Biopharma, FDA and Side effects

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

MedCity News

MARCH 22, 2024

Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease.

Side effects

Side effects FDA Patients Biopharma

Santhera seeks speedy FDA review of Duchenne drug vamorolone

pharmaphorum

OCTOBER 27, 2022

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

FDA

FDA Side effects Biopharma Marketing

FDA slaps partial hold on Biogen, InnoCare MS drug

pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. billion buyout of Principia Biopharma.

FDA

FDA Side effects Biopharma Prospecting

Liver injuries prompt clinical hold on Sanofi BTK drug

pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.

Side effects

Side effects Safety Biopharma Recruitment

Myovant Sciences rejects $2.5bn takeover bid from Sumitomo Pharma

Pharmaceutical Technology

OCTOBER 13, 2022

Myovant Sciences has rejected an acquisition offer from Sumitovant Biopharma and its wholly owned subsidiary, Sumitomo Pharma. The drug won its original FDA approval in May last year to treat heavy menstrual bleeding that accompanies uterine fibroids in premenopausal women.

Pharma

Pharma Food and Drug Administration Side effects FDA

The evolution of AAVs in cell and gene therapy

European Pharmaceutical Review

JULY 20, 2023

More recently, the FDA granted approval of Roctavian in June 2023. She stated that some of the key concerns were around viral safety, immunogenicity and the fact that long term side effects are unknown. This included the EC’s approval of Roctavian in August 2022, which was the first gene therapy for haemophilia A.

Consulting

Consulting Side effects Manufacturing Safety

Regulators and HTAs tune in to patient preference data

Clarivate

JUNE 26, 2023

In their first Guidance in the Patient-Focused Drug Development (PFDD) series, the Food and Drug Administration (FDA) references the importance of obtaining patient preference data as part of contextualizing the patient journey through their condition.

Food and Drug Administration

Food and Drug Administration Patients Side effects Medicine

Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

Medgadget

FEBRUARY 17, 2023

Interestingly, due to FDA’s regulatory methodology, surgical robots have to be approved for specific indications by the agency. ” An attractive proposition in a world in which technology has contributed significantly to the distancing of physicians from their patients, usually leading to negative side effects.

Physicians

Physicians Engineering Side effects Leads

The State of the Union in Cancer Innovation

PM360

JULY 13, 2023

The FDA has granted Fast Track Designation for our HER2-targeted ADC, ARX788, and we are enrolling the signal-seeking ACE-Breast-03 Phase 2 clinical study in post-Enhertu mBC patients throughout 2H 2023. Not only can we design drugs better, but we can understand their effects better to engineer small molecules in a more efficient way.

Patients

Patients Engineering Side effects Leads

Drug repurposing, real world data and AI/ML: perspectives and opportunities

Clarivate

OCTOBER 19, 2023

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects). For example, in the U.S.,

Networking

Networking Consulting Safety Side effects

Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

OCTOBER 19, 2023

billion deal, in which Eli Lilly agreed to acquire two of POINT Biopharma Global’s late-stage radioligand therapies for oncological indications. This has been demonstrated recently with PLUVICTO ® , which was the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer.

Food and Drug Administration

Food and Drug Administration Side effects Manufacturing Doctors

How to Work with Patient Advocates, Influencers, and Ambassadors

PM360

JUNE 11, 2022

For example, everyone must be steeped in both FDA and FTC guidelines. Regardless of the tactics and strategies employed, I would encourage more biopharma professionals to get personally involved in patient engagement programs. Once you choose a patient partner, transparency is tantamount to building a successful working relationship.

Patients

Patients Pharma Education Media

Pharma Rep Focus

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

Santhera seeks speedy FDA review of Duchenne drug vamorolone

Trending Sources

FDA slaps partial hold on Biogen, InnoCare MS drug

Liver injuries prompt clinical hold on Sanofi BTK drug

Myovant Sciences rejects $2.5bn takeover bid from Sumitomo Pharma

The evolution of AAVs in cell and gene therapy

Regulators and HTAs tune in to patient preference data

Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

The State of the Union in Cancer Innovation

Drug repurposing, real world data and AI/ML: perspectives and opportunities

Targeting tumours with novel radiopharmaceuticals

How to Work with Patient Advocates, Influencers, and Ambassadors

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