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Kaleido Biosciences Emerges From Stealth Mode With $65 Million and Will be Helmed by Fomer Cubist Exec

Kaleido Biosciences emerged from stealth mode with an additional capital raise, hitting a total of $65 million. In addition, the company appointed Mike Bonney as chief executive officer and chairman of the board.

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Roche Slammed With Partial Holds for Two Combo Cancer Trials

Two Roche drugs were placed on partial clinical hold as the U.S. FDA continues to examine potential dangers of checkpoint inhibitors following deaths associated with Merck’s Keytruda.

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Exclusive: FDA plans new compounding pharmacy policy, agency head says

The head of the U.S. Food and Drug Administration said the agency is working on a new policy that would encourage more compounding pharmacies to register under a law enacted in the wake of a deadly 2012 meningitis outbreak linked to one such company.

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European panel backs Janssen’s psoriasis drug

A European Medicines Agency panel recommended the approval of Johnson & Johnson unit Janssen’s drug guselkumab for treating plaque psoriasis in adults.

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EU agency backs Tesaro’s ovarian cancer drug

A European Medicines Agency panel recommended the approval of Tesaro Inc.’s key drug niraparib for the treatment of recurrent ovarian cancer.

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Drug industry on tenterhooks as Maryland price-gouging law nears

As U.S. consumer outrage grows over prescription drug prices, state authorities and patient advocates in Maryland are preparing to enforce the nation’s first law designed to punish drugmaker price-gouging.

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Bavarian Nordic Plummets 49% After Cancer Vaccine Flunks Late-Stage Test

Shares of Bavarian Nordic A/S were down more than 49 percent following the failure of the company’s late-stage prostate cancer drug Prostvac.

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Massachusetts’ Flexion Terminates R&D Deal With AstraZeneca

Flexion Therapeutics scrapped an eight-year-old agreement with pharma giant AstraZeneca to develop an end-stage osteoarthritis treatment.

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FDA Approves First Cancer Biosimilar

Amgen, in partnership with Allergan, announced that the U.S. Food and Drug Administration approved its biosimilar for Genentech’s Avastin. The biosimilar Mvasi (bevacizumab-awwb) was approved for a broad swath of cancer indications.

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Santhera shares plummet after negative CHMP opinion

Swiss drugmaker Santhera’s shares plunged nearly 60 percent after a European panel recommended against approving one of the company’s drugs to be used in patients with Duchenne muscular dystrophy (DMD).

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December 2018 Focus: Healthcare Agency Roundtable, Mobile Marketing, and more!


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