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Clinical / R&D

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Latest From Research & Development

Medically Senseless: Why EU Pediatric Investigation Plans Should be Abandoned

Most clinical trials required under EU pediatric investigation plans are medically senseless, and many cause harm to patients, argues consultant Klaus Rose. This is a challenge not only for the pharmaceutical industry but for regulators and wider society as well.

Pediatrics Europe

Keeping Track Of CRLs: US FDA Again Faults Bausch + Lomb Manufacturing

A look at recent developments tracked by the Complete Response Letters chart on the Pink Sheet's US FDA Performance Tracker.

Complete Response Letters Regulation

English PrEP Study To Use Mylan’s Generic Version Of Gilead’s Truvada

A study of tenofovir plus emtricitabine in HIV pre-exposure prophylaxis is to begin in England in September, using Mylan’s generic version of Gilead’s originator drug Truvada. Wales is running a similar trial with Truvada, while Scotland has decided to fund the drug for PrEP under the National Health Service.

Clinical Trials Cost Effectiveness

Keeping Track: US FDA Approvals Of Mavyret, Idhifa, Vyxeos Headline Week Of Breakthroughs, Hematology And Hematology BTDs

The latest drug development news and highlights from our FDA Performance Tracker.

Approvals Biosimilars

Commercial Capsules: Pfizer's Tax Reform M&A Pause; PARP Deals; PD-1 Sales; Antimicrobial Financing

Pfizer's CEO says uncertainty over US tax reform was staying his hand in M&A; following AstraZeneca's MYSTIC miss, Bristol-Myers Squibb and Merck & Co. were duly grilled over their own PD-1/CTLA-4 combination programs; recent deals highlight gathering enthusiasm for combining PARP and PD-1/PD-L1 inhibition. Commercial Capsules rounds up key commercial news reported recently by sister publication Scrip.

Deals Commercial

Cancer Immunotherapy: When To Stop Treatment Remains Unanswered Question

Long-term or open-ended treatment with PD-1/PD-L1 inhibitors is a burden for patients and the healthcare system and does not fit the biological paradigm of cancer immunotherapies, experts say; however, challenges to studying shorter durations include fears of undertreatment and patient objections to stopping a therapy that appears to be working.

ImmunoOncology Clinical Trials
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