Generics - Biotechnology, Regulation

Filter

Current filters:

BiotechnologyRegulation

Popular Filters

1 to 25 of 45 results

Final approval for California's SB 598 Biosimilars Bill

05-09-2013

A bill updating US State of California's pharmacy substitution law to allow greater patient access to…

BiotechnologyGenericsLegalNorth AmericaRegulation

Phase III data support biosimilarity of BOW-015 to Remicade

29-08-2013

Privately-held US biotech firm EPIRUS Biopharmaceuticals, which is focused on the development and production…

Anti-Arthritics/RheumaticsBiotechnologyEPIRUS BiopharmaceuticalsGenericsinfliximabRegulationRemicadeResearch

California Assembly passes controversial biosimilars bill

29-08-2013

In the USA this week, the California Assembly has passes legislation that would allow pharmacists to…

BiotechnologyGenericsLegalNorth AmericaPoliticsRegulation

US payers have more faith in biosimilars from multinationals

22-07-2013

US payer's trust in specific biosimilar manufacturers could dictate which companies will be most successful…

BiotechnologyEuropeGenericsNorth AmericaProductionRegulation

EMA's CHMP backs approval of first two monoclonal antibody biosimilars of blockbuster Remicade

29-06-2013

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended…

Anti-Arthritics/RheumaticsBiotechnologyCellTrionEuropeGenericsHospiraInflectraMerck & CoRegulationRemsima

Increased focus on generics and biosimilars only way to make European health care sustainable, says EGA

13-06-2013

Addressing delegates at the 19th European Generic medicines Association (EGA) Annual Conference in Athens,…

BiotechnologyEuropeFinancialGenericsHealthcareRegulation

EMA initiates consultation on guideline on biosimilars containing biotechnology-derived proteins

10-06-2013

The European Medicines Agency today (June 10) released a revision of the guideline addressing the clinical…

BiotechnologyEuropeGenericsRegulation

New Florida law takes a major step in promoting access to biologic medicines

06-06-2013

Legislation amending the US state of Florida's existing prescription drug substitution law has the potential…

BiotechnologyGenericsLegalMarkets & MarketingNorth AmericaRegulation

Florida joins growing list of US states blocking some Biosimilars Bills provisions

08-05-2013

Last Friday, the US state of Florida joined several states, most recently Indiana, in refusing to enact…

BiotechnologyGenericsLegalNorth AmericaRegulation

EU member states urged to boost biosimilars market access

26-04-2013

"Safe and effective biosimilar monoclonal antibodies will arrive soon," announced Gudbjorg Edda Eggertsdottir,…

BiotechnologyEuropeGenericsRegulation

Support for introduction of a global regulatory process for biosimilars

16-04-2013

The majority of surveyed US and European physicians and payers are in favor of the introduction of a…

BiotechnologyGenericsGlobalRegulationResearch

US FY 2014 budget continues push to curb patent settlements, shorten biologics exclusivity; a lawyer's view

12-04-2013

At first look, the US Food and Drug Administration appears to have fared rather well under President…

BiotechnologyGenericsNorth AmericaPatentsPoliticsRegulationResearch

Florida Biosimilars Bill seeks to notify patients and doctors of changes to prescriptions

03-04-2013

The US State of Florida Senate Committee on Health Policy has passed Senate Bill (SB) 732. Under this…

BiotechnologyGenericsLegalNorth AmericaRegulation

Mixed industry views on Virginia's law on biosimilar substitutions

25-03-2013

A new law in the US state of Virginia signed into law last week by Governor Bob McDonnell - designed…

BiotechnologyGenericsLegalNorth AmericaPoliticsRegulation

EMA focuses on new legislation, increased efficiency and transparency in 2013 work program

13-03-2013

The European Medicines Agency has published its work program for 2013. This year, the Agency's priorities…

BiotechnologyEuropeGenericsPharmaceuticalRegulation

New US Federal Trade Commission chairman - Edith Ramirez - to be designated by President

03-03-2013

President Barack Obama intends to designate Edith Ramirez as Chairman of the Federal Trade Commission…

BiotechnologyGenericsManagementNorth AmericaPharmaceuticalRegulation

US biotech giants lobbying to block biosimilars, NTY claims

31-01-2013

Some of the USA's biggest biotechnology companies are lobbying intensively to limit generic competition…

AmgenBiotechnologyGenentechGenericsNorth AmericaPoliticsRegulation

Sales of antiretroviral agents for HIV will decline slightly over next decade

18-12-2012

Major-market sales of antiretroviral (ARV) agents for HIV will decline slightly over the next decade,…

Anti-viralsBiotechnologydolutegravirGenericsGlaxoSmithKlineGlobalMarkets & MarketingPharmaceuticalRegulationViiV Healthcare

EMA 2013 work program and budget endorsed by management board

18-12-2012

The European Medicines Agency's Management Board revealed yesterday that, at its meeting on December…

BiotechnologyEuropeFinancialGenericsPharmaceuticalRegulation

EMA expects lower rate of generic applications; Issues guidelines on schizophrenia and MS

11-10-2012

In its mid-year report for 2012, the European Medicines Agency's management board yesterday provided…

BiotechnologyEuropeGenericsNeurologicalPharmaceuticalRegulationResearch

FDA approves pediatric Afinitor from Novartis and Teva's tbo-filgrastim

30-08-2012

The US Food and Drug Administration yesterday approved Swiss drug major Novartis' (NOVN: VX) Afinitor…

AfinitorBiotechnologyGenericsNorth AmericaNovartisOncologyPharmaceuticalRegulationSicor Biotechtbo-filgrastimTeva Pharmaceutical Industries

World's first (official) biosimilar antibody goes to reumatoid arthritis

09-08-2012

The end of July 2012 proved exciting for the world of biosimilar manufacturers. However, for the regulatory…

BiotechnologyCellTrionGenericsGlobalinfliximabJohnson & JohnsonMarkets & MarketingRegulationRemicadeRemsima

1 to 25 of 45 results

Back to top