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A new chapter emerged this week in the contentious issue of patent thickets, a web of overlapping patents filed on a single existing product to create barriers to competition and extend effective patent life. Read More
Despite the introduction of eight Humira (adalimumab) biosimilars last year, AbbVie is still holding on to its gargantuan 96 percent market share, largely because pharmacy benefit managers (PBM) are suppressing biosimilar competition, according to two new reports. Read More
A drug manufacturing facility with ungowned, barefoot employees received an FDA Warning Letter that cited “insanitary conditions” in the production of sterile ophthalmic drug products, and was among the manufacturers cited in a recent FDA consumer warning on the risk of contaminated eye drops. Read More
In its first annual report, the CDER Office of Communications pointed to its three main goals, all of which focus on supporting the public’s faith in the FDA to protect public health. Read More
Many drug developers could improve the alignment of their quality units and their business units — and potentially avoid Form 483 inspection observations — if they dusted off and applied the International Council on Harmonization’s ICH Q10 Pharmaceutical Quality System guidance, according to one pharma quality expert. Read More
In a JAMA commentary on the research paper, scholars wrote that production problems are responsible for 70 percent or more of shortages on record. Read More
Following ample input and data provided by the FDA, HHS has issued a white paper detailing its progress in reducing what it labels a “decades-long public health issue” — drug shortages and supply chain vulnerabilities. Read More
Most cancer drugs that gain an Accelerated Approval don’t end up showing any clinical benefit in their confirmatory trials, exposing thousands of patients to ineffective therapeutics that may linger on the market for years until postmarketing studies show their true clinical impact, a new analysis has shown. Read More
Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. Read More