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Pharmaceuticals, health and wellness

Merck’s Keytruda scores first-in-class nod in early triple-negative breast cancer despite FDA’s prior reluctance

The FDA had reservations about Merck & Co.’s proposed use of Keytruda around surgery for patients with early triple-negative breast cancer. But less than three months after seeing additional clinical data, the agency has overcome its reluctance. Overturning a previous rejection, Keytruda has won an FDA go-ahead to be used alongside chemotherapy before surgery and […]

‘Godmother of Soul’ joins pharma-backed campaign to boost cancer screenings after pandemic dropoff

Grammy-award winning singer Patty LaBelle is taking to the kitchen to increase cancer screenings as part of a new effort sponsored by more than a dozen pharma companies. The Godmother of Soul talks about the importance of time in cooking—time to add salt or time to take food off the burner—and relates it to the importance of routine testing in the public […]

As GlaxoSmithKline works to get Shingrix back on track, an FDA approval increases the key vaccine’s reach

In response to the coronavirus pandemic knocking Shingrix off its juggernaut course, GlaxoSmithKline plans a “relaunch” to get the rising star vaccine back on its upward trajectory. Now, that effort has received a boost as the FDA on Monday approved the shingles vaccine in adults age 18 and older who are immunocompromed and thus are at a greater […]

Emergent’s new opioid awareness campaign taps NFL’s Darren Waller to tackle overdose stigma

While COVID-19 dominated headlines last year, an epidemic of overdoses roiled quietly in the background. Amid the pandemic, U.S. officials recorded the highest tally of drug overdose deaths ever over a 12-month period, with the vast majority stemming from opioids. Now, Emergent BioSolutions has joined forces with a syndicate of nonprofits—plus a former Congresswoman, a […]

Pfizer, Johnson & Johnson settle high-profile Remicade biosim lawsuit on undisclosed terms

For nearly four years, pharmaceutical heavyweights Johnson & Johnson and Pfizer have sparred in court over competitive dynamics of the biosimilar industry, demanding the attention of the industry in a groundbreaking case that had some promise to serve as a bellwether for the future. Instead, the closely-watched battle, in which Pfizer claimed J&J unfairly stifled competition […]

Look out, Lilly: Biogen’s Aduhelm likely won’t be the only Alzheimer’s med subject to Medicare’s coverage review

When the Biden administration eventually makes its decision over whether Medicare will cover the controversial and costly Alzheimer’s drug Aduhelm, Biogen shouldn’t be the only drugmaker paying attention.  That’s because whatever consensus the Centers for Medicare and Medicaid Services (CMS) reaches over Aduhelm will apply to all future monoclonal antibodies, including Eli Lilly’s beta amyloid-targeting […]

Better together: McCann and FCB health chiefs talk strategy and strengths in creating IPG Health

With 39 agencies now under its collective umbrella, there aren’t many pharma marketing challenges that the new IPG Health can’t address. And that’s the point, say IPG Health’s executive chairman John Cahill and chief commercial officer Mike Guarino. Marrying McCann Health’s global footprint and science communication strengths with FCB Health’s creativity and specialty data strategies […]

Despite JAK ‘anxiety,’ ICER experts overwhelmingly back Incyte’s ruxolitinib cream in atopic dermatitis

Officials may have concerns about JAK inhibitor safety overall, but the case for Incyte’s ruxolitinib cream in atopic dermatitis looks good, experts convened by the Institute for Clinical and Economic Review said. At an evidence review panel late last week, ICER’s panel voted 12 to 1 in favor of ruxolitinib cream’s net benefit, RBC Capital Markets analysts wrote in […]

Bristol Myers, yielding to FDA pressure, pulls Opdivo in post-Nexavar liver cancer

Amid a regulatory campaign targeting immuno-oncology agents, Bristol Myers Squibb figured it’s probably futile to keep fighting the FDA on Opdivo’s shaky use in previously treated liver cancer. On Friday, Bristol Myers said it’s voluntarily withdrawing Opdivo’s approval in hepatocellular carcinoma patients who previously received Bayer’s standard-of-care Nexavar. The decision came about three months after […]

AstraZeneca’s newly acquired Soliris is overpriced in myasthenia gravis, cost watchdog says

Now that Alexion’s Soliris is in AstraZeneca’s hands, the drugmaker is counting on the C5 inhibitor to help push it toward billions in sales in just a few years. But a prominent drug pricing watchdog is raising a red flag over its costs for patients with a rare neuromuscular disorder.  The Institute for Clinical and […]

Lumen plots site at nearby Seattle bakery as it ramps up production of algae-based biologics

To unlock the potential of biologics, Seattle, Washington-based startup Lumen Bioscience turned to a blue-green algae most popular in recent years as a dietary supplement. With three clinical programs now headed for phase 2, the company has decided it’s time to expand.  Lumen has snagged the lease to a former Seattle bakery that it will soon use to make large volumes […]

Takeda lays out $126M to tap robotics, virtual reality and more at California production site

After recently opening one cell therapy plant and breaking ground on another in Massachusetts, Takeda is pivoting westward to beef up production in California. The Japanese drugmaker is injecting $126 million into its Thousand Oaks facility to boost manufacturing and support new product lines, Pacific Coast Business Times first reported. Takeda was joined by the city’s mayor, […]