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Seasonal flu shots: Are they responsible for the adverse reactions? Investigations on

After the seasonal flu vaccines caused over 250 cases of fever, vomiting and convulsions and one reported death in under-fives there has been intense investigations to detect the cause. Further vaccinations were stopped last Friday.

28 Apr 2010

Positive results from interim analysis of ongoing Phase 2a study of BCX4208

BioCryst Pharmaceuticals, Inc. announced positive top-line results from a planned interim analysis of its ongoing Phase 2a, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered BCX4208 in patients with gout.

28 Apr 2010

Diamyd Medical to focus on completion of Diamyd Phase III studies and preparation for market launch

“Besides our ongoing partnership discussions, we will primarily focus on completing the Phase III studies and prepare for market launch of Diamyd®.”

28 Apr 2010

Takeda settles with six defendants in generic ACTOS, ACTOplus met patent infringement lawsuit

Takeda Pharmaceutical Company Limited announced today that Takeda and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc., have completed settlement agreements with six out of eight defendants in patent infringement litigation brought against these parties in response to their Abbreviated New Drug Applications for generic ACTOS® (pioglitazone HCl) and ACTOplus met® (pioglitazone HCl and metformin HCl). Takeda recently concluded litigation with the sixth settling defendant.

28 Apr 2010

AHF applauds Merck for doubling Isentress discount rebates and freezing price for ADAPs

Following an innovative, years long advocacy campaign spearheaded by AIDS Healthcare Foundation (AHF) that targeted Merck and Co. Pharmaceuticals over the pricing of its AIDS drug Isentress—one of the most expensive first line AIDS therapies on the US market today—officials from AHF lauded Merck today for significant concessions that the drug giant is putting in place on its pricing and rebate policies for the nation's AIDS Drug Assistance Programs (ADAP), the federally funded, state run programs that supply lifesaving AIDS drugs to low-income Americans in need.

28 Apr 2010

BiondVax announces successful conclusion of second Phase I/II trial of Multimeric-001 Universal Flu Vaccine

BiondVax Pharmaceuticals Ltd., an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a Universal Influenza Vaccine, announced the successful conclusion of the Company's second Phase I/II clinical trial of the Multimeric-001 Universal Influenza Vaccine.

28 Apr 2010

Trade negotiations between EU, India could affect access to low-cost generics

The Associated Press examines the ongoing free-trade negotiations between the EU and India - a country that according to PricewaterhouseCoopers currently "makes one-fifth of the world's generics." The negotiations "could make it harder for millions … across the developing world to get lifesaving drugs. The deal is taking shape as India tries to transform itself from a generics powerhouse into a base for drug discovery - a trend that could ultimately do more than any trade agreement to curtail its reign as a pharmacy to the poor."

28 Apr 2010

Diamyd Medical reports group net sales of MSEK 0.2 for second-quarter 2010

Second quarter report for Diamyd Medical AB (publ), fiscal year 2009/2010

28 Apr 2010

Shire receives Paragraph IV Notice Letter from Anchen over filing of ANDA for generic INTUNIV

Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Anchen Pharmaceuticals, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV(TM).

28 Apr 2010

Researchers receive $5.7M in funding to investigate new ways to treat uterine fibroids

As many as 75 percent of women have uterine fibroids (leiomyomas), and approximately one-third to one-half of those women become symptomatic at some point during their reproductive lives - experiencing irregular uterine bleeding, anemia, pelvic pain or recurrent pregnancy loss.

28 Apr 2010

Discovery Labs reports first-quarter results, updates on Surfaxin and key pipeline programs

Discovery Laboratories, Inc., a biotechnology company developing its novel synthetic surfactant and aerosol technologies for respiratory diseases, today provides an update on Surfaxin® and key pipeline and business initiatives and reports financial results for the first quarter ended March 31, 2010.

28 Apr 2010

AstraZeneca to pay $520 million in largest pharmaceutical civil settlement

AstraZeneca will pay the federal government $520 million in civil fines to settle charges of off-label marketing of the powerful antipsychotic drug Seroquel. The settlement is the largest pharmaceutical civil settlement and among the top five civil and criminal drug company settlements in U.S. history.

