Ad Header

PharmaLive

Slogan

The Pulse of the Pharmaceutical Industry

  • Filter By Category

  • Filter By Author

Akorn gets another FDA warning letter, shares slide

Akorn Inc. received a warning letter from the U.S. Food and Drug Administration regarding a manufacturing facility in New Jersey, the latest in a string of setbacks for the generic drugmaker, sending the company’s shares down nearly 13 percent.

Read More »

Only Half of Post-Marketing Commitments Get Published in Peer-Reviewed Jounals, Study Shows

Concern about clinical trial transparency, or more accurately the lack of transparency, is an ongoing problem. A new report shows that the lack of transparency also extends to post-marketing commitments that companies agreed to, following regulatory approval of a drug.

Read More »

Catalyst Pharma sues FDA over approval of cheaper rival drug

Catalyst Pharmaceuticals Inc., under fire for a high price tag on a rare disease drug, sued the U.S. Food and Drug Administration to challenge the recent approval of a lower-cost rival medicine.

Read More »

FDA’s Draft Guidance Proposes Ways to Increase Patient Diversity in Clinical Trials

The U.S. Food and Drug Administration issued a draft guidance on improving the diversity of patient populations in clinical trials.

Read More »

Medication-free treatment for depression launches in the UK

Flow, a medical device company, launched a medication-free treatment for depression comprising a brain stimulation headset and therapy app.

Read More »

Weekend Highlights from 2019 ASCO Annual Meeting

There was a flurry of activity during the first few days of the American Society of Clinical Oncology, with multiple presentations made showing the benefits of various oncology treatments.

Read More »

New Phase 3 Interim Results Support Safety and Efficacy of Diroximel Fumarate in Multiple Sclerosis

New interim data from the ongoing open-label, pivotal EVOLVE-MS-1 study indicate that Biogen’s investigational treatment diroximel fumarate was generally well tolerated in people with relapsing MS.

Read More »

BioMarin’s Hemophilia A Gene Therapy Shows Promise in Clinical Trial

San Rafael, Calif.-based BioMarin Pharmaceutical announced positive Phase III clinical trial results for the company’s gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.

Read More »

Nektar Forms New Subsidiary

With an opioid molecule awaiting regulatory review, Nektar Therapeutics announced the launch of Inheris Biopharma, which will be responsible for the commercialization of NKTR-181.

Read More »

Boehringer Ingelheim Lands Positive Results in Lung Disease Trial

Boehringer Ingelheim’s SENSCIS Phase III clinical trial met the primary endpoint for nintedanib in patients with SSc-ILD.

Read More »

Ad Right Top

MedAdNews

Extensive pharmaceutical business and marketing intelligence. For back issues, please contact MDAD@kmpsgroup.com.

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

Subscribe

Ad Right Bottom