Fri.Jan 26, 2024

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EMA recommends earlier use of Bristol Myers cell therapy for multiple myeloma

Bio Pharma Dive

The opinion would allow Abecma to be prescribed after two standard therapies and is the latest sign of CAR-T’s growing use in earlier cancer treatment.

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CAR-T therapies and cancer risk: No easy answers for the FDA

Pharmaceutical Technology

CAR-T cell therapies can provide durable cancer remission, however, a recent FDA investigation into reports of secondary T-cell malignancies has increased scrutiny of their risk profiles.

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PTC Duchenne drug approval set to be revoked in Europe

Bio Pharma Dive

The EMA’s drugs committee again recommended rescinding an OK for Translarna, which was cleared in 2014 despite questions about its benefit.

Drugs 182
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Atossa Therapeutics progresses Phase II preventative breast cancer therapy

Pharmaceutical Technology

Atossa Therapeutics estimates a Q3 Phase II readout for Z-endoxifen, as it plans a Phase III preventative breast cancer trial.

Trials 162
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Merck's Keytruda extends life for kidney cancer patients after surgery, while Bristol's Opdivo fails again

Fierce Pharma

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. | Merck’s unique approval for Keytruda as a postsurgerical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives.

Trials 132
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Drug shortages challenge type 2 diabetes patients in the UK

Pharmaceutical Technology

Type-2 diabetes patients continue to be impacted by GLP-1 RA drug shortages in the UK with an NHS alert issuing guidelines on drug substitutions.

Drugs 147

More Trending

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FDA expands approval of Dupixent for eosinophilic esophagitis in children

Pharmaceutical Technology

Regeneron and Sanofi’s blockbuster anti-inflammatory drug generated global sales of $8.68bn in 2022.

Sales 147
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BHF data reveals early heart disease deaths rise to highest level

Pharma Times

In 2022, over 39,000 people in England died prematurely of cardiovascular conditions

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Travere signs $120m licensing deal with Renalys for sparsentan in Asia

Pharmaceutical Technology

Renalys plans to start a registrational trial for sparsentan as a treatment for IgA nephropathy in Japan in Q2 2024.

Licensing 147
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After Padcev combo’s major triumph, Merck’s Keytruda delivers partial win in bladder cancer

Fierce Pharma

The combination of Merck's Keytruda and Pfizer and Astellas' Padcev recently made waves in bladder cancer—and the broader oncology world—by delivering a massive life-extension benefit against | The combination of Merck's Keytruda and Pfizer and Astellas' Padcev recently made waves in bladder cancer—and the broader oncology world—by delivering a massive life-extension benefit.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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What to know after a colon cancer diagnosis

Antidote

Colorectal cancer (often shortened simply to colon cancer) is the fourth-most commonly diagnosed cancer in the United States, and it is estimated that around 150,000 Americans are diagnosed each year. While the average age of diagnosis is 66, young adults are getting diagnosed in higher numbers every year, and researchers are still unsure as to why.

Research 122
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J&J, Merck CEOs dodge subpoenas by agreeing to testify at Senate committee's pricing hearing

Fierce Pharma

With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. | With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP).

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World Cancer Day 2024: Trends in Oncology Research and More

XTalks

World Cancer Day 2024 is a global initiative that emphasizes the importance of heightened awareness about cancer. This day is observed annually on February 4th since its inception by the Union for International Cancer Control (UICC) in 2000. World Cancer Day is dedicated to encouraging early detection, prevention and treatment while also advocating for improved access to healthcare services for those affected by cancer.

Research 118
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Sanofi and Regeneron's Dupixent picks up FDA nod to treat kids with eosinophilic esophagitis

Fierce Pharma

At Sanofi and Regeneron, it’s all about the kids—at least with respect to their recent advancements of anti-inflammatory powerhouse Dupixent. | The FDA has signed off on Sanofi and Regeneron's Dupixent to treat children between the ages of 1 and 11 who weigh at least 33 pounds with eosinophilic esophagitis. Dupixent becomes the first treatment in the U.S. for children in this age group with the disorder.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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JP Morgan 2024 – Frank Gleeson

pharmaphorum

JP Morgan 2024 – Frank Gleeson Mike.

