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 The leading web portal for pharmacy resources, news, education and careers July 3, 2015
Pharmacy Choice - News - Pharmaceutical Industry Trends and Policy - July 3, 2015

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 Pharmaceutical Industry Trends and Policy
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7/3/15 - Approval for manufacture and sale of XIAFLEX (collagenase clostridium histolyticum) in Japan
Asahi Kasei Pharma today obtained approval for the manufacture and sale of XIAFLEX* injection for the treatment of Dupuytren's contracture in Japan. Asahi Kasei Pharma received rights to develop and market XIAFLEX in Japan through an agreement concluded in March 2011. After conducting a Phase III clinical trial in Japan, Asahi Kasei Pharma filed an
7/3/15 - Big Pharma looks to long term in China [China Daily: Europe Weekly]
While the situation provides opportunities for big pharma companies to expand their markets in China, they are also hoping that offshoring research and development to China may contribute to reconfiguring their R&D models with its weak record of producing new drugs. Drawing on interviews with pharma R&D centers in Shanghai, patent analyses and indu
7/3/15 - Breathe Technologies, Inc. Announces FDA Clearance for Life2000 Ventilation System
By a News Reporter-Staff News Editor at Health& Medicine Week Breathe Technologies, Inc., a developer and manufacturer of medical technologies for patients with respiratory insufficiency and neuromuscular diseases, announced that the U.S. Food and Drug Administration has granted 510 clearance for its critical care Breathe Technologies Life2000...
7/3/15 - Cutting Edge Information: 87% of IIT Teams Use Achieving Target Patient Enrollment as a Milestone Payment [Health & Beauty Close - Up]
Increased regulatory and compliance concerns mean that investigator-initiated trial teams have to be especially careful about who and what they fund, reports pharmaceutical intelligence firm Cutting Edge Information. As a result, the group noted, IIT teams thoroughly vet each proposal before approving it. "Essentially, companies pay investigators
7/3/15 - District Court Enters Permanent Injunction against New Jersey Drug Manufacturer and its President to Stop Distribution of Unapproved and Misbranded... [FARS News Agency]
Acino manufactures and distributes hydrocortisone acetate suppositories under the brand names Rectacort-HC and GRx HiCort 25. Deshpande is Acino's president and is responsible for, and has authority over, all operations at the firm. The department filed a complaint in the U.S. District Court for the District of New Jersey at the request of the U.S.
7/3/15 - EnterNext welcomes Kiadis Pharma on Euronext Amsterdam and Euronext BrusselsKiadis Pharma raises EUR 32.7 million in successful IPO
Release date- 02072015- EnterNext, the Euronext subsidiary designed to promote and grow the market for SMEs, today welcomed Kiadis Pharma on the Amsterdam and Brussels market of Euronext. Kiadis Pharma is a clinical stage biopharmaceutical company focused on research, development and future commercialisation of cell-based immunotherapy products for
7/3/15 - Epizyme to Participate at the European Cancer Congress [Manufacturing Close - Up]
Epizyme reported that updated data from the phase 1 portion of its ongoing phase 1/ 2 study of tazemetostat will be presented during the European Cancer Congress 2015, hosted by the European Society of Medical Oncology, to be held in Vienna, Austria, September 25- 28. In a release, the Company noted that tazemetostat is a first-in- class EZH2 inhib
7/3/15 - Goldman Comments On Vertex After FDA Approval; Arrowhead Initiates Dosing of ARC-AAT in Patients
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 2, 2015.{ nfg} Shares of Vertex Pharmaceuticals Incorporated were trading higher by nearly 4 percent on Thursday after the FDA approved the company's Orkambi for the treatment of cystic fibrosis patients 12 years and older. Commenting on the FDA's
7/3/15 - IGI Laboratories Submits Fifth ANDA Submission of 2015 [Health & Beauty Close - Up]
New Jersey- based IGI Laboratories on June 30 reported that it has submitted its fifth abbreviated new drug application to the U.S. Food and Drug Administration of 2015, which brings the Company's total number of ANDA submissions now pending at the FDA to twenty-seven. Jason Grenfell-Gardner, President and CEO of the Company, commented, "We believe
7/3/15 - Johnson & Johnson -Investigational HIV Vaccine Regimen Shows Encouraging Results in Non-Human Primates
Release date- 02072015- NEW BRUNSWICK, N.J.,- Johnson& Johnson announced today that scientists at Beth Israel Deaconess Medical Center, Crucell Holland B.V, one of the Janssen Pharmaceutical Companies of Johnson& Johnson, and several other collaborators today published results from a preclinical study of an HIV vaccine regimen used in in non-human
7/3/15 - Levaquin Lawsuit Attorneys at Bernstein Liebhard LLP Comment on Decision to Grant Summary Judgment in Generic Drug Case [FARS News Agency]
According to an Order issued in the U.S. District Court, Southern District of West Virginia on June 26th, the Court rejected the Plaintiff's assertion that one manufacturer can be held liable for injuries stemming from another manufacturer's product. Because of FDA regulations governing generic drug labels, they are pre-empted from bringing certain
7/3/15 - Lupin Acquires Biocom
Deal Type: Acquisition Deal Sub Type: 100% Acquisition Deal Country: Russia Deal Status: Completed Deal Value: 0.0000 USD. Lupin Limited, a pharmaceutical company, has acquired 100% stake in Biocom, a generic pharma company. Biocom generated sales of RUB861.2 million in financial year 2014. The company operates a modern European GMP compliant plant
7/3/15 - Medipure Reports Filing of Provisional Patent for Pain Management [Health & Beauty Close - Up]
