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

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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10/13/17 - FDA panel unanimously endorses Spark's gene therapy for rare blindness pioneered at CHOP []
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 - Rockford nurse takes part in OSF Saint Anthony breast cancer clinical trial [Rockford Register Star, Ill.]
Oct. 12 ROCKFORD Since receiving a stage 2 A breast cancer diagnosis in September 2015, there have been instances where OSF Saint Anthony Medical Center registered nurse Maria "Thess" Superticioso has had the opportunity to share her experience with cancer patients she's treated. "We're on the same page; we share the same story," the Machesney
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 - 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 - Adamas Appoints Mardi C. Dier to its Board of Directors [Palestine News Agency (WAFA)]
-Adamas Pharmaceuticals, Inc. today announced the appointment of Mardi C. Dier, Chief Financial Officer of Portola Pharmaceuticals, Inc., to its Board of Directors. First, I would like to thank Richard for his years of service to Adamas, during which time we brought Adamas public, financed GOCOVRI through FDA approval and launch, as well as funded
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 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 - 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. 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 - BIOPHYTIS completes a 10.4 M capital increase to finance mid-stage clinical trials for two novel anti-aging drug-candidates [T-break Tech (Middle East)]
BIOPHYTIS, a biotechnology company specializing in the development of drug candidates to treat age-related diseases, announces entry into definitive agreements for a 10.4 million capital raise via the issuance of new ordinary shares without shareholders preferential subscription rights and reserved to institutional investors in Europe and the...
10/12/17 - Boehringer Ingelheim - FDA grants Priority Review to Gilotrif for uncommon EGFR mutations in advanced NSCLC
Release date- 11102017- Ridgefield, Conn.- Boehringer Ingelheim today announced that the supplemental New Drug Application for Gilotrif has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration. The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-sma
10/12/17 - Call for overhaul of EU rules on GMO clinical trial [Arab News (Saudi Arabia)]
Four organisations representing pharmaceutical firms, biotech companies, universities, and research institutes are calling on the European commission to update, streamline and standardise regulations used to assess applications for clinical trials of new therapies using genetically modified organisms, saying that the current process is outdated...
10/12/17 - Cellectar Biosciences and Pierre Fabre Extend Collaboration for Development of New Phospholipid Drug Conjugates
Release date- 11102017- MADISON- Cellectar Biosciences, Inc., an oncology focused, clinical stage biotechnology company, together with leading French pharmaceutical company Pierre Fabre, today announce the extension of their ongoing collaboration to develop new phospholipid drug conjugates for oncology applications. 'The extension of our research..
10/12/17 - China Grand's glaucoma generics drug approved for production [ET Net News (China)]
China Grand Pharmaceutical and Healthcare. production approval issued by the China Food and Drug Administration. approval from CFDA in March 2017 and already made contributions to the results of the.
10/12/17 - China will accept data from overseas clinical trials to hasten drug approvals [Arab News (Saudi Arabia)]
Access to medicines could be hastened in China after the countrys government said it planned to accept data from overseas clinical trials for the first time. They also proposed increasing the number, and improving the quality, of clinical trial testing centres in China. The worlds second largest pharmaceutical market, China, has increasingly opened
10/12/17 - Clinical Study with BGB324, BerGenBio's Selective First-in-Class AXL Inhibitor, to be Presented at the 9th World Congress of Melanoma
Bergen, Norway, Oct 12 2017- BerGenBio ASA, a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors for multiple cancer indications, announces that the clinical trial of BGB324 in combination with either MEKINIST plus TAFINLAR or KEYTRUDA in advanced melanoma, will be presented at the 9th World Congress
10/12/17 - Clinical Study with BGB324\, BerGenBio's Selective First-in-Class AXL Inhibitor\, to be Presented at the 9th World Congress of Melanoma
Bergen, Norway, Oct 12 2017- BerGenBio ASA, a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors for multiple cancer indications, announces that the clinical trial of BGB324 in combination with either MEKINIST plus TAFINLAR or KEYTRUDA in advanced melanoma, will be presented at the 9th World Congress
10/12/17 - ColonaryConcepts Announces Commencement of Phase 2b Trial of Novel Colonoscopy PreparationKit
ColonaryConcepts, LLC today announced that its partner, Sebela Pharmaceuticals, plans to initiate a Phase 2 b clinical trial with its proprietary colonoscopy preparation kit, EC Prep. EC Prep is comprised of nutritionally balanced and palatable bars and beverages incorporating the standard purgative active ingredient, PEG 3350, as well as electroly
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