PHARMACIST CURRENTS NEWS

10/9/18 - Adamas Presents Final Results from the Two-Year, Phase 3 Open-Label Study of GOCOVRI in Parkinsons Disease Patients with Dyskinesia [Sudan Tribune]
-Adamas Pharmaceuticals, Inc., a fully integrated pharmaceutical company pioneering time-dependent medicines for central nervous system disorders, today announced the presentation of final results from EASE LID 2, the companys two-year Phase 3 open-label study of GOCOVRI extended release capsules, the first and only medicine approved by the U.S. Fo
10/9/18 - Bayer to Showcase Latest Oncology Research at ESMO 2018 Congress
Bayer will present new data from the company's growing oncology portfolio at the ESMO 2018 Congress taking place October 19-23 in Munich, Germany. Larotrectinib is currently under review by the U.S. Food and Drug Administration and the European Medicines Agency, with additional filings in other countries underway or being planned. "We look forwa
10/9/18 - Dr. Reddy's Laboratories announces the launch of Colesevelam Hydrochloride Tablets in the U.S. Market
HYDERABAD, India& PRINCETON, N.J. Dr. Reddy s Laboratories Ltd. today announced that it has launched Colesevelam HCl Tablets, USP, a therapeutic equivalent generic version of WELCHOL Tablets in the United States market approved by the U.S. Food and Drug Administration. The WELCHOL brand and generic had U.S. sales of approximately $471 millio
10/9/18 - Drug and Gene Delivery Systems Market to Reach US$ 917 Bn by 2025 [ClickPress (UK)]
Drug and Gene Delivery Systems Market: Snapshot. Drug delivery includes formulations, technologies, methods, and systems used for transferring an active pharmaceutical ingredient into the body as desired, in order to safely accomplish its therapeutic effect. The global drug and gene delivery systems market was valued at approximately US$ 512 Bn in
10/9/18 - FDA guides drugmakers on generic versions applied to skin
The U.S. Food and Drug Administration has released a series of documents to aid in the development of generic copies of complex drugs applied to a patient's skin. Scott Gottlieb, the FDA commissioner, said in a press release. Also, the FDA is also issuing 25 product-specific guidance documents that include two new and 23 revised guidances that will
10/9/18 - Global Implantable Drug Infusion Pumps Market Forecast to 2025 : Johnson & Johnson, Medtronic, Baxter International, Smiths Med
Albany, NY 10/08/2018 This report studies the global market size of Implantable Drug Infusion Pumps in key regions like North America, Europe, Asia Pacific, Central& South America and Middle East& Africa, focuses on the consumption of Implantable Drug Infusion Pumps in these regions. This research report categorizes the global Implantable Dru
10/9/18 - National Comprehensive Cancer Network Adds Verastem Oncology's COPIKTRA? (duvelisib) Capsules to Clinical Practice Guidelines in Oncology for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Verastem, Inc., focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the National Comprehensive Cancer Network added COPIKTRA? capsules to the Clinical Practice Guidelines in Oncology for chronic lymphocytic leukemia/small lymphocytic lymphoma.
10/9/18 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
As part of the U.S. Food and Drug Administration's efforts to promote drug competition and patient access, we've advanced many policies aimed at making it more efficient to bring generic competition to the market. We have been especially focused on a category of medicines known as complex drugs. These are drugs that, by nature of their formulatio
10/8/18 - Adamas Presents Final Results from the Two-Year, Phase 3 Open-Label Study of GOCOVRI? in Parkinson's Disease Patients with Dyskinesia
Adamas Pharmaceuticals, Inc., a fully integrated pharmaceutical company pioneering time-dependent medicines for central nervous system disorders, today announced the presentation of final results from EASE LID 2, the company s two-year Phase 3 open-label study of GOCOVRI? extended release capsules, the first and only medicine approved by the
10/8/18 - ANI Pharmaceuticals Announces Launch of Authorized Generic of Atacand HCT Tablets
BAUDETTE- ANI Pharmaceuticals, Inc. today announced the launch of Candesartan Hydrochlorothiazide Tablets, 16 mg/12. 5 mg, 32 mg/12. 5 mg, and 32 mg/25mg, an authorized generic of Atacand HCT. The current annual U.S. market for this product is approximately $20 million, according to Iqvia/IMS Health. ANI Pharmaceuticals, Inc. is an integrated speci
10/8/18 - Dr. Greg Grillo of Grillo Robeck Dental Files a Petition with the Food and Drug Administration Requesting Regulation of Dangerously Acidic Oral Moisturizers
Greg Grillo recently filed a petition with the Food and Drug Administration requesting to regulate the manufacturing of dangerously acidic oral moisturizers currently sold over the counter in the US. The recent studies prompted Dr. Grillo to initiate the petition aimed at increasing awareness of the troubling issue. In addition to the FDA filing, D
10/8/18 - Global Drug Delivery Systems Market Size and Forecast 2018-2025: Novartis, Amgen, Roche, Pfizer, Johnson & Joh
The study objectives are to present the Drug Delivery Systems development in United States, Europe and China. The key players covered in this study- Novartis- Amgen- Roche- Pfizer- Johnson& Johnson- Becton Dickinson- AstraZeneca- Baxter- Bayer- Boston Scientific. The study objectives of this report are:- To analyze global Drug Delivery Systems stat
10/8/18 - Health and Human Services Department; Food and Drug Administration (F.R. Page 47923) - Meeting
EVENT: Health and Human Services Department; Food and Drug Administration holds a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the efficacy, safety, and risk-benefit profile of new drug application 210417 for buprenorphine and samidorphan sublingual tablets,.
