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Unauthorized knock-offs of Gilead’s pricey blockbuster hepatitis C therapy, Sovaldi, may soon hit the market in India after the government refused to grant it patent protection. Read More
Drug companies will find more payers refusing to reimburse for cancer drugs if they don’t reduce their prices, pharmacy benefits manager Express Scripts says. Read More
Concerns over potential heart risks have prompted the UK’s Medicines and Healthcare products Regulatory Agency to reclassify the anti-inflammatory drug diclofenac from OTC to prescription-only in tablet form. Read More
The FDA has issued an import alert for an Australian manufacturing plant, barring it from shipping Eli Lilly’s erectile dysfunction drug Cialis into the U.S. Read More
Tekmira Pharmaceuticals is merging with OnCore BioPharma in an effort to develop a cure for hepatitis B and corner a potentially lucrative market. Read More
India appears intent on mending its reputation as being unfriendly to foreign drug patents, with a court temporarily blocking Cipla from marketing its own generic version of Novartis’ COPD therapy Onbrez. Read More
Hikma Pharmaceuticals will launch its gout treatment, Mitigare, after a federal court rejected Takeda’s arguments to block the product, which would compete with Takeda’s drug Colcrys. Read More
Dendreon has not demonstrated that its prostate cancer drug Provenge provides enough benefit over less expensive drugs to justify reimbursement, UK healthcare cost watchdog said this week. Read More
Beginning yesterday, all NDAs will undergo a risk assessment by a team of FDA reviewers that will follow the drug from preapproval through manufacturing and into any eventual generic forms in an effort to ensure quality throughout a product’s lifecycle. Read More