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FDA approves pathogen reduction system to treat platelets

Posted 2 days ago in Pharma Industry News

December 19, 2014 -- The U.S. Food and Drug Administration yesterday approved the Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets. The system is for use by blood establishments that collect and manufacture blood and blood components to prepare pathogen reduced platelets for transfusion to reduce the risk of transfusion-transmitted infections. On Dec. 16, the FDA also approved the Intercept Blood System for the preparation of...

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FDA approves first pathogen reduction system to treat plasma

Posted 5 days ago in Pharma Industry News

December 16, 2014 -- The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI). “The approval of devices like the Intercept Blood System allows blood establishments to prepare plasma that carries a lower risk of transmitting infectious pathogens through transfusion,” said Karen Midthun,...

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FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency

Posted 6 days ago in Pharma Industry News

December 15, 2014 -- The U.S. Food and Drug Administration today allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns. According to the Centers for Disease Control and Prevention, approximately 40 to 100 new cases of SCID are identified in newborns in the United States each year. SCID is a group of disorders caused by defects in genes involved in the development and function of T...

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FDA clears test that helps predict the risk of coronary heart disease

Posted 6 days ago in Pharma Industry News

December 15, 2014 -- The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks. FDA cleared the test for use in all adults with no history of heart disease, but studies submitted by the company and reviewed by the FDA show that the test is better at discerning this risk in women, particularly black women. “A cardiac test that helps better predict future CHD risk in...

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FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis

Posted 6 days ago in Pharma Industry News

December 15, 2014 -- The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of health care settings. According to the U.S. Centers for Disease Control and Prevention (CDC), about 55,000 people in the United States are newly infected with syphilis annually. During the 1990s, syphilis primarily...

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FDA approves first test to confirm the presence of Human T-cell Lymphotropic Virus-I/II antibodies

Posted 10 days ago in Pharma Industry News

December 11, 2014 -- The U.S. Food and Drug Administration today approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay test intended to confirm infection...

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FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products

Posted 2 weeks ago in Pharma Industry News

December 3, 2014 -- The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding. The final...

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Monthly News Roundup - November 2014

Posted 3 weeks ago in Pharma Industry News

Purdue Pharma’s Abuse-Deterrent Hysingla ER Approved for Pain The U.S. Food and Drug Administration (FDA) has approved Hysingla ER (hydrocodone bitartrate), an acetaminophen-free, extended-release (ER) opioid for severe pain requiring daily, long-term treatment and for which no alternatives exist. Hysingla ER abuse-deterrent properties may reduce, but not totally prevent, abuse of the drug. The tablet forms a thick gel and cannot be easily prepared for injection, and is difficult to crush,...

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FDA issues additional guidance for outsourcing facilities that compound sterile human drugs

Posted 4 weeks ago in Pharma Industry News

November 21, 2014 -- Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013. The DQSA added section 503B to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 503B, a compounder can elect to...

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FDA Concerns About Therapeutic Equivalence with Two Generic Versions of Concerta Tablets

Posted 5 weeks ago in Pharma Industry News

November 13, 2014 -- Based on an analysis of data, FDA has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets), used to treat attention-deficit hyperactivity disorder in adults and children, are therapeutically equivalent to the brand-name drug. The two approved generic versions of Concerta are manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd. As a result, the FDA has changed the...

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Monthly News Roundup - October 2014

Posted 7 weeks ago in Pharma Industry News

AstraZenenca’s Xigduo XR Approved for Type 2 Diabetes Type 2 diabetes is estimated to affect 29.1 million people in America. The U.S. Food and Drug Administration (FDA) has approved once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a combination drug of two agents that work together to lower blood sugar. Dapagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin is a biguanide. Clinical evidence of safety and efficacy for Xigduo...

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Pfizer’s Pristiq Demonstrates Low Potential For Sexual Dysfunction in Adults with Major Depressive Disorder

Posted 7 weeks ago in Pharma Industry News

October 29, 2014 - Pfizer Inc. today announced the publication of a clinical study in the Journal of Clinical Psychiatry showing comparable sexual function in adult patients diagnosed with major depressive disorder (MDD) treated daily with Pristiq (desvenlafaxine) Extended Release Tablets 50mg and 100mg doses versus placebo. Sexual dysfunction is often an issue for patients treated with antidepressants, and Pfizer conducted the study pursuant to a postmarketing requirement by the U.S. Food and...

