Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Assessing the extent of a molecular target's substantial relevance to pediatric cancer could give sponsors more regulatory certainty as to whether they likely would be required to conduct pediatric investigations early in a drug’s development, US FDA's Gregory Reaman says at advisory committee review of molecular target candidate lists.

The European Medicines Agency has updated its guidance on Brexit to offer companies more advice on the regulatory changes they will need to make in areas like transfers of MAs, rapporteurships and orphan designations, multi-country packs, and Article 58 opinions.

Venezuela has accused the pharmaceutical industry of holding up medicines supplies and says it will acquire them instead through the Pan American Health Organization.

Promising non-traditional antibiotic therapies need a clear path to market to entice investment, US Biomedical Advanced Research and Development Authority official says.

Promising non-traditional antibiotic therapies need a clear path to market to entice investment, US Biomedical Advanced Research and Development Authority official says.

With Flatiron, Roche is at the forefront of the emerging field of RWE. Roche Pharma President O’Day described how the company is using such data in the real world of regulation and reimbursement.

The four latest products to be accepted onto the European Medicines Agency’s popular priority medicines scheme target mantle cell lymphoma, chikungunya, hematopoietic stem cell transplant patients, and the rare monogenic disease, X-linked myotubular myopathy.

Third-party value assessment organization says AbbVie/Neurocrine's elagolix would be cost effective for endometriosis and associated pain, using a placeholder price of $7,000 per year. But the cost would be substantial for health budgets given the broad prevalence of the condition. 

Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but six states. Interactive map notes state-by-state provisions.

FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.

The European Medicines Agency has updated its guidance on Brexit to offer companies more advice on the regulatory changes they will need to make in areas like transfers of MAs, rapporteurships and orphan designations, multi-country packs, and Article 58 opinions.

US FDA touts new evidence that high performance of pharmaceutical manufacturing sites on 10 quality maturity metrics correlates with robust pharmaceutical quality systems, operational excellence and good business. An FDA-funded study by St. Gallen also finds that low performance, on the other hand, correlates with manufacturing problems.

"We can say we are OTC but the botanicals are doing a lot of the heavy lifting," says Kelli Rodriquez, the firm's sales and marketing chief. Salicylic acid supports the acne treatment claim under an OTC monograph; leaving out benzoyl peroxide, an allergen for some consumers, also allows labeled use more frequently with a claim of faster symptom reduction.

Energy & Commerce's Republican and Democrat leadership ask FDA Commissioner Scott Gottlieb about work by the agency's Office of Criminal Investigations focused on opioid drugs, the office's staffing and its priorities. They note FDA's FY2018 appropriation included $94m for its work in international mail facilities.