Wed.Aug 03, 2022

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Alnylam drug succeeds in key heart disease study, boosting company

Bio Pharma Dive

The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application.

Drugs 363
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Should you take a job with a biotech startup?

World of DTC Marketing

At first, the opportunity to join a small biotech startup sounds excellent. Smaller staff usually means less bureaucracy and being on the ground floor of a potentially financially rewarding career. But there are risks. Leaving the comforts of a big company with a calcified infrastructure, laser-focused job roles, well-established SOPs, deeper pockets, and excellent job security for the scramble and chaos of a younger company isn’t for everyone. .

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Roche digs into off-the-shelf cell therapy with Poseida deal

Bio Pharma Dive

The pharma has now signed two alliances with allogeneic drug developers since September, signalling its interest in CAR-T treatment alternatives.

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Rigel and Forma enter licence deal for acute myeloid leukaemia therapy

Pharmaceutical Technology

Rigel Pharmaceuticals has signed a licence agreement with Forma Therapeutics for developing, producing and marketing olutasidenib to potentially treat relapsed/refractory acute myeloid leukaemia (