MedCity News

JANUARY 23, 2024

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

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MedCity News

JULY 6, 2023

While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks. Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval.

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MedCity News

JUNE 11, 2023

With animal testing requirements finally removed, the pharma industry and its constituents can hope for faster innovation. Human tissues, coupled with AI that can deal with terabytes of data will blow mice models out of the water.

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MedCity News

JANUARY 2, 2024

Longboard Pharmaceuticals’ epilepsy drug candidate bexicaserin met the main efficacy goal of its Phase 1b/2a study along with safety data suggesting a potential edge over current treatments. With Longboard now preparing to advance to Phase 3 testing, its stock price soared more than 300%.

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MedCity News

SEPTEMBER 27, 2024

Bristol Myers Squibb’s Cobenfy treats schizophrenia by going after a different target than currently available antipsychotic drugs, which is intended to offer better efficacy and safety. The drug came from the pharma giant’s $14 billion acquisition of Karuna Therapeutics.

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MedCity News

SEPTEMBER 29, 2023

Preliminary weight loss and safety data for Structure Therapeutics’ drug candidate suggest it’s competitive with other oral GLP-1 targeting contenders from big pharma companies.

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MedCity News

JULY 7, 2022

Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.

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MedCity News

AUGUST 7, 2023

Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.

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MedCity News

NOVEMBER 30, 2022

Eisai has presented and published full data from the Phase 3 clinical trial for its Alzheimer’s disease drug lecanemab, with results showing a statistically significant slowing decline associated with the neurodegenerative disorder.

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MedCity News

JULY 29, 2024

As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility. The post Enabling Clinical Trial Innovation Through AI Regulation at FDA appeared first on MedCity News.

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MedCity News

APRIL 30, 2024

With cancer as its initial focus, the startup contends its approach could offer safety and efficacy advantages compared to currently available targeted therapies. Enlaza Therapeutics’ drugs form covalent bonds that lock the therapy onto its target. The post J.P.

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MedCity News

MARCH 31, 2024

Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020. The FDA rejected the drug two years ago due to concerns about cardiovascular safety.

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MedCity News

OCTOBER 15, 2024

In addition to meeting the main safety and tolerability goal, MieraGTx Holdings’ gene therapy for Parkinson’s disease also showed signs of efficacy. The one-time treatment is intended to reprogram dysfunctional brain circuits.

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European Pharmaceutical Review

JANUARY 23, 2025

1 all revenue in big pharma now come from dealmaking, confirming a need for robust inorganic growth and value creation strategies The year began with this forecast holding true, as the pharmaceutical industry declared major M&A deals including Johnson & Johnsons acquisition of Intra-Cellular Therapies, Inc. trillion Firepower.

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MedCity News

NOVEMBER 7, 2022

No details about the FDA’s questions or concerns were disclosed; so far, no serious safety problems have been reported in the U.K. The FDA placed a clinical hold on Verve Therapeutics’ application to begin human testing of its gene-editing therapy for an inherited form of high cholesterol.

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MedCity News

APRIL 4, 2023

The Scorpion drugs could have safety advantages over approved Johnson & Johnson and Takeda therapies that address the same rare genetic signature.

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MedCity News

JULY 6, 2022

Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test is already underway and could post data next year but the company is also talking with regulators about the possibility of a submission under the accelerated approval pathway.

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MedCity News

JUNE 1, 2023

But the decision keeps the spirit of an earlier coverage determination, which called for the gathering of more evidence about the safety and efficacy of these therapies. Medicare will cover Alzheimer’s disease drugs granted traditional FDA approval, CMS announced.

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MedCity News

JUNE 30, 2022

tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring. The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury.

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MedCity News

OCTOBER 17, 2022

Gilead Sciences is betting that a MacroGenics antibody drug for blood cancers can offer a safety edge over others that address the same target. It’s the second partnership between the two companies; an alliance that began in 2013 expired without Gilead licensing any molecules from the deal.

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MedCity News

MARCH 22, 2023

In addition to demonstrating efficacy and safety according to measures the FDA says are needed to support a regulatory submission, 89bio says the results also show its drug could offer a dosing edge over potential rivals. 89bio reported its NASH drug candidate met the main endpoints of a mid-stage clinical trial.

