News Releases
Bayer Announcement – Xofigo® has Resumed Production
Bayer Provides Product Supply Update on Xofigo® (radium Ra 223
dichloride) Injection

Whippany, NJ, November 3, 2014 - Bayer HealthCare is pleased to announce that
supply of Xofigo (radium Ra 223 dichloride) Injection has resumed following a drug
shortage due to a production issue.

Through the standard inspection process, Bayer determined that recently produced drug
product did not meet the high quality standards due to small fibrous particles found in
some of the vials. Therefore, this drug product was not distributed. Previously released
product met the quality standards in place for Xofigo.

After identification of the root cause, Bayer has, in consultation with the FDA and
relevant Health Authorities, implemented a comprehensive program of corrective and
preventative measures in order to restore quality of product and resume patient supply
as quickly as possible.

Bayer is in regular communications with physicians and clinical investigators to provide
updates about Xofigo supply and to discuss rescheduling patients. Your doctor should
be in touch with you to discuss your individual treatment plan.

Bayer regrets the impact of this disruption on patients and treating physicians. We are
committed to ensuring patient access to Xofigo. For further information, patients should
contact their healthcare professionals or the Bayer Call Center at 1-888-84-Bayer, or
1-888-842-2937. We have extended our business hours to accommodate patient
questions.

1. When can I expect to re-schedule my therapy?
We are in regular communications with physicians and clinical investigators to
provide updates about Xofigo supply so that patients may be re-scheduled to receive
their Xofigo treatment.

Please contact your doctor for more information.

2. Will I be notified when Xofigo is available?
We are in the process of contacting doctors and sites with patients who have
experienced treatment delays as a result of this drug shortage. You should expect to
be notified by your physician within the coming week.

3. Is the product still effective if a scheduled dose is missed?
The impact of a dose delay or treatment interruption is not known in detail. We are
advising patients to discuss their personal therapy management with their healthcare
provider.

4. I was about to start my first treatment with Xofigo but then my appointment
was cancelled. When can I expect to be re-scheduled?

We are committed to providing treatment to all patients as soon as possible. Our
current focus is on the needs of those patients whose treatments have been delayed.
New patients will not be administered Xofigo until the regular production is resumed.
We recognize the disruption that this shortage is causing patients and their families.
Bayer is committed to restoring the full supply of Xofigo as quickly as possible.

5. Why wasn’t there an extra drug supply available for these situations?
Due to the nature of Xofigo as a radio pharmaceutical, it is not possible to build up
reserve supplies of the drug.

6. What measures have been taken to fix the particle issue at the production site?
Following an extensive search into the root cause analysis, Bayer implemented a
comprehensive program of corrective and preventative measures in order to restore
quality of product and resume patient supply as quickly as possible.

7. How will I know this won’t happen again in the future?
Bayer is determined to do everything possible to ensure the quality and ongoing
availability of Xofigo.

Bayer® and the Bayer Cross® and Xofigo® are registered trademarks of Bayer.
PP-600-US-0612
Bayer Provides Product Supply Update on Xofigo® (radium Ra 223 dichloride) Injection
Bayer Provides Product Supply Update on Xofigo® (radium Ra 223 dichloride) Injection Please see PDF for details or visit : http://www.xofigo-us.com/patient/
Should Men Get PSA Tests?
One in six American men will be diagnosed with prostate cancer in their lifetimes. In most cases, the disease grows so slowly it doesn't cause problems. Yet some prostate cancers are fast-moving and lethal; about 28,000 U.S. men die every year because it wasn't detected and treated in time.

A test for prostate-specific antigen, or PSA, a protein made in the prostate, can give an early warning sign of cancer. But PSA tests also give many false alarms, prompting more than one million unnecessary biopsies every year. And when prostate cancer is found, more than 80% of men opt for surgery, radiation or hormone therapy that sometimes leaves them incontinent or impotent, even though their cancer probably wasn't life-threatening.
U.S. FDA Approves XTANDI(R) (enzalutamide)

August 31, 2012

U.S. FDA Approves XTANDI(R) (enzalutamide) After Priority Review for Patients With

Metastatic Castration-Resistant Prostate Cancer Previously Treated With Docetaxel

Medivation to Host Conference Call Today at 11:45am PT

SAN FRANCISCO, CA and TOKYO -- (Marketwire) -- 08/31/12 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to XTANDI® (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. XTANDI is an oral, once-daily androgen receptor inhibitor.

