Pharmaceutical Technology

FEBRUARY 16, 2023

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) for Shanghai Henlius Biotech ’s proposed biosimilar HLX02 (trastuzumab for injection). Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA.

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Pharmaceutical Technology

FEBRUARY 15, 2023

Kinnate Biopharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its pan-FGFR inhibitor, KIN-3248, to treat unresectable, locally advanced or metastatic cholangiocarcinoma (CCA). Kinnate Biopharma expects to receive initial dose escalation data in the second half of this year.

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Food and Drug Administration FDA Biopharma Safety 52

MedCity News

NOVEMBER 7, 2022

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. No details about the FDA’s questions or concerns were disclosed; so far, no serious safety problems have been reported in the U.K.

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MedCity News

JUNE 30, 2022

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. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

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MedCity News

NOVEMBER 30, 2022

While an accelerated approval decision is expected in early 2023, the latest trial data are key because they represent the confirmatory study that could support an application for full FDA approval.

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MedCity News

AUGUST 7, 2023

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

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Pharmaceutical products Safety FDA Pharma 84

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.

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MedCity News

JUNE 1, 2023

Medicare will cover Alzheimer’s disease drugs granted traditional FDA approval, CMS announced. 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.

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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.

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European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent.

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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

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

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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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. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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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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pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease.

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pharmaphorum

DECEMBER 9, 2022

Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd., This means that enrolment is now completed for the initial target or morphological cohort to form the basis of a Biological License Application (BLA) submission by the end of CY2023 to the US Food and Drug Administration (FDA). Autolus Therapeutic Plc.

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Food and Drug Administration Safety Biopharma Patients 79

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.

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Food and Drug Administration Medicine Food Government 115

Clarivate

NOVEMBER 13, 2023

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. These incorporated a variety of methodologies including literature reviews, patient preferences, exit interviews and FDA dossier development. All data were collated in FDA COA Evidence Dossiers.

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Patients Food and Drug Administration FDA Safety 52

Pharmaceutical Technology

JULY 7, 2022

While just two gene therapy products have been approved by the FDA, a number of companies are nearing the market with therapies targeting rare diseases, including 14 candidates in Phase III plus three in the pre-registration phase, according to GlobalData.

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Clarivate

APRIL 4, 2024

That’s a problem for patients, in whom treatment safety and efficacy can sometimes vary by ethnicity, as well as developers, who are under increasing pressure from regulators like FDA to demonstrate how their products stand to impact diverse populations. Such insights aid in gauging the market demand for newly developed medications.

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Clarivate

NOVEMBER 10, 2022

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. Several years of evidence generation culminated in the FDA approval of the first systemic treatment for alopecia areata. The FDA included Clarivate data from the COA development by in the approved labelling.

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Patients Food and Drug Administration FDA Safety 52

European Pharmaceutical Review

JULY 20, 2023

Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. More recently, the FDA granted approval of Roctavian in June 2023.

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Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Extension of the patient: expanding the role of caregivers in biopharma development.

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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.,

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pharmaphorum

DECEMBER 20, 2022

If the efficacy and safety data stands up to deeper scrutiny and support approval, Madrigal will have succeeded where so many other companies have failed in NASH, including Gilead Sciences , Genfit , Albireo, CymaBay, Cirius, and NGM Biopharma.

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World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? John Carroll, Endpoints.

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FDA Food and Drug Administration Patients Biopharma 207

PM360

DECEMBER 14, 2023

With its new funding, the company is developing a roadmap to an overall goal of automating the entire document process across pharma, from preclinical trials all the way through FDA approval. The company’s enterprise software platform, Yseop Copilot, leverages pre-trained large language models (LLM) built for the biopharma industry.

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Pharmaceutical Technology

DECEMBER 20, 2022

Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. McCall sees the whole experience as a positive one for biopharma: “When I started in industry, this type of data sharing and collaboration was unheard of.

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Clarivate

OCTOBER 10, 2022

Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. Key ESMO findings. months; HR: 0.321, P<0.001). months; HR: 0.321, P<0.001). Market impact.

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Clarivate

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Medicine use during pregnancy: balancing risks.

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Food and Drug Administration Safety FDA Ethics 10

pharmaphorum

JANUARY 6, 2023

Veeva’s industry experts share their predictions about how breaking down silos across clinical, regulatory, safety, and quality teams will benefit patients. This will enable biopharmas to create a more streamlined drug development process rooted in lean process execution and higher-quality data.”.

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Safety Management Patients Biopharma 100

PM360

SEPTEMBER 15, 2022

With a more patient-inclusive approach focused on DEI, clinical research can promote health equity and the safety and effectiveness of new treatments for all patients. In order to improve patient inclusivity in clinical trials, the biopharma industry must incorporate DEI in all processes. Michael Zilligen.

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Clarivate

MAY 24, 2022

Approval pathways have been established that allow manufacturers to bring innovative therapies to market without conducting trials in Mainland China, provided the safety and efficacy of the drugs have been demonstrated through real world data (RWD) in other markets. 3] Rare Diseases at FDA [online]. [4] 10] [11] [12]. 2011; 6:81-82. [3]

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pharmaphorum

SEPTEMBER 12, 2022

Dr Prasanth Reddy, head of oncology at LabCorp, tells us how the company works with cancer care teams, biopharma partners, and patients as an integral part of the patient journey from testing to treatment. They offer the only diagnostic kit cleared by the US FDA for pan-solid cancer comprehensive tumour profiling using a 500+ gene panel.

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Patients Medicine FDA Healthcare 95

PM360

JUNE 11, 2022

For example, everyone must be steeped in both FDA and FTC guidelines. Then, the MRL team and the influencer must align on where there is flexibility within messaging while still abiding to brand safety guidelines, as you don’t want to lose the authenticity that the influencer brings.

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PM360

JULY 13, 2023

However, due to conjugation instability and unfavorable safety profiles of currently available ADCs, we can still do more to ensure ADCs are more broadly available and amenable options for the patients who need them. What Other Developments Within Oncology Excite You? When Will this Breakthrough Result in Treatments?

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