Regulation - North America, Mergers & Acquisitions

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FTC approves final order regarding Actavis’ acquisition of Warner Chilcott

FTC approves final order regarding Actavis’ acquisition of Warner Chilcott

12-12-2013

Following a public comment period, the US Federal Trade Commission has approved a final order settling…

ActavisGenericsMergers & AcquisitionsNorth AmericaRegulationReproductiveWarner Chilcott

Actelion bid for Ceptaris looks secured as FDA approves Valchlor

26-08-2013

Privately-held USA-based Ceptaris Therapeutics revealed yesterday (August 26) that the US Food and Drug…

ActelionBiotechnologyCeptaris TherapeuticsDermatologicalsMergers & AcquisitionsNorth AmericaRegulationValchlor

Bayer and Onyx file for EU and US approval for expanded use of Nexavar; completes Steigerwald buy

01-07-2013

German drug major Bayer (BAYN: DE) and US partner Onyx Pharmaceuticals (Nasdaq: ONXX) have filed for…

BayerBiotechnologyEuropeMergers & AcquisitionsNexavarNorth AmericaOncologyOnyx PharmaceuticalsPharmaceuticalRegulationSteigerwald

Briefs: Depomed drops Sefelsa after CRL: Sun Pharma stalking Meda?

03-06-2013

US specialty drugmaker Depomed (Nasdaq: DEPO) says that Food and Drug Administration issued a complete…

DepomedMedaMergers & AcquisitionsMetabolicsNorth AmericaPharmaceuticalRegulationResearchSefelsaSun Pharmaceutical Industries

Briefs: Sanofi to up stake in Regeneron; Bayer files for riociguat approval

12-02-2013

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) saw its shares rise 4.8% to $173.84 in early trading…

BayerBiotechnologyEuropeFinancialMergers & AcquisitionsNorth AmericaPharmaceuticalRegeneronRegulationRespiratory and PulmonaryriociguatSanofi

FDA approves Protein Sciences egg-free flu vaccine Flublok; and Octapharma's Octaplas

18-01-2013

The US Food and Drug Administration revealed it has approved privately-held US biotech firm Protein Sciences…

Anti-viralsBiotechnologyFlublokMergers & AcquisitionsNorth AmericaOctapharmaOctaplasPanblokPharmaceuticalProtein Sciences CorpRegulationVaccines

Bayer's Xarelto gets EU clearance for PE and prevention of DVT; gives up on Schiff acquisition

21-11-2012

Following swiftly on similar news from the US Food and Drug Administration, German drug major Bayer (BAYN:…

BayerCardio-vascularEuropeJanssenJohnson & JohnsonMergers & AcquisitionsNorth AmericaPharmaceuticalRegulationSchiff Nutrition InternationalXarelto

US FDA clears Amarin's Vascepa, a competitor for Lovaza

30-07-2012

The US Food and Drug Administration has approved biotech firm Amarin's (Nasdaq: AMRN) Vascepa (icosapent…

AmarinBiotechnologyCardio-vascularGlaxoSmithKlineLovazaMergers & AcquisitionsNorth AmericaRegulationVascepa

GSK and Theravance file for FF/VI approval in the USA and Europe; Talks with Human Genome?

16-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) announced on Friday…

BiotechnologyBreoEuropeGlaxoSmithKlineHuman Genome SciencesMergers & AcquisitionsNorth AmericaPharmaceuticalRegulationRelovairRelvarRespiratory and PulmonaryTheravance

GlaxoSmithKline pulls sNDA for Tykerb plus Herceptin; Watson/Actavis update

13-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed yesterday that it has withdrawn a supplemental New…

ActavisGenericsGlaxoSmithKlineHerceptinMergers & AcquisitionsNorth AmericaOncologyPharmaceuticalRegulationRocheTykerbWatson Pharmaceuticals

US regulator puts conditions on Johnson & Johnson's proposed buy of Synthes

12-06-2012

The US Federal Trade Commission will require health care giant Johnson & Johnson (NYSE: JNJ) to sell…

Johnson & JohnsonMergers & AcquisitionsNorth AmericaPharmaceuticalRegulationSynthes

J&J's Janssen files Xarelto with FDA for new indication; buys Chinese firm

03-05-2012

US health care major Johnson & Johnson's (NYSE: JNJ) subsidiary Janssen Research & Development says it…

Asia-PacificBayerBioseal BiotechBiotechnologyCardio-vascularJanssenJohnson & JohnsonMergers & AcquisitionsNorth AmericaPharmaceuticalRegulationXarelto

Mylan gets OK for generic Crestor in Canada; Rottapharm deal looks dead

18-03-2012

The Canadian subsidiary of US generic drugmaker Mylan (Nasdaq: MYL) has received approval from Health…

AstraZenecaCardio-vascularCrestorEuropeGenericsMergers & AcquisitionsMylan LaboratoriesNorth AmericaPharmaceuticalRegulationRottapharm

Shire to acquire FerroKin BioSciences; drops Replagal BLA

16-03-2012

Ireland-headquartered Shire (LSE: SHP) said yesterday that it has signed an agreement to acquire privately-held…

FerroKin BioSciencesMergers & AcquisitionsNorth AmericaOncologyPharmaceuticalRare diseasesRegulationReplagalShire

Hikma adds to stake in Promopharm; gets US appro for argatroban

22-01-2012

Fast-growing Jordan headquartered Hikma Pharmaceuticals (LSE: HIK) says that it has increased its stake…

ArgatrobanCardio-vascularGenericsHikma PharmaceuticalsMergers & AcquisitionsNorth AmericaPharmaceuticalPromopharmRegulationRest of the World

Biotech predictions for 2012 from sector specialist Steven Burrill

03-01-2012

As 2011 drew to a close, Steven Burrill, chief executive of global life sciences financial services firm…

BiotechnologyFinancialMergers & AcquisitionsNorth AmericaPharmaceuticalRegulation

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