‘Extends’ Tagged Posts

Novel drug extends survival for ladies with HR-positive metastatic breast most cancers

The drug palbociclib, utilized in mixture with customary remedy, improved survival for ladies with hormone receptor-positive metastatic breast most ...

 

The drug palbociclib, utilized in mixture with customary remedy, improved survival for ladies with hormone receptor-positive metastatic breast most cancers, based on a big part III scientific trial.

“The outcomes of the examine present that it’s potential to enhance and delay the lifetime of sufferers with hormone receptor-positive metastatic breast most cancers. We now have strong information to recommend that this remedy ought to be the brand new customary of care,” mentioned lead creator Dr. Massimo Cristofanilli, a professor of hematology/oncology at Northwestern College Feinberg College of Drugs and a Northwestern Drugs doctor.

Dr. Cristofanilli can be affiliate director for translational analysis on the Robert H. Lurie Complete Most cancers Middle of Northwestern College.

The examine was printed Oct. 20 within the New England Journal of Drugs.

The vast majority of breast cancers are categorised as hormone receptor-positive (HR-positive), indicating that the most cancers cells develop in response to hormones, comparable to estrogen. Sufferers with HR-positive breast most cancers are usually handled with hormone remedy, which prevents estrogen from attaching to receptors and fueling most cancers progress. However over time, many sufferers develop resistance to such remedy, and there may be important want for brand spanking new therapies for sufferers with superior illness.

Palbociclib is a novel oral drug that inhibits enzymes vital in cell division known as cyclin-dependent kinase (CDK) four/6.

A global scientific trial known as PALOMA-Three evaluated palbociclib in 521 girls with HR-positive metastatic breast most cancers who had relapsed or progressed after prior hormone remedy. (All individuals additionally had HER2-negative breast most cancers, a classification that signifies the most cancers has little or no HER2, a protein which drives most cancers progress.)

The trial individuals have been randomized to obtain both palbociclib and fulvestrant (a normal remedy) or a placebo and fulvestrant.

In a earlier evaluation of PALOMA-Three led by Cristofanilli and printed in The Lancet Oncology, palbociclib and fulvestrant was discovered to be related to a big enchancment in progression-free survival, in comparison with fulvestrant alone.

The findings led to FDA approval of palbociclib for sufferers with HR-positive, HER2-negative metastatic breast most cancers who skilled illness development following hormone remedy.

The present examine, printed within the New England Journal of Drugs, reported total survival outcomes for individuals in PALOMA-Three. It’s the first to report total survival information from a part III trial testing a CDK4/6 inhibitor on this affected person inhabitants, mentioned Cristofanilli.

Investigators discovered palbociclib led to a clinically significant enchancment in total survival; median total survival was 34.9 months within the palbociclib and fulvestrant group, in comparison with 28 months within the management group. The profit was even better in sufferers with sensitivity to prior hormone remedy.

“Sometimes, therapies for estrogen-positive metastatic breast most cancers delay the development of most cancers however nearly by no means delay the lifetime of sufferers. This remedy is the primary of its variety to point out such an vital profit,” Cristofanilli mentioned.

Cristofanilli can be director of the OncoSET Precision Drugs Program on the Lurie Most cancers Middle.

The examine outcomes have been additionally offered on the European Society for Medical Oncology (ESMO) 2018 Congress in Munich on Oct. 20.

Supply:

https://www.northwestern.edu/

FDA Extends Expiration Date for Sure Plenty of EpiPen

 
The FDA emphasized that these products should continue to be stored as directed on the label to ensure patient safety

The FDA emphasized that these products should continue to be stored as directed on the label to ensure patient safety

The Food and Drug Administration (FDA) has extended the expiration date of certain lots of Mylan’s EpiPen (epinephrine) Auto-Injector 0.3mg by 4 months past the labeled date. 

This date modification beyond the approved 20-month shelf life was based an FDA review of product stability data submitted by Mylan. Several factors contributed to the product’s limited availability in certain areas of the US, including regional supply disruptions and manufacturer issues. Specifically, Mylan cited intermittent supply constraints due to manufacturing delays from their partner, Meridian Medical Technologies, a subsidiary of Pfizer. Continual supply from Meridian is still ongoing and Mylan is expediting shipment to wholesalers upon receipt. Meridian also manufactures EpiPen Jr 0.15mg Auto-Injectors and the authorized generic versions of these strengths. 

The full list of EpiPen Auto-Injectors and Epinephrine Injection, USP Auto-Injectors 0.3mg with extended expiration dates can be found here. Patients with product from these batch numbers will be able to use them through the new use dates provided.

“We’ve completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or close to expiring. We’re hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

Konica Minolta Extends Flagship Product Line with bizhub PRESS C7000/C6000 Series of Color Digital Presses

 


Konica Minolta bizhub PRESS C7000


Ramsey, NJ (Vocus) October 3, 2010

Konica Minolta Business Solutions U.S.A., Inc. (Konica Minolta), a leading provider of advanced imaging and networking technologies for the desktop to the print shop, today at GRAPH EXPO 2010 will introduce the next three systems in the bizhub® PRESS Series of color digital presses. With the bizhub PRESS C7000, bizhub PRESS 7000P, and bizhub PRESS C6000, Konica Minolta is introducing disruptive, industry-leading technologies that further strengthen its market-leading position in the production print arena and enhance print professionals’ return on investment (ROI). Building upon the advanced imaging technology in the award-winning bizhub PRESS C8000, customers will immediately recognize how the product line’s innovative new engine improves image quality while reducing costs.

