Biosimilar News: Breaking Biosimilar News, Comments and Articles. - Page: 4

Xtalks Announces Its May 2013 Life Sciences Webinar Calendar

All events are complimentary and are delivered by leading industry experts. Click on the webinars of your choice to learn more and register: May 2  

Actavis Acquires Worldwide Rights for Valeant's Metronidazole 1.3% Vaginal Gel

PARSIPPANY, N.J. and MONTREAL, May 1, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT), and Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that Actavis Specialty Brands (the "Company") has acquired worldwide rights to Valeant's Metronidazole 1.3% Vaginal Gel antibiotic development product, a topical antibiotic for the treatment of bacterial vaginosis. ...

Biosimilar firms urge government action to boost sluggish market

A feeling that biosimilars have still not delivered on their promise despite their years on the market pervaded this year’s annual biosimilars conference held by the European Generic medicines Association (EGA) at the Tower Hotel in.....

State Roundup: Health Costs Could Undermine State Budget Recoveries

A selection of health policy stories from California, Virginia, Nevada, Missouri, Minnesota and Wisconsin. Reuters: Health Care Costs To Negate State, Local Budget Improvements: Outlook State and local governments can expect ever-widening budget gaps through 2060, as rising health care costs for both citizens and public employees surpass recent improvements in their revenue, the Government Account...

Pfenex Inc. Awards Glide Pharma Development Contract for a Solid Formulation of Recombinant Anthrax Vaccine

SAN DIEGO, Calif. and OXFORD, England, April 30, 2013 /PRNewswire/ -- Glide Pharma® today announced the award of a sub-contract from Pfenex Inc. to develop a solid formulation containing the recombinant Protective Antigen (rPA) from Bacillus anthracis expressed in Pfenex Expression Technology™ suitable for delivery with the Glide SDI® (solid dose injector).  T...

Dr. Reddy's to Release Q4 and Full Year FY13 Results on May 14, 2013

Dr. Reddy's Laboratories (NYSE: RDY) will announce results for the Fourth Quarter and Full year ended March 31, 2013 on Tuesday, May 14, 2013 after the Board Meeting. The results will be available on the Company’s website www.drreddys.com Summary of Events Event  ...

Sandoz Files Application In Japan For Approval Of G-CSF Formulation Biosimilar

Sandoz has filed for the approval in Japan of a biosimilar recombinant human G-CSF for the treatment of neutropenia, a side effect of chemotherapy, the company announced on April 25.

Sandoz Files Application In Japan For G-CSF Biosimilar

Sandoz has filed for approval in Japan of a biosimilar recombinant human G-CSF for the treatment of neutropenia, a side effect of chemotherapy.

Japan briefs: Takeda files for Azilva comb; Sandoz seeks filgrastim biosimilar approval

Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) says that it submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan for a fixed-dose combination of Azilva (azilsartan) and amlodipine besylate tablets for tr...

Hospira marks five years of biosimilars

Self-proclaimed world leader in injectable drugs, Hospira, commemorated five years of providing biosimilars to the European market at the BIO International Convention in Chicago, USA, on 24 April 2013.

Celltrion stops phase III trial of biosimilar rituximab

South Korean biotechnology company Celltrion has stopped the late-stage trial of its biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).

iBio, Inc. closes $4.2 million public offering and terminates At-the-market offering

NEWARK, Del., April 29, 2013 /PRNewswire/ -- iBio, Inc. (NYSE MKT: IBIO) announced today that the Company closed an underwritten public offering of 8,925,000 shares of the Company's common stock and warrants to purchase 3,570,000 shares of the Company's common stock.  The securities were sold as a unit with each unit consisting of one share of common stock and 4/10ths of a warrant to purchase...

Biosimilar Vs. Therapeutic Protein Immunogenicity: Industry Makes Distinction

Responding to FDA’s draft guidance on immunogenicity assessment for therapeutic protein products, BIO says the agency should consider different principles when deciding procedures to detect immune response to biosimilars; Momenta wants the agency t...

