/Wired Science reports. Researchers have been monitoring drug resistance along the Thailand-Cambodia border where patients taking artemisinin combination therapy - the most potent treatment for malaria - have been clearing the parasite from their bodies more slowly.

20 Nov 2009

"Hotline" report on finasteride for prevention of prostate cancer

In response to a recent New York Times article that questions why currently available medications designed to treat and prevent some cancers are being ignored, ECRI Institute, an independent nonprofit organization, is offering a roadmap to the evidence on Finasteride for Prevention of Prostate Cancer for free download.

20 Nov 2009

Antigenics to withdraw its MAA for Oncophage following CHMP’s negative opinion

Antigenics Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has formally adopted a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) as a treatment in earlier-stage, localized renal cell carcinoma (kidney cancer).

20 Nov 2009

FDA acknowledges Dendreon's amended BLA for PROVENGE as a complete response

Dendreon Corporation today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

20 Nov 2009

Pfizer’s Revatio Injection receives FDA approval

Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.

20 Nov 2009

FDA extends Exalgo NDA review by three months

CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months.

20 Nov 2009

Quest Diagnostics reports sharp downward trends in cocaine and methamphetamine use

New data released today by Quest Diagnostics Incorporated, the nation's leading provider of employment-related drug testing services, reveal that drug testing of hair specimens from employees and job applicants in the general U.S. workforce has tracked sharp downward trends in cocaine and methamphetamine use from 2005 to the first half of 2009 that mirror similar drops shown by urine testing.

From Quest Diagnostics 20 Nov 2009

Soligenix receives $9.4M NIAID grant to develop technology for advancing rapidly acting vaccines

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has formed a consortium to develop thermostable technology to advance RiVax(TM) and other rapidly acting vaccines. Soligenix received a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), to support this work.

20 Nov 2009

Inovio Biomedical announces positive test results of its consensus influenza vaccines

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that a combination of its synthetic consensus H1N1, H2N2, H3N2, and H5N1 influenza vaccine candidates achieved protective antibody responses against several different influenza sub-types and strains in ferrets.

20 Nov 2009

BioForm Medical and Galderma Laboratories Chiefs to offer their perspectives on aesthetics market at ODAC conference

The Orlando Dermatology Aesthetic & Clinical (ODAC) conference is proud to welcome two leading executive officers offering their unique perspectives on the state of the industry and future opportunities at its 7th annual program, being held on January 15, 2010 at The Peabody Orlando in Orlando, Florida.

20 Nov 2009

Only 1 in 4 Americans aged 50-64 regularly take advantage of preventive screenings, says report

Only about 1 in 4 Americans aged 50-64 regularly take advantage of preventive services such as screenings and immunizations, according to a report from the Centers for Disease Control and Prevention in collaboration with AARP and the American Medical Association (AMA).

20 Nov 2009

Study examines temporal association between media coverage and opioid-related deaths

Increases in deaths from opioid drugs such as OxyContin may be linked to the volume of coverage such deaths receive in the news, according to a study from Children's Hospital Boston and the University of North Carolina (UNC), Chapel Hill. The study compared patterns of opioid deaths and patterns of news coverage between 1999 and 2005, during which time mortality rates from opioid abuse doubled.

20 Nov 2009

LAIV and TIV vaccines appear to offer protection against A/H1N1 virus

Immunization with either live attenuated influenza vaccine (LAIV, also known as FluMist®), or trivalent inactivated influenza vaccine (TIV), appears to offer a protection (~ 45%) against the novel A/H1N1 virus, the cause of the present influenza pandemic. However, the benefit was largely attributed to the youngest age group. The finding emerges from an evaluation of medical encounters and seasonal influenza immunization of U.S. military service members.

20 Nov 2009

Deloitte Consulting offers new sales strategy for pharmaceutical companies

Pharmaceutical companies face a fundamental decision about the best way to sell their products. Even if they could find a way to make the current sales model work, pharma companies still face sky-high commercial costs. So, the question is, should pharma companies stick with their traditional sales approach or blow it up and try something new?

20 Nov 2009

Global initiative battles online supply of dangerous and illegal medicines

In response to an ever-increasing number of websites supplying dangerous and illegal medicines, Operation Pangea II, involving 24 countries, was coordinated by INTERPOL and the World Health Organization's International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to highlight the dangers of buying medicines online.

20 Nov 2009

Significant increases in IT use have not reduced drug review process

Drug approvals are taking just as long as they ever did despite increased expenditure on new information technology at the Food and drug Administration. So says a statistical analysis of approval intervals from 1997 to 2006, published in the International Journal of Electronic Healthcare.

20 Nov 2009

Health care reform will not impact America's pharmaceutical research industry

A recent Reuters article reported that America's pharmaceutical research and biotechnology companies don't expect an industry increase as a result of broader insurance coverage proposed in health care reform.

20 Nov 2009

Pharmaceutical News

FDA Warning Letter for Deconsal: Cornerstone Therapeutics preparing a response

Evidence does not connect H1N1 vaccine to patient deaths, WHO says

Antibiotic resistance a growing problem, particularly in southern, eastern Europe

News outlets examine malaria drug resistance, hope for malaria eradication in Africa

"Hotline" report on finasteride for prevention of prostate cancer

Antigenics to withdraw its MAA for Oncophage following CHMP’s negative opinion

FDA acknowledges Dendreon's amended BLA for PROVENGE as a complete response

Pfizer’s Revatio Injection receives FDA approval

FDA extends Exalgo NDA review by three months

Quest Diagnostics reports sharp downward trends in cocaine and methamphetamine use

Soligenix receives $9.4M NIAID grant to develop technology for advancing rapidly acting vaccines

Inovio Biomedical announces positive test results of its consensus influenza vaccines

BioForm Medical and Galderma Laboratories Chiefs to offer their perspectives on aesthetics market at ODAC conference

Only 1 in 4 Americans aged 50-64 regularly take advantage of preventive screenings, says report

Study examines temporal association between media coverage and opioid-related deaths

LAIV and TIV vaccines appear to offer protection against A/H1N1 virus

Deloitte Consulting offers new sales strategy for pharmaceutical companies

Global initiative battles online supply of dangerous and illegal medicines

Significant increases in IT use have not reduced drug review process

Health care reform will not impact America's pharmaceutical research industry

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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