Konica Minolta’s powerful trio of new digital color presses, along with the recently launched bizhub PRESS C8000, raises the bar in color quality, providing customers with world-class imaging at up to 70 color ppm to meet the needs of fast-paced production environments. The bizhub PRESS C7000 (70ppm) and bizhub PRESS C6000 (60ppm) provide high-speed print professionals with built-in print/copy/scan capability, while the bizhub PRESS C7000P offers a high-speed color print system that users can count on to stay ahead of rising and unpredictable workloads. Thanks to Konica Minolta technology innovations that improve throughput speed and output quality, customers will experience outstanding color stability from the first print to the last print of any job.

Setting New Color Standards

With the growing bizhub PRESS line of color digital presses, Konica Minolta is setting a new color standard in light production printing while also reducing overhead costs. The bizhub PRESS C7000/C6000 Series will create extraordinary color images with 1200dpi resolution and automatic Image Density Control (IDC) that ensures consistently outstanding image fidelity over long runs. By employing true 8-bit data compression, Konica Minolta has minimized RIP time while keeping color production in high gear from start to finish. An air assist paper separation system provides enhanced support for heavy and coated stocks and powerful print control combined with flexible in-line finishing options let users build a system customized to their production environment. The bizhub PRESS C7000/C6000 Series will integrate with a host of third-party workflow solutions. Additionally, in another Konica Minolta first, the Series will offer the home-grown IC-601 color image controller, which was uniquely designed for the high-demand needs of print professionals.

“With our bizhub PRESS product line, we have succeeded in delivering an even higher color quality, lower total cost of ownership and increased customer satisfaction – all great reasons to count on Konica Minolta,” said Kevin Kern, Senior Vice President, Marketing, Konica Minolta Business Solutions U.S.A., Inc. “The bizhub PRESS C7000/C6000 Series is comprised of big-iron production systems that will meet rising production needs in corporate, commercial and print-for-pay applications, and print professionals will see an immediate difference with the brilliant, natural image quality.”

A Decided Advantage for Print Professionals

Konica Minolta’s exclusive Simitri® HD color polymerized toner uses biomass, an organic resource that reduces environmental impact compared to conventional toner. It leverages smaller, more uniform particles to reproduce ultra-fine image detail. In all three new bizhub PRESS models, optimized 1200 dpi print resolution achieves sharper lines, smoother graphics realism, and edge distortion, all while being easier on the environment. Another advantage of Simitri HD color polymerized toner is its thinner core shell structure, requiring a lower fusing temperature than conventional toner particles. This allows print professionals to achieve faster print processing speeds and increased image stability, a major benefit for production jobs demanding heavy paper stock.

Availability

The bizhub PRESS C7000/C6000 Series of Color Digital Presses is available now through Konica Minolta’s North American direct sales and authorized dealer sales channels.

Konica Minolta Press Conference @ GRAPH EXPO 2010

Konica Minolta will hold a press conference on October 4th – starting at 11a CT – in Room S505A to review our award-winning technologies geared towards the Production Print marketplace.

GRAPH EXPO 2010 takes place at McCormick Place South in Chicago, Illinois from October 3 through October 6. To schedule a personal tour of the Konica Minolta Booth (#2244), reserve a spot at the Konica Minolta Press Conference, and/or an executive interview, please contact Doreen Maciak at dmaciak@kmbs@konicaminolta.us.

About Konica Minolta

Konica Minolta Business Solutions U.S.A., Inc. is a leader in advanced imaging and networking technologies for the desktop to the print shop. In 2009, Konica Minolta was named Supplier of the Year by both the Allegra Network and the National Association of Quick Printers (NAQP), as well as received the Sales Support Award from Mail Boxes Etc., Inc. For more information, please visit http://www.CountOnKonicaMinolta.com and follow Konica Minolta on Facebook (@Konica Minolta Business Solutions U.S.A), YouTube (@KonicaMinoltaUS), and Twitter (@KonicaMinoltaUS).

Konica Minolta Corporate Contact

Doreen Maciak

Konica Minolta Business Solutions U.S.A., Inc.

+1 978.969.1504

dmaciak(at)kmbs.konicaminolta(dot)us

Konica Minolta is a registered trademark of Konica Minolta Holdings, Inc. bizhub PRESS is a registered trademark of Konica Minolta Business Technologies, Inc. Simitri is a registered trademark of Konica Minolta Business Solutions. All other trademarks mentioned in this document are the property of their respective owners.