BioSavita and Quanta BioDesign Collaborate to Develop Novel Biological Drugs With Enhanced Activity

PLYMOUTH, MI and POWELL, OH -- (Marketwired) -- 04/29/13 -- BioSavita and Quanta BioDesign, announced today a collaboration to develop BioSuperior XL™ therapeutics, which are novel, biological drugs based on proven clinical mechanisms, but with an improved drug profile. The collaboration unites the strengths of the two companies' proprietary drug development technologies. BioSavita's geneticall...

NHS Wasting Hundreds Of Millions By Not Using Biosimilars

UK lagging behind Europe in take-up of complex medicines. Cost-effective alternatives could improve access to life-saving drugs The NHS is wasting millions of pounds a year by not using biosimilar medicines as much as its European counterparts, costi...

EU member states urged to boost biosimilars market access

"Safe and effective biosimilar monoclonal antibodies will arrive soon," announced Gudbjorg Edda Eggertsdottir, president of the European Generic Medicines Association (EGA) in her opening address at the 11th EGA International Symposium on Biosimilars...

Enbrel's Asian Biosimilar Competitors

By Peter Geschek: Enbrel Enbrel, co-promoted by Amgen (AMGN) and Pfizer (PFE) is one of the most successful drugs in history. Amgen sells it in the U.S. and Canada, Pfizer sells it to the rest of the world. In 2012, Enbrel was the world's second best-selling drug, earning $4.2 billion for Amgen and $3.7 billion for Pfizer from sales outside the U.S. and Canada. Pfizer also received $

Actavis Announces OxyContin® Patent Challenge Settlement

PARSIPPANY, N.J., April 26, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT), a leading specialty pharmaceutical company, today announced that it has entered into an agreement with Purdue Pharma to settle all outstanding patent litigation related to Actavis' generic version of the currently marketed abuse-deterrent formulation of OxyContin®. Under the terms of the agreement, Actavis will...

BioOutsource opens North American facility in Cambridge, Massachusetts

BioOutsource Ltd, a specialist in the biological analysis of biosimilar molecules, has opened a new facility in Cambridge, Massachusetts, the company’s first in the USA. BioOutsource plans to apply its experience in biosimilar characterisation assa...

Korea’s Celltrion Seeks New Trial Design For Rituxan Biosimilar Phase III

Celltrion says it will launch Phase III trials in the second half of 2013 with a new design, after completing a Phase I trial this month.

Actavis Reaches Agreement with Shire to Launch a Generic Version of Intuniv® in December 2014

PARSIPPANY, N.J., April 25, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT), a leading specialty pharmaceutical company, today announced that is has reached a settlement agreement with Shire plc resolving outstanding patent litigation related to Actavis' generic version of INTUNIV® (guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder.  The sett...

[Pfenex] and [Agila] form biosimilars joint venture

Indian company [Agila Biotech Pvt. Ltd.] and [Pfenex Inc.] (recombinant protein expression techniques for producing follow-on biologics and vaccines) have established a joint venture to develop, manufacture, and sell biosimilars worldwide.

Hospira Marks Five Years of Biosimilars Success at 2013 BIO International Convention

Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, today announced an important milestone, commemorating five years of providing biosimilars to the European market and delivery of more than five million doses of high-quality biosimilar medicines at a lower cost to patients in Europe and Australia....

BioOutsource Opens First United States Facility

BioOutsource Ltd. (“BioOutsource”), a global leader in the biological analysis of biosimilar molecules for the biopharmaceutical industry, announced the opening of a new facility in Cambridge, Mass., the company’s first in the United States. Th...

Baxter Evaluates Biomanufacturing at New Minnesota Plant

Baxter says it is evaluating a number of options at its newly acquired Minnesota facility, though biosimilars will be the main focus.