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Generic in Biological Technology

KV Pharmaceutical Announces Stockholder Action to Amend By-Laws is Invalid

... the introduction or potential introduction of generic or competing products against products sold by ... competitors or to the Company's ability to market generic products due to brand company patents and ... introduction or potential introduction of generic or competing products by third parties against ...

Shire plc: Core Portfolio of Products Delivers 20% Sales Growth

... Industries Ltd ("Teva") of an authorized generic version of ADDERALL XR, higher sales ... commercial shipment of its authorized generic version of ADDERALL XR. In Q2 2009 sales of ... decline in ADDERALL XR sales subsequent to generic launch was anticipated and was already ...

Endo Pharmaceuticals Reports Strong Second Quarter 2009 Financial Results

... million in the same period in 2008. generic AND NON-PROMOTED PRODUCTS For the second quarter of 2009, net sales from the company's generic products were $30.3 million compared with $24.0 ... ended June 30, 2009, net sales from the company's generic products were $72.7 million compared with $45.8 ...

Mylan Reports Adjusted Diluted EPS of $0.32 for the Quarter Ended June 30, 2009

... agreement with Biocon in the area of generic biologics." Coury continued: "On the ... by unfavorable pricing as a result of additional generic competition on certain products. In the current ... Transdermal System (Fentanyl), Mylan's AB-rated generic alternative to Duragesic(R), continued to ...

"Over the Next 2-3 Years We Will Leverage Developmental Capabilities and Explore In-licensing and a Co-development Model to Consolidate Our Presence in Japan" - Dr. Kailash Sharma, President, Japan Operations, Zydus Cadila

... a big boost to its operations in the Japanese generic market which is still evolving. While the total pharma market in Japan is estimated at $ 60 bn the generic market is only about 6% of this in value terms ... companies to make an early foray in the Japan generic market. In 2007, the group acquired Nippon ...

Wyeth Announces Stockholder Approval of Pfizer Merger at 2009 Annual Meeting

... difficult economic environment and an unexpected generic attack on our third largest product, Protonix, ... the expected declines of products with emerging generic competition. The Company will report its second ... in our industry, including from branded and generic products; emerging data on our products and ...

GPhA Calls Senate HELP Committee Action Disappointing for Countless Patients

... Va., July 13 /PRNewswire-USNewswire/ -- The generic Pharmaceutical Association (GPhA) released the ... the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors ... and suppliers of other goods and services to the generic drug industry. Generics represent 69% of the ...

GPhA Says BIO Cries Wolf on Senate Biogenerics Proposal

... ARLINGTON, Va., July 9 /PRNewswire/ -- The generic Pharmaceutical Association (GPhA) released the ... and much needed consumer access. "While the generic industry still supports the proven successful ... the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors ...

Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Casodex(R) Tablets

... its Abbreviated New Drug Application (ANDA) for generic Casodex(R) tablets. Bicalutamide tablets are ... D2 metastatic carcinoma of the prostate. This generic version of Bicalutamide 50 mg tablets is ... develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's ...

New Report Just Published: World Prostate Cancer Therapeutics Market Report

... and Lung Cancer II-66 Barr Unveils generic Version of Proscar(R) Tablets II-67 IRX ... Prostate Cancer II-67 Actavis Introduces New generic Drugs in Europe II-67 Robot-Assisted Radical ... II-76 Bentley Receives Approval for generic Version of Casodex II-76 GSK Acquires Praecis ...

Mylan Announces Strategic Collaboration with Biocon to Enter the Global Generic Biologics Market

... and commercialization of multiple, high value generic biologic compounds for the global marketplace. ... to secure a leading position in the emerging generic biologics industry. Mylan's Chairman and CEO ... a strong and effective long-term partnership. generic biologics, especially monoclonal antibodies, are ...

Hospira Receives Favorable Court Decision on Eloxatin(R)

... Hospira, Inc. (NYSE: HSP ), the world leader in generic injectable pharmaceuticals, today announced that ... U.S. Food and Drug Administration (FDA) for its generic version of the product. Hospira expects full FDA ... Hospira's version of Eloxatin, which goes by the generic name oxaliplatin injection, will be one of the ...

Clinical Pharmacology Study With AZILECT(R) (Rasagiline Tablets) Demonstrated It Does Not Increase Tyramine Sensitivity

... companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active ... products, the introduction of competing generic equivalents, the extent to which we may obtain ...

Mylan Again Calls for an End to Authorized Generics During 180-Day Exclusivity Period

... between branded pharmaceutical companies and generic pharmaceutical companies. During her testimony, ... Mylan's position that the launch of an authorized generic by brand companies during a generic company's 180-day exclusivity period undermines ...