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AbbVie pumps $223M into Singapore biologics plant, plots 100 hires

Fierce Pharma

In late 2022, GSK, Sanofi and Takeda signed on with a partnership of local agencies to advance biologic manufacturing in Singapore. | In late 2022, GSK, Sanofi and Takeda signed on with a partnership of local agencies to advance biologic manufacturing in Singapore. Now, a little more than a year later, AbbVie is getting in on the action by starting a major production expansion in the Garden City.

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Adverse Event Reports Linked to Counterfeit Ozempic on the Rise

Pharmaceutical Commerce

Concerns regarding hypoglycemia potentially linked to a counterfeit version of Ozempic come at a time in which reports have grown regarding the improper use of GLP-1 receptor agonists for the purpose of cosmetic weight loss.

Cosmetics 115
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Bristol Myers wins, Apellis loses in busy week at Europe's drug regulator

Fierce Pharma

Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of a marketing authorization | Shortly after Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended refusal of marketing authorization for Apellis’ geographic atrophy (GA) drug Syfovre (pegcetacoplan injection), the company said it will appeal the guidance.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AbbVie invests $223m in Singapore biologics site

pharmaphorum

AbbVie has broken ground on a new $223 million expansion of its biologics manufacturing facility in Singapore, creating around 100 new jobs

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Does Patient Priorities Care Result in Better Outcomes for Patients?

Pharmaceutical Commerce

A non-randomized control trial investigates whether older adults with multiple chronic conditions can benefit by receiving more specialized services.

Trials 103
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New NHS trust should oversee, sell patient data, says report

pharmaphorum

Report on UK biotech sector by Tony Blair and William Hague calls for an NHS trust to be set up to oversee and sell patient data

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Amgen’s Prolia Gets FDA Boxed Warning for Risk of Severe Hypocalcemia

XTalks

The US Food and Drug Administration (FDA) has added a boxed warning to the safety information of Amgen’s osteoporosis drug Prolia (denosumab) for the increased risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD). Hypocalcemia refers to an abnormally low level of calcium in the blood. The FDA said that CKD patients on dialysis or who have mineral and bone disorders (CKD-MBD) are at the greatest risk of the condition.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Britain will be first to get new Mounjaro device, says Lilly

pharmaphorum

Eli Lilly is weeks away from launching Mounjaro in the UK, after getting approval from the MHRA for a multi-dose injector version for diabetes and obesity

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‘The Top Line’: Closing the $1 trillion women’s health gap

Fierce Pharma

‘The Top Line’: Closing the $1 trillion women’s health gap aellison Fri, 01/26/2024 - 09:55

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Then there were two: ArriVent set to list after $175m IPO

pharmaphorum

ArriVent BioPharma completes the second biotech IPO of 2024, raising $175m that will help advance its late-stage lung cancer drug furmonertinib

Drugs 103
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How Elo Life Systems Is Innovating in Sweeteners and Agriculture

XTalks

In the competitive ingredients market, North Carolina’s Elo Life Systems has quickly become a leader in sustainable food solutions. Just a year after raising $24.5 million in Series A funding , the company has earned another $20.5 million in a Series A2 funding round jointly led by DCVC Bio and Novo Holdings. Founded in 2021, the company has already made a mark with its focus on plant-based sweeteners and crop protection.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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From pandemic spotlight to global progress: Navigating technology transfer for healthcare innovation

pharmaphorum

From pandemic spotlight to global progress: Navigating technology transfer for healthcare innovation Mike.

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Bristol Myers reveals subcutaneous Opdivo data in kidney cancer as I-O battle heads to new front

Fierce Pharma

Bristol Myers Squibb is offering a detailed look at pivotal data showing that an under-the-skin version of its PD-1 inhibitor Opdivo works as well as the original intravenous formulation in kidney | Bristol Myers Squibb is offering a detailed look at pivotal data showing an under-the-skin version of its PD-1 inhibitor Opdivo works as well as the original intravenous formulation in kidney cancer.

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GLP-1 Agonists Could Be Key in Reducing Severe Liver Disease for Type 2 Diabetes Patients

Pharmaceutical Commerce

GLP-1 agonists may be an effective therapy to avoid severe liver disease in those with concurrent type 2 diabetes.

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Polymer Chemistry & Formulation in Drug Delivery

pharmaphorum

Design Your Novel Polymers & Maximize Payload Compatibility for Sustained & Controlled Release

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.