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Endo Submits Biologics License Application to FDA for CCH in Patients with Cellulite

Endo International plc submitted a Biologics License Application to the U.S. Food and Drug Administration for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.

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Immunomedics’ CEO and President Steps Down

Morris Plains, N.J.-based Immunomedics announced that the company’s president, chief executive officer and board member, Michael Pehl, was stepping down for personal reasons.

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FDA Approves Split-Dosing Regimen for Darzalex

The U.S. Food and Drug Administration gave Janssen Biotech and the Johnson & Johnson company’s research partner Genmab an approval for their Darzalex split-dosing regimen.

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FDA Places Cervical Cancer Study on Clinical Hold

The U.S. Food and Drug Administration placed Princeton, N.J.-based Advaxis’ Phase III clinical trial of axalimogene filolisbac (AXAL) in advanced cervical cancer on partial clinical hold.

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Amid Government Shutdown, Companies Try New Approaches to IPOs

2018 was a record year for biotech initial public offerings (IPOs), but 2019 is off to a slow and rocky start because of the government shutdown.

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FDA Gives Merck Thumbs-Up for Two New Indications

Merck received FDA approval for new indications for the PARP inhibitor Lynparza – which is jointly developed and commercialized by AstraZeneca – and the checkpoint inhibitor Keytruda.

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Momenta Slashes Workforce and Leadership Following Strategic Review

Despite winning regulatory approval for a copycat version of Copaxone earlier in 2018, Cambridge, Mass.-based Momenta Pharmaceuticals completed a strategic review that includes slashing staff by 50 percent as the company focuses resources on two biosimilar candidates in the pipeline.

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FDA extends review of Roche’s Tecentriq by 3 months

Roche said the U.S. FDA extended by three months the review period for Tecentriq in combination therapy as a first-line treatment for a form of lung cancer.

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Eylea Shows Promising Data for Diabetic Retinopathy

Regeneron Pharmaceuticals announced positive top-line data from the Phase III PANORAMA study of Eylea (aflibercept) injection in moderately severe to severe non-proliferative diabetic retinopathy.

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FDA Accepts for Filing Supplemental Biologics License Application for Xeomin in Adult Patients with Sialorrhea

Merz North America announced today that the U.S. Food and Drug Administration accepted for filing a supplemental Biologics License Application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients.

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