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 The leading web portal for pharmacy resources, news, education and careers October 20, 2017
Pharmacy Choice - News - Pharmaceutical Industry Trends and Policy - October 20, 2017

Pharmacy News

 Pharmaceutical Industry Trends and Policy
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10/13/17 - FDA panel unanimously endorses Spark's gene therapy for rare blindness pioneered at CHOP [Philly.com]
In a unanimous vote, a U.S. Food and Drug Administration committee recommended approval of Philadelphia drugmaker Spark Therapeutics' first-ever gene therapy for a genetic disease in the United States. If the FDA accepts the recommendation, which is considered likely, the treatment developed by Spark and researchers at Children's Hospital of Philad
10/13/17 - Optinose Announces Pricing of Initial Public Offering
OptiNose, Inc., a specialty pharmaceutical company focused on the development and commercialization of products for patients treated by ear, nose and throat and allergy specialists, today announced the pricing of its initial public offering of 7,500,000 shares of common stock at a public offering price of $16.00 per share, before underwriting dis
10/12/17 - 33 Stocks Moving In Thursday's Mid-Day Session
Infinity Pharma reported an IPI-549 late-breaking presentation at the 2017 Society for Immunotherapy of Cancer Annual Meeting. Ardelyx Inc shares surged 43.5 percent to $7.75 after the company disclosed that its pivotal Phase 3 study of tenapanor hit primary and all secondary endpoints. Polar Power Inc shares gained 16.6 percent to $6.19 as the com
10/12/17 - AbbVie and Turnstone Biologics Announce Global Collaboration on Viral Immunotherapies in Oncology
Release date- 11102017- NORTH CHICAGO, Ill. and OTTAWA, Ontario and NEW YORK- AbbVie, a global biopharmaceutical company, and Turnstone Biologics, a clinical stage immunooncology company, today announced a research, option and license agreement whereby AbbVie obtained an exclusive option to license up to three of Turnstone's next-generation oncolyt
10/12/17 - Access to medicines
As per the statistics shared by the World Health Organisation, some 28 million people in low-middle income countries die from non-communicable diseases every year. According to WHO, more than 74 percent deaths in LMICs are caused by non-communicable diseases, while in Pakistan, over 52% males and 53% females under the age of 70 die of NCDs every ye
10/12/17 - ACELRX PHARMACEUTICALS INC FILES (8-K) Disclosing Results of Operations and Financial Condition, Other Events, Financial Statements and Exhibits
On October 12, 2017, AcelRx Pharmaceuticals, Inc. issued a press release that disclosed that the Company's estimated cash balance as of September 30, 2017 was $67.9 million. On October 12, 2017, the Company issued a press release entitled "AcelRx Pharmaceuticals Receives Complete Response Letter from the FDA for DSUVIA? NDA," a copy of which is a
10/12/17 - AcelRx Pharmaceuticals Receives Complete Response Letter from the FDA for DSUVIA? NDA
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for DSUVIA?, 30 mcg. The CRL states that the FDA determined it cannot approve the NDA in its present form and provides recommendations needed
10/12/17 - ACUITYADS RECEIVES ORDER VALUED AT $750,000 FROM A GLOBAL PHARMACEUTICAL COMPANY AND IS RECOGNIZED AS ONE OF CANADA'S FASTEST GROWING COMPANIES
Release date- 11102017- TORONTO, ON; NEW YORK, NY- TORONTO and NEW YORK- AcuityAds Holdings Inc., a technology leader that provides targeted digital media solutions enabling advertisers to connect intelligently with audiences across video, mobile, social and online display campaigns, today announced that it received an order from a global pharmaceu
10/12/17 - ADMA BIOLOGICS, INC. (NASDAQ:ADMA) Files An 8-K Entry into a Material Definitive Agreement
ADMA BIOLOGICS, INC. (NASDAQ:ADMA) Files An 8-K Entry into a Material Definitive AgreementItem 1.01 Entry into a Material Definitive Agreement. Overview On October 10, 2017 (the Closing Date), ADMA Biologics, Inc. (the Company) entered into a Credit Agreement (the Credit Agreement) with ADMA Plasma Biologics, Inc. (ADMA Plasma
10/12/17 - AG Schimel Reaches Settlement Agreement With Manufacturer of EpiPen(R)
Attorney General Brad Schimel announced today that Wisconsin has joined 49 states and the District of Columbia in settling allegations against Mylan Inc. and its wholly-owned subsidiary, Mylan Specialty L.P.. Pursuant to a settlement Mylan entered with the United States in August, Mylan was to pay up to $465 million to the United States and the Sta
10/12/17 - Akari Therapeutics Announces Further Clinical Progress [Tehran Times (Iran)]
-Akari Therapeutics, Plc, a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically the complement system, the eicosanoid system and the bioamine system for the treatment of rare and orphan diseases, announces that three additional patients have been enrolled in the ongoing Phase II COBALT clinical
10/12/17 - Allergan Announces Settlement on RESTASIS (Cyclosporine Ophthalmic Emulsion) 0.05% Patent Litigation with InnoPharma, Inc.
Allergan plc, a leading global pharmaceutical company, and its subsidiaries today announced that the Company has reached an agreement with InnoPharma Inc. resolving patent litigation regarding United States Patent Nos. 8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930 and 9,248,191 covering RESTASIS 0.05%. Pursuant to the terms of the sett
10/12/17 - Allergan Announces that the FDA Accepts New Drug Application for Ulipristal Acetate for Uterine Fibroids
Release date- 11102017- DUBLIN- Allergan plc today announced that the U.S. Food and Drug Administration has accepted the New Drug Application for ulipristal acetate, an investigational drug for the treatment of abnormal uterine bleeding in women with uterine fibroids. 'Women with symptomatic uterine fibroids may suffer from physical and emotional..
