STAT+: Pharmalittle: AstraZeneca plans to ‘love’ China’s Communist Party; U.S. Supreme Court rules against Amgen in patent case
The U.S. Supreme Court upheld a ruling that Amgen failed to disclose sufficient information about patent claims for its cholesterol drug Repatha.
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We plan to manicure the Pharmalot grounds, catch up on our reading, promenade with the official mascot and his stay-over playmate, and of course, hold a listening party with Mrs. Pharmalot. So far, the rotation will include this, this, this and this. And what about you? This may be an opportunity to tend to the grounds or conduct a wee bit of spring cleaning. You could take a long walk in a park or wander about city streets. Or you could be zen for a while, relax your mind and do absolutely nothing. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
In a case that had the pharmaceutical industry on edge, the U.S. Supreme Court upheld a lower court ruling that Amgen failed to disclose sufficient information about patent claims for a best-selling drug, STAT tells us. The court ruled unanimously that Amgen failed to provide what amounts to a roadmap for others to recreate the claims made in two patents for Repatha, a cholesterol medication. A federal appeals court had previously invalidated the patents after deciding that Amgen filed an overly expansive patent claim that did not disclose enough information so someone else can make the same product, or invention.
A U.S. Food and Drug Administration advisory panel recommended the agency approve a Pfizer RSV vaccine, although the panelists expressed some safety concerns, STAT writes. The committee voted 14-0 that Pfizer data showed the shot was effective in preventing severe disease in infants born to people who were vaccinated during pregnancy. But on a second question — whether the available data support the safety of immunization with this vaccine — the committee voted 10-4. The vaccine could be a game changer. RSV sends about half a million children to emergency departments in the U.S. each year. Between 58,000 and 80,000 of those children end up being hospitalized.
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