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Merck's HIV drug receives preliminary European approval

American Pharmacy News Reports | Jun 2, 2017
Patients who weigh at least 88 pounds should take two of the tablets once a day.

Merck has received approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for ISENTRESS, a 600 mg. tablet coated in film and paired with other anti-retroviral prescriptions for those who have been diagnosed HIV-1. Read More »

FDA to review Aptiom for children who experience seizures

American Pharmacy News Reports | Jun 2, 2017
The FDA decision could come up with a decision as soon as Sept. 13 under the Prescription Drug User Fee Act.

The FDA says it is willing to look into and evaluate a drug that could help treat children who suffer from seizures. Read More »

Hematogenix included as Merck & Co. lab for FDA-approved PD-L1 companion

American Pharmacy News Reports | Jun 2, 2017
Hematogenix is a CAP/CLIA-certified laboratory.

Hematogenix Laboratory Services, a company that provides integrated pathology services for drug development, recently announced that that Merck & Co. Inc. has included it as one of the national reference laboratories for U.S. Food and Drug Administration (FDA)-approved PD-L1 companion diagnostic assay PD-L1 IHC 22C3 pharmDx for Keytruda. Read More »

Otsuka earns licensing rights in Japan for Teva's migraine drug

American Pharmacy News Reports | May 31, 2017
Preliminary results for fremanezumab in Phase IIb studies for both chronic and episodic migraines have been promising.

Otsuka Pharmaceutical has entered into a licensing agreement that gives it exclusive rights to develop and commercialize Teva Pharmaceutical Industries' migraine prevention drug fremanezumab in Japan. Read More »

Allergan completes $2.9 billion acquisition of LifeCell Corp.

American Pharmacy News Reports | May 31, 2017
Allergan acquired LifeCell's commercial portfolio, as well as its New-Jersey-based manufacturing capabilities and its R&D operations.

Allergan PLC, a global biopharmaceutical company, recently concluded its $2.9 billion acquisition of LifeCell Corp., a business that develops regenerative medicine. Read More »

Janssen Human Microbiome Institute enters new partnerships

American Pharmacy News Reports | May 31, 2017
The collaborations and investments will create critical new insights to address metabolic disorders.

Janssen Research & Development LLC has identified new partnerships through the company’s Janssen Human Microbiome Institute, a program that develops microbial products through innovation and discovery. Read More »

AM-Pharma concludes largest study ever for Acute Kidney Injury

American Pharmacy News Reports | May 30, 2017
The first portion of the test was completed using data from 131 patients, to determine the ideal dosage.

AM-Pharma B.V. has finished recruiting for its Phase II trial of treatment for individuals with Acute Kidney Injury. Read More »

FDA posts documents for Puma Biotech's briefing on PB272

American Pharmacy News Reports | May 30, 2017
The ODAC meeting covered PB272 (neratinib), which is an adjuvant treatment for HER2-positive early stage breast cancer.

Puma Biologics reports the U.S. Food and Drug Administration has posted the documents that were used for briefing at the Oncologic Drugs Advisory Committee (ODAC) May 24. Read More »

TapImmune completes successful multi-gram scale-up of TPIV 200

American Pharmacy News Reports | May 30, 2017
TapImmune will use this vaccine product for its ongoing Phase 2 study of TPIV.

TapImmune Inc. has completed a multi-gram scale-up and GMP manufacturing of a second clinical lot of TPIV 200, which is a multi-epitope T-cell vaccine developed by the company that targets the folate receptor alpha. Read More »

Electronic prescribing company DrFirst acquires VisibilityRx

American Pharmacy News Reports | May 30, 2017
With the acquisition, the 60,000 physician clients that use DrFirst can now more easily identify and refer patients to new clinical trials.

DrFirst, an electronic prescribing company, has acquired VisibilityRx, a provider of clinical trial recruitment services to life sciences, clinical research organizations and pharmacies. Read More »

Personal Genome Diagnostics receives contract from National Cancer Institute

American Pharmacy News Reports | May 27, 2017
The contract gives the company an opportunity to work with various pharmaceutical partners to develop the MutatorDETECT assay.

Personal Genome Diagnostics Inc. has received a National Cancer Institute contract to develop a novel diagnostic for helping identify patients who are most likely to benefit from cancer drugs called checkpoint inhibitors. Read More »

Mylan releases statement in response to Financial Times article

American Pharmacy News Reports | May 27, 2017
Mylan claimed that the author of the piece did not accurately analyze the ARV market.

Mylan N.V. recently released a statement in response to a Financial Times article entitled “HIV/Aids drug for developing world face threat of disruption.” Read More »

Abbott's RealTime Zika Test approved for use in U.S.

American Pharmacy News Reports | May 27, 2017
The test can distinguish Zika from other viruses such as dengue or chikungunya.

Abbott recently announced that its molecular test, the Abbott RealTime Zika Test, has been authorized by the U.S. Food and Drug Administration (FDA). Read More »

Glaukos Corp. stents prove cheaper than alternate treatments

American Pharmacy News Reports | May 27, 2017
The five-year cost for a two-stent operation was $4,420.

A new Glaukos Corporation study reveals that the cost of two iStent Trabecular Micro-Bypass Stents could cost lower cumulatively in five years compared to others like the selective laster trabeculoplasty (also known as the SLT) or topical glaucoma medication. Read More »

CVS Health's Foulkes tapped to chair Go Red For Women

Mark Iandolo | May 27, 2017
Helena Foulkes, president of CVS Pharmacy, has been named as the inaugural national chair for Go Red For Women.

CVS Health recently announced that it will sponsor the American Heart Association’s Go Red For Women movement and pledge to raise $10 million over the next three years to support research efforts. Read More »

NovellusDX receives patent for mutation identification method

American Pharmacy News Reports | May 27, 2017
Variants of Uncertain Significance may find more difficulty in receiving regular treatments.

NovellusDx has been given a new patent by the name of "Methods and Systems for Identifying Patient Specific Driver Mutations." Read More »

FDA approves first subcutaneous treatment for giant cell arteritis

American Pharmacy News Reports | May 27, 2017
A majority of the patients who received subcutaneous Actemra with regular prednisone regimens and a lower dosage did achieve the goal.

The U.S. Food and Drug Administration (FDA) has permitted the use of subcutaneous Actemra (tocilizumab) to assist adults who are receiving treatment for giant cell arteritis. Read More »

EMED Technologies' SCIg60 Infusion System attains FDA approval

American Pharmacy News Reports | May 26, 2017
EMED's is the first Immune Globulin Subcutaneous (Human) mechanical pump infusion system to be approved.

EMED Technologies Corp.'s SCIg60 Infusion System is the first Immune Globulin Subcutaneous (Human) mechanical pump infusion system to be approved by the U.S. Food and Drug Administration. Read More »

Lancet HIV publishes study linking drug criminalization to HIV's spread

American Pharmacy News Reports | May 26, 2017
The research was based on 106 global and peer-reviewed studies.

A recent publication by Lancet HIV found a link between the criminalization of drugs and the spread of HIV. Read More »

Bayer receives priority review for lymphoma drug

American Pharmacy News Reports | May 26, 2017
The data that was submitted with the application was from a Phase II open-label, single-arm CHRONOS-1 study.

The U.S. Food and Drug Administration has given Bayer a priority review for its New Drug Application for copanlisib, a drug to be used for relapses of refractory follicular lymphoma in individuals who have had a minimum of two therapies. Read More »

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