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US FDA revokes Roche/Genentech Avastin license for metastatic breast cancer


After months of deliberations, the US Food and Drug Administration (FDA Commissioner is revoking the…

AvastinBiotechnologyGenentechNorth AmericaOncologyPharmaceuticalRegulationRoche

Bipartisan bill introduced in USA to increase penalties for counterfeit drugs


Bipartisan, bicameral legislation was introduced in the USA last week by Senators Patrick Leahy (Democrat,…

HealthcareLegalNorth AmericaPharmaceuticalRegulation

FDA approves Regeneron’s Eylea for wet age-related macular degeneration


Following unanimous advisory panel support for the drug, the US Food and Drug Administration has approved…

BayerBiotechnologyEyleaNorth AmericaOphthalmicsPharmaceuticalRegeneronRegulation

EMA says bleeding risks associated with Boehringer Ingelheim’s Pradaxa can be managed


The European Medicines Agency on Friday providing an update on the safety of independent German drug…

Boehringer IngelheimCardio-vascularEuropePharmaceuticalPradaxaRegulation

Pfizer’s Vyndaqel, first drug to treat rare and fatal disease TTR-FAP, approved in Europe


Following a positive opinion from an advisory committee in the summer (The Pharma Letter July 23), the…

EuropePfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

AstraZeneca’s thyroid cancer drug Caprelsa gets positive CHMP opinion


Anglo-Swedish drug major AstraZeneca (LSE: AZN) revealed this morning that its Marketing Authorization…


EU Commission unveils 12 concrete actions against antimicrobial resistance for the next five years


With about 25,000 patients dying per year in the European Union from infections caused by drug resistant…

Antibiotics and Infectious diseasesEuropePharmaceuticalRegulationResearch

UK’s NICE rejects Eisai’s Halaven for advanced breast cancer


In a second negative from the UK’s National Institute for Health and Clinical Excellence, in final…


Health organizations in USA will act despite political and economic uncertainty, PwC survey finds


In its annual report on the top health industry issues for the year ahead, PwC's Health Research Institute…

HealthcareNorth AmericaPharmaceuticalRegulationResearch

Increase in US drug recalls and warning caused by manufacturing errors and regulatory non-compliance issues, says GBI


The numbers of warning letters and drug recalls issued by and reported to the US Food and Drug Administration…

BiotechnologyNorth AmericaPharmaceuticalRegulation

Dyax and Sigma Tau unit pull EU filing on Kalbitor


USA-based Dyax Corp (Nasdaq: DYAX) says it reached agreement with Defiante Farmaceutica, a unit of privately-held…

Defiante FarmaceuticaDyax CorpEuropeKalbitorPharmaceuticalRare diseasesRegulationSigma Tau

APEC Summit endorses Principles for Industry Codes of Ethics for pharma


The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said yesterday…

Asia-PacificMarkets & MarketingPharmaceuticalRegulation

Another FDA rejection for Alimera’s DME drug Iluvien


Shares of US ophthalmic drug develop Alimera Sciences (Nasdaq: ALIM) plunged nearly 73% to $2 on Friday,…

Alimera SciencesIluvienNorth AmericaOphthalmicsPharmaceuticalpSividaRegulation

Turkey issues new unilateral Health Application Announcement


The Turkey pharmaceutical industry has criticized the new Health Application Announcement (SUT) prepared…


FDA priority review for Roche/Genentech’s vismodegib for skin cancer


The US Food and Drug Administration has accepted and filed Swiss drug major Roche (ROG: SIX) subsidiary…

BiotechnologyCurisGenentechNorth AmericaOncologyPharmaceuticalRegulationRochevismodegib

UK’s NICE says no to AstraZeneca breast cancer drug Faslodex


There was negative news this morning for Anglo-Swedish drug major AstraZeneca (LSE: AZN), when the UK’s…


Will the USA’s Hatch-Waxman lock be sprung in 2012? asks HP&M lawyer


In the USA, there have been rumors for several weeks that, once the ball gets rolling in Congress with…

GenericsLegalNorth AmericaPharmaceuticalPoliticsRegulation

Recordati’s Normosang now approved in Russia; posts strong financials


Italian drugmaker Recordati (REC: MI) and wholly-owned subsidiary Orphan Europe announced that Normosang,…

EuropeFinancialNormosangPharmaceuticalRare diseasesRecordatiRegulation

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