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Par Pharmaceutical starts shipping generic version of Exforge

Par Pharmaceutical Companies, Inc. today announced that it has begun shipping all four strengths of amlodipine and valsartan tablets, the generic version of Novartis' Exforge. Par received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for amlodipine and valsartan and was granted 180 days of marketing exclusivity.

30 Sep 2014

AAN releases new position statement on opioids for chronic non-cancer pain

According to a new position statement from the American Academy of Neurology, the risk of death, overdose, addiction or serious side effects with prescription opioids outweigh the benefits in chronic, non-cancer conditions such as headache, fibromyalgia and chronic low back pain.

30 Sep 2014

Mitnick Law Office files motion for declaratory judgment related to hemp-based CBD products

Mitnick Law Office has filed a motion for declaratory judgment in the Superior Court of New Jersey, asking the Court to declare that hemp-derived CBD products are legal to possess and to be sold in the State of New Jersey and should not be considered marijuana.

30 Sep 2014

Seven NIH research contracts awarded to identify novel adjuvant candidates

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has awarded seven research contracts to discover and characterize new adjuvants, or substances formulated as part of vaccines to enhance their protective ability.

30 Sep 2014

Baxter to establish new innovation and R&D center in Cambridge, MA

BioMed Realty Trust, Inc. (NYSE: BMR) announced today the signing of a new lease for approximately 200,000 square feet for 12 years with Baxter Healthcare Corporation, a subsidiary of Baxter International Inc., at 650 East Kendall Street in Cambridge, Massachusetts, which is owned by BioMed Realty through a joint venture with Prudential Real Estate Investors.

From Baxter International Inc. 30 Sep 2014

Apexus secures HRSA contract, continues to serve as prime vendor of 340B Drug Pricing Program

Apexus, LLC, the prime vendor for the 340B Drug Pricing Program, has announced that it has been selected by the Health Resources and Services Administration (HRSA) to continue serving in its role as the prime vendor through September 29, 2019.

30 Sep 2014

Teva Canada recalls Biomedic Acetaminophen with Codeine owing to missing child-resistant packaging

Teva Canada Limited, in consultation with Health Canada, is recalling one lot (#669745) of Biomedic Acetaminophen with Codeine (30 caplets with 300 mg acetaminophen and 8 mg codeine) due to missing child-resistant packaging.

30 Sep 2014

Guerbet wins Drug Shortage Assistance Award from FDA

Guerbet, a pioneer in the field of contrast agents for medical imaging, has received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration for its assistance in preventing or alleviating a drug shortage.

29 Sep 2014

Protein Sciences releases Flublok influenza vaccine for the 2014/2015 season

Protein Sciences Corporation, manufacturer of the revolutionary Flublok influenza vaccine, announced today that doses of the vaccine have been released and are now available for shipment.

29 Sep 2014

FDA grants multiple Orphan Drug Designations for CytRx's aldoxorubicin

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced that the U.S. Food and Drug Administration has granted multiple Orphan Drug Designations for the Company's lead drug candidate, aldoxorubicin, in three indications: glioblastoma multiforme (GBM), small cell lung cancer and ovarian cancer.

29 Sep 2014

Study correlates HPV vaccine series completion among young US women

According to a recent study in the journal Human Vaccines & Immunotherapeutics, only 60% of young US women who received the first dose of the human papilloma virus (HPV) vaccine went on to complete the three-dose vaccine series.

29 Sep 2014

NJHF awards grant to help launch drug discovery facility at Rutgers University

In its continuing effort to advance the biomedical sciences, New Jersey Health Foundation has awarded a pivotal $35,000 grant to the Office of Translational Sciences at Rutgers, The State University of New Jersey, to help launch a Fragment Based Drug Discovery (FBDD) core facility.

29 Sep 2014

Alimera announces FDA approval of ILUVIEN for treatment of diabetic macular edema

Alimera Sciences, Inc., a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the U.S. Food and Drug Administration has approved ILUVIEN for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP).

27 Sep 2014

Researchers develop new strategy for reducing serious side effects of modern anticancer drugs

An interdisciplinary team of researchers from the University of Vienna (Institute of Inorganic Chemistry) and the Medical University of Vienna (Institute for Cancer Research) has successfully developed a new strategy for reducing the often serious side effects of an important class of modern anticancer drugs (tyrosine kinase inhibitors).

26 Sep 2014

AcelRx plans for resubmission of Zalviso NDA

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today provided an update on the plans for the resubmission of the Company's New Drug Application (NDA) for Zalviso (sufentanil sublingual tablet system).

26 Sep 2014

Access to potentially life-extending cancer drugs varies worldwide

Access to potentially life-extending cancer drugs varies significantly in different regions of the world, two new studies show at the ESMO 2014 Congress in Madrid, Spain.

26 Sep 2014

International organizations join forces to develop inhaled form of oxytocin for postpartum hemorrhage

An international group of public and private organizations is collaborating to accelerate development of an innovative heat-stable and low-cost inhaled form of oxytocin to manage postpartum hemorrhage in resource-poor settings.

26 Sep 2014

Sumitomo Dainippon Pharma, SanBio to jointly develop SB623 in the U.S. and Canada

Sumitomo Dainippon Pharma Co., Ltd. and SanBio Co., Ltd., acting through its U.S. subsidiary SanBio, Inc., announced on September 26 that the two companies have entered into a joint development and license agreement for exclusive marketing rights in the U.S. and Canada ("Agreement") for SB623, a cell therapy for the treatment of patients with chronic stroke discovered and currently under development by SanBio.

26 Sep 2014

IGI Laboratories acquires regulatory rights for 18 drug products from AstraZeneca

IGI Laboratories, Inc., a New Jersey based specialty generic pharmaceutical company, today announced it has acquired the regulatory rights and related documents and records for 18 drug products from AstraZeneca, 17 of which were marketed.

25 Sep 2014

CorMedix submits IND application to FDA for Neutrolin

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, is pleased to announce that an Investigational New Drug application (IND) for Neutrolin was submitted to the United States Food and Drug Administration on Wednesday, September 24, 2014.

25 Sep 2014

Pharmaceutical News

Par Pharmaceutical starts shipping generic version of Exforge

AAN releases new position statement on opioids for chronic non-cancer pain

Mitnick Law Office files motion for declaratory judgment related to hemp-based CBD products

Seven NIH research contracts awarded to identify novel adjuvant candidates

Baxter to establish new innovation and R&D center in Cambridge, MA

Apexus secures HRSA contract, continues to serve as prime vendor of 340B Drug Pricing Program

Teva Canada recalls Biomedic Acetaminophen with Codeine owing to missing child-resistant packaging

Guerbet wins Drug Shortage Assistance Award from FDA

Protein Sciences releases Flublok influenza vaccine for the 2014/2015 season

FDA grants multiple Orphan Drug Designations for CytRx's aldoxorubicin

Study correlates HPV vaccine series completion among young US women

NJHF awards grant to help launch drug discovery facility at Rutgers University

Alimera announces FDA approval of ILUVIEN for treatment of diabetic macular edema

Researchers develop new strategy for reducing serious side effects of modern anticancer drugs

AcelRx plans for resubmission of Zalviso NDA

Access to potentially life-extending cancer drugs varies worldwide

International organizations join forces to develop inhaled form of oxytocin for postpartum hemorrhage

Sumitomo Dainippon Pharma, SanBio to jointly develop SB623 in the U.S. and Canada

IGI Laboratories acquires regulatory rights for 18 drug products from AstraZeneca

CorMedix submits IND application to FDA for Neutrolin

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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