Industry calls for more education amid concerns that brand sales reps are encouraging providers to use only interchangeable products because they are better than biosimilars.

Commercials citing non-severe side effects dilute message, London study concludes; US FDA finds price comparison claims may cause physicians to think a drug's risks are less severe and that risk info is less prominent on mobile devices.

A biological that is being developed to treat the life-threatening genetic disorder, XLHED, in babies has had its ups and downs, but it has now been accepted on the European Medicines Agency’s PRIME scheme for getting drugs for unmet medical needs to patients faster. Other recipients of PRIME designations this month are Ignyta and, seemingly, GSK.

HTA body NICE has rejected in draft guidance the use in the NHS in England of Opdivo (nivolumab) in bladder cancer. Also, the BMS product is unlikely to gain reimbursement from the Cancer Drugs Fund for the indication because further clinical trials in bladder cancer are not ongoing. Similar issues affect the initial rejection by NICE of lenvatinib and sorafenib in advanced metastatic differentiated thyroid cancer patients.

Senators and witnesses rehashed years-old arguments and found little common ground on which elements of drug pricing to address.

Upcoming White House report on antibiotic incentives will provide a strong endorsement of one-time payments to reward successful development of new therapeutics. That is a mixed blessing for advocates for legislative action for incentives who are focusing on 'wildcard' patents.

Research centers are collaborating on projects to find causes of disease; Ampligen, Rituxan and KPAX-002 are only drugs in clinical trials.

Phase I/II data from Opdivo/Yervoy combination in SCLC provide more evidence that tumor mutation burden is emerging as a biomarker for immunotherapy, but commercial value is unclear and results don't have implications for the all-important CheckMate 227 non-small cell lung cancer trial, analysts say.

Following a public consultation earlier this year, Health Canada has asked for expert advice on its plans to allow the release of clinical data that is currently considered confidential. It expects to publish draft regulations this autumn.

Hybrid approach to pharmacy benefit management expected to save insurer $4bn annually after Anthem ends its relationship with Express Scripts in 2020. Integration of medical and Rx benefit data could lead to more value-based contracting.

Sam Taylor, Pfizer’s head of global pricing, shares his wisdom on the increasingly complex subject of international reference pricing.

As Pfizer re-examines a potential sale of its consumer business, analysts expect it would attract suitors for its unit, with $15bn to $17bn a likely price, but also say it might be better off continuing to compete in the sector that accounted for around $3.4bn of its 2016 revenues.

FDA is on track to name eight EU member country inspectorates as partners capable of conducting GMP surveillance inspections on behalf of the US by a Nov. 1 deadline. Another four are expected to be named by March 2018. The FDA plans to name all 28 EU member countries as partners by mid-2019.

Dasan didn't test glycerin for DEG; Akorn didn't see the problem with washed-vial conveyor belt crumbs; Evertogen was undone by a desk audit; six unsanitary compounders were warned; four firms were hit with drug GMP import alerts.

ANDA sponsors can file a 'request for reconsideration' disputing regulatory decisions and can appeal some – but not all – of the agency's decisions. If manufacturers are still not happy with outcome, they can go through the formal dispute resolution process.

Maker of Rx Vascepa says it's not asking trade panel to interpret the FD&C Act, but to investigate whether some omega-3 ingredient suppliers and marketers are failing to fulfill "certain marketplace expectations about the nature" of their products. ITC is about to decide whether to investigate complaint, which could impact a number of dietary supplement firms.

Compiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

J&J’s worldwide OTC drug division sales rose 4.4% to $1bn, driven by the Tylenol and Nicorette brands, the firm reports Oct. 17. Those revenues helped offset softness in the firm’s Listerine and other oral care products due to more competition online from start-ups selling straight to consumers.