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Hi-Tech Pharmacal second quarter net sales increase 27% to 56,875,000

Hi-Tech Pharmacal Co., Inc. today reported results for the Company's fiscal second quarter ended October 31, 2011.

5 Dec 2011

Targacept commences two clinical studies of TC-5619 for schizophrenia and ADHD

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced the initiation of two clinical studies of TC-5619, a Phase 2b study evaluating the product candidate as a treatment for negative symptoms and cognitive dysfunction in schizophrenia and a Phase 2 study evaluating the product candidate in adults as a treatment for attention deficit/hyperactivity disorder (ADHD), inattentive-predominant.

5 Dec 2011

Zalicus commences Z160 Phase 1 clinical trial for pain

Zalicus Inc. a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced the initiation of a Phase 1 clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160 (formerly NMED-160), a novel oral N-type calcium channel blocker.

5 Dec 2011

Spectrum seeks FDA IND approval for SPI-014 to treat hyperphosphatemia

Spectrum Pharmaceuticals today announced that it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration for SPI-014 (previously referred to as RENAZORB), a second-generation lanthanum-based nanoparticle phosphate binding agent, that has the potential to treat hyperphosphatemia in patients with Stage 5 chronic kidney disease, or end-stage renal disease (ESRD).

5 Dec 2011

Novartis to showcase 160 presentations on breast cancer, hematological disease drugs at SABCS and ASH

Novartis Pharmaceuticals Corporation will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.

3 Dec 2011

State news: Mass. seeks Medicaid waiver extension; Calif. payment reform

The Employees Retirement System of Texas removed about 5 percent of those receiving state health benefits as dependents after they couldn't prove their rights to get the aid, the pension plan said in a report, citing an audit. Health care cost the $23.6 billion fund $2.29 billion in fiscal 2011.

3 Dec 2011

American Society of Hematology 2012 Scholar Awards announced

The American Society of Hematology (ASH) announces the recipients of its 2012 Scholar Awards. The ASH Scholar Awards provide monetary support for fellows and junior faculty pursuing research careers to assist them during the critical period in which they must complete their training and achieve status as an independent investigator.

3 Dec 2011

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Shire plc, the global specialty biopharmaceutical company, announces that it has reached an agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration to conduct additional clinical trials to confirm the clinical benefit of ProAmatine (midodrine HCl), a medicine approved in 1996 under Subpart H for the treatment of symptomatic orthostatic hypotension (SOH).

3 Dec 2011

Brazil's ANVISA grants registration for child-adapted formulation of benznidazole for Chagas disease

Today, at the occasion of the 4th DNDi Partners' Meeting in Rio de Janeiro, Brazil, Dr Carlos Gadelha, Secretary of Science, Technology and Strategic Products, Brazilian Ministry of Health, announced that Brazil's National Health Surveillance Agency (ANVISA) granted registration of a new paediatric dosage form of benznidazole, developed through a partnership between the Pernambuco State Pharmaceutical Laboratory (LAFEPE) of Brazil and the Drugs for Neglected Diseases initiative (DNDi).

3 Dec 2011

Pfizer acquires Excaliard

Pfizer Inc. announced today that it has completed its acquisition of Excaliard Pharmaceuticals, Inc., a privately owned biopharmaceutical company focused on developing novel drugs for the treatment of skin fibrosis, more commonly referred to as skin scarring.

3 Dec 2011

Bristol-Myers Squibb and Tibotec partner to evaluate daclatasvir-TMC435 combination for HCV

Bristol-Myers Squibb Company announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).

3 Dec 2011

Bristol-Myers Squibb, Tibotec partner for TMC435 Phase II combination study in HCV

Medivir AB, the research-based speciality pharmaceutical company focused on the development of high-value treatments for infectious diseases, announces that its development partner, Tibotec Pharmaceuticals, has entered into an agreement with Bristol-Myers Squibb Company.