Simcere Pharmaceutical Group Reports Unaudited First Quarter 2009 Results

... ), a leading manufacturer and supplier of branded generic and innovative pharmaceuticals in China, today ... of 2009. Revenue from other branded generic products totaled RMB207.7 million (US$30.4 ... is a leading manufacturer and supplier of branded generic and innovative pharmaceuticals in China. In ...

Savient Pharmaceuticals Reports First Quarter 2009 Financial Results

... condition, as a result of the continued impact of generic competition partially offset by lower provisions ... that revenues from Oxandrin and our authorized generic product oxandrolone will decrease or remain flat in future periods, due to generic competition and overall demand for the product. ...

Cambrex Reports First Quarter 2009 Results

... revenues, partially offset by lower sales of generic APIs. First quarter 2009 Gross Margin ... of 2009 compared to earlier forecasts. Our generic APIs continue to be under price and volume ... chain. To combat this, we are working on 14 new generic APIs, and expect to benefit from the introduction ...

Shire begins the year with a strong performance

... that it had commenced commercial shipment of its generic version of ADDERALL XR(R)(mixed salts of single ... of ADDERALL XR will decrease significantly due to generic competition. We are reiterating our ... as a consequence of shipment of authorized generic ADDERALL XR to Teva in April 2009 and the impact ...

ViroPharma Incorporated Reports First Quarter 2009 Financial Results

... be $250 to $270 million. This guidance assumes no generic versions of Vancocin are approved in 2009 and ... approach considered for use in approving generic formulations of Vancocin that does not require ... citizen petition for Vancocin or the approval of generic versions of Vancocin. If we are unable to change ...

Medco Delivers First-Quarter 2009 GAAP Diluted EPS of $0.58; Diluted EPS Excluding Amortization of Intangible Assets of $0.63; Reaffirms 2009 EPS Guidance; Announces Win of Coventry Commercial Business Starting January 1, 2010

... 21.0 percent to a record $2.3 billion - generic dispensing rate increased 3.5 percentage points ... offset by higher volumes of lower-priced generic drugs. Medco's generic dispensing rate increased 3.5 percentage points ...

Pharmaceutical Institute Launches New Training Series Focused on Managed Markets Excellence

... selection, and the impact of tier placement and generic availability on market share. ... and costs, the impact of patent expiration and generic utilization on branded products, tactics health plans use to drive generic utilization, and potential future trends in ...

Delaware Court Rules That Watson Does Not Infringe Patent Related to Generic Version of Concerta(R) and Declares Patent Invalid

... the District of Delaware has ruled that Watson's generic version of Concerta (methylphenidate ... Judge Joseph Farnan, Jr., and applies to Watson's generic versions of Concerta(R) in the 18 mg, 27 mg, 36 ... for patent infringement related to the generic version of Concerta(R). Watson acquired Andrx ...

Mylan Confirms Four First-to-File Challenges

... 1 mg, 2 mg and 3 mg. Eszopiclone Tablets are the generic version of Sepracor's insomnia treatment ... 100 mg and 150 mg. Erlotinib HCl Tablets are the generic version of OSI Pharmaceuticals' lung cancer ... mg. Lanthanum Carbonate Chewable Tablets are the generic version of Shire's kidney disease treatment ...

Publication of Shire plc's Annual Report 2008

... operations. In addition, the entrance of generic competitors for ADDERALL XR or other leading ... anticipated erosion of ADDERALL XR sales by generic competitors; - the development and marketing ... of competitive pharmaceuticals, including generic versions; - loss of patent protection or ...

Pathway for Biosimilars Act Protects Patients, Promotes Competition, Preserves Innovation and Creates Quality Jobs, Lilly Says

... an abbreviated approval process under which generic versions of those new medicines can to come to ... of time has passed for recouping its investment, generic companies can copy those innovations in a safe, ... from competition, including protection from generic copies. However, effective patent protection is ...

PharmaNet Development Group Gives Notice of Anticipated Fundamental Change and Merger to Holders of Its Convertible Notes

... to innovative pharmaceutical, biotechnology, generic drug and medical device companies, announced ... of services to the pharmaceutical, biotechnology, generic drug and medical device industries. The Company ... the branded pharmaceutical, biotechnology, generic drug and medical device industries, the reduction ...

Simcere Pharmaceutical Group Reports Unaudited Fourth Quarter and Fiscal Year 2008 Results

... ), a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the ... million). Revenue from other branded generic products totaled RMB 190.2 million (US$27.9 ... the full year of 2008, revenue from other branded generic products totaled RMB 786.4 million (US$115.3 ...