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MedCity News

JULY 20, 2023

Sanofi is interested in Recludix Pharma’s approach to treating inflammation with an oral small molecule that targets a protein thought to be undruggable. If it works, the drug could have safety and dosing advantages over currently available biologic drugs, including blockbuster Sanofi drug Dupixent.

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MedCity News

MARCH 20, 2023

The antibody was designed to offer a safety edge over other CTLA-4-blocking drugs it’s on track for a Phase 3 test in non-small cell lung cancer. BioNTech is expanding its cancer immunotherapy scope by partnering with OncoC4 on clinical testing of its lead drug.

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Pharma Marketing Network

MARCH 25, 2022

5 While the CDC gathers information on these topics for public health planning, there are immediate needs that pharma can address. . What Can Pharma Do? Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Sunny White.

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European Pharmaceutical Review

DECEMBER 7, 2022

Biopharma Akeso Inc. state the therapy could help reduce side effects and safety concerns. The post $5 billion bispecific antibody pharma collaboration appeared first on European Pharmaceutical Review. has announced it will enter into a collaboration potentially worth up to $5 billion with Summit Therapeutics Inc.,

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MedCity News

MAY 1, 2024

Pepper Bio has licensed rights to lerociclib, a molecule that G1 Therapeutics designed to offer dosing and safety advantages over approved therapies in the same drug class. EQRx previously held rights to the drug, but returned them after the company was acquired last year.

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Clarivate

OCTOBER 17, 2024

Audience members during the recent Clarivate webinar Emerging Deal Trends in Biotech and Pharma identified three of the biggest challenges they face when securing deals. Finding the right partners Selecting the right partners in pharma dealmaking is crucial to ensuring the success of a partnership.

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European Pharmaceutical Review

SEPTEMBER 14, 2023

This includes its Macclesfield campus, the UK’s largest pharma manufacturing site. The pharma company’s sites in Macclesfield, Cambridge, Luton and Speke will be supplied by energy from the biomethane facility. Supply of the renewable gas is planned through a new 15-year partnership with Future Biogas.

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Clarivate

OCTOBER 25, 2021

The move further expands and integrates drug toxicity data and translational safety intelligence from OFF-X into all aspects of the life science cycle.

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PM360

DECEMBER 20, 2023

With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. This may best be achieved by large pharma companies, with their combined $200bn annual R&D budget, compared to smaller companies that are relying on external investment.

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World of DTC Marketing

JUNE 8, 2021

Instead of pulling away from the amyloid theory, or going past it, they are now giving it a tremendous boost, despite a mountain of data that proves it’s the wrong path — at least on its own” Ultimately, this is a disaster that will once again create a serious atmosphere of financial toxicity, for everyone in biopharma.

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European Pharmaceutical Review

JUNE 28, 2024

Data integrity and AI: how pharma can build a data-driven future LabVantage Solutions explains that data integrity remains a core responsibility – and challenge – as pharmaceutical organisations seek to leverage AI and data lakes to grow, innovate and serve patients.

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Clarivate

JUNE 29, 2023

These include: Assisting in molecule design with desired properties using predictive analytics, a hotbed of pharma dealmaking in recent years, including last year’s Sanofi-Exscientia collaboration , which featured a potential value of up to $5.2

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PM360

SEPTEMBER 28, 2022

Now, as the President of Accord BioPharma , the U.S. The entire premise was that because biosimilars were so new, and there was not a lot of information on the safety and efficacy of those products, customers should be a bit leery prior to jumping on the biosimilar bandwagon. specialty division of Intas Pharmaceuticals, Ltd.,

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Pharma Pathway

SEPTEMBER 20, 2022

Ltd- Biopharma started its operations in 1987 at Raichur, Karnataka-India. As part of Covid-19 safety measures, candidates are requested to sanitize their hands at the entrance, Maintain social distance and ware face mask before entering the venue. Job Description. Shilpa Biologicals Pvt. Contact : 9809818187, 8099056599.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The speciality drug channel participants, including speciality pharmacies, biopharma companies, and distributors, are transforming their operations with automated and secure data systems and next-generation analytics, which will improve data collection, partner performance and strategy effectiveness. Discover the top speciality pharmacies.

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MedCity News

JANUARY 11, 2024

The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing.

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