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Research Points to Inconsistent Use of Patient Experience Data in FDA Approvals

Sanofi is pressing the U.S. Food and Drug Administration to keep the company’s patient experience data consistent following a review of approved applications required by the 21st Century Cures Act.

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4D Pharma and Merck Team to Develop Microbiome-based Vaccines

Leeds, UK-based 4D Pharma and Merck/MSD are developing Live Biotherapeutics vaccines, a new class of medicines.

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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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