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Pharmaceuticals, health and wellness

AbbVie’s post-Humira stalwarts Skyrizi, Rinvoq performing exactly as hoped, CEO says

AbbVie is relying on its next-gen immunology drugs Skyrizi and Rinvoq to fill what will be a massive sales gap once blockbuster Humira faces generic foes in the U.S. And as the company sees it, everything is going according to plan.  As those meds start to take off, the Chicago-based pharma expects the pair to […]

GlaxoSmithKline’s Nucala beats AZ’s Fasenra to the IL-5 punch in nasal polyps

GlaxoSmithKline’s antibody drug Nucala may not have been the first biologic approved in nasal polyps—that distinction goes to Sanofi and Regeneron’s Dupixent. But on Thursday, it did become the first IL-5 inhibitor to break into the indication, notching a win over AstraZeneca’s would-be rival Fasenra. The FDA gave Nucala the green light to treat chronic rhinosinusitis […]

‘New GSK’ shows strength amid investor pressure, but Shingrix still needs to regain its footing

As activist investor Elliott Management turns up the heat on GlaxoSmithKline, CEO Emma Walmsley’s new vision for the company is showing strength. But while Glaxo’s vaccines business does gangbusters overall, its crown jewel Shingrix has yet to hit its stride after the pandemic knocked it off its course. GSK’s shingles vaccine reeled in £295 million […]

‘I don’t like it:’ Biogen’s latest Alzheimer’s ad rouses fresh Aduhelm concerns—and some defense

Maybe you occasionally forget appointments or social events, or lose your train of thought in a conversation. Maybe you’re feeling depressed or overwhelmed when making a decision.  According to a online symptoms quiz from Biogen and Japanese partner Eisai, those are just a handful of signs of mild cognitive impairment (MCI), an early indication of […]

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 […]

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, […]

J&J’s COVID-19 shot scores safety backing from CDC experts but booster need left for FDA

Johnson & Johnson’s COVID-19 vaccine presents greater benefits than it does safety risks, especially amid the quickly spreading Delta variant, a key CDC expert panel decided. However, the panel said that a ruling over the need for a booster added to all COVID shots will have to start with the FDA.  The CDC’s Advisory Committee […]

Johnson & Johnson eyes $2.5B in COVID vaccine sales as key immunology, oncology meds trounce expectations

Johnson & Johnson certainly hasn’t had the easiest COVID-19 shot rollout. Still, with sales predictions ranging in the billions and a series of manufacturing improvements ongoing, the company sees its pandemic hustle as the start of a new era for an emerging vaccine business.  Johnson & Johnson is forecasting $2.5 billion in full-year sales of its one-shot COVID-19 vaccine, company executives […]

Albireo’s rare liver disease drug Bylvay scores back-to-back approvals in U.S., Europe

With a pair of approvals on both sides of the Atlantic, liver disease-focused biotech Albireo is off and running with its new medicine Bylvay. The oral drug, the first treatment for pruritus in patients with progressive familial intrahepatic cholestasis (PFIC), scored an FDA nod Tuesday and a European approval Monday. With the FDA’s blessing, Albireo is kicking off an “immediate” […]

High-profile Biogen ads hype early Alzheimer’s detection as hospitals reject Aduhelm prescriptions

How do you sell an Alzheimer’s treatment mired in controversy over its disputed benefits? Biogen is turning to “Jim and Jane” for help.  That’s the couple grappling with the memory-robbing disease that Biogen and Japanese partner Eisai have placed at the center of their new marketing campaign, “It’s Time We Know.” The campaign is designed […]