Ranbaxy sues FDA over revoking approvals for Nexium, Valcyte copies

MUMBAI (Reuters) – Ranbaxy Laboratories Ltd has sued the U.S. Food and Drug Administration (FDA) for revoking approvals granted to the Indian firm to launch copies of two drugs including AstraZeneca Plc’s heartburn pill Nexium, court documents showed. The FDA told Ranbaxy this month that it believed its decisions to grant the company tentative approvals for copies of Nexium and Roche AG’s antiviral Valcyte were “in error”, after it found that Ranbaxy’s plants at the time were not compliant with the FDA’s manufacturing quality standards. …
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Reggae icon Bob Marley’s family to lend name to cannabis brand

A portrait of Bob Marley hangs next to a menu at the medical marijuana farmers market in Los AngelesBy Eric M. Johnson SEATTLE (Reuters) – The family of Reggae icon Bob Marley and a Seattle-based private equity firm on Tuesday said they are launching the first global cannabis brand with marijuana products sold under a name long tied to a plant he lovingly called "the herb". The brand, dubbed Marley Natural, marks the first time the family's name would adorn packages of cannabis products ranging from strains similar to those Bob might have smoked in his homeland Jamaica to concentrates, oils and infused lotions sold in countries and U.S. …

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FDA puts partial hold on CytRx cancer drug trials

(Reuters) – CytRx Corp said the U.S. Food and Drug Administration placed a hold on enrolling new patients in clinical trials of its experimental cancer drug after a patient died, sending the company’s shares down 11 percent in premarket trading. The patient received the drug, aldoxorubicin, under the company’s expanded access program that makes promising drugs and devices available to patients with serious diseases who do not qualify for the trials. Patients already enrolled in the trials, currently in mid stage, will continue receiving the treatment, CytRx said. …
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AstraZeneca trumpets solo strength in cancer drugs post Pfizer struggle

A sign is seen at an AstraZeneca site in MacclesfieldBy Ben Hirschler and Simon Jessop LONDON (Reuters) – AstraZeneca touted an "industry-leading" line-up of hot new cancer drugs at an investor day on Tuesday, aiming to show it has a strong independent future after seeing off a $118 billion bid from Pfizer in May. The company also brought forward the filing date for a new lung cancer pill, and said it could win between eight and 10 new approvals in 2015-2016 for drugs dealing with a wide range of diseases. …

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