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FDA grants interim approval for Mylan’s TLD formulation

American Pharmacy News Reports | Aug 16, 2017
Mylan's TLD formulation is the first fixed-dose combination of its type to be distributed specifically for HIV/AIDS.

International pharmaceutical provider Mylan recently obtained what it called tentative approval of its New Drug Application for an antiretroviral formula to circulate as a preferred treatment for HIV/AIDS patients in developing nations. Read More »

NYU Langone Medical Center releases results from Alzheimer's study

American Pharmacy News Reports | Aug 16, 2017
Results of the trial were presented in London in July at the Alzheimer’s Association International Conference.

New York University Langone Medical Center has released results of an Alzheimer’s disease study that shows combining a specific care management program with commonly prescribed drugs multiplies the drug’s ability to improve daily function by roughly 7.5 times and stalls some of the disease’s effects. Read More »

Pharmacy association's executive director responds to DIR fee report

American Pharmacy News Reports | Aug 15, 2017
Sheila Arquette said the study is one of many in a long line paid for by pharmacy benefit managers.

National Association of Specialty Pharmacy Executive Director Sheila Arquette recently responded to a report on direct and indirect remuneration fees commissioned by the Pharmaceutical Care Management Association. Read More »

Moleculin Biotech comments on FDA approvals for AML drugs

American Pharmacy News Reports | Aug 15, 2017
Moleculin Biotech specializes in developing anti-cancer drug candidates.

Moleculin Biotech Inc. recently released comments regarding recent FDA approvals for new drugs that treat acute myeloid leukemia. Read More »

Radicava attains FDA approval for ALS treatment

American Pharmacy News Reports | Aug 15, 2017
Service care specialists are available to assist patients in finding the closest infusion facility.

Mitsubishi Tanabe Pharma America Inc. of New Jersey has reported that Radicava (edaravone), an intravenous therapy for adults with amyotrophic lateral sclerosis (ALS), is now available in the U.S. Read More »

Aimmune Therapeutics posits tentative peanut allergy answer

Carol Ostrow | Aug 15, 2017
t Aimmune’s investigational therapy targets an immune cell subset called TH2A cells — potentially desensitizing patients to the peanut allergy.

A trial treatment for peanut allergy has attracted attention in the media, with a recent Washington state publication highlighting California-based Aimmune Therapeutics Inc.’s “AR101” as a potential immunotherapy with the ability to impact allergen-specific T cells. Read More »

FDA approves Genentech’s Zelboraf for rare blood disease

American Pharmacy News Reports | Aug 15, 2017
Officials noted that the method is especially useful for work with rare diseases.

The U.S. Food and Drug Administration recently accepted Genentech’s supplemental New Drug Application for Zelboraf (vemurafenib) — including breakthrough therapy designation — to address a form of Erdheim-Chester disease, a rare blood disorder. Read More »

FDA approves Mavyret for hepatitis C virus

American Pharmacy News Reports | Aug 15, 2017
Previously, the course of hepatitis C virus therapy lasted at least 12 weeks.

The first eight-week medication cycle for chronic hepatitis C virus (HCV) recently earned approval from the U.S. Food and Drug Administration (FDA) in the form of Mavyret (glecaprevir and pibrentasvir), shortening treatment duration by one-third. Read More »

Impax Labs settles with parties on Opana ER rights

American Pharmacy News Reports | Aug 14, 2017
Impax Laboratories, Endo International and Penwest Pharmaceuticals recently revealed a mutual settlement agreement.

Resolving a contractual dispute dating to 2010 regarding three-way collaboration on Opana ER tablets — between Impax Laboratories, Endo International plc and Penwest Pharmaceuticals — Impax recently revealed a mutual settlement agreement from its Hayward, California hub. Read More »

Teva’s unique asthma inhaler gains FDA approval

American Pharmacy News Reports | Aug 14, 2017
Research has shown that approximately three-quarters of patients experience difficulty with MDI inhaler use.

