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 The leading web portal for pharmacy resources, news, education and careers April 26, 2015
Pharmacy Choice - News - U.S. Pharmaceutical Industry - April 26, 2015

Pharmacy News

 U.S. Pharmaceutical Industry
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4/26/15 - Clinical trial uses patients' own cells for treatment after bone marrow transplant
Physician-researchers at the Aflac Cancer and Blood Disorders Center at Children's Healthcare of Atlanta and Winship Cancer Institute of Emory University will harvest bone marrow cells from children and adults with GVHD. Muna Qayed, MD, MSc. a pediatric hematologist-oncologist at the Aflac Cancer Center at Children's and an assistant professor at E
4/26/15 - Court Overseeing Federal Testosterone Treatment Lawsuits Convenes April Case Management Conference
A Case Management Conference was convened on April 21, 2015 in the U.S. District Court, Northern District of Illinois, where hundreds of federally-filed testosterone lawsuits have been consolidated for the purposes of coordinated pretrial proceedings. The Court's discussion pertaining to generic drug cases was especially timely, as the FDA is curre
4/26/15 - FDA Announces Availability of Electronic Common Technical Document Draft Implementation Guidance
WASHINGTON, April 26 The Department of Health& Human Services published the following notice in the Federal Register from the Food& Drug Administration:. M8 Electronic Common Technical Document v4.0 Draft Implementation Guide v2.0; Electronic Common Technical Document v4.0 Implementation Package Draft Specification for Submission Formats v2.0;...
4/26/15 - Pittsburgh Post-Gazette Len Boselovic's Heard Off the Street column [Pittsburgh Post-Gazette]
April 26 It's impossible to make a "compelling" case that hiring William Shakespeare to author corporate communications like the ones currently circulating among drug makers Mylan, Teva Pharmaceutical Industries and Perrigo would "enhance shareholder value." Consider this offering last month from Heinz spokesman Michael Mullen on the proposed mer
4/26/15 - United States : Mylan Makes Offer to Acquire Perrigo [TendersInfo (India)]
Davis Polk is advising Goldman Sachs as lender and financial adviser to Mylan N.V. in connection with its proposal to acquire Perrigo Company plc for $60 in cash and 2.2 Mylan shares per Perrigo share. Perrigo is a leading global health care supplier that develops, manufactures and distributes over-the-counter and prescription pharmaceuticals,...
4/25/15 - "Data-Enabled Pharmaceutical Container and Methods for Using Same" in Patent Application Approval Process
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week A patent application by the inventors Burrows, Mark; Eckhaus, Neal; Grubbe, Donald; Christoffersen, George, filed on October 1, 2013, was made available online on April 9, 2015, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This pate
4/25/15 - AbbVie Presents Late-Breaking, Preliminary Phase 3b Data with VIEKIRAX + EXVIERA in Chronic Hepatitis C Patients with Renal Impairment at The International Liver Congress? 2015
AbbVie today announced new, preliminary safety and efficacy data from the first cohort of its ongoing, Phase 3 b RUBY-I study. "RUBY-I is part of AbbVie's broader Phase 3 b program and demonstrates our continued focus on people living with hepatitis C that have specific needs," said Scott Brun, M.D., vice president, pharmaceutical development, A
4/25/15 - Athersys to Host Shareholder Conference Call [Cihan News Agency (Turkey)]
-Athersys, Inc. announced today that it will be hosting a shareholder conference call on Wednesday, April 29, 2015 to present the recently announced interim results of its exploratory Phase 2 clinical study of the intravenous administration of MultiStem cell therapy to treat patients who have suffered an ischemic stroke. Gil Van Bokkelen, Chairm
4/25/15 - Drug cost mystery: older multiple sclerosis medicines skyrocket despite competition [The Oregonian, Portland, Ore.]
Instead of competition driving prices down when superior competing drugs were introduced, costs in the U.S. went up even faster than before, according to the study conducted by researchers at Oregon State University and Oregon Health& Science University. "'Economics 101' would suggest that competition should lower prices," said Daniel Hartung, an
4/25/15 - Enanta Pharmaceuticals Announces Preliminary Data from AbbVie's Phase 3b RUBY-I Study in Chronic Hepatitis C Patients with Renal Impairment Presented at The International Liver Congress? 2015
Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced today new preliminary safety and efficacy data from the first cohort of AbbVie s ongoing, Phase 3 b RUBY-I study. The first ten patients, or 100 percent, who have rea
4/25/15 - INC Research Collaborates With DrugDev to Create Innovative, Cloud-Based Solutions That Drive Increased Efficiencies for Feasibility, Site Selection... [Palestine Chronicle, The]
-INC Research Holdings, Inc., a leading, global Phase I to IV contract research organization, today announced a strategic collaboration with DrugDev to drive increased efficiencies in clinical trials through enhanced access to and management of critical investigator and site data. Under the agreement, INC Research becomes the first CRO to complete.