28 Apr 2010

Lexicon Pharmaceuticals to present Phase 2 study results of LX1031 for non-constipating IBS at DDW 2010

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that the company will be giving poster and oral presentations on results from its Phase 2 clinical study with LX1031 in patients with non-constipating irritable bowel syndrome (IBS) at Digestive Disease Week (DDW) 2010 in New Orleans, Louisiana.

28 Apr 2010

Phase II clinical trial to test safety and efficacy of transplanted encapsulated islets

The Juvenile Diabetes Research Foundation announced today that it is partnering with Living Cell Technologies, a New Zealand-based biotechnology company focused on developing cell based therapeutics, in a Phase II clinical trial to study the safety and effectiveness of transplanting encapsulated insulin-producing cells from pigs as a treatment for type 1 diabetes with significant hypoglycemia unawareness.

28 Apr 2010

Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB) under investigation for the treatment of hypertension. Discovered by Takeda, azilsartan medoxomil is designed to lower blood pressure by blocking the action of a vasopressor hormone, angiotensin II.

28 Apr 2010

Hospira reports net sales of $1.0 billion for first-quarter 2010

Hospira, Inc., a leading global specialty pharmaceutical and medication delivery company, today reported results for the first quarter ended March 31, 2010. Net sales for the quarter were $1.0 billion, and adjusted diluted earnings per share were $0.94.

28 Apr 2010

Life Technologies first-quarter non-GAAP 2010 revenue increases 13% to $887 million

Life Technologies Corporation today announced results for its first quarter ending March 31, 2010. Non-GAAP revenue for the first quarter was $887 million, an increase of 13 percent over the $785 million reported for the first quarter of 2009. Excluding the impact of currency and completed acquisitions and divestitures, organic revenue for the quarter grew 10 percent over the same period in the previous year.

28 Apr 2010

Hana Biosciences announces completion of Marqibo pre-NDA meeting with FDA

Hana Biosciences, a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the Company has completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL).

28 Apr 2010

Freedland Russo announces $520M settlement over Seroquel marketing practice lawsuit against AstraZeneca

Freedland Russo is pleased that Eric Holder, U.S. Attorney General, announced the $520 million dollar settlement of a lawsuit filed against AstraZeneca. The settlement announced today in Philadelphia indicates marketing practices for Seroquel included promotion of the drug by physicians participating in clinical studies and drug sales representatives encouraging doctors to prescribe for the unapproved uses.

28 Apr 2010

AMAG Pharmaceuticals reports Feraheme net product revenues of $13.1M for first-quarter 2010

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 first quarter ended March 31, 2010.

28 Apr 2010

Pharmaceuticals News and Research

Seasonal flu shots: Are they responsible for the adverse reactions? Investigations on

Positive results from interim analysis of ongoing Phase 2a study of BCX4208

Diamyd Medical to focus on completion of Diamyd Phase III studies and preparation for market launch

Takeda settles with six defendants in generic ACTOS, ACTOplus met patent infringement lawsuit

AHF applauds Merck for doubling Isentress discount rebates and freezing price for ADAPs

BiondVax announces successful conclusion of second Phase I/II trial of Multimeric-001 Universal Flu Vaccine

Trade negotiations between EU, India could affect access to low-cost generics

Diamyd Medical reports group net sales of MSEK 0.2 for second-quarter 2010

Shire receives Paragraph IV Notice Letter from Anchen over filing of ANDA for generic INTUNIV

Researchers receive $5.7M in funding to investigate new ways to treat uterine fibroids

Discovery Labs reports first-quarter results, updates on Surfaxin and key pipeline programs

AstraZeneca to pay $520 million in largest pharmaceutical civil settlement

Lexicon Pharmaceuticals to present Phase 2 study results of LX1031 for non-constipating IBS at DDW 2010

Phase II clinical trial to test safety and efficacy of transplanted encapsulated islets

Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

Hospira reports net sales of $1.0 billion for first-quarter 2010

Life Technologies first-quarter non-GAAP 2010 revenue increases 13% to $887 million

Hana Biosciences announces completion of Marqibo pre-NDA meeting with FDA

Freedland Russo announces $520M settlement over Seroquel marketing practice lawsuit against AstraZeneca

AMAG Pharmaceuticals reports Feraheme net product revenues of $13.1M for first-quarter 2010

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