Medipure Holdings reported that its subsidiary, Medipure Pharmaceuticals Inc., has filed a provisional patent application with the United States Patent and Trademark Office for a therapeutic, cannabinoid-based formulation for pain management, which is the base of Medipure's MP-10X product line. "We are very pleased to formally file this provisiona
7/3/15 - Morphine Tolerance Significantly Delayed by Prismic's Palmitoylethanolamide
By a News Reporter-Staff News Editor at Drug Week Prismic Pharmaceuticals, Inc., the specialty pharmaceutical company developing FDA- approved prescription drugs and FDA- regulated medical foods, announced that its lead development molecule, palmitoylethanolamide when used concomitantly with morphine in two animal pain models demonstrated an abil
7/3/15 - News story: PHE drug development to transfer to new state-owned company
The transfer of Public Health England's clinical drug development and production capability into a stand-alone, state-owned biopharmaceutical limited company has been approved by the Secretary of State for Health. The new company, Porton Biopharma Limited, which is wholly owned by the Secretary of State for Health, will employ over 200 people at th
7/3/15 - North American Health Headlines At 6:09 a.m. EDT
US woman's measles death is first in US since 2003 Insurer Aetna to buy Humana in $37 B deal FDA clears drug for leading form of cystic fibrosis OxyContin maker bows out of meeting on harder-to-abuse drug FDA weighs new restrictions on liquid nicotine products
7/3/15 - Ortho-Clinical Diagnostics, Inc. Receives FDA 510k Clearance for VITROS Chemistry Products HbA1c Reagent Kit, an Enhanced Diabetes Testing Assay
By a News Reporter-Staff News Editor at Health& Medicine Week Ortho-Clinical Diagnostics, Inc. announced that the U.S. Food and Drug Administration has cleared the VITROS Chemistry Products HbA1c Reagent Kit to be used on the VITROS 5600 Integrated System, VITROS 4600 Chemistry System, and the VITROS 5,1 FS Chemistry System. The test
7/3/15 - Patent Issued for Polymorphic Form of a Calcimimetic Compound
By a News Reporter-Staff News Editor at Drug Week LEO PHARMA A/S has been issued patent number 9056814, according to news reporting originating out of Alexandria, Virginia, by NewsRx editors. The patent's inventors are Ebdrup, Soren; Nielsen, Kim Troensegaard; Greve, Tanja Maria. This patent was filed on June 24, 2011 and was published online on
7/3/15 - Pfizer Announces FDA Acceptance for Review of New Drug Application for A Once-Daily Formulation of XELJANZ (tofacitinib citrate) Modified Release Tablets
Release date- 02072015- Pfizer Inc. announced today that the United States Food and Drug Administration accepted for review Pfizer's new drug application for XELJANZ 11 mg once daily modified release tablets for the treatment of moderate to severe rheumatoid arthritis in patients who have had an inadequate response or intolerance to methotrexate.
7/3/15 - Progress in clinical trials for the FDA application for The NGAL Test? and launch of new generic strip test
BioPorto has conducted a preliminary internal assessment of the data from the completed clinical trials in the USA. The preliminary internal assessment of data support the further application process, including the formulation of the application, which is expected to be submitted to the FDA in September 2015 at the latest. BioPorto has in licensed
7/3/15 - Report Summarizes Biotechnology Study Findings from M.S. Kinch and Co-Researchers (Sources of innovation: an assessment of intellectual property)
According to news reporting originating in Geneva, Switzerland, by NewsRx journalists, research stated, "An analysis of US Food and Drug Administration- approved new molecular entities reveals dynamism in terms of new innovation. For more information on this research see: Sources of innovation: an assessment of intellectual property. Drug Discovery
7/3/15 - Reports on Drug Discovery from University of Cambridge Provide New Insights (Using transcriptomics to guide lead optimization in drug discovery...
For more information on this research see: Using transcriptomics to guide lead optimization in drug discovery projects: Lessons learned from the QSTAR project. Drug Discovery Today, 2015; 20: 505-513. Drug Discovery Today can be contacted at: Elsevier Sci Ltd, The Boulevard, Langford Lane, Kidlington, Oxford OX5 1 GB, Oxon, England. Our news journa
7/3/15 - Theravance Biopharma Receives Marketing Authorization for VIBATIV (Telavancin) in Russia for Treatment of Multiple Infections Caused by Gram-Positive... [Health & Beauty Close - Up]
Theravance Biopharma reported that the Ministry of Health of the Russian Federation has granted marketing authorization for VIBATIV for the treatment of complicated skin and soft tissue infections, as well as nosocomial pneumonia, caused by Gram-positive bacteria, including methicillin-resistance Staphylococcus aureus. This marketing clearance...
7/3/15 - United States : Fujifilm signs an exclusive market agreement with Chinese major pharmaceutical company Shenzhen Main Luck for the distribution of its... [TendersInfo (India)]
United States: Fujifilm signs an exclusive market agreement with Chinese major pharmaceutical company Shenzhen Main Luck for the distribution of its oral synthetic quinolone antibacterial agent. FUJIFILM Corporation has announced that it signed an exclusive marketing agreement with China's major pharmaceutical company Shenzhen Main Luck...
7/3/15 - Vertex drug gets FDA approval [Boston Herald]
July 03 The Food and Drug Administration yesterday approved Vertex Pharmaceuticals' latest cystic fibrosis drug, offering new hope for about 8,500 of the 30,000 Americans who suffer from the life-threatening genetic disease. "I was driving home from work when the news popped up on my phone, and I started bawling; I called my dad and said,' Thank
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