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NW Bio to expand manufacturing of DCVax products

27-01-2014

US biotech firm Northwest Biotherapeutics has entered into a set of agreements for large-scale expansion…

BiotechnologyDCVaxEuropeNorth AmericaNorthwest BiotherapeuticsProductionRegulationUSA

Another ban by US FDA on a Ranbaxy production facility

Another ban by US FDA on a Ranbaxy production facility

24-01-2014

As if the Indian drug major has not had enough negative news from the US regulator, the US Food and Drug…

Asia-PacificDaiichi SankyoGenericsIndiaNorth AmericaProductionRanbaxy LaboratoriesRegulationUSA

Joint generic drug inspections initiative announced by FDA and EMA

Joint generic drug inspections initiative announced by FDA and EMA

19-12-2013

In a joint statement, the US Food and Drug Administration and the European Medicines Agency revealed…

EuropeGenericsNorth AmericaProductionRegulation

Drug Quality and Security Act passes in US Senate

20-11-2013

After months of discussion in the US Congress, finally HR 3204, the Drug Quality and Security Act, which…

LegalMarkets & MarketingNorth AmericaPharmaceuticalProduction

Sagent Pharma debuts Carboplatin Injection

Sagent Pharma debuts Carboplatin Injection

04-11-2013

US specialty drugmaker Sagent Pharmaceuticals has announced the launch of Carboplatin Injection, an antineoplastic…

Asia-PacificCarboplatinMarkets & MarketingNorth AmericaOncologyPharmaceuticalProductionSagent Pharmaceuticals

Genzyme to invest $80 million to expand capacity for Fabrazyme

Genzyme to invest $80 million to expand capacity for Fabrazyme

15-10-2013

French drug major Sanofi’s US biotech subsidiary Genzyme says that it is investing $80 million to build…

BiotechnologyFabrazymeFinancialGenzymeNorth AmericaProductionRare diseasesSanofi

FDA clears Eisai Zonegran facility in UK for US exports

FDA clears Eisai Zonegran facility in UK for US exports

15-10-2013

Eisai says the US Food and Drug Administration has approved the US supply of the epilepsy drug Zonegran…

EisaiEuropeNeurologicalNorth AmericaPharmaceuticalProductionRegulationZonegran

Roche investing 800 million Swiss francs to expand biologics production

Roche investing 800 million Swiss francs to expand biologics production

14-10-2013

Roche said this morning it plans to invest 800 million Swiss francs ($879.2 million) within its global…

BiotechnologyEuropeFinancialGenentechKadcylaNorth AmericaPerjetaProductionRoActemraRoche

Epic Pharma gets rights to sell 12 generics

08-10-2013

Elite Pharmaceuticals (OTCBB: ELTP) has signed a manufacturing and license agreement with fellow USA-based,…

Epic PharmaGenericsLicensingNorth AmericaProduction

Boehringer’s US injectables to cease production

Boehringer’s US injectables to cease production

07-10-2013

Ben Venue Laboratories, a subsidiary of Boehringer Ingelheim, has decided to cease production by the…

Ben Venue LabsBoehringer IngelheimNorth AmericaPharmaceuticalProduction

Ban on FDA-regulated drugs from Ranbaxy's Mohali plant

17-09-2013

There was another blow for India's largest drugmaker Ranbaxy Laboratories (BSE: 500359) yesterday (September…

Asia-PacificDaiichi SankyoGenericsNorth AmericaProductionRanbaxy LaboratoriesRegulation

Eisai's EMEA operation cleared as US supplier of Fycompa in USA

11-09-2013

The US Food and Drug Administration has approved the US supply of Japanese pharma major Eisai's (TYO:…

EisaiFycompaNeurologicalNorth AmericaPharmaceuticalProduction

Theravance reintroduces Vibativ in USA

14-08-2013

US drug developer Theravance (Nasdaq: THRX) says it has commenced shipments of Vibativ (telavancin) into…

Antibiotics and Infectious diseasesAstellas PharmaMarkets & MarketingNorth AmericaPharmaceuticalProductionTheravanceVibativ

Amerigen collaborates with Forest Labs

01-08-2013

US generics drugmaker Amerigen Pharmaceuticals has entered into a collaboration agreement with Forest…

Amerigen PharmaceuticalsForest LaboratoriesGenericsNorth AmericaProduction

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

Grindeks gains new export opportunities in the USA

15-07-2013

Latvian drugmaker JSC Grindeks (GRD1R: RI ) says it has successfully passed a US Food and Drug Administration…

EuropeGenericsGrindeksNorth AmericaProductionRegulation

Waiver from European Commission to help exporting for US pharmaceutical manufacturers

24-06-2013

The US Food and Drug Administration announced on Friday (June 21) that the USA is now a "listed country"…

EuropeGenericsNorth AmericaPharmaceuticalProductionRegulation

US DoJ says Ranbaxy pleads guilty and agrees to pay $500 million in settlements

14-05-2013

In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA, a subsidiary…

Asia-PacificDaiichi SankyoFinancialGenericsLegalNorth AmericaProductionRanbaxy LaboratoriesRegulation

Canada strengthens drug safety with GMP now to apply to all APIs

09-05-2013

Canada's Health Minister Leona Aglukkaq this week announced that Canada's Food and Drug Regulations have…

GenericsNorth AmericaPharmaceuticalProductionRegulation

FDA sends CRL rejecting Allergan's migraine drug Levadex on quality issues

17-04-2013

US drugmaker Allergan (NYSE: AGN) said yesterday (April 16) that the US Food and Drug Administration…

AllerganLevadexNeurologicalNorth AmericaPharmaceuticalProductionRegulation

XenoPort reports Horizant "stockout" due to GSK manufacturing delays

12-04-2013

USA-based XenoPort (Nasdaq: XNPT) says that UK pharma giant GlaxoSmithKline (LSE: GSK), who holds commercialization…

GlaxoSmithKlineHorizantMarkets & MarketingNorth AmericaPharmaceuticalProductionXenoPort

Eli Lilly views additional $180 million investment to expand insulin making in Indianapolis

02-04-2013

US pharma major Eli Lilly (NYSE: LLY) says that it is working closely with the City on a proposal to…

DiabetesFinancialInsulinLillyNorth AmericaPharmaceuticalProduction

GlaxoSmithKline cleared for $91M flu vaccine plant in USA; Gets CRL on Q-Plan H5N1

27-03-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and The Texas A&M University System (TAMUS) say that the US…

GlaxoSmithKlineNorth AmericaPharmaceuticalProductionQ-Plan H5N1RegulationVaccines

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