Cost gatekeepers give final ‘no’ to Pfizer’s targeted cancer drug Xalkori

Tracy Staton Clinically effective but not cost-effective. That's what U.K. watchdogs have determined about Pfizer's targeted lung cancer drug, Xalkori. Despite a discount offer ...

Merck gives up on unsuccessful Januvia combo drug Juvisync

Tracy Staton As it announced cuts to its full-year sales forecast in July, Merck was able to point to growth in sales of Januvia and its offshoots, if only in the low-single-digit range. FiercePharma ...

UK To Keep Special Cancer Drug Fund As Battle Over NICE Rages

esilverman The pharmaceutical industry has won a victory in the UK, where the government has decided to renew more than $ 300 million in special funding for a controversial ...

U.K. to extend cancer drug fund for treatments NICE rejects

Eric Palmer The cancer drug fund has been an important safety valve for some drugmakers. FiercePharma News

Nektar Therapeutics shares crash on PhII pain drug trial flop

John Carroll FierceBiotech News

Infinity dumps lung cancer drug after PhII trial fails survival test

John Carroll Investigators say that the treatment failed to produce a statistically significant improvement in overall survival, forcing the biotech to wash its hands of the program ...

Duragesic (fentanyl) Patches: Drug Safety Communication – Packaging Changes to Minimize Risk of Accidental Exposure

barbara.lempert Duragesic (fentanyl) Patches: Drug Safety Communication – Packaging Changes to Minimize Risk of Accidental Exposure AUDIENCE: Pharmacy, Patient ISSUE: FDA is ...

Roche lung cancer drug bags another ‘breakthrough’ at the FDA

John Carroll Roche has won bragging rights to the FDA's new Breakthrough Therapy designation for its ALK inhibitor alectinib, a non-small cell lung cancer drug which will be featured ...

Novartis COPD drug gets approvals in EU, Japan

Eric Palmer Novartis is launching the expected blockbuster into a rapidly expanding but increasingly competitive market as established players and newcomers vie for their piece of the ...

Indian drug regulator reaches out to other countries as issues mount

Eric Palmer With problems for its drugmakers mounting, Drug Controller General of India G. N. Singh is confabbing with regulators in Europe this week about the cGMP standards that they ...

Under Sedation? A Merck Setback As FDA Rejects Anesthesia Drug

esilverman (In a move that is unlikely to come as a big surprise, the FDA has bounced a Merck drug for anesthesia over concerns about a hypersensitive study that had been requested ...

Merck R&D hammered by another setback as FDA rejects anesthesia drug (again)

John Carroll According to the pharma giant, this latest black eye for the trouble-prone R&D group comes after the FDA "raised concerns about operational aspects of a hypersensitivity ...
Page 20 of 45« First...10...1819202122...3040...Last »
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS