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Approvals & Launches

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Lumakras A Big Focus For Amgen; More Data Coming Soon

Amgen reported 5% year-over-year revenue growth to $6.5bn in the second quarter, up 11% from Q1. It did not break out Lumakras sales but detailed upcoming data that may support future indications.

Sales & Earnings Launches

Podcast: What's Ahead For Aduhelm's Launch And Reimbursement

Scrip and Pink Sheet editors join Datamonitor Healthcare analysts to discuss Biogen's Aduhelm for Alzheimer's disease, including the expected launch trajectory, early commercial barriers to uptake and the Medicare reimbursement environment.

Neurology Launches

AstraZeneca To Challenge GSK After Clinching Lupus Drug Approval

Fears that US regulators would take issue with AstraZeneca's decision to change the endpoints of a second pivotal trial for anifrolumab were unfounded and the first-in-class type I interferon inhibitor is the first new treatment for systemic lupus erythematosus in more than 10 years.

Approvals Immune Disorders

Pipeline Watch: Phase III Readouts For COVID-19, Alzheimer's And Cancer Pain

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

UCB And Analysts Believe Bimekizumab Will Be Super-Blockbuster

The psoriasis market is a tough one for bimekizumab to crack but UCB head of immunology Emmanuel Caeymaex believes the clinical package and investment in promotion will see the IL-17A and IL-17F inhibitor topple its rivals.

Launches Sales & Earnings

GSK’s Shingrix Vaccine Can Reach Millions More

The shingles vaccine could potentially be used in about three million immunocompromised people, according to GSK, but CDC’s advisory committee will weigh in with recommendations.

Approvals Vaccines

Pipeline Watch: Phase III Starts In Hemophilia, Alzheimer's

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Biogen Fires Back At Critics In Defense Of Aduhelm

Management tried to sidestep controversy around the approval of Aduhelm and said it remains confident the drug will be reimbursed.

Sales & Earnings Neurology

Albireo Dashes Into PFIC Market As FDA, EMA Approve Bylvay

The company anticipates an addressable global market for progressive familial intrahepatic cholestasis of 2,500 patients, with initial plans to focus on around 100 physicians at 60 centers.

Rare Diseases Approvals

Biogen: Aduhelm Price Is Part Of Alzheimer's ‘Evolution’

The company insists it will reconsider the price of Aduhelm if the market turns out to be larger than Biogen anticipates, but big price reductions for branded drugs are rare.

Pricing Strategies Launches

Almirall Focus Firmly On Lebrikizumab After Securing Klisyri Approval

Now that the actinic keratosis treatment Klisyri has got the green light in Europe, the Spanish firm's attention will be on atopic dermatitis and forthcoming Phase III data on lebrikizumab, a potential rival to Dupixent.

Approvals Dermatology

Coronavirus Update: Japan Approves Antibody Cocktail In Short Order

Japan has granted an emergency approval to Chugai/Roche/Regeneron's antibody cocktail after a rapid review, while India has emerged as one of the top purchasers globally of COVID-19 vaccines as it looks to protect more of its population. 

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