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Health Highlights: July 28, 2014

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: 2 Americans Working in Liberia Are Infected With Ebola Two Americans working to help Ebola victims in the West African country of Liberia have themselves become infected, an aid organization said. According to the Associated Press, Dr Kent Brantly, 33, has tested positive for the highly contagious, often fatal...

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Chronic Medical Conditions Can Shorten Seniors' Lives: Study

Posted today in Medical

MONDAY, July 28, 2014 -- The more chronic medical conditions people have at retirement age, the shorter their life expectancy may be, a new study claims. Since nearly four in five older Americans have multiple health issues, scientists at Johns Hopkins Bloomberg School of Public Health in Baltimore said the findings may help explain why gains in life expectancy are slowing in the United States. "Living with multiple...

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Inflammatory Muscle Disorder May Raise Risk for Heart Attack, Stroke

Posted today in Medical

MONDAY, July 28, 2014 -- A common inflammatory muscle disorder that causes pain and stiffness in older people may increase the risk for heart attack and stroke, new research suggests. A British study found that patients with polymyalgia rheumatica are more likely to develop vascular disease -- conditions that affect the blood vessels. Doctors should carefully manage the vascular risk factors of patients with...

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'Fist Bump' May Beat Handshake for Cleanliness

Posted today in Medical

MONDAY, July 28, 2014 -- British researchers report that an alternative to the traditional handshake might spread far fewer germs around. In their experiments, the scientists found that clasping hands transferred 10 times more germs from one person to the other than what is known as a fist bump. They suggest the more casual exchange might suffice as a cultural substitute for the firm gripping of hands. The findings...

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Healthy 'Brown Fat' May Cut Odds for Obesity, Diabetes

Posted today in Medical

MONDAY, July 28, 2014 -- People with higher levels of brown fat have a reduced risk for obesity and diabetes, a new study suggests. Unlike white fat, which lowers insulin sensitivity, researchers found that brown fat actually improves insulin sensitivity, blood sugar control and fat-burning metabolism. "This is good news for overweight and obese people," Labros Sidossis, a professor of internal medicine in the...

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AcelRx Pharmaceuticals Receives Complete Response Letter from FDA for NDA for Zalviso

Posted 2 days ago in New Drug Applications

REDWOOD CITY, Calif., July 25, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for...

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FDA Approves Flonase Allergy Relief for Sale Over-the-Counter in the United States

Posted 2 days ago in New Drug Approvals

London UK and Parsippany, US - Thursday 24 July 2014, GlaxoSmithKline plc today announced that the U.S. Food and Drug Administration (FDA) has approved Flonase Allergy Relief (fluticasone propionate 50 mcg spray), containing the No. 1 prescribed allergy treatment ingredient1, as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.2 Flonase Allergy...

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Boehringer Ingelheim: Benefits and Safety of Pradaxa Repeatedly Confirmed

Posted 4 days ago in Pharma Industry News

Ridgefield, CT, July 23, 2014 – Boehringer Ingelheim (BI) wants to set the record straight following misleading statements that the British Medical Journal (BMJ) published today regarding Pradaxa® (dabigatran etexilate mesylate). We are concerned that this publication may alarm patients and prompt them to stop taking Pradaxa, thereby increasing their risk of stroke. To be clear, many of the allegations made by...

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FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia

Posted 4 days ago in New Drug Approvals

WOODCLIFF LAKE, N.J.(BUSINESS WIRE) July 23, 2014 -- Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX) today announced that the U. S. Food and Drug Administration (FDA) has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal...

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FDA announces voluntary nationwide recall of all non-expired sterile drugs from Unique Pharmaceuticals

Posted 4 days ago in Pharma Industry News

July 23, 2014 -- The U.S. Food and Drug Administration is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas. The recalled products include lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products. Health care professionals should immediately check...

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FDA Approves Targiniq ER Extended-Release Oxycodone with Abuse-Deterrent Properties

Posted 4 days ago in New Drug Approvals

July 23, 2014 -- Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic...

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FDA Approves Zydelig (idelalisib) for CLL and Lymphoma

Posted 4 days ago in New Drug Approvals

July 23, 2014 -- The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three B-cell blood cancers. Zydelig is a first-in-class inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that is over-expressed in many B-cell malignancies. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned...

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Lightlake Therapeutics Inc. Files Investigational NDA For Naloxone Nasal Spray For Reversing Opioid Overdose

Posted 5 days ago in New Drug Applications

LONDON, July 23, 2014 /PRNewswire/ -- Lightlake Therapeutics Inc. ("Lightlake") (OTCQB: LLTP), a biopharmaceutical company developing addiction treatments based on its expertise in opioid antagonists, announced today that it has filed an investigational new drug application ("IND") with respect to its naloxone-based opioid overdose reversal nasal spray. Lightlake also announced today that it has received an...

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FDA Consumer Advice on Powdered Pure Caffeine

Posted 6 days ago in Pharma Industry News

July 21, 2014 -- The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products. In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet. The FDA is aware of at least one death of a teenager who used these products. These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is...

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Medicines360 and Actavis Announce FDA Acceptance for Filing of NDA for Levosert IUD

Posted 6 days ago in New Drug Applications

San Francisco, CA and Dublin, Ireland, – June 21, 2014 - Medicines360, a non-profit women’s health pharmaceutical company, and Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360’s New Drug Application (NDA) for Levosert™ (levonorgestrel), a hormonal intrauterine contraceptive (IUC)...

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Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs

Posted 9 days ago in Pharma Industry News

July 17, 2014 -- The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act. Agents from FDA’s Office of...

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FDA Approves Ruconest for Hereditary Angioedema

Posted 10 days ago in New Drug Approvals

July 17, 2014 -- The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Hereditary angioedema, which is caused by having insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6,000 to 10,000 people in the United...

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InterMune Receives FDA Breakthrough Therapy Designation for Pirfenidone, an Investigational Treatment for IPF

Posted 11 days ago in New Drug Applications

BRISBANE, Calif., July 17, 2014 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that pirfenidone has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial...

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Boehringer Ingelheim’s Investigational Therapy Nintedanib Receives FDA Breakthrough Therapy Designation

Posted 11 days ago in New Drug Applications

Ridgefield, Conn., July 16, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to nintedanib, an investigational therapy currently under FDA review for the treatment of people with idiopathic pulmonary fibrosis (IPF). The efficacy and safety of nintedanib in the treatment of IPF has not been...

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Popping Pills in America: Can the DEA Fix This?

Posted 13 days ago in Pharma Industry News

There's no doubt about it - the U.S. is a big consumer of prescription painkillers. In fact, in 2010 enough prescription painkillers were prescribed to medicate each American adult every four hours for an entire month. A report released in March 2014 from the U.S. National Safety Council shows that prescription drug overdoses – more than car accidents – are the leading cause of accidental death among...

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Merck Initiates Phase 3 Study of Letermovir for Prevention of Cytomegalovirus (CMV) Infection

Posted 3 days ago in Clinical Trials

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- July 24, 2014 -- Merck, known as MSD outside the United States and Canada, today announced that the first patient has been enrolled in a global Phase 3 clinical study of letermovir (MK-8228), an investigational antiviral agent. The multicenter, randomized, placebo-controlled study will evaluate the efficacy and safety of letermovir for the prevention of...

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Kinex Pharmaceuticals Announces Allowance of the IND application for KX2-391 Ointment by the FDA

Posted 3 days ago in Clinical Trials

July 24, 2014 -- Kinex Pharmaceuticals announced the receipt of an allowance by the US FDA for the Company's KX2-391 Ointment for the commencement of a Phase I clinical study in actinic keratosis. This is the Company's third IND to be allowed by the US FDA in the past 12 months. KX2-391 is a synthetic, orally active and highly selective inhibitor of Src tyrosine kinase signaling and tubulin polymerization....

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Galectin Therapeutics Announces First Patient Dosed in Cohort 1 of Phase 1B Clinical Trial of GR-MD-02

Posted 6 days ago in Clinical Trials

NORCROSS, Ga., July 22, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the first patient has been dosed in cohort 1 of the Company's Phase 1B clinical trial evaluating GR-MD-02 in combination with ipilimumab (Yervoy®) in patients with metastatic melanoma. Providence Portland...

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Advaxis and MedImmune Partner on Immuno-Oncology Combination Clinical Trial

Posted 6 days ago in Clinical Trials

PRINCETON, N.J., July 22, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, has entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca. The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint...

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Ignyta Announces Initiation of STARTRK-1 Global Phase I/II Clinical Trial of RXDX-101

Posted 6 days ago in Clinical Trials

SAN DIEGO--(BUSINESS WIRE) July 21, 2014 -- Ignyta, Inc., an oncology precision medicine biotechnology company, today announced the multicenter initiation of the company's global Phase I/II clinical trial of RXDX-101, its proprietary oral tyrosine kinase inhibitor targeting multiple solid tumor indications. This clinical trial is called STARTRK-1, which stands for Study Targeting ALK, ROS1 or TRKA/B/C, and is a...

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