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Blood test can identify fetal sex as early as 7 weeks gestation

August 9, 2011

August 9, 2011 Fetal sex can be determined reliably with a non-invasive genetic test as early as 7 weeks into a pregnancy, according to a new meta-analysis published this week in the Journal of the American Medical Association. The results of the NIH-funded analysis have important implications for early diagnosis of genetic diseases linked to […]

UPDATE 2-Novo Nordisk settles U.S. probe for $25 million

June 10, 2011

Click here for link to article * Settlement resolves probe into drug marketing practices * Novo Nordisk does not admit wrongdoing in settlement * Company to enter corporate integrity agreement NEW YORK, June 10 (Reuters) – Danish drugmaker Novo Nordisk (NOVOb.CO) will pay $25 million to settle a lawsuit over the alleged improper marketing of […]

Anschutz Medical Campus researchers discover new process to cultivate adult blood cells

June 7, 2011

Direct link to article By Margaret Jackson The Denver Post Posted:聽06/06/2011 01:00:00 AM MDT Updated:聽06/06/2011 09:39:32 AM MDT   Research assistant Patti Estes with Taiga Biotechnologies prepares stem cells for an experiment at the Anschutz Medical Campus in Aurora last week. Taiga estimates that it could create new adult blood cells for trials on humans […]

Drugs for rare cancers approved after subpar tests

June 7, 2011

Direct link to article By Frederik Joelving NEW YORK | Mon Jun 6, 2011 5:39pm EDT (Reuters Health) – Drugs for rare cancers are allowed to hit the U.S. market based on low-quality clinical tests that raise concerns about both safety and efficacy, researchers said Monday. Known as orphan drugs, such medications are used to […]

Viral Outbreaks in Dogs Yield Clues on Origins of Hepatitis C

May 31, 2011

New York Times article link By CARL ZIMMER Published: May 30, 2011 Hepatitis C is, in some ways, a high-profile disease. Worldwide, an estimated 200 million people are infected with the virus. Some of them will suffer cirrhosis, liver cancer and even death. Celebrities like Steven Tyler of Aerosmith and “American Idol” have spoken publicly […]

FDA approves new HIV treatment

May 23, 2011

FDA NEWS RELEASE For Immediate Release: May 20, 2011 Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA Click here for a link to the full press release. FDA approves new HIV treatment The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection […]

GTC Biotherapeutics, Inc., a LFB Group Company, Granted Protection until 2027 on Broad Transgenic Protein Production Patent, and is Also Granted New Patent on Recombinant Anti-Thrombin Produced Transgenically

May 20, 2011

Click here for full Business Wire article FRAMINGHAM, Mass.–(BUSINESS WIRE)–GTC Biotherapeutics, Inc. (GTC) (a wholly-owned subsidiary of LFB Biotechnologies S.A.S., Les Ulis, France), announced today that the United States Patent and Trademark Office (USPTO) granted (to GTC) a patent covering DNA constructs for the production of any therapeutic protein in the milk of any transgenic […]

Merck’s Hepatitis C Drug Wins F.D.A. Approval

May 16, 2011

Click here for New York Times article. By ANDREW POLLACK Published: May 13, 2011 The Food and Drug Administration approved on Friday the first of a new generation of hepatitis C drugs that promises to increase the cure rate while shortening the time required for treatment. The new drug, Victrelis from Merck, effectively cured more […]

U-M creates new stem cell lines

April 5, 2011

Link to Article Embryonic tools will boost research into inherited diseases Kim Kozlowski / The Detroit News Ann Arbor鈥 A collaboration between the University of Michigan and a renowned Detroit doctor has led to new embryonic stem cell lines that will allow researchers to study how certain diseases form and progress, officials will announce today. […]

H&P Industries, Inc. Issues a Voluntary Nationwide Recall of All Lots of POVIDINE PREP PADS

March 21, 2011

Contact: Customer Service 262-538-2900 FOR IMMEDIATE RELEASE 鈥 March 15, 2011 鈥擧artland, Wisconsin, H&P industries, Inc.,聽a manufacturer of over-the-counter products has initiated a voluntary product recall of ALL LOTS of POVIDINE PREP PADS manufactured by H&P Industries, Inc. but which are private labeled for many accounts.聽This recall has been initiated due to results of the […]

Pfizer Inc. And Progenics Alert Physicians And Patients To Information Related To Triad Group Alcohol Prep Products Included In U.S. RELISTOR Kit Packaging Wed, 26 Jan 2011 10:53:00 -0600 NEW YORK, N.Y. and TARRYTOWN, N.Y.

January 26, 2011

Pfizer Inc. and Progenics Pharmaceuticals, Inc. have learned of a United States market recall of alcohol prep pads and swabs manufactured by the Triad Group. In the interest of patient safety, Pfizer and Progenics are alerting U.S. patients and physicians to Triad’s recall.

