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FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

05-12-2014

The US Food and Drug Administration has granted tentative approval for New Drug Applications by US generic…

Abacavir Sulfate and Lamivudine TabletsAnti-viralsGenericsMylanRegulationUSA

FDA guidance for prospective ANDA sponsors

FDA guidance for prospective ANDA sponsors

04-12-2014

The US Food and Drug Administration has issued new guidance in its efforts to assist in certain circumstances…

FDAGenericsPharmaceutical sciencesRegulationUSA

Nippon Kayaku launches biosimilar Remicade in Japan

Nippon Kayaku launches biosimilar Remicade in Japan

01-12-2014

Japanese drugmaker Nippon Kayaku has launched the sale of Infliximab BS for IV Infusion 100mg, a biosimilar…

Anti-Arthritics/RheumaticsBiosimilarsGenericsinfliximabJapanJohnson & JohnsonMarkets & MarketingNippon KayakuRemicade

Global oncology biosimilars market 2014-2018

28-11-2014

The global oncology biosimilars market is expected to expand at a compound annual growth rate (CAGR)…

BioconBiosimilarsCellTrionDr Reddy's LaboratoriesGenericsGlobalHospiraMarkets & MarketingMylanSandoz

Russia tightens procedure for accelerated registration of drugs

27-11-2014

Only the first three generics, along with generics intended for minors, as well as orphan drugs, will…

GenericsRegulationRussia

AbbVie acquires API facility in Singapore; Amgen completes new unit

AbbVie acquires API facility in Singapore; Amgen completes new unit

26-11-2014

US pharma major AbbVie has acquired a small-molecule active pharmaceutical ingredient (API) manufacturing…

AbbVieAmgenBiotechnologyGenericsProductionSingapore

Mylan confirms first-to-file patent challenge relating to Brevibloc

25-11-2014

US generic drugmaker Mylan today confirmed that it and several subsidiaries have been sued by US drugmaker…

Baxter InternationalBreviblocCardio-vascularGenericsLegalMylanPatentsRegulationUSA

Supernus sues Zydus for infringement of Trokendi XR patents

25-11-2014

US drugmaker Supernus Pharmaceuticals has sued generic drug makers Zydus Pharmaceuticals (USA) and Indian…

GenericsLegalNeurologicalPatentsSupernus PharmaceuticalsUSAZydus Cadila

GPhA slams mischaracterized facts about generic drug pricing

GPhA slams mischaracterized facts about generic drug pricing

24-11-2014

Commenting on recent evaluations of generic drug prices, Ralph Neas, president and chief executive of…

GenericsLegalPoliticsPricingUSA

China pharma excipients market to reach $8.9 billion in 2017

China pharma excipients market to reach $8.9 billion in 2017

24-11-2014

Currently, pharmaceutical excipients account for about 2%-3% of China's total output value of pharmaceutical…

ChinaGenericsMarkets & MarketingProduction

Beximco Pharma receives GMP approval from Health Canada

Beximco Pharma receives GMP approval from Health Canada

24-11-2014

Bangladeshi drugmaker Beximco Pharma has received Good Manufacturing Practices approval from Health Canada,…

BangladeshBeximco PharmaceuticalsCanadaGenericsProductionRegulation

Cipla links with SII for affordable pediatric vaccines in Europe

20-11-2014

The European subsidiary of Indian drugmaker Cipla has entered a distribution agreement with Serum Institute…

CiplaEuropeGenericsMarkets & MarketingSerum Institute of IndiaVaccines

Opportunity to promote good antibiotics prescription practices, says EGA

19-11-2014

The European Generic medicines Association (EGA) used the platform of European Antibiotic Awareness Day…

Antibiotics and Infectious diseasesEuropeGenericsMarkets & MarketingPricing

India’s Competition Commission asks Sun Pharma to amend Ranbaxy takeover deal

India’s Competition Commission asks Sun Pharma to amend Ranbaxy takeover deal

17-11-2014

The Competition Commission has asked Indian generics company Sun Pharmaceutical Industries, which acquired…

GenericsIndiaMergers & AcquisitionsRanbaxy LaboratoriesSun Pharmaceutical

Good results from Stada Arz, despite challenging conditions

13-11-2014

German drugmaker Stada Arzneimittel has posted financial results for the first nine months of 2014, showing…

Eastern EuropeFinancialGenericsRussiaSTADA Arzneimittel

India takes action on spurious and sub-standard drugs

India takes action on spurious and sub-standard drugs

10-11-2014

An American pharmacist and an Indian pharmacologist charged with smuggling four million fake pharmaceuticals…

GenericsIndiaMarkets & MarketingPharmaceuticalPoliticsRegulation

Advent and Avista acquire UCB’s generics subsidiary Kremers Urban

Advent and Avista acquire UCB’s generics subsidiary Kremers Urban

07-11-2014

Global private equity investors Advent International and Avista Capital Partners have signed an agreement…

BelgiumGenericsKremers Urban PharmaceuticalsMergers & AcquisitionsUCB

Actavis third-qtr sales rocket, but loss posted

Actavis third-qtr sales rocket, but loss posted

05-11-2014

Ireland-headquartered generics drug major Actavis today reported net revenue leapt 83% to $3.7 billion…

ActavisFinancialGenerics

EGA and EBG see EMA latest biosimilars guidance as “important step forward”

EGA and EBG see EMA latest biosimilars guidance as “important step forward”

04-11-2014

The European Generic medicines Association (EGA) and the European Biosimilars Group (EBG), a sector group…

BiosimilarsEuropeGenericsRegulation

New analysis of potential savings from Biosimilars in USA

New analysis of potential savings from Biosimilars in USA

04-11-2014

Introducing competing “biosimilar” versions of complex biologic drugs used to treat illnesses such…

Anti-Arthritics/RheumaticsBiosimilarsFinancialGenericsOncologyRegulationSandozUSA

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