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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

Pharma associations strongly support Senate bill on FDA User Fees sequestration exemptions

05-08-2013

In the USA last week, Mark Pryor (Democrat, Arkansas), chairman of the Senate Appropriations Subcommittee…

BiotechnologyFinancialGenericsLegalNorth AmericaPharmaceuticalPolitics

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

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

US Senate confirms appointment of Marilyn Tavenner as CMS Administrator

16-05-2013

US Health and Human Services (HHS) Secretary Kathleen Sebelius announced that the US Senate has confirmed…

BiotechnologyGenericsHealthcareManagementNorth AmericaPharmaceutical

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

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

US pulmonologists view refractory asthma patient treatment with biosimilar Xolair by end-2018

10-04-2013

US pulmonologists surveyed by health care advisory firm Decision Resources estimate that only 19% percent…

BiotechnologyBoehringer IngelheimGenentechGenericsMarkets & MarketingNorth AmericaNovartisPfizerRespiratory and PulmonarySpirivaXolair

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

FTC files Amicus Brief, saying improper use of restricted drug distribution programs may impede generic competition

13-03-2013

The US Federal Trade Commission has filed an amicus brief in the US District Court for the District of…

ActavisActelionApotexBiotechnologyGenericsLegalNorth AmericaRare diseasesRespiratory and PulmonaryRoxaneTracleerZavesca

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

Gilead and Teva settle Viread patent litigation

20-02-2013

US biotech firm Gilead Sciences (Nasdaq: GILD), a global leader in the HIV/AIDS drug market, has reached…

Anti-viralsBiotechnologyGenericsGilead SciencesNorth AmericaPatentsTeva Pharmaceutical IndustriesViread

US pharma organizations work together to foster supply chain security and integrity

31-01-2013

The 100th meeting of the USA-based National Conference of Pharmaceutical Organizations (NCPO) - consisting…

BiotechnologyGenericsHealthcareMarkets & MarketingNorth AmericaPharmaceutical

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

Canada's Pharmascience sets up JV with Korea Kolmar; buys Rivex

03-01-2013

Privately-held Canadian drugmaker Pharmascience and Korea Kolmar Holdings, based in Seoul, South Korea,…

Asia-PacificBiotechnologyGenericsHelix BioPharmaKorea KolmarMergers & AcquisitionsNeurologicalNorth AmericaPharmaceuticalPharmascienceRivex Pharma

Medicines for normal aging conditions overtakes costs of treating most chronic diseases; Express Scripts

30-10-2012

In the USA, prescription-drug treatment regimens for conditions that are a normal part of aging are now…

BiotechnologyFinancialGenericsHealthcareNorth AmericaPharmaceutical

Most US and European physicians believe automatic substitution of biosimilars is a bad idea

05-09-2012

Specialist physicians surveyed in the USA and Europe are generally opposed to pharmacy-level automatic…

BiotechnologyDiabetesEuropeGenericsMarkets & MarketingNorth America

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

South and Central America API market closing gap on northern neighbors

13-08-2012

The market for active pharmaceutical ingredients (API) t in the Americas was worth a staggering $46 billion…

BiotechnologyGenericsMarkets & MarketingNorth AmericaSouth America

High expectations for new US biosimilars following FDA guidance documents

10-05-2012

In light of the upcoming FDA guidance for biosimilar approval, Novation, health care supply chain expertise…

BiotechnologyGenericsNorth AmericaPricingRegulation

US medicines spending rose 3.7% in 2011, held back by healthcare reforms, IMS study reveals

05-04-2012

Total health care spending on medicines in the USA increased 3.7% to $320 billion in 2011, a year which…

BiotechnologyGenericsHealthcareMarkets & MarketingNorth AmericaPharmaceuticalPricing

US FDA ties up another Biosimilars loose end

23-03-2012

The US Food and Drug Administration issuance of three long-awaited and highly anticipated draft biosimilar…

BiotechnologyGenericsNorth AmericaRegulation

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