The FDA accepted the XTANDI New Drug Application (NDA) on July 23, 2012, and granted the filing Priority Review Designation with a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012. Medivation and Astellas expect to make XTANDI available to patients in the United States in mid-September 2012, and the specific availability date will be announced on www.XtandiHCP.com as soon as it is known. Separately, a Marketing Authorization Application for XTANDI has been accepted for review by the European Medicines Agency (EMA).


http://investors.medivation.com/releasedetail.cfm?releaseid=703823
FDA Approves Agent for Detecting Prostate Cancer

FDA NEWS RELEASE

For Immediate Release: Sept. 12, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves production of imaging agent that helps detect prostate cancer
Mayo Clinic is the first facility approved to manufacture Choline C 11 Injection

The U.S. Food and Drug Administration today approved the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer.

Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue sampling and testing in men with recurrent prostate cancer.

PET imaging with Choline C 11 Injection is performed in patients whose blood prostate specific antigen (PSA) levels are increasing after earlier treatment for prostate cancer. An elevated PSA result suggests that prostate cancer may have returned, even though conventional imaging tests, such as computerized tomography (CT), have not shown any signs of cancer. PET imaging is not a replacement for tissue sampling and testing.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319201.htm
Enzalutamide (MDV3100) Available Sites

From the Early/Expanded Access Committee – Enzalutamide (MDV3100) Now available in 10 states (see below)
(more sites expected):

Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Medivation PC drug gets priority review

July 24 | Tue Jul 24, 2012 5:21pm IST

(Reuters) - Medivation Inc's experimental prostate cancer drug enzalutamide was granted priority review status by the U.S. Food and Drug Administration, potentially reducing the review time by half.

The drug, formerly called MDV3100, was developed in partnership with Japan's Astellas Pharma Inc for the treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

The acceptance of the drug for review triggered a $10 million milestone payment to Medivation from Astellas, the companies said in a joint statement.

Prostate cancer kills about 250,000 men a year globally and the market for drugs to treat the disease is expected to grow to more than $10 billion in 2020, according to market research firm Decision Resources.

New and potential treatments for the deadly cancer are watched closely by industry analysts and investors alike. Drugs on the market include Johnson & Johnson's Zytiga and Dendreon Corp's vaccine Provenge. Bayer AG is also developing an experimental drug called alpharadin

Early Access of Enzalutamide (formerly MDV3100)
SAN FRANCISCO, CA and TOKYO -- May 30, 2012 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (Tokyo: 4503) announced that the U.S. Food and Drug Administration (FDA) agreed that Medivation and Astellas may proceed with an Expanded Access Program (EAP) for the investigational therapy enzalutamide (formerly MDV3100) under a treatment protocol in the U.S. while marketing approval is being sought from the FDA.

http://investors.medivation.com/releasedetail.cfm?ReleaseID=678010
Pres. Proclamation-Nat. Prostate Cancer Month
NATIONAL PROSTATE CANCER AWARENESS MONTH, 2012
 
BY THE PRESIDENT OF THE UNITED STATES OF AMERICA
 
A PROCLAMATION
 
Prostate cancer is among the most common cancers for men living in the United States, and despite the progress we have made in controlling it, the disease continues to take a devastating toll on thousands of lives every year. During National Prostate Cancer Awareness Month, we remember those we have lost to prostate cancer, and we renew our commitment to preventing, detecting, and treating this terrible illness.
 
While the causes of prostate cancer are still unknown, men with certain risk factors may be more likely to develop the disease. Most men who suffer from prostate cancer are over the age of 65; those whose fathers, brothers, or sons have had prostate cancer are also at greater risk. Prostate cancer is especially prevalent among African American men, who experience both the highest incidence and the highest mortality rates of prostate cancer. I encourage all men to visit www.Cancer.gov to learn the warning signs of this disease.