An innovative new asthma treatment from Teva Pharmaceutical Industries Ltd. recently gained U.S. Food and Drug Administration approval, permitting the breath-activated inhaler to enter the market as a prophylactic maintenance medication. Read More »

CDC outlays over $200 million to curb contagious disease

Carol Ostrow | Aug 14, 2017
The 2017 investment will create a national laboratory for TB study.

Upping its game against certain candida, tuberculosis and gonorrhea strains, the U.S. Centers for Disease Control and Prevention recently allotted more than $200 million to help jurisdictions curtail both emerging and re-emerging infectious diseases. Read More »

Opiant obtains ‘Orange Book’ approval for Narcan Nasal Spray

American Pharmacy News Reports | Aug 14, 2017
Opiant’s formulation attained FDA approval in January.

Making progress in the fight against opioid abuse, California-based Opiant Pharmaceuticals Inc. recently obtained a U.S. patent for its 2mg formula of Narcan Nasal Spray and product inclusion in U.S. Food and Drug Administration’s listings. Read More »

Epclusa now approved to treat HCV/HIV co-infections

American Pharmacy News Reports | Aug 11, 2017
Gilead first received regulatory approval for Epclusa in June 2016.

Gilead Sciences Inc.'s updated labeling for Epclusa has been approved by the U.S. Food and Drug Administration. Read More »

Biothera Pharmaceuticals begins patient dosing for cancer study

American Pharmacy News Reports | Aug 11, 2017
The trial brings together a promising combination approach that may increase patient responses to Keytruda.

Biothera Pharmaceuticals Inc. recently announced that the patient dosing has begun in a Phase 1b/2 clinical study at the Big Ten Cancer Research Consortium to evaluate Biothera’s Imprime PGG in combination with the Merck anti-PD-1 therapy, Keytruda (pembrolizumab), in second-line non-small cell lung cancer. Read More »

Cidara Therapeutics publishes data from study of echinocandin as IAC treatment

American Pharmacy News Reports | Aug 11, 2017
Cidara undertook the study in part because of the current treatments’ 40 percent failure rate.

Cidara Therapeutics Inc., a biotechnology company with a focus on developing anti-infective immunotherapies, recently published data from a study analyzing its next-generation echinocandin agent as a comparison to the treatment for intra-abdominal candidiasis. Read More »

Thermo Fisher Scientific's new opioid treatment gains 501(k) clearance

Mark Iandolo | Aug 11, 2017
Buprenorphine can be a more practical and often more effective alternative to methadone in treating opioid addiction.

Thermo Fisher Scientific recently received U.S. Food and Drug Administation 510(k) clearance for the company’s new immunoassay for the specific detection of buprenorphine and its three major metabolites. Read More »

Novartis reports positive 5-year efficacy data from Cosentyx study

American Pharmacy News Reports | Aug 11, 2017
Cosentyx works by specifically inhibiting the IL-17A cytokine that plays a role in driving inflammation.

Novartis, an immunology and dermatology company, recently reported positive five-year efficacy and safety results for Cosentyx after completing a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis. Read More »

Amgen and Allergan submit biosimilar candidate for Herceptin

American Pharmacy News Reports | Aug 10, 2017
Allergan and Amgen are collaborating on four oncology biosimilars.

Amgen and Allergan submitted a Biologics License Application for ABP 980, a biosimilar candidate to Herceptin, to the U.S. Food and Drug Administration. Read More »

Pharmacy Times ranks highest for ad visibility and readership

American Pharmacy News Reports | Aug 10, 2017
Pharmacy Times’ departments work together to deliver content on the evolving pharmacy industry.

Pharmacy Times, the leading media resource for pharmacists and the pharmacy industry, ranked highest in ad visibility and highest in readership in the 2017 Kantar Media Pharmacy Readership study. Read More »

Neovac moves forward with dermatomyositis treatment

American Pharmacy News Reports | Aug 10, 2017
The trial will examine the immunogenicity, tolerability and biological and clinical efficacy of IFNalpha Kinoid.

Neovacs, a company focusing on immunotherapies that treat autoimmune diseases, recently announced its Investigation New Drug application for IFNalpha Kinoid was cleared by the U.S. Food and Drug Administration. Read More »

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