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Is GSK’s 15-day accelerated approval withdrawal the new normal? Hear FDA commissioner Califf’s response

In a surprising move, GSK recently pulled multiple myeloma therapy Blenrep off the U.S. market just 15 days after the drug flunked a confirmatory trial. …

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Regional News

Amid launch spree, Eli Lilly expects revenue growth at the ‘high end of the industry,’ CFO says

Eli Lilly is entering 2023 still riding a high from last year. Amid an expansion spree thanks to launches such as Mounjaro in diabetes, the company is gearing …

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Regional News

Lilly, Biogen and more gear up for blockbuster launches in 2023: report

With many of the world’s top-selling drugs speeding toward patent expirations over the next few years, pharmaceutical companies are hurrying to identify replacements. In its …

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Regional News

AstraZeneca’s first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use

As AstraZeneca fights to defend its aging two-drug inhaler Symbicort against generics, the company has a new approval to bolster its respiratory business. Wednesday, the …

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Regional News

POCN creates HIV Center of Excellence learning hub for NPs and PAs

Last month, POCN, the largest network of physician associates and nurse practitioners, launched the first HIV Center of Excellence in conjunction with HIV Awareness Month. …

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Regional News

Pfizer wins—again—in courtroom fight versus Astellas over Lexiscan patents

It’s near the end of the game and Astellas is running out of timeouts as it tries to stave off generic competition for its scanning …

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Regional News

Amgen garners wide support from pharma peers in Supreme Court patent fight with Sanofi

In a closely watched patent dispute playing out at the U.S. Supreme Court, Amgen has drummed up support from fellow drugmakers large and small, plus …

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Regional News

Novartis pays $245M to settle Exforge generic pay-for-delay lawsuit

Novartis has decided to end a classic generic pay-for-delay legal battle with a series of settlements. The Swiss pharma will pay altogether $245 million in …

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Regional News

Biogen, FDA’s inappropriate Aduhelm coordination detailed in blistering congressional report

A scathing congressional report has detailed communications described as “inappropriate” and “atypical” between Biogen and the FDA regarding the approval of Alzheimer’s disease drug Aduhelm …

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Regional News

Antibiotics pro Centrient runs afoul of FDA at Indian manufacturing plant

The FDA’s cadre of Indian manufacturing investigators has dished up yet another warning letter. This time, the dishonor goes to the local branch of Dutch …

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