10/12/17 - Allergy Immunotherapy Market Trends, Size, Growth, Opportunities and 2021 Forecast Report Available at MarketReportsOnline
PUNE, India, Oct. 12, 2017/ PRNewswire-iReach/ This latest report titled "Global Allergy Immunotherapy Market", provides an in-depth analysis of the global allergy immunotherapy market by value, by methods of administration, by region, etc. The report provides a regional analysis of the allergy immunotherapy market, including the following region
10/12/17 - Allergy Immunotherapy Market: Strong Expansion USD 4,324.7 Million by 2023, at 10.85 % of CAGR: Confirms MRFR
Allergy Immunotherapy market Analysis, By Key Companies- by treatment, by allergy type- global forecast till 2023 Pune, India 10/11/2017 Market Research Future published a research report on "Global Allergy Immunotherapy Market Research Report Forecast to 2023" Market Analysis, Scope, Stake, Progress, Trends and Forecast to 2023. According
10/12/17 - Alzheon to Make Presentations on ALZ-801 and Its Anti-Oligomer Mechanism at the 10th Clinical Trials on Alzheimer's Disease Congress
Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for patients suffering from Alzheimer s disease and other neurological and psychiatric disorders, today announced that the company will be making three presentations at the 10th Annual Clinical Trials on Alzheimer s Disease congress to be held on Nov
10/12/17 - Amgen Wins Reprieve on Its 2nd-Best-Selling Drug [Arab News (Saudi Arabia)]
That may mean it`s only a matter of time before generic drug companies, including Mylan, win FDA approval of biosimilar copycats. Last year, Novartis received an FDA rejection for its Neulasta biosimilar, which prompted it to withdraw its application for approval in Europe earlier this year. Today, Mylan became the latest upstart to stumble at the
10/12/17 - ANSM grants authorisation for phase I/II clinical study for retinitis pigmentosa [Arab News (Saudi Arabia)]
A French biotech company based in Paris and Nantes, which specialises in gene therapy for the treatment of rare, inherited retinal diseases, has announced that it has been authorised by the French National Agency for Medicines and Health Products Safety to launch a Phase I/II clinical trial for HORA-PDE6B, in the treatment of a retinitis pigmentosa
10/12/17 - ANTARES PHARMA, INC. (NASDAQ:ATRS) Files An 8-K Financial Statements and Exhibits
ANTARES PHARMA, INC. (NASDAQ:ATRS) Files An 8-K Financial Statements and ExhibitsItem 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit Index ANTARES PHARMA, INC. ExhibitEX-99.1 2 atrs-ex991-6.htm EX-99.1 PRESS RELEASE DATED OCTOBER 12,?To view the full exhibit click here About ANTARES PHARMA, INC. (NASDAQ:ATRS) Antares Pharma, Inc. (
10/12/17 - ANTARES PHARMA, INC. FILES (8-K) Disclosing Other Events, Financial Statements and Exhibits
On February 24, 2017, the Company received a letter from the FDA notifying the Company that the FDA assigned a Prescription Drug User Fee Act target date for completion of its review by October 20, 2017. On October 11, 2017, the Company received a letter from the FDA stating that, as part of its ongoing review of the NDA, the FDA has identified def
10/12/17 - ARDX Surges After-hours, MBVX Abuzz, TRVN Keeps Its Focus
KENILWORTH- Today's Daily Dose brings you news about positive results from Ardelyx's phase III study of Tenapanor for irritable bowel syndrome with constipation; Flexion's stock offering; Merck' s decision of not to submit applications for regulatory approval for its anti-cholesterol drug Anacetrapib; Trevena's reduction in workforce and MabVax's..
10/12/17 - ASIT biotech Announces the Publication of Its First Clinical Data with gp-ASIT+? in the Journal of Allergy and Clinical Immunology (JACI)
ASIT biotech, a Belgian clinical-stage biopharmaceutical company focused on the research, development and future commercialization of breakthrough immunotherapy products for the treatment of allergies, announces the publication of the first clinical trial data with gp-ASIT+?, its lead product candidate for grass pollen rhinitis, in the Journal of
10/12/17 - Astellas and Seattle Genetics Initiate Pivotal Trial of Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer
Release date- 11102017- TOKYO and BOTHELL- Astellas Pharma Inc. and Seattle Genetics Inc., today announced dosing of the first patient in EV-201, a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor therapy.
10/12/17 - AYTU BIOSCIENCE, INC - 10-K/A - Management's Discussion and Analysis of Financial Condition and Results of Operations
Through a multi-step reverse triangular merger, on April 16, 2015, Vyrix Pharmaceuticals, Inc. and Luoxis Diagnostics, Inc. merged with and into our Company and we abandoned our pre-merger business plans to solely pursue the specialty healthcare market, including the business of Vyrix and Luoxis. On June 8, 2015, we reincorporated as a domestic Del
10/12/17 - Behavioral Disorders Drug Development Pipeline Review, 2017 - Research and Markets
The "Behavioral Disorders Drug Development Pipeline Review, 2017" report has been added to Research and Markets' offering. 5 Companies Involved in Therapeutics Development. 4 D Pharma PLC 4 P-Pharma SAS APeT Holding BV AbbVie Inc Addex Therapeutics Ltd Amarantus Bioscience Holdings Inc Amorsa Therapeutics Inc Anima Biotech Ltd BCWorld Pharm Co Ltd
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