Court orders US FDA to award Bendeka seven years of exclusivity without requiring clinical superiority test; law codifying FDA policy passed prior to suit and is not retroactive.

The Office of Pediatric Therapeutics is working with the Office of Orphan Products Development to make rare pediatric disease determinations, which can help sponsors obtain a priority review voucher.

In addition to reviewing proposed lists of targets for relevance to pediatric cancer, advisory committee will discuss possible criteria for prioritizing same-in-class agents for evaluation and ways to promote international collaboration and global development; proposed list of substantially relevant targets is growing.

Third US Senate committee hearing on 340B reforms focuses on the need for legislation requiring that providers report the drug discounts received and how they use the savings, but prospects for achieving change are unclear.

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.

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.

Predictive Toxicology Roadmap will help make drug development more efficient by promoting new technologies for safety testing, Commissioner Gottlieb says.

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.

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.

Generic industry officials ask that information requests and discipline review letters be issued during ANDA amendment assessments, but the US agency says they are not allowed in GDUFA II.

The potential of an impending “apocalypse” of antibiotic drug shortages means that the pharmaceutical industry should pay careful attention to managing fragile supply chains for these drugs. A report details how manufacturers can manage these supply chains to avert potential shortages.

"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.

Target date moved from August 2018 to February 2019 for publishing an NPRM for allowing currently Rx drug ingredients to be available nonprescription under conditions of safe use. US HHS annual spring update on regulatory priorities for FDA and its other agencies also pushes back target dates for other OTC drug NPRMs, including FDA's long-delayed finalization of several monographs including sunscreen ingredients.