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

FEBRUARY 7, 2024

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

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Safety Leads FDA Biopharma 109

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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Specialization Leads Pharma Side effects 45

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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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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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

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

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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Pharma Safety FDA Pharmaceutical 103

European Pharmaceutical Review

DECEMBER 12, 2023

Yannis Morel, Executive Vice President of product portfolio strategy and business development of Innate Pharma SA, offers insight on engineering antibodies to develop antibody-based NK cell therapeutics. As a biotech, what work does Innate Pharma do in the biopharma industry?

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Pharma Engineering Safety Patients 108

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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Safety FDA Biopharma Pharma 98

Pharmaceutical Technology

SEPTEMBER 13, 2022

An international team of scientific, regulatory, and safety and compliance (GxP) specialists, PharmaLex is based in Germany. The company provides strategic assistance and regulatory support to biopharma firms across the lifecycle of the product.

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pharmaphorum

AUGUST 4, 2022

This is due to the specialist nature of roles and the growth and diversification of biopharma, which requires an increasingly sophisticated and skilled workforce. Furthermore, by simulating real-life scenarios, AR offers the chance for staff in the pharma industry to practice complex operations without the associated risks.

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Recruitment Pharma Training Pharmaceutical manufacturing 86

Pharmaceutical Technology

MAY 23, 2023

The safety and effectiveness of the drug prophylaxis for acute HAE attacks are yet to be proved. In June 2022, BioCryst signed an exclusive partnership with Austrian company Pint Pharma to register and promote ORLADEYO across Latin America.

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Marketing Biopharma Safety Pharma 52

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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MedCity News

FEBRUARY 20, 2024

The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule. The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug.

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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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Safety Biopharma Pharma 57

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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Electronics Biopharma Safety Manufacturing 85

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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Safety Biopharma Competition Management 110

Salesforce

JUNE 11, 2019

Biopharma companies have consistently had to reimagine themselves over the years to confront globalization, the entry of generics and biosimilars, and now the advent of precision medicine and value-based care. Simply put, it’s taking more time and money ($2B+) to get new drugs approved, and the peak sales per drug is declining.

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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

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

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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Safety Biopharma Pharma 114

European Pharmaceutical Review

DECEMBER 19, 2022

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.

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Medicine Biopharma Safety Food 52

PM360

DECEMBER 14, 2023

Moderna Joins CEPI Pandemic Preparedness Mission After making its debut in the pharma market during the COVID-19 pandemic, Moderna is preparing for the next pandemic. The pharma company has joined the Coalition for Epidemic Preparedness Innovations (CEPI) in a partnership that aims to shorten vaccine development timelines down to 100 days.

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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

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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Safety FDA Biopharma Pharma 102

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 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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Pharmaceutical Technology

NOVEMBER 4, 2022

The expertise in procurement for new projects is a definite advantage with choosing a CMO like Baxter BioPharma Solutions. As such, a reconfiguration of the supply chain is regarded by industry experts as the only long-term solution to safeguard the pharma industry from further impact.

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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 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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Safety Leads Biopharma Pharma 82

pharmaphorum

DECEMBER 20, 2022

The road to the development of treatments for non-alcoholic steatohepatitis (NASH) is littered with failed projects, but US biotech Madrigal Pharma thinks it now has enough evidence for its drug resmetirom to support regulatory filings. Although, so far efforts to bring a therapy to market have failed.

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Pharmaceutical Technology

JULY 7, 2022

But getting these drugs to patients requires risky transportation, and safety and success hinges on reliable, temperature-controlled logistics. The company is often a first choice for these innovators due to its specialised services for cryogenic shipments, including a variety of dry shippers and accessories.

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Medicine Transportation Manufacturing Biopharma 98

European Pharmaceutical Review

DECEMBER 21, 2022

Despite the tidal wave of renewed interest in psychedelic therapies, there is still much to be learned about them, including their precise mechanisms of action, their long- and short-term safety profiles, the durability of their effect, and their adverse effects—which can be severe. Authorisation under exceptional circumstances. References.

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Food and Drug Administration Medicine Food Government 109

Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. That leaves three years for pharma companies to prepare. asked panel chair Ipsita Smolinski, MD of consultancy Capitol Street.

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Clarivate

JULY 31, 2023

In product applications, key solutions, e.g. the Dialog platform and Drug Safety Triager will be developed and marketed under the Clarivate brand. The Dialog Solutions website ( [link] ) will be migrated over to clarivate.com , enabling these products and solutions to reach a broader global audience.

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Healthcare Healthcare Safety Competition 52