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Merck Receives FDA Breakthrough Therapy Designation for Keytruda in Advanced Non-Small Cell Lung Cancer

Posted 7 weeks ago in Pharma Industry News

WHITEHOUSE STATION, N.J.-- October 27, 2014 --Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on...

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FDA Approves Edenbridge Pharmaceuticals' Generic Stromectol (Ivermectin Tablets 3mg)

Posted 8 weeks ago in Pharma Industry News

Parsippany, New Jersey, October 24, 2014 -- Edenbridge Pharmaceuticals, LLC today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Merck & Co., Inc.'s Stromectol (ivermectin tablets 3 mg). Prior to today, there have been no FDA approved generic versions of Stromectol and Edenbridge intends to begin shipping its Ivermectin Tablets USP 3mg product shortly. This is Edenbridge's first FDA...

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GSK update on current development status of the GSK/NIH Ebola vaccine candidate

Posted 9 weeks ago in Pharma Industry News

London UK -- 18 October 2014 -- With the Ebola crisis in west Africa continuing, GSK is working closely with the World Health Organization (WHO), regulators and other partners to respond to the outbreak, to accelerate development of our investigational Ebola vaccine and to ramp up production as quickly as possible. Development of the vaccine candidate is progressing at an unprecedented rate, with first phase 1 safety trials with the vaccine candidate underway in the USA, UK and Mali, and...

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Joan Rivers Died from Complications Under Propofol, Coroner Rules

Posted 9 weeks ago in Pharma Industry News

THURSDAY, Oct. 16, 2014 -- Joan Rivers has died of "therapeutic complications" while undergoing a procedure to evaluate vocal and gastrointestinal issues, according to the New York medical examiner. The death was caused by a lack of oxygen to the brain during a laryngoscopy, a procedure to view the vocal chords, and an upper gastrointestinal endoscopy. She was sedated with the drug propofol, the medical examiner said. The medical examiner ruled that the cause of death was "anoxic...

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FDA Approves Lutonix 035 DCB - First Drug-Coated Angioplasty Balloon Catheter to Treat Vascular Disease

Posted 10 weeks ago in Pharma Industry News

October 10, 2014 -- The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD). PAD occurs when fatty material (plaque) builds up in the arteries that carry blood to the limbs, usually affecting...

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Rescheduling of Hydrocodone Combo Prescriptions: As of Today, Refills Become More Difficult

Posted 10 weeks ago in Pharma Industry News

October 6, 2014 -- Today the final DEA rule on switching hydrocodone combination products like Lortab and Vicodin from schedule III to schedule II comes into effect. This rule has been put into place to help curb abuse and encourage patients and prescribers to consider alternative ways to deal with pain. What does this mean? Until now, hydrocodone combination products were regulated as schedule III drugs. These drugs, used as pain relievers or cough suppressants, contain both hydrocodone...

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Re-scheduling prescription hydrocodone combination drug products: An important step toward controlling misuse and abuse

Posted 10 weeks ago in Pharma Industry News

October 6, 2014 -- Hydrocodone is the most prescribed opioid in the United States, including 137 million prescriptions in 2013. While it is useful in the treatment of pain, it has also contributed significantly to the very serious problem of opioid misuse and abuse in the United States. With the aim of curbing this misuse and abuse, new prescribing requirements go into effect today for hydrocodone combination products, which include products such as Anexsia, Lorcet, Vicodin, and some cough...

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CDC and Texas Health Department Confirm First Ebola Case Diagnosed in the U.S.

Posted 11 weeks ago in Pharma Industry News

September 30, 2014 -- The Centers for Disease Control and Prevention (CDC) confirmed today, through laboratory tests, the first case of Ebola to be diagnosed in the United States in a person who had traveled to Dallas, Texas from Liberia. The patient did not have symptoms when leaving West Africa, but developed symptoms approximately four days after arriving in the U.S. on Sept. 20. The person fell ill on Sept. 24 and sought medical care at Texas Health Presbyterian Hospital of Dallas on...

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