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Vizimpro Receives EU Marketing Authorization for First-Line Treatment of Adults with EGFR-Mutated NSCLC

Pfizer Inc. announced that the European Commission approved Vizimpro (dacomitinib), a tyrosine kinase inhibitor, as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

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Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analyses of Opdivo in Previously Treated NSCLC Patients

Bristol-Myers Squibb Company announced results from pooled analyses of survival data from four studies (CheckMate -017, -057, -063 and -003; n=664) in patients with previously treated advanced non-small cell lung cancer (NSCLC) who were treated with Opdivo (nivolumab).

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Top 10 Pipelines To Watch: 2019 Annual Report

The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

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J&J’s Janssen Inks Deal With Korea’s Yuhan for NSCLC Drug Valued at up to $1.25 Billion

South Korea-based Yuhan Corporation inked a licensing deal with Janssen for the non-small cell lung cancer drug candidate lazertinib that has the potential to be worth up to $1.25 billion.

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Merrimack Halts Lung Cancer Trial; Stock Plunges More Than 32 Percent

Merrimack Pharmaceuticals’ stock plunged more than 32 percent after the company announced the termination of the SHERLOC Phase II clinical trial.

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FDA snubs Novartis bid to repurpose inflammation drug for heart attacks

The U.S. Food and Drug Administration rejected Novartis’ bid to repurpose canakinumab, a drug already approved for rare inflammatory diseases, for use in a group of heart attack survivors.

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Pfizer’s lung cancer drug gets FDA approval

Pfizer Inc.’s once-daily oral drug Vizimpro to treat a rare form of lung cancer received approval from the U.S. Food and Drug Administration.

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AstraZeneca buoyed as Imfinzi cuts lung cancer deaths by a third

AstraZeneca’s immunotherapy drug Imfinzi cut the risk of death in patients with mid-stage lung cancer by nearly a third in a closely watched clinical study, reinforcing the case for using the drug in earlier disease.

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JHL Biotech Receives Positive CHMP Scientific Advice for Global Phase III Clinical Trial of Proposed Bevacizumab Biosimilar to Treat Lung Cancer

JHL Biotech received a positive Scientific Advice from the Committee for Medicinal Products for Human Use of the European Medicines Agency related to the EU approval pathway for its proposed bevacizumab biosimilar JHL1149 to treat patients with non-small cell lung cancer.

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Anti-PD-L1 Immunotherapy Plus Abraxane Significantly Reduced Risk of Disease Worsening or Death in Patients with Metastatic or Locally Advanced Triple Negative Breast Cancer

Celgene Corporation today announced that the Phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival.

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!


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