10/8/18 - Injection Devices for Biological Drugs
Biological drugs as a class continue to outpace all other NCEs in development pipelines and clinical trials. Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by patients who may have limitations directly related to their...
10/8/18 - National Comprehensive Cancer Network Adds Verastem Oncology's COPIKTRA? (duvelisib) Capsules to Clinical Practice Guidelines in Oncology
Verastem, Inc., focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the National Comprehensive Cancer Network added COPIKTRA? capsules to the Clinical Practice Guidelines in Oncology for follicular lymphoma. The U.S. Food and Drug Administration granted accele
10/8/18 - Novartis announces FDA filing acceptance of siponimod (BAF312), the first and only oral drug shown to delay disability progression in typical SPMS patients
Novartis today announced that the US Food and Drug Administration has accepted the company's New Drug Application for investigational oral, once-daily siponimod for the treatment of secondary progressive multiple sclerosis in adults. This phase of multiple sclerosis can substantially impact lives, due to vision impairment, fatigue, dependence on.
10/8/18 - Novitium Pharma Launches Prazosin Hydrochloride Capsules USP
Novitium Pharma LLC today announced that it has received U.S. Food and Drug Administration approval on its Abbreviated New Drug Application for Prazosin Hydrochloride Capsules USP 1 mg, 2 mg, and 5 mg, and has immediately initiated commercialization activities. Prazosin Hydrochloride USP is a therapeutic equivalent to the reference listed drug Mi
10/8/18 - Ocular Drug Delivery Technology Market to be Worth US$ 18.124 Bn by 2025 [ClickPress (UK)]
Global Ocular Drug Delivery Technology Market: Overview. The top three players in the global ocular drug delivery technology market hold more than 50.0% share in it. This makes the competitive landscape consolidated.
10/8/18 - Theravance Biopharma Reports Positive New Data from Multiple Studies of VIBATIV (telavancin) at IDWeek? 2018
Theravance Biopharma, Inc. today announced that positive new data from multiple studies of VIBATIV were presented at IDWeek? 2018, which was held in San Francisco, CA, on October 3 7, 2018. Two presentations were made reporting new data from the ongoing Telavancin Observational Use Registry study, which is designed to report how VIBATIV
10/8/18 - West Highlights Integrated Solutions Offering and Related Technical and Regulatory Expertise at Upcoming Industry Events
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, today announced that it will introduce a new Integrated Solutions Program to help to reduce risk, mitigate regulatory complexity and simplify the journey from molecule to market for pharmaceutical partners at the PDA Universe of Prefill
10/6/18 - Verastem Oncology Announces Publication of the Phase 3 DUO Study Results in the Journal Blood [Tehran Times (Iran)]
Verastem, Inc., focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the results of the Phase 3 DUO study, which evaluated COPIKTRA capsules versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, was publis
10/5/18 - "Device For Releasing A Pharmaceutical Onto The Skin Of A Patient" in Patent Application Approval Process (USPTO 20180264242)
By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors HOFFMAN, Andrew; KIRBY, Martin; GRAY, Aaron; WALKER, Doug; BROMAN, Craig; BISSELL, Derek, filed on February 2, 2018, was made available online on September 20, 2018, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This
10/5/18 - 2-Day Conference: Inhaled Drug Delivery London, United Kingdom - November 1-2, 2018 - ResearchAndMarkets.com
By a News Reporter-Staff News Editor at Drug Week The "Inhaled Drug Delivery" conference has been added to ResearchAndMarkets.com' s offering. Inhaled drug delivery is achieved using four principle technologies, dry powder inhalers, metered dose inhalers, nebulizers and liquid inhalers. The future European and UK regulatory processes following Br
10/5/18 - Breckenridge Announces Final Approval of its ANDA for Roflumilast Tablets (Daliresp)
Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Roflumilast Tablets, 500 mcg, generic for Daliresp Tablets by AstraZeneca Pharmaceutical LP. Breckenridge's Roflumilast Tablets product was developed by Ferrer Internacional, S.A..
10/5/18 - Clinical trial of Inofer has started
The clinical study for the iron tablets Inofer, which Drugsson AB has the rights for in Sweden, Norway, Denmark and Finland has now begun. A clinical trial of Inofer was approved, as previously reported, by the Swedish Medical Products Agency and the Ethical Vetting Board on June 20th and yesterday, 4th of September, the first patient received trea