www.whitehouse.gov/the-press-office/2012/08/31/presidential-proclamation-national-prostate-cancer-awareness-month-2012
Gene May Be Good Target for Tough-to-Kill Prostate
Gene May Be Good Target for Tough-to-Kill Prostate Cancer Cells...
Purdue University scientists believe they have found an effective target for killing late-stage, metastatic prostate cancer cells. (sciencedaily.com)
FDA prioritizes review of Ra-223 and MDV3100
The arsenal of prostate cancer treatments for men with advanced prostate cancer may soon be strengthened as the FDA prioritizes the review of both Ra-223 and MDV3100 for treating metastatic castration-resistant prostate cancer (CRPC). Based on positive, independent research of each drug, better survival rates and improved bone health for patients with late-stage prostate cancer may be within reach.

www.news-medical.net/news/20120218/FDA-prioritizes-review-of-Ra-223-and-MDV3100-for-treating-CRPC.aspx
Unanimous Support Early Detection of PC

Senator John Kerry Leads Unanimous Passage Of The Legislation In U.S. Senate Urging Federal Research Support To Improve Early Detection Of Prostate Cancer

 

 

BOSTON, July 30, 2012 /PRNewswire via COMTEX/ -- U.S. CONGRESS SETS HISTORIC PRECEDENT IN RECOGNIZING HEALTH CARE CRISIS KILLING AFRICAN AMERICAN MEN DISPROPORTIONATELY

U.S. Sen. John F. Kerry (D-MA) led unanimous passage of the Senate Resolution 493 to recognize prostate cancer as an epidemic striking African American men disproportionately, with 250% higher mortality and 60% higher incidence. This bipartisan legislation urges federal agencies to support research for the advancement of diagnostic tools, including novel biomarkers and imaging technologies. Improved diagnostic tools will save lives and assure individualized, the least invasive and the most cost-effective patient care in millions of American men.

Senator Kerry said, "Prostate cancer is an epidemic - it kills every 16 minutes. This disease killed my dad, but I was lucky to beat it ten years ago, I introduced this resolution in the Senate to bring attention to this silent killer, how it disproportionately affects African Americans, and the need for additional federal investment in prostate cancer research, education, and awareness. I've been through the battle against prostate cancer and I understand the strain a diagnosis places on the patient and their loved ones. We need to stay focused on research and arm Americans with the tools to prevent, detect, cure and treat this disease, and I'm grateful to my colleagues and our advocates for pushing this resolution through."

Dr. Faina Shtern, President of AdMeTech Foundation who worked with Senator Kerry and his staff for several years on prostate cancer research funding issues commented, "We applaud Senator Kerry's leadership in national recognition of prostate cancer as a public health priority and a health care crisis in African American men. This legislation offers hope to millions of men who are left in the state of shock and confusion by the recent recommendation of the US Preventive Services Task Force against PSA screening, the only diagnostic tool currently available for early detection. Ending PSA screening is not the answer to the prostate cancer crisis. The Kerry resolution in support of research to improve diagnostic tools is."

Prostate cancer is the most common malignancy in the United States, but federal research support is lagging behind, and men do not have reliable diagnostic tools. The impact is sobering: While prostate cancer is curable when detected early, it remains the second most lethal cancer in men, killing over 30,000 men each year.

Boston-based AdMeTech Foundation is a non-profit organization providing international leadership in prostate cancer research, education, and awareness ( www.admetech.org ).

Medicare to pay for cancer drug
Medicare to pay for cancer drug

WASHINGTON – Medicare officials said Wednesday that the program will pay the $93,000 cost of prostate cancer drug Provenge, an innovative therapy that typically gives men suffering from the disease an extra four months to live. The Centers for Medicare and Medicaid said the biotech drug made by Dendreon Corp. is a “reasonably and necessary” medicine. The decision ensures that millions of men would be able to afford the drug through the government-backed health care coverage. With government reimbursement, analysts estimate Provenge could rack up $1 billion in sales next year. The decision will be finalized by June 30. Medicare cannot consider price when deciding whether to pay for a new treatment.
Eggs and Cancer

Eating just THREE eggs a week 'increases chance of men getting prostate cancer'

  • Men who ate the most eggs also more likely to have a poor diet, be overweight, smoke and take less exercise


Read more: http://www.dailymail.co.uk/health/article-2043180/Prostate-cancer-Eating-just-3-eggs-week-significantly-increases-risk.html#ixzz1ZLGqc539
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