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Quality issue roundup: J & J revamping controls; The odds for orthopedic surgery; Automatic prescription refills and patient compliance

The New York Times: Johnson & Johnson has said it will "revamp its quality controls, creating a single framework for its drug, medical device and consumer health care divisions." The move comes after the drugmaker saw a number of recalls of its medicines, such as Tylenol and Motrin, as well as probes by a congressional committee and the FDA into actions at its McNeil Consumer Healthcare subsidiary.

20 Aug 2010

Scientists suggest combination vaccine prevents pertussis

If you think you shouldn't be worried about your child's—or your—lingering, nagging cough, think again. Pertussis has reemerged on the scene. In what some public health officials are calling the worst outbreak in 50 years, pertussis, better known by its unique sound—whooping cough, has been found in six states with 1,500 cases reported, six of them fatal.

19 Aug 2010

Novartis sales representatives increase calls to healthcare providers by 7%: SDI report

In the first 6 months of 2010, according to SDI, calls made by Novartis sales representatives to physicians, nurse practitioners, and physician assistants increased 7% compared with the last 6 months of 2009.

19 Aug 2010

PharmaVentures announces global expansion of PharmaDeals Agreements

PharmaVentures, the company behind the PharmaDeals(R) range of business information, announced today the expansion of its PharmaDeals Agreements coverage that includes exclusive interviews with deal makers around the world. The announcement follows major enhancement of its dedicated, market leading platform delivering deal data and information to the pharmaceutical and biotechnology sector.

19 Aug 2010

Effects of illegal drugs on health

Illegal drugs are responsible for up to 1,600 deaths a year in the UK, and destroy thousands of relationships, families and careers. Find out about the most commonly used illegal drugs in England and Wales and the effects they can have on your health.

19 Aug 2010

Treatment with DMARDs reduces rheumatoid arthritis disability: Study

For people living with rheumatoid arthritis (RA), the level of disease activity measured using the standard DAS 28 score is the factor most strongly affecting the level of RA-related disability, according to a study in Journal of Clinical Rheumatology.

19 Aug 2010

USFDA approves Sun Pharma's generic Venlafaxine Hydrochloride Extended Release tablets ANDA

Sun Pharma announced that USFDA has granted an approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Venlafaxine Hydrochloride Extended Release tablets.

19 Aug 2010

Scientists suggest immunization against oncogenic herpesviruses can prevent cancer

Viruses that can invade host cells, initiate cancer and then flee fromb their own trail of destruction could be stopped in their tracks, say researchers writing in the September issue of the Journal of General Virology.

19 Aug 2010

New clues to molecular action of Alzheimer's drug memantine

Alzheimer's disease destroys brain cells and their connections (called synapses), causing memory loss and other cognitive problems that disrupt work, hobbies and daily life. Symptoms can be alleviated, in part, by the drug memantine (marketed in the United States as Namenda), which is currently FDA-approved to treat moderate-to-severe Alzheimer's disease and was, in part, developed by Stuart A. Lipton, M.D., Ph.D., Director of the Del E. Web Center for Neuroscience, Aging and Stem Cell Research at Sanford-Burnham Medical Research Institute (Sanford-Burnham).

19 Aug 2010

Scientists reveal lab approach method to treat neuroblastoma in children

A study led by scientists at The Hospital for Sick Children (SickKids) reveals a new method of identifying drugs to treat children suffering from fatal cancers for which an effective treatment has not been found. Rather than developing a new drug from scratch, which is a complicated and time-consuming process, they tried a different approach: in the lab, they tested existing drugs on cancer stem cells from young patients with neuroblastoma, one of the common cancers of infants and children.

19 Aug 2010

FDA accepts to review Bristol-Myers Squibb's ipilimumab for melanoma

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the Biologics License Application (BLA) for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated. The company also announced today that the application has been granted a priority review designation by the FDA.

19 Aug 2010

FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA, is also the first and only SCIg in the U.S. that may be stored at room temperature.