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FDA Extends Comment Period on Bid to Ban Natural Hormones

 

Croton on Hudson, NY (PRWEB) April 10, 2006

The FDA announced that it would allow comments on the Citizens Complaint against bio identical hormones until May 4, 2006 although the original comment period expired on April 4, 2006. Wyeth filed their complaint (Docket: 2005P-0411) on October 6, 2006 asking the FDA to impose significant restrictions on consumer’s access to bio identical hormones. These natural molecules are prescribed by physicians in amounts and delivery systems which are customized to the need of each patient. The prescription is then filled by special pharmacists who are trained in the compounding of these individualized formulations.

Comments may be sent to the FDA at http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=3356.

Consumers, compounding pharmacists, physicians practicing bio identical and health freedom advocates are up in arms over this action by Wyeth. States, not the federal government have jurisdiction over compounding pharmacies. Health freedom advocates characterize Wyeth’s move as seeking an extension of federal power on its behalf and attempting to eliminate a competitor in a failing market.

Health freedom advocates also fear that this is merely another step in the restriction of the consumer’s right to make their own health choices whether or not they add to the pharmaceutical or medical coffers. Physicians and patients who have experienced the benefit of bio identical hormones fear that they will loose a powerful, gentle and effective option to drugs when they need to replace and regulate their hormone levels. During the final days of the comment period, the traffic was so heavy that the FDA’s electronic comment system was reportedly overwhelmed.

Hormones are biologically active molecules which have body-wide effects at very low concentrations. Women’s bodies make reproductive hormones throughout their reproductive lives but the levels fall sharply, changing their balance, during and after menopause. Natural hormones cannot be patented because they occur in nature so they are less expensive than prescription drugs despite the effort involved in compounding them individually. Synthetic and conjugated hormones, on the other hand, are patented and thus carry a higher cost to cover the expenses involved in developing and marketing the drug.

Small changes in molecules which render them patentable may also render them toxic or difficult for the body to process. Hormone receptors and enzymes are powerfully impacted by slight differences in molecules and many women find that their bodies react with difficulty to altered molecules leading to increased side effects and dangerous consequences to synthetic hormones. Bio identical hormones are exactly like the ones that a woman’s body has processed over the years of her reproductive life and, when customized for her individual needs, are often accepted by the body with little or no discomfort and, supporters believe, without the risks posed by pharmaceutical, patented hormones. The long-term safety of the use of bio identical hormone replacement therapy for more than five years has not been established although several smaller studies reported positive results without adverse outcomes (http://www.consciousliving.net.au/articles.htm?74&PHPSESSID=e02c491567b54227173e785227262ef7).

Hormone replacement therapy (HRT) is frequently prescribed for women to alleviate symptoms associated with menopause (hot flashes, night sweats, memory problem, mood changes, wrinkles, weight gain, etc.) and to prevent serious diseases (breast, colorectal and uterine cancer, heart disease, senility, osteoporosis, strokes, etc.).

HRT was studied by the NIH because of its anticipated benefits in over 161,000 women in a large 15 year study which began in 1991. The study, called the Women’s’ Health Initiative (WHI) was an observational study designed to examine the effects of Premarin (conjugated estrogen derived from PREgnant MARes’ urINe) or Prempro (Premarin plus synthetic progesterone or”progestin”). Because the WHI found that the women taking either Premarin or Prempro we at increased risk of breast and colorectal cancer, stroke, blood clots, heart disease, osteoporosis and a host of other serious disease, the study was halted years early (May, 2003) and women in the study who were taking either Premarin or Prempro received letters telling them to stop the medication. Wyeth provided both Premarin and Prempro to the WHI although it was not involved in the analysis or conclusions of the study.

Critics of Wyeth’s challenge to bio identical hormones contend that the action is designed to bolster flagging sales of the “Premarin family” of drugs. According to Wyeth (http://wyeth.com), profits for the synthetic hormones declined by 68% between 2002 and 2004 ($ 2,072,000,000 in 2002, $ 1,275,000,000 in 2003, $ 880,000,000 in 2004).

Total profits for Wyeth in the same period have declined by 72% (2002:$ 4,447,000,000; 2003:$ 2,051,192,000; 2004: $ 1,234,000,000).

Since the only significant non pharmaceutical competitor for the HRT prescription dollar is bio identical hormones, industry watchers link the move with an attempt to regain lost sales and profits. L. D. King, Executive Director of the International Association of Compounding Pharmacists, a professional association of special pharmacists notes, “Wyeth’s aims are clear: to restrict the ability of physicians to prescribe and patients to use customized BHRT following studies that have raised serious health concerns with the company’s own products,” (http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-27-2005/0004197725&EDATE=)

Wyeth maintains that its actions are motivated by concerns about the safety of the natural substances and the way the prescriptions for them are filled. In its complaint it alleges that compounding pharmacists state that natural hormones are safer than synthetic, patented ones and that some have been “illegally” mass produced, rather than individually compounded. Wyeth also asks the FDA to regulate compounding pharmacists although they are regulated by the states, not by the federal government. (Supreme Court Decision – Thompson et al. v. Western States Medical Center et al., U.S. Supreme Court Case No. 01-344, Decided April 29, 2002m http://www.fda.gov/cder/pharmcomp/supremeCourt.pdf.)

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