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Pharmaceuticals, health and wellness

Good pharma citizenship is more than tree hugging. ESG needs drug pricing input, analysts say

Pharma environment and social goals need to include—the Institute for Clinical and Economic Review (ICER)? They should, one analyst firm says. The independent drug pricing assessments by ICER could play a role in determining good pharma corporate citizenship, Bernstein analysts say. While environment, social and governance (ESG) measures generally evaluate corporate citizenship around issues like […]

Sandoz’s Enbrel biosim case turned away at SCOTUS, giving Amgen’s blockbuster 8 more years of free rein

After back-to-back losses in court, Novartis’ generics outfit Sandoz had hoped the U.S. Supreme Court would take up its long shot biosimilars case against Enbrel maker Amgen. But now that effort has failed, giving Amgen a clear path to many more years of blockbuster sales for its top drug.  The U.S. Supreme Court denied taking up Sandoz’s petition […]

Charles River lays out $293M to snap up viral vector specialist Vigene, its 2nd M&A deal this year

A few short months after Charles River Laboratories acquired Cognate BioServices, the company is folding yet another CDMO into its cell and gene network, signing more than $1 billion in M&A outlays so far this year.  Charles River Laboratories has inked a deal to pay $292.5 million in cash for gene therapy CDMO Vigene Biosciences, which specializes […]

ACC 2021: Regeneron’s Evkeeza aces triglyceride control, but only in certain patients

Regeneron’s new med Evkeeza already sports an approval in the ultra-rare disease homozygous familial hypercholesterolemia, which is associated with extreme levels of cholesterol. But thanks to competition in the field, it’s not expected to make a big splash, sale-wise. Now, though, Evkeeza boasts data that could help it garner bigger approval in severe hypertriglyceridemia—provided it can find the right […]

ACC 2021: J&J, Bayer pad case for Xarelto in post-surgery artery disease patients

With an approval filing already on the FDA’s docket, Bayer and Johnson & Johnson are padding their case for launching legacy blood thinner Xarelto in artery disease patients after surgery. In long-term data from its pivotal trial in peripheral artery disease, Xarelto plus aspirin cut the risk of a variety of clot-related episodes—acute clots in the limbs, a major […]

ACC 2021: AstraZeneca’s Farxiga failed to help COVID-19 patients, but it’s safe for them to use

As doctors faced the novel coronavirus without an arsenal early last year, AstraZeneca wondered whether its diabetes drug Farxiga could help prevent organ failure and death among the most vulnerable COVID-19 patients. Because the oral SGLT2 inhibitor can protect organs in people with Type 2 diabetes, heart failure and chronic kidney disease, it might do the same for at-risk patients hospitalized with […]

Moderna, Pfizer join the popular crowd, catapulting into the top 10 of America’s favorite companies

Americans love their vaccine makers. Cases in point? Moderna and Pfizer leapt into the top 10 best-regarded companies in the U.S. in the annual Axios Harris 100 survey. They’re the first biopharma companies to crack the top 10 in the ranking’s 20-year history. Johnson & Johnson, which counts pharma as one of its three divisions, has landed in the […]

Can a small biotech challenge Alexion’s Soliris? With Empaveli’s FDA nod, Apellis can give it a try

More than a year after Apellis Pharmaceuticals proved its C3 inhibitor pegcetacoplan could go head-to-head with industry heavyweight Soliris in patients with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), the biotech is finally getting its shot at the market.  The FDA on Friday approved Apellis’ pegcetacoplan, an under-the-skin injection now dubbed Empaveli, to treat adults with PNH. The disease […]

ACC 2021: Novartis looks for silver linings in Entrestro’s narrow loss to an ACE inhibitor in heart attack patients

Novartis had hoped Entresto could find itself yet another niche, this time in patients who’d had a heart attack. But in late April, a large study found the heart failure drug couldn’t quite top the widely used ACE inhibitor ramipril in those patients, at least in a statistically significant way. But that doesn’t mean the company isn’t […]

FDA releases treasure trove of Trump administration emails from early days of COVID-19 crisis

What was going through the minds of the FDA officials during the earliest days of the COVID-19 pandemic? Thanks to hundreds of emails released by the FDA on Thursday—forced through the Freedom of Information Act—enquiring minds can find out. It’s still just a glimpse, however, as quite a bit of the text copy, subject lines […]

Heron’s newly-minted opioid alternative for post-surgical pain headed for blockbusterland, analysts say

The third time’s the charm for Heron Therapeutics, which unveiled an FDA approval for its opioid alternative for post-operative pain, Zynrelef, on Thursday. To the company’s chagrin, Zynrelef’s U.S. label is slimmer than anticipated. Still, analysts are already predicting the drug could spread its wings beyond its three initial indications—and eventually soar into blockbuster territory. […]

Zero Johnson & Johnson COVID-19 vaccine doses set to ship next week as production holdup lingers

Johnson & Johnson’s COVID-19 vaccine ran into a big setback in late March when U.S. officials paused the rollout to investigate rare blood clots. While that issue has been resolved with a new warning about the rare risk, the company’s shot is running into another type of pause—a lack of supply.  The federal government doesn’t plan to ship any J&J COVID-19 […]