19 Aug 2010

USPTO grants Collegium second patent for tamper-resistant DETERx formulation platform

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that a new patent has been issued by the U.S. Patent and Trademark Office (USPTO) relating to its tamper-resistant DETERx™ formulation platform. US Patent Number 7,771,707 contains claims that cover Collegium's proprietary extended-release formulations, which are designed to resist dose dumping when subjected to a variety of physical methods of tampering.

18 Aug 2010

Wound Management Technologies' CellerateRX introduced at DFWG congress in South Africa

Wound Management Technologies, Inc. announced today that its new international distributor, Spiramed (Pty) Ltd, exhibited its advanced wound care collagen product, CellerateRX® last weekend at the DFWG (Diabetic Foot Working Group) congress in Cape Town and has already planned exhibitions at two additional upcoming conferences. This second meeting of the DFWG congress was attended by over 120 diabetic foot specialists.

18 Aug 2010

NASN encourages parents to vaccinate their children against meningococcal disease

More than half of adolescents 13 to 17 years of age have not been vaccinated against meningococcal disease, a rare but serious disease that can cause meningitis and take the life of a child in just a single day. In a recent Ipsos national survey, the majority of mothers with children in this age group had not vaccinated their children because they were not fully aware of the need for vaccination.

18 Aug 2010

Experts to discuss the problem of antibiotic resistance

The growing problem of antibiotic resistance, which compromises our ability to treat common infections, represents one of the greatest threats to public health worldwide. Researchers, politicians and representatives from public health organisations and the pharmaceutical industry will gather in Uppsala from 6-8 September to discuss global strategies.

18 Aug 2010

Pharmacies in Massachusetts to make available lock boxes for sale

On August 9, 2010 Massachusetts passed Chapter 283 of the Acts of 2010, adding Safeguards to the Prescription Monitoring Program and furthering Substance Abuse Education and Prevention. Section 11 of the act requires all pharmacies in Massachusetts that dispense schedule II, III, IV, or V prescription drugs to make available lock boxes for sale at each location.

18 Aug 2010

XOMA sells royalty interest in CIMZIA

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced today that it has sold its royalty interest in CIMZIA® (certolizumab pegol) marketed by UCB S.A. for $4 million to an undisclosed buyer. The manufacture of CIMZIA is covered by a license to XOMA's Bacterial Cell Expression technology.

18 Aug 2010

FDA grants orphan drug designation to NephRx's lead product NX001

NephRx Corporation today announced that the U.S. Food and Drug Administration has granted orphan drug designation to its lead product NX001 for the prevention of delayed graft function in renal transplant recipients. NX001 is a kidney growth factor peptide that has demonstrated good safety and promising efficacy in two animal models of acute renal failure.

18 Aug 2010

Study finds pharmaceuticals as a two-tier market for producing 'lemons' and serious harm

The pharmaceutical industry is a "market for lemons," a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe, according to an analysis that will be presented at the 105th Annual Meeting of the American Sociological Association.

18 Aug 2010

Pharmaceutical News

Quality issue roundup: J & J revamping controls; The odds for orthopedic surgery; Automatic prescription refills and patient compliance

Scientists suggest combination vaccine prevents pertussis

Novartis sales representatives increase calls to healthcare providers by 7%: SDI report

PharmaVentures announces global expansion of PharmaDeals Agreements

Effects of illegal drugs on health

Treatment with DMARDs reduces rheumatoid arthritis disability: Study

USFDA approves Sun Pharma's generic Venlafaxine Hydrochloride Extended Release tablets ANDA

Scientists suggest immunization against oncogenic herpesviruses can prevent cancer

New clues to molecular action of Alzheimer's drug memantine

Scientists reveal lab approach method to treat neuroblastoma in children

FDA accepts to review Bristol-Myers Squibb's ipilimumab for melanoma

FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

USPTO grants Collegium second patent for tamper-resistant DETERx formulation platform

Wound Management Technologies' CellerateRX introduced at DFWG congress in South Africa

NASN encourages parents to vaccinate their children against meningococcal disease

Experts to discuss the problem of antibiotic resistance

Pharmacies in Massachusetts to make available lock boxes for sale

XOMA sells royalty interest in CIMZIA

FDA grants orphan drug designation to NephRx's lead product NX001

Study finds pharmaceuticals as a two-tier market for producing 'lemons' and serious harm

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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