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Merck Cancer Drug Shines Against Skin, Lung Cancer

Merck’s immune-boosting cancer drug, Keytruda, bested the standard of care in advanced melanoma, the deadly skin cancer, and showed promising results in non-small cell lung cancer. Based on these data, Merck says it has filed an application with the Food and Drug Administration for Keytruda to be used in non-small cell lung cancer, and will soon […]

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Opiate overdoses fall after debut of abuse-resistant OxyContin

(Reuters Health) – Opiate prescriptions and overdoses in the U.S. have declined since the debut of an abuse-resistant version of the painkiller OxyContin and the market withdrawal of the narcotic Darvon, a study finds. Researchers reviewed insurance claims records with data on prescriptions and hospitalizations for more than 30 million adults covered by UnitedHealthCare from […]

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Merck Announces Submission of Supplemental Biologics License Application to U.S. FDA for KEYTRUDA in Advanced Non-Small Cell Lung Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer (NSCLC). KEYTRUDA previously received Breakthrough Therapy […]

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Teva shares slide on generic Copaxone fears

(Reuters) – Teva Pharmaceutical Industries shares slid five percent on Sunday after U.S. regulators approved a generic version of its top-selling multiple sclerosis drug and amid reports it was mulling a bid for rival Mylan. Teva’s Tel Aviv shares fell to 249.80 shekels ($64) late on Sunday, the first day of trading since both news […]

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Bristol’s Opdivo proves effective against second type of lung cancer

A large study of Bristol-Myers Squibb Co’s Opdivo treatment has been halted after proving the drug is effective against the most common form of lung cancer, the company said, positioning the medicine for far wider use than its already approved lung cancer and melanoma indications. The U.S. drugmaker on Friday said the study, called Checkmate-057, […]

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Pfizer wins first U.S. trial over Zoloft birth-defect risk

  Pfizer Inc. scored a key victory Friday when it was cleared of liability in the first U.S. trial involving claims that its antidepressant Zoloft can cause birth defects in children born to women who take the drug while pregnant. Plaintiff Kristyn Pesante claimed that Pfizer failed to warn that using Zoloft during pregnancy could […]

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U.S. FDA approves Amgen’s Corlanor heart failure drug

An Amgen sign is seen at the company’s office in South San Francisco, California, October 21, 2013. Reuters/Robert Galbraith (Reuters) – U.S. health regulators on Wednesday approved Amgen Inc’s Corlanor to treat patients with chronic heart failure, giving the world’s largest biotechnology company its first cardiovascular product. The Food and Drug Administration approved the use […]

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Should The FDA Require CV Outcome Studies For Diabetes Drugs Before Approval?

As the waistline of Americans has increased, so has the incidence of Type 2 diabetes. Startling data from the Centers for Disease Control  shows that that prevalence of this disease, which is directly related to obesity, now exceeds 9% in the adult population. It was less than half that rate in 1996. Furthermore, there doesn’t […]

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Diabetes Drugs Get Neither Restrictions Nor Endorsements From FDA Committee

Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical  trials with the drugs be added to the drugs’ labels. […]

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FDA panel backs safety updates for AstraZeneca, Takeda drugs

A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. Reuters/Phil Noble (Reuters) – AstraZeneca Plc’s diabetes drug Onglyza and Takeda Pharmaceutical Co.’s rival product Nesina should carry information about the risk of heart failure, an advisory committee to the U.S. Food and Drug Administration said on Tuesday.   Heart […]

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