GPhA Statement on the Introduction of the Bipartisan Biogenerics Consensus Bill: 'Promoting Innovation and Access to Life-Saving Medicine Act'

... ARLINGTON, Va., March 11 /PRNewswire/ -- The generic Pharmaceutical Association (GPhA) released the ... health care system's successful experience with generic medicines for the past 25 years. The market ... the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors ...

Hospira Supports Newly Introduced Biogenerics Legislation

... Hospira, Inc. (NYSE: HSP ), the world leader in generic injectable pharmaceuticals, announced today its ... soon. Although biogeneric drugs - generic versions of currently marketed biopharmaceuticals ... that provided access to safe and affordable generic drugs, would allow innovator companies - those ...

Teva Applauds Historic Biotech Competition Legislation

... -- Teva Pharmaceuticals USA, the leading generic pharmaceutical company, today applauded the ... bill that would bring safe and affordable generic biologics to all Americans. Energy and Commerce ... benefits managers, health plans, consumer groups, generic drug manufactures and others have been waiting ...

KV Pharmaceutical Enters Into Consent Decree With FDA

... the introduction or potential introduction of generic or competing products against products sold by ... competitors or to the Company's ability to market generic products due to brand company patents and ... introduction or potential introduction of generic or competing products by third parties against ...

Simcere Pharmaceutical Group to Announce 2008 Fourth Quarter and Full Year Earnings On Thursday, March 12, 2009

... is a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented ... strategy on the development of first-to-market generic and innovative pharmaceuticals, and has introduced a first-to-market generic stroke management medication under the brand ...

ViroPharma Incorporated Reports Fourth Quarter and Full Year 2008 Financial Results

... be $250 to $270 million. This guidance assumes no generic versions of Vancocin are approved in 2009 and ... approach considered for use in approving generic formulations of Vancocin that does not require ... citizen petition for Vancocin or the approval of generic versions of Vancocin. If we are unable to change ...

Frontage Laboratories Continues to Grow Its China Business and Add Corporate Financial, Regulatory and Clinical Pharmacology Talent

... Beijing Pharma's entrance into the international generic drug market. In addition, Frontage recently ... and Chinese companies' development programs in generic drugs, and to help them gain access to ... with developing new chemical entities, generic equivalent products, and supporting research for ...

Mylan Reports Adjusted Diluted EPS of $0.26 for the Quarter Ended Dec. 31, 2008, and Adjusted Diluted EPS of $0.80 for the Year Ended Dec. 31, 2008

... Transdermal System ("fentanyl"), Mylan's AB-rated generic alternative to Duragesic(R), are primarily ... by unfavorable pricing as a result of additional generic competition on certain products, was also ... the entrance into the market of additional generic competition in August 2007, sales of fentanyl ...

PharmaNet Development Group, Inc. Expands Latin America Operations with Opening of Brazil Office

... to innovative pharmaceutical, biotechnology, generic drug and medical device companies, today ... of services to the pharmaceutical, biotechnology, generic drug and medical device industries. The Company ... the branded pharmaceutical, biotechnology, generic drug and medical device industries, the reduction ...

Cephalon's New Product Launches Pace Record 2008 Sales

... from $512.6 million in 2007 due primarily to generic competition for ACTIQ(R) (oral transmucosal ... ACTIQ (39) 6 (29) generic OTFC (37) - (37) FENTORA ... ACTIQ (38) 32 (26) generic OTFC (26) - (26) FENTORA ...

An Affiliate of JLL Partners, Inc. Commences Cash Tender Offer to Acquire PharmaNet Development Group, Inc. at $5.00 per Share

... of services to the pharmaceutical, biotechnology, generic drug and medical device industries. The Company ... the branded pharmaceutical, biotechnology, generic drug and medical device industries, the reduction ... by branded pharmaceutical, biotechnology, generic drug or medical device companies, actions or ...

BioComp Pharma Launches First Generic Drug for Tindamax(R)

... Pharma, Inc. launched Tinidazole 500, the first generic version of the FDA-approved drug Tindamax(R). ... (BV). BioComp Pharma will begin shipping the generic version of Tindamax(R) in February 2009. generic drugs have the same active ingredients and ...

PharmaNet Development Group Agrees to be Acquired by JLL Partners

... of services to the pharmaceutical, biotechnology, generic drug and medical device industries. The Company ... the branded pharmaceutical, biotechnology, generic drug and medical device industries, the reduction ... by branded pharmaceutical, biotechnology, generic drug or medical device companies, actions or ...
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