“Recommendations from the EGAPP Working Group: Routine testing for Factor V Leiden and prothrombin mutations in adults with a history of idiopathic venous thromboembolism and their adult family members”

January 17, 2011

“Recommendations from the EGAPP Working Group: Routine testing for Factor V Leiden (R506Q) and prothrombin (20210G>A) mutations in adults with a history of idiopathic venous thromboembolism and their adult family members” EGAPP recommendations

Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication

January 14, 2011

Full FDA Article [Posted 01/13/2011] AUDIENCE: Pharmacy, Pain Management ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will […]

RECALL: Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination

January 7, 2011

Article Link Contact: Eric Haertle, COO 262-538-2900 FOR IMMEDIATE RELEASE – January 5, 2011 – Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to […]

Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

November 15, 2010

Link to Recall Audience: Risk Manager, Nursing Issue: FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700.聽 These units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. […]

Press Release: EEOC Issues Strong Final Rule Implementing GINA

November 9, 2010

Click here for official press release The Council for Responsible Genetics, a public interest organization, is hailing the Final Rule implementing the Genetic Information Nondiscrimination Act (GINA) released today by the Equal Employment Opportunity Commission (EEOC). In its Final Rule, the EEOC lays out in detail strong protections against genetic discrimination and employer access to […]

‘Herculean’ achievement cracks HIV puzzle

November 5, 2010

http://www.philly.com/inquirer/breaking/news_breaking/20101104_Herculean_achievement_cracks_HIV_puzzle.html By Faye Flam INQUIRER STAFF WRITER AIDS researchers announced Thursday that they’d finally cracked a long-standing puzzle: Why a few people can get infected with the AIDS virus and remain healthy without treatment? It was the culmination of a 16-year effort that started with one HIV-positive minister coming into the office of AIDS researcher […]

Valeant, Kadmon sign deals on hepatitis C drugs

November 2, 2010

Link to article Mon Nov 1, 2010 11:01am EDT TORONTO (Reuters) – Canada’s Valeant Pharmaceuticals International (VRX.TO: Quote) and U.S. company Kadmon Pharmaceuticals said on Monday they have signed two deals to partner on hepatitis C drugs as Valeant moves to end development of antiviral drugs but seeks to bolster its offering of already commercialized […]

B. Braun Voluntarily Recalls Seven Lots of Heparin Manufactured in 2008 Due to Supplier-Initiated Recall of Heparin Active Pharmaceutical Ingredient (API)

November 1, 2010

Fri, 29 Oct 2010 12:59:00 -0500聽聽Read More B. Braun Medical Inc. (B. Braun) was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of a lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because additional testing of retained crude heparin samples used by SPL to […]

U.S. Sues Michigan Blue Cross Over Pricing

October 22, 2010

Link to article By ROBERT PEAR, Published: October 18, 2010 WASHINGTON 鈥 The Justice Department sued Blue Cross Blue Shield of Michigan on Monday, asserting that the company, the state’s dominant health insurer, had violated antitrust laws and secured a huge competitive advantage by forcing hospitals to charge higher prices to Blue Cross’s rivals. The […]

WebMD: “New Hepatitis C Drugs in the Works”

October 15, 2010

Click here for full article Hepatitis Health Center New Hepatitis C Drugs in the Works Study Show 2 Experimental Drugs Are Able to Reduce Virus Levels in Blood By Salynn Boyles WebMD Health News Reviewed by Laura J. Martin, MD Oct. 14, 2010 — The long wait for new drugs that cure hepatitis C virus […]

URGENT: Voluntary Market Withdrawal – September 23, 2010 Octagam [Immune Globulin Intravenous (Human)] 5% Liquid Preparation

September 24, 2010

Visit FDA link to learn more: <http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm227133.htm>

Medical Alert: Shortage of DDAVP IV

September 24, 2010

NHF Medical Advisory #411: September 24, 2010 Shortage of DDAVP IV The Food and Drug Administration has issued a notice that there is currently a shortage of Desmopressin Acetate (DDAVP), Intravenous Formulation, due to increased demand and manufacturing delays. Three pharmaceutical companies currently distribute and market this product in the US.聽 Hospira reports that it […]

American Plasma Users Coalition, A-PLUS, Seeks FDA-Community Research Agenda to Enhance The Safety of Our Nation’s Blood Supply

June 9, 2010

The Department of Health and Human Services, Advisory Committee on Blood Safety and Availability will be reviewing the current Food and Drug Administration (FDA) policy recommending that men wh have sex with another man (MSM) even one time since 1977 should be deferred indefinitely from donating blood. Click here for the Release

Joint Statement on Addressing the MSM Blood Ban by Groups Representing People Living with Hemophilia, Gay Men and People Living with HIV/AIDS

June 9, 2010

The Department of聽 Health & Human Services, Advisory Committee on Blood Safety and Availability will be reviewing the current Food and Drug Administration (FDA) policy recommending that men who have sex with another man (MSM) even one time since 1977 should be deferred indefinitely from donating blood.聽聽Click here for the Press Release.

Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall

January 26, 2010

Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets Exel/Exelint “Securetouch+” Safety Huber Infusion Sets Audience: Hospital Risk Managers, Surgical Service personnel FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation due to […]

Posted: 11/6/2009

November 6, 2009

Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion聽(PDF – 68KB)

Leland

October 20, 2009

Leland is a teenager with hemophilia and an inhibitor who is concerned with lifetime caps and how they affect his future in the bleeding disorders community.

Heparin: Change in Reference Standard

October 1, 2009

FDA MedWatch Heparin: Change in Reference Standard – The change will result in 10% reduction in the potency of the heparin marketed in the U.S. Audience: Pharmacists, physicians, hospital risk managers and consumers FDA notified healthcare professionals and patients of a change to heparin, effective October 1, 2009, which will include a new reference standard […]


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