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Business Strategy

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Cortexyme Alzheimer’s Study Fails; Drug Slows Cognitive Decline In Some Patients

Atuzaginstat targets a bacteria associated with Alzheimer’s disease. The higher of two doses showed a 57% slowing in cognitive decline in the Phase II/III GAIN trial in mild to moderate patients with P. gingivalis infection confirmed by saliva test.

Clinical Trials Neurology

Lilly Targets Aduhelm With Aggressive Plans For Donanemab In Alzheimer’s

Lilly plans a head-to-head study of donanemab versus Biogen’s Aduhelm to see which clears amyloid plaque better and has begun a rolling BLA toward accelerated approval of the Alzheimer’s drug.

Sales & Earnings Business Strategies

Pfizer/Lilly Discontinue Tanezumab, The Likely End For A Class Dogged By Safety

The nerve growth factor inhibitor for osteoarthritis pain is one of the last still in development after safety largely sidetracked the class of drugs.

Complete Response Letters Safety

Cosentyx And Entresto Keep Powering Novartis As Firm Mulls Sandoz Sale

CEO Vas Narasimhan sees Novartis very much as an innovative company so the long-awaited strategic review of Sandoz suggests that the generics/biosimilars business could be spun off or sold fairly soon.

Sales & Earnings Business Strategies

Horizon Will Submit Krystexxa sBLA To Strengthen Clinical Profile In Gout

A clinical trial confimred Krystexxa in combination with methotrexate increased response rates in patients with uncontrolled gout.

Clinical Trials Rare Diseases

Metacrine’s Shift Means Further Attrition In FXR Agonist Class For NASH

Metacrine halts development of its FXR agonist compounds in NASH and turn its focus to inflammatory bowel disease. Firm plans Phase II ulcerative colitis study in 2022 with MET642.

Business Strategies Drug Approval Standards

Sanofi/Regeneron’s Esophagitis Data Add To Dupixent’s Winning Streak

The companies announced positive Phase III data for the drug in patients with eosinophilic esophagitis and plan to take the results to regulators in 2022.

Gastrointestinal Clinical Trials

Novartis Hopes For Canakinumab In Lung Cancer Nosedive

After deciding to examine canakinumab's potential in lung cancer on the back of the CANTOS cardiovascular trial, Novartis designed a major late-stage program in oncology for the interleukin-1 beta inhibitor. The second of those CANOPY trials has just come crashing down.

Cancer Clinical Trials

Finance Watch: Four New IPOs Hold Steady In First Days Of Trading

Public Company Edition: Xilio, Ventyx, MiNK and Context went public in the US and later traded at or above their initial public offering prices. Also, Sarepta raised $500m and Relay grossed $350m in new offerings, while Oncopeptides, Esperion, Zymergen and Ardelyx reorganized and cut jobs.

Financing Business Strategies

Ocular’s Dry Eye Drug Fails In Phase II, But It Isn’t Giving Up Yet

Company hopes a different formulation of its intracanicular insert of cyclosporin might provide longer duration of drug in the eye and better tear production with it.

Clinical Trials Drug Approval Standards

Sanofi Scores Clinical Win In Sixth Disease For Dupixent

The French major and partner Regeneron expect to file Dupixent for the rare skin disease next year after a Phase III trial of the blockbuster hit its primary and secondary endpoints.

Inflammation Clinical Trials

Acceleron Investors Want Merck To Pay More, Ask Company To Wait For Better Offer

Avoro Capital, Holocene Advisors and Darwin Global say that Acceleron should sell later for a higher price based on forthcoming data or Merck should raise its bid above $180 per share.

Deals M & A
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