2 Dec 2011

Mylan's NDA for Atazanavir Sulfate and Ritonavir Tablets receives tentative FDA approval through PEPFAR

Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Atazanavir Sulfate and Ritonavir Tablets, 300 mg/100 mg.

2 Dec 2011

DNDi highlights lack of healthcare coverage for children with HIV/AIDS

Less than one-quarter (23%) of children with HIV/AIDS who need treatment are getting it, according to a report released by the World Health Organization (WHO) on the occasion of World AIDS Day.

2 Dec 2011

Assembly Bill 5502-B would raise cost of many prescriptions in NY by 10%

Assembly Bill 5502-B—transmitted to Governor Andrew Cuomo yesterday—would needlessly raise the cost of many prescriptions in New York by 10 percent, according to the Pharmaceutical Care Management Association. If enacted, the Bill would prohibit consumers from getting discounted prescriptions through mail-service pharmacies.

2 Dec 2011

UA researchers receive NSF grant to develop terahertz spectral imager

Researchers at the University of Arizona College of Engineering have been awarded $530,000 to develop a unique piece of scientific equipment that will further spectral imaging research.

2 Dec 2011

The Lipitor story: Drug companies brace for losses as patents expire on this and other popular medications

News outlets analyze the impact that generic Lipitor could have on costs and the "era of 'blockbuster drugs'" as well as the strategies from Lipitor's maker to block its generic competitors. Meanwhile, some of these generics are already reaching the marketplace.

2 Dec 2011

Novelos prices underwritten public offering of $5,904,000 of common stock

Novelos Therapeutics, Inc., a pharmaceutical company developing novel drugs for treatment and diagnosis of cancer, today announced the pricing of an underwritten public offering of 9,840,000 units at $0.60 per unit for gross proceeds of $5,904,000.

2 Dec 2011

Arbor files first NDA with U.S. FDA

Arbor Pharmaceuticals announced today that it has filed its first New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The recently filed product has been granted an Orphan designation by the FDA which provides seven years of market exclusivity.

2 Dec 2011

Idera receives FDA notification to proceed with IMO-3100 Phase 2 clinical trial for psoriasis

Idera Pharmaceuticals, Inc. today announced the receipt of verbal notification from the Food and Drug Administration that the company may proceed with a Phase 2 clinical trial of IMO-3100 in patients with psoriasis based on a trial protocol submitted by the company in October 2011.

2 Dec 2011

Pharmaceuticals News and Research

Hi-Tech Pharmacal second quarter net sales increase 27% to 56,875,000

Targacept commences two clinical studies of TC-5619 for schizophrenia and ADHD

Zalicus commences Z160 Phase 1 clinical trial for pain

Spectrum seeks FDA IND approval for SPI-014 to treat hyperphosphatemia

Novartis to showcase 160 presentations on breast cancer, hematological disease drugs at SABCS and ASH

State news: Mass. seeks Medicaid waiver extension; Calif. payment reform

American Society of Hematology 2012 Scholar Awards announced

CDER, Shire enter agreement for ProAmatine clinical trial to treat symptomatic orthostatic hypotension

Brazil's ANVISA grants registration for child-adapted formulation of benznidazole for Chagas disease

Pfizer acquires Excaliard

Bristol-Myers Squibb and Tibotec partner to evaluate daclatasvir-TMC435 combination for HCV

Bristol-Myers Squibb, Tibotec partner for TMC435 Phase II combination study in HCV

Mylan's NDA for Atazanavir Sulfate and Ritonavir Tablets receives tentative FDA approval through PEPFAR

DNDi highlights lack of healthcare coverage for children with HIV/AIDS

Assembly Bill 5502-B would raise cost of many prescriptions in NY by 10%

UA researchers receive NSF grant to develop terahertz spectral imager

The Lipitor story: Drug companies brace for losses as patents expire on this and other popular medications

Novelos prices underwritten public offering of $5,904,000 of common stock

Arbor files first NDA with U.S. FDA

Idera receives FDA notification to proceed with IMO-3100 Phase 2 clinical trial for psoriasis

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