4/25/15 - Innocoll AG Announces Pricing of Follow-On Offering [Jerusalem Post (Israel)]
-Innocoll AG, a specialty pharmaceutical company, today announced the pricing of its follow-on public offering of 3,321,669 American Depositary Shares at a public offering price of $9.00 per ADS. The offering of these securities is being made only by means of a prospectus, copies of which can be obtained from: Piper Jaffray& Co., Attention: Prospec
4/25/15 - Lipocine Announces Proposed Public Offering of Common Stock [Jerusalem Post (Israel)]
-Lipocine Inc., a specialty pharmaceutical company, today announced that it has commenced an underwritten public offering of its common stock. In addition, Lipocine expects to grant the underwriters a 30- day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering solely to cover over-allotment
4/25/15 - Lipocine Prices $30.2 Million Public Offering of Common Stock [Jerusalem Post (Israel)]
-Lipocine Inc., a specialty pharmaceutical company, today announced that it has priced an underwritten public offering of 4,650,000 shares of its common stock at $6.50 per share for gross proceeds of $30.2 million. Lipocine has also granted the underwriters a 30- day option to purchase up to an additional 697,500 shares of common stock to cover...
4/25/15 - Mylan raises bid for fellow drugmaker; Perrigo says 'no' [The Pittsburgh Tribune-Review]
April 24 Mylan NV launched a hostile takeover bid for fellow generic drug maker Perrigo Co., telling the company's stockholders Friday it will pay them $31.2 billion if they tender their shares. The board of Ireland- based Perrigo, which makes over-the-counter medicines and nutritional products, urged its shareholders to take no action, arguing t
4/25/15 - The Hartford Courant Jon Lender column [The Hartford Courant]
April 25 Unregulated drugs produced by controversial compounding pharmacies are costing Connecticut taxpayers up to $24 million this year in prescription payments on behalf of state employees and retirees, a stunning 3,000 percent increase from their $800,000 price just three years ago. For example, the compounding pharmacies often use a medicati
4/25/15 - Zogenix Closes Sale of Zohydro(R) ER Business to Pernix [National News Agency (Lebanon)]
-Zogenix, Inc., a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders, announced today that it has closed the sale of its Zohydro ER business to a wholly-owned subsidiary of Pernix Therapeutics Holdings, Inc. for $80 million in cash, approximately 1.68 million shares of Pernix comm
4/24/15 - "Novel Pharmaceutical Composition of Linezolid" in Patent Application Approval Process
By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors Panandikar, Aditi; Bambolkar, Sundeep; Inamdar, Kavita; Ramesh, Sapna; Burkul, Amol; Shaikh, Nasir, filed on August 2, 2013, was made available online on April 9, 2015, according to news reporting originating from Washington, D.C., by NewsRx correspondents. Th
4/24/15 - "Smoking Cessation Device" in Patent Application Approval Process
By a News Reporter-Staff News Editor at Health& Medicine Week A patent application by the inventor Park, Andrew Chunkil, filed on October 1, 2014, was made available online on April 9, 2015, according to news reporting originating from Washington, D.C., by NewsRx correspondents. "According to the U.S. Food and Drug Administration, tobacco use is
4/24/15 - ' 350 medicines brought under price control' [Mail Today (India)]
CHEMICAL and fertiliser minister Ananth Kumar told the Lok Sabha on Thursday that 350 drugs had been brought under price control providing additional benefit of more than ` 3,000 crore to customers. The Centre will also come out with incentives to boost bulk drug industry, Kumar said while noting that 60 per cent of drug import costing ` 12,000 cro
4/24/15 - Abbreviated New Drug Applications and 505(b)(2) Applications; Extension of Comment Period
In the proposed rule, FDA requested comments on its proposal to implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which amended provisions of the Federal Food, Drug, and Cosmetic Act that govern the approval of 505 applications and abbreviated new drug applications. FDA also requested comm
4/24/15 - Actavis Announces Topline Phase 3 Clinical Trial Results for Single-Dose DALVANCE (dalbavancin) in the Treatment of ABSSSI
Single-dose dalbavancin has shown positive results for the treatment of serious skin infections and can be an important new treatment option for patients, "said David Nicholson, Actavis Executive Vice President, Global Brands R&D. Actavis plans to file a supplemental New Drug Application with these data in Q3 2015.. This study was conducted pursuan
4/24/15 - Anavex to Present on Sigma-1 Receptors at the World Orphan Drug Congress and to Reveal New Epilepsy Data at Antiepileptic Drug Trials XIII Conference
Release date- 23042015- NEW YORK, NY- Anavex Life Sciences Corp. today announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will present at the World Orphan Drug Congress on Thursday, April 23, 2015 at 11:10 a.m. ET at The Washington Hilton in Washington, DC. On Friday, May 15, 2015 at 3:30 p.m. ET, Dr. Missling will
4/24/15 - Anavex to Present on Sigma-1 Receptors at the World Orphan Drug Congress and to Reveal New Epilepsy Data at Antiepileptic Drug Trials XIII Conference [Yemen Times]
-Anavex Life Sciences Corp. today announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will present at the World Orphan Drug Congress on Thursday, April 23, 2015 at 11:10 a.m. ET at The Washington Hilton in Washington, DC. In a presentation titled "Potential applications of sigma-1 receptors in orphan indications," Dr
4/24/15 - Athersys to Host Shareholder Conference Call
Athersys, Inc. announced today that it will be hosting a shareholder conference call on Wednesday, April 29, 2015 to present the recently announced interim results of its exploratory Phase 2 clinical study of the intravenous administration of MultiStem cell therapy to treat patients who have suffered an ischemic stroke. Gil Van Bokkelen, Chair
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