And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. Our agenda is somewhat ambitious. We plan to take Mrs. Pharmalot pear picking — yes, pears — and take a few naps when not catching up on our reader. And what about you? You could go door-to-door canvassing for one of the presidential candidates, which could get interesting. Find a quiet spot to enjoy the great outdoors. Or simply plan the rest of your life. Well, whatever you do, have a grand, old time. But be safe. Enjoy, and see you soon …
The third time is the charm for Alkermes after a late-stage clinical trial found its experimental antidepressant demonstrated positive results, Reuters tells us. The drug, known as ALKS 5461, suffered a serious setback earlier this year when two other studies failed to achieve primary endpoints, sending its stock diving at the time, given that the company touted the drug as a potential blockbuster. This may be a test for the US Food and Drug Administration, since Alkermes hopes to win approval based on just one trial, Forbes adds.
The European Medicines Agency has initiated an effort to proactively publish clinical trials data by releasing clinical reports for two drugs, Kyprolis and Zurampic, on a new online database, Regulatory Focus reports. The agency also added that it will publish the results of all trials submitted, regardless of whether the product is ultimately authorized, rejected, or withdrawn.
Gilead Sciences reported that an experimental drug showed promise in reducing liver scarring known as fibrosis in a midstage trial, TheStreet reports. The plan is to advance the drug, called GS-4997, into Phase 3 trials against the fatty liver disease known as NASH. But the drug failed to achieve the main goal of midstage trials for pulmonary arterial hypertension or diabetic kidney disease based on preliminary data analysis
Merck reported that its Keytruda immunotherapy helped previously treated patients with advanced bladder cancer live longer in a late-stage study, prompting an independent monitoring panel to recommend stopping the trial early, Reuters tells us. The drug, along with rival Bristol-Myers Squibb’s Opdivo, is already approved to treat a common form of lung cancer.
Roche’s bid to follow its blockbuster Avastin cancer drug with a newer and better med suffered a setback after an experimental treatment failed in a study against metastatic colorectal cancer, Reuters writes. Roche hoped the drug, called vanucizumab, would win regulatory approval as a stand-alone follow-up for Avastin, after its US patent protection expires in 2019, and biosimilar versions become available.
The UK’s National Institute for Health and Care Excellence switched gears and endorsed Bristol-Myers Squibb’s Opdivo for adults with advanced renal cell carcinoma after prior therapy, PharmaTimes says.
Merck KGgA has merged its pharmaceuticals and consumer health care businesses as part of a major makeover of operations to India, according to The Economic Times.
China Resources Pharmaceutical Group, the nation’s second-largest drug maker, raised $1.8 billion after pricing an intial public offering, below the midpoint of a marketed range, Bloomberg News writes.
Dual challenge for Alkermes:
1) Only one positive trial
2) Sequential Parallel Comparison Designs (SPCDs), where placebo non responders get re-randomized for the second leg of the trial have, to my knowledge never been accepted by FDA as proof of efficacy for purposes of registration. Will be interesting to see what happens.
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