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FDA approves Cuvposa Oral Solution for chronic severe drooling in children

The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.

29 Jul 2010

Bioniche, Synerx announce FDA approval and launch of Isosulfan Blue Injection 1%

Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, and Synerx Pharma, LLC announced today the FDA approval and launch of Isosulfan Blue Injection 1%.

29 Jul 2010

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Chimerix, Inc., a biopharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of research results demonstrating the potential of CMX157 (hexadecyloxypropyl tenofovir) to effectively suppress replication of human immunodeficiency virus (HIV) that cannot be treated with currently available nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), including tenofovir disoproxil fumarate (Viread), due to the development of multi-drug resistance. Earlier this year, Chimerix initiated a dose-escalating Phase 1 clinical trial of CMX-157 to evaluate drug safety, tolerability and pharmacokinetics.

29 Jul 2010

Rite Aid agrees to pay $1 million to settle medical privacy questions

The Wall Street Journal: "Rite Aid Corp. agreed to pay $1 million to settle potential violations of government privacy rules after regulators said it failed to protect customers' and employees' financial and medical information. The drug-store chain's agreement with the Federal Trade Commission requires the company to establish an information-security program and obtain a third-party audit of its compliance to that effect every two years for the next 20 years."

29 Jul 2010

AMAG attributes increased second-quarter revenues of $18.8 million to Feraheme

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the second quarter and six months ended June 30, 2010. For the second quarter, AMAG reported total revenue of $18.8 million, including $16.0 million of Feraheme® (ferumoxytol) Injection for intravenous (IV) use net product revenues.

29 Jul 2010

HIV drug can raise the risk of heart disease: Study

There are a handful of drugs effective in treating HIV/AIDS. However new research shows that some of these drugs can increase the risk of heart attacks. The results come from a Garvan Institute of Medical Research study involving 20 people, 10 taking the drug Ritonavir and 10 others the drug Raltegravir for one month.

28 Jul 2010

Aging thalidomide victims to receive $50 million in compensation

Thalidomide was sold in a number of countries across the world from 1957 until 1961 when it was withdrawn from the market after being found to be a cause of birth defects in what has been called "one of the biggest medical tragedies of modern times".

28 Jul 2010

Pain Therapeutics second-quarter collaboration revenue decreases to $0.1 million

Pain Therapeutics, Inc., a biopharmaceutical company, today reported second quarter financial results. Net loss for the quarter ended June 30, 2010 was $0.8 million, or $0.02 per share, compared to net loss of $34,000, or $0.00 per share, for the second quarter of 2009. Pain Therapeutics had cash, cash equivalents and marketable securities of $176.2 million, or about $4.14 cash per share, and no debt as of June 30, 2010.

28 Jul 2010

FDA approves Tris Pharma's first-time generic of Methylphenidate Hydrochloride Oral Solution

Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced that the US Food and Drug Administration (FDA) has approved a first-time generic of Methylphenidate Hydrochloride Oral Solution equivalent to brand name Methylin® Oral Solution marketed by Shionogi Pharmaceuticals, Inc.

28 Jul 2010

Dyax second-quarter total revenues increase to $15.1 million

Dyax Corp. today announced financial results for the second quarter ended June 30, 2010.

28 Jul 2010

ViroPharma second-quarter net sales increase 33% to $109.0 million

ViroPharma Incorporated reported today its financial results for the second quarter ended June 30, 2010.

28 Jul 2010

Allos reports net loss of $20.0 million for second-quarter 2010

Allos Therapeutics, Inc. today reported its financial results and business highlights for the quarter and six months ended June 30, 2010.

28 Jul 2010

New £50M fund made available to help patients get access to innovative new cancer drugs

The government has announced a new £50 million fund to improve access to cancer drugs until the new Cancer Drugs Fund comes into effect in April 2011.

28 Jul 2010

Taiwanese hemophiliacs infected by HIV-contaminated medications petition US Supreme Court

Baum Hedlund announces that Taiwanese hemophiliacs infected by HIV-contaminated medications have petitioned the United States Supreme Court to allow their claims to proceed in California. Their suits contend that California-based defendants illegally used paid plasma donors at high risk for transmitting blood-borne diseases (i.v. drug users, prisoners, and promiscuous urban gay males) to make injected anti-hemophilia medications.

28 Jul 2010

PhRMA asks FDA to be more straightforward on safeguards it wants to fight drug risks

The pharmaceutical industry trade group PhRMA said Monday that the Food and Drug Administration should do a better job of explaining additional safeguards it mandates against certain drugs when it issues warnings, Reuters reports.

28 Jul 2010

FDA accepts for filing Cladribine Tablets NDA for MS

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS).

28 Jul 2010

Morphine blocks new blood vessel and tumor growth: Study

Current research suggests that taking morphine can block new blood vessel and tumor growth. The related report by Koodie et al, "Morphine suppresses tumor angiogenesis through a HIF1α/p38MAPK pathway," appears in the August 2010 issue of the American Journal of Pathology.

28 Jul 2010

Regeneron second-quarter total revenues increase to $115.9 million

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2010. The Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for the second quarter of 2010 compared with a net loss of $14.9 million, or $0.19 per share (basic and diluted), for the second quarter of 2009.

28 Jul 2010

New York Times examines questions left unanswered by microbicide trial

The New York Times examines a set of questions raised by news out of the International AIDS Conference-AIDS 2010 last week that a microbicide gel containing the antiretroviral tenofovir used by women before and after sex helped reduce their risk of HIV infection by 39 percent.

28 Jul 2010

Genzyme accepts CMS decision for delaying Renvela administration to dialysis patients

Genzyme Corp.today said it welcomed the Centers for Medicare and Medicaid Services' decision not to include oral medications without IV equivalents in Medicare's End Stage Renal Disease patient benefit. According to the final rule, these medications, including Genzyme's Renvela (sevelamer carbonate), will not be included in the bundle until January 1, 2014.

28 Jul 2010

Pharmaceutical News

FDA approves Cuvposa Oral Solution for chronic severe drooling in children

Bioniche, Synerx announce FDA approval and launch of Isosulfan Blue Injection 1%

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Rite Aid agrees to pay $1 million to settle medical privacy questions

AMAG attributes increased second-quarter revenues of $18.8 million to Feraheme

HIV drug can raise the risk of heart disease: Study

Aging thalidomide victims to receive $50 million in compensation

Pain Therapeutics second-quarter collaboration revenue decreases to $0.1 million

FDA approves Tris Pharma's first-time generic of Methylphenidate Hydrochloride Oral Solution

Dyax second-quarter total revenues increase to $15.1 million

ViroPharma second-quarter net sales increase 33% to $109.0 million

Allos reports net loss of $20.0 million for second-quarter 2010

New £50M fund made available to help patients get access to innovative new cancer drugs

Taiwanese hemophiliacs infected by HIV-contaminated medications petition US Supreme Court

PhRMA asks FDA to be more straightforward on safeguards it wants to fight drug risks

FDA accepts for filing Cladribine Tablets NDA for MS

Morphine blocks new blood vessel and tumor growth: Study

Regeneron second-quarter total revenues increase to $115.9 million

New York Times examines questions left unanswered by microbicide trial

Genzyme accepts CMS decision for delaying Renvela administration to dialysis patients

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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