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Innovus Pharma seeks to release hemorrhoid pain relief cream in Canada

American Pharmacy News Reports | Aug 7, 2017
The drug is a

Innovus Pharmaceuticals Inc., an expanding commercial-stage medication company that provides over-the-counter products for both men and women, will be filing a product licence application in Canada for its drug, Xyralid. Read More »

LabCorp to acquire Chiltern in $1.2 billion cash deal

American Pharmacy News Reports | Aug 7, 2017
Chiltern expects 2017 revenue of approximately $550 million.

LabCorp, a provider of diagnostic solutions and breakthrough medicines, recently announced plans for its all-cash acquisition of international contract research firm Chiltern of England for approximately $1.2 billion, enhancing LabCorp’s portfolio and capabilities. Read More »

Insys Therapeutics rolls out ‘milestone’ Syndros formula

American Pharmacy News Reports | Aug 6, 2017
Dronabinol is a pharmaceutical cannabinoid.

Phoenix-based Insys Therapeutics Inc. recently revealed that its new branded liquid formulation Syndros (dronabinol oral solution) is on the market to address side effects of AIDS and chemotherapy such as weight loss and related symptoms. Read More »

FDA plans to curb tobacco deaths with new regulation

American Pharmacy News Reports | Aug 6, 2017
Ninety percent of adult smokers began the habit before the age of 18.

The U.S. Food and Drug Administration is creating new regulation on tobacco and nicotine to reduce diseases and death brought on by tobacco use. Read More »

Eagle Pharmaceuticals receives FDA reply for Ryanodex

American Pharmacy News Reports | Aug 6, 2017
The FDA has asked Eagle to perform another clinical trial for Ryanodex as it pertains to treating EHS in tandem with external cooling treatments.

In answer to New Jersey-based Eagle Pharmaceuticals Inc.’s New Drug Application (NDA) for Ryanodex (dantrolene sodium) to treat exertional heat stroke (EHS), the U.S. Food and Drug Administration (FDA) recently issued a Complete Response Letter. Read More »

Biologics named limited distributor of Nerlynx

American Pharmacy News Reports | Aug 6, 2017
Biologics uses a “high-touch care model” emphasizing a team approach to the patient’s experience.

Los Angeles-based Puma Biotechnology Inc.’s FDA-approved Nerlynx (neratinib) tablets — a kinase inhibitor developed to treat breast cancer — will be circulated by Cary, North Carolina’s Biologics Inc. as per a limited distribution agreement between the companies. Read More »

Teligent's topical erythromycin gel receives FDA approval

American Pharmacy News Reports | Aug 6, 2017
Teligent now has 19 topical generic pharmaceutical products in the U.S.

New Jersey-based specialty generic pharmaceutical manufacturing firm Teligent recently obtained U.S. Food and Drug Administration approval — its third in 2017 — for its Abbreviated New Drug Application (ANDA) regarding its Erythromycin ​​​​​Topical Gel USP, 2%. Read More »

Vizient releases Drug Price Forecast for 2018

Mark Iandolo | Aug 6, 2017
Health systems should see a 7.61 percent average increase in price on pharmaceutical purchases in 2018.

Vizient Inc. recently released its July 2017 Drug Price Forecast, which provides pharmacy leaders and health system executives with insights on pricing and practice changes throughout the pharmaceutical industry. Read More »

EnvisionRx receives renewed accreditation from URAC

American Pharmacy News Reports | Aug 4, 2017
EnvisionRx has URAC accreditation for drug therapy management.

EnvisionRx, a pharmacy benefit manager (PBM) and division of EnvisionRxOptions, a wholly owned subsidiary of Rite Aid Corporation, recently announced that the health care accrediting organization URAC renewed the company’s accreditation for pharmacy benefit management. Read More »

Gilteritinib gains orphan-drug status to combat AML

American Pharmacy News Reports | Aug 4, 2017
Gilteritinib works by inhibiting certain receptors involved in cancer cell growth.

Because acute myeloid leukemia (AML) impacts relatively few individuals nationwide, gilteritinib — an anti-cancer medication developed by Tokyo-based Astellas Pharma Inc. — recently attained orphan-drug designation from the U.S. Food and Drug Administration. Read More »

Pfizer's Avastin biosimilar meets primary endpoint in study

American Pharmacy News Reports | Aug 4, 2017
PF-06439535, which Pfizer is developing as a potential biosimilar to Avastin, met its primary objective.

Pfizer Inc. recently announced positive results for its Reflections B7391003 study, which evaluated the safety and efficacy of PF-06439535 as compared to Avastin (bevacizumab). Read More »

Eisai's supplemental application for Fycompa CIII accepted

American Pharmacy News Reports | Aug 3, 2017
After first being approved for adjunctive use in POS in 2012, Fycompa went on to receive approval in 55 countries.

Eisai Inc.'s supplemental New Drug Application for Fycompa CIII has been accepted by the U.S. Food and Drug Administration. Read More »

Thermo Fisher adds mini implant line to its drug implant development line

American Pharmacy News Reports | Aug 3, 2017
Pharmaceutical manufacturers are seeking fast, reliable solutions for continuous production of novel drug delivery systems.

Thermo Fisher Scientific Inc. recently announced the availability of a fully integrated solution for polymer-based drug implant development and production using hot melt extrusion (HME). Read More »

Lexicon and Ipsen's MAA for Xermelo given positive opinion by CHMP

American Pharmacy News Reports | Aug 3, 2017
The European Commission will now make a final decision on whether to approve the MAA for the drug.

Lexicon Pharmaceuticals Inc.'s Xermelo, a carcinoid syndrome diarrhea treatment created in collaboration with Ipsen, has been given a positive opinion for Marketing Authorization Application by the Committee for Medicinal Products for Human Use, the committee of the European Medicines Agency responsible for human medicines. Read More »

Merck launches Renflexis as biosimilar with FDA consent

American Pharmacy News Reports | Aug 3, 2017
Renflexis is a tumor necrosis factor (TNF) blocker and is indicated for the treatment of several digestive and autoimmune disorders.

New Jersey-based Merck recently introduced Renflexis (infliximab-abda) in the United States as a biosimilar of Remicade (infliximab) following its FDA approval last April for all eligible indications. Read More »

Accord acquires rights to sell Custodiol HTK Solution

American Pharmacy News Reports | Aug 3, 2017
The acquisition gives Accord the rights to sell Custodiol HTK Solution.

Accord Healthcare has acquired Essential Pharmaceuticals, a New Jersey company that provides products, services and contributions to transplant medicine. Read More »

European agency approves Tocagen's treatment for high grade glioma

American Pharmacy News Reports | Aug 3, 2017
HGG is a common form of brain cancer that is highly aggressive.

Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, recently announced that its Toca 511 was awarded PRIME designation by the European Medicines Agency for treating high grade glioma patients. Read More »

Health Canada to review Sunovion's schizophrenia treatment

American Pharmacy News Reports | Jul 31, 2017
Schizophrenia is a critical, often disabling brain disorder.

Sunovion Pharmaceuticals Inc. of Marlborough, Massachusetts recently gained approval for its supplemental new drug submission regarding Latuda (lurasidone HCI) — aimed at relieving adolescent schizophrenia — from Health Canada, potentially extending the treatment’s age range. Read More »

Luminex Corp.'s c. difficile assay attains FDA clearance

American Pharmacy News Reports | Jul 31, 2017
C. difficile is an urgent threat as it is now the most common microbial cause of health care-associated infections in U.S. hospitals.

Luminex Corporation recently announced that its ARIES clostridium difficile (c. difficile) assay has been given U.S. Food and Drug Administration (FDA) clearance. Read More »

Chinese officials accept study application for GBM treatment

American Pharmacy News Reports | Jul 31, 2017
The company will begin enrollment for the trial in the next few weeks at Sun Yat-sen University Cancer Center.

DelMar Pharmaceuticals' application for a Phase II study evaluating a treatment for newly diagnosed MGMT-unmethylated glioblastoma multiforme has been accepted by the Human Genetic Resources Administration of China. Read More »

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