BioSpace News Archive

Policy

FTC Supports PTO Push for Patent Settlement Scrutiny, Better Antitrust Oversight

The Federal Trade Commission is supporting the U.S. Patent and Trademark Office’s proposed new rules requiring parties to a patent dispute to disclose all settlement agreements, including pharmaceutical drug settlements.

June 20, 2024
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2 min read
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Tristan Manalac
Drug Development

PTC Reports Positive Phase II Huntington’s Data, FDA Lifts Partial Clinical Hold

PTC Therapeutics said Thursday the FDA has lifted a partial clinical hold on its Huntington’s disease candidate PTC518 after displaying favorable clinical trends in a mid-stage study.

June 20, 2024
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2 min read
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Tyler Patchen
Drug Development

Gilead’s Twice-Yearly Shot Shows 100% Efficacy in Phase III HIV Prevention Trial in Women

Gilead Sciences reported zero cases of HIV infection occurred in the lenacapavir candidate group, compared to 16 cases in the Truvada arm and 39 incidents for those treated with Descovy, Gilead’s approved daily PrEP pills.

June 20, 2024
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2 min read
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Kate Goodwin
Policy

How Pfizer, Bristol Myers Squibb and Johnson & Johnson Are Confronting Patent Cliffs

The pharma industry is staring down the barrel of a widespread loss of exclusivity, with more than 190 products going off-patent between 2022 and 2030. Here are some strategies company are employing to manage the drop in revenue.

June 20, 2024
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5 min read
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Ben Hargreaves
Drug Development

Experimental Parkinson’s Treatment Elicits Antibodies Against Toxic Protein in Phase I

Vaxxinity published data from an early-stage clinical trial showing that its investigative immunotherapy, UB-312, could improve movement in Parkinson’s disease and protect against pathological alpha-synuclein.

June 20, 2024
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2 min read
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Heather McKenzie
Policy

Lilly Takes More Legal Actions Over Compounded Tirzepatide, Warns About Counterfeits

Eli Lilly on Thursday said it is again suing spas and clinics over compounded and counterfeit forms of tirzepatide, the active ingredient in blockbusters Mounjaro and Zepbound, which the pharma says can cause harmful side effects.

June 20, 2024
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2 min read
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Tristan Manalac
FDA

Sarepta Wins Full Approval and Label Expansion for DMD Gene Therapy

On the heels of a Phase III flop for Pfizer’s Duchenne muscular dystrophy gene therapy candidate, the FDA has green lighted the expanded use of Sarepta Therapeutics’ Elevidys.

June 20, 2024
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6 min read
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Tyler Patchen
Prostate Drugs May Find New Use in Reducing Risk of Dementia: Study

A new observational study from the University of Iowa points to the potential of alpha-blocker drugs, commonly used to treat enlarged prostates, as a preventive therapeutic option for dementia with Lewy bodies.

June 20, 2024
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2 min read
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Tristan Manalac
Drug Development

Depression Is Notoriously Difficult to Treat. Can Psychedelic Therapies Help?

Psychedelic drug developers are homing in on the potential $16 billion depression treatment market, with a particular focus on treatment-resistant depression.

June 20, 2024
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6 min read
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Heather McKenzie
Drug Development

NIH Finds Non-Chemo Drug Combo Induces Lasting Remission in DLBCL Patients

National Institutes of Health researchers in a Phase Ib/II study found a five-drug combination elicits strong remission rates in diffuse large B-cell lymphoma patients without using chemotherapeutic agents.

June 20, 2024
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2 min read
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Tristan Manalac