January 2024

FDA slams Eugia with Form 483 and posts older reprimands for AGC, Baxter

FDA slams Eugia with Form 483 and posts older reprimands for AGC, Baxter

Aurobindo subsidiary Eugia US received an FDA Form 483 write-up following a recent manufacturing inspection that turned up 10 observations at the company’s facility in New Jersey, including issues with a construction project posing a contamination risk. The agency conducted its Eugia inspection from Dec. 11 to Dec. 22, according to the document. During the visit, the agency […]

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Novo Nordisk doubles stock of Wegovy starter doses but supply constraints persist: CEO

Novo Nordisk doubles stock of Wegovy starter doses but supply constraints persist: CEO

Even with a competitor’s drug now on the scene, Novo Nordisk is aiming for another year of dominance in the obesity arena thanks in large part to a resupply of starter doses of the company’s weight-loss blockbuster Wegovy. Still, resources and capacity will continue to weigh on GLP-1 sales growth in the coming months and

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In continuing its transformation, Teva confirms plan to sell off API business

In continuing its transformation, Teva confirms plan to sell off API business

Teva’s transformation under new CEO Richard Francis is taking another turn. Wednesday, the company confirmed plans to sell its active pharmaceutical ingredients business as part of Francis’ “pivot to growth” strategy. The confirmation comes after speculation that Teva was weighing a potential sale of its small molecule API business. Six months ago, Bloomberg reported that

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Grail teams up with 2 golfers to push cancer screening blood test ahead of sponsored tournament

Grail teams up with 2 golfers to push cancer screening blood test ahead of sponsored tournament

Grail is again turning to golf to reach the over-50 audience targeted by its cancer screening blood test, teaming up with two professionals to get its message out ahead of the second edition of the tournament it sponsors.  The demographics of the audience for the PGA Tour Champions, a tour for professional golfers aged 50

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After Novartis’ radiotherapy Pluvicto disappoints, CEO touts ‘compelling case’ for future growth

After Novartis’ radiotherapy Pluvicto disappoints, CEO touts ‘compelling case’ for future growth

Even though Novartis grew sales and profits in the last quarter of 2023, the magnitude of the increases was not satisfactory to the Swiss pharma’s investors. Novartis’ fourth-quarter sales grew 10% year over year at constant currencies to $11.4 billion. The number missed analysts’ expectations by 1%, according to the team at ODDO BHF. The company’s

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Obesity drug boom pushes Novo Nordisk shares to record high

Obesity drug boom pushes Novo Nordisk shares to record high

Novo Nordisk shares hit a record high after the Danish company reported soaring sales of its obesity and diabetes drugs Wegovy and Ozempic, pushing its market value past $500bn and cementing its position as Europe’s most valuable company. Runaway demand for the drugs, which are taken by celebrities including Oprah Winfrey and Elon Musk, has

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GSK confirms Arexvy is a blockbuster but says the RSV battle has just begun

GSK confirms Arexvy is a blockbuster but says the RSV battle has just begun

Beaten to the punch by Pfizer in developing a vaccine for COVID, GSK has regained some of its lost luster as a vaccine powerhouse with its advancement of respiratory syncytial virus (RSV) shot Arexvy. Wednesday, when GSK reported its quarterly and annual earnings, it confirmed that Arexvy was blockbuster in its first year on the

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Biogen abandons Aduhelm efforts, focuses on Eisai-partnered Leqembi and pipeline drugs

Biogen abandons Aduhelm efforts, focuses on Eisai-partnered Leqembi and pipeline drugs

More than two years after Aduhelm’s controversial and ill-fated FDA accelerated approval, Biogen is discontinuing the Alzheimer’s disease therapy after walking a rocky path. Tuesday, Biogen said it’s pulling all efforts from the first-of-its-kind anti-amyloid beta therapy to focus on Leqembi, its Eisai-partnered newer medicine, and its pipeline candidates. The newer drug, Leqembi, won a full

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MRC Laboratory of Medical Sciences worth £120m opens on ICL campus – PharmaTimes

MRC Laboratory of Medical Sciences worth £120m opens on ICL campus – PharmaTimes

The institute is one of two UK laboratories wholly funded by the MRC The Medical Research Council (MRC) has opened a new Laboratory of Medical Sciences (LMS), worth £120m, at Imperial College Healthcare NHS Trust’s Hammersmith hospital. The institute is one of two laboratories in the UK that is wholly funded by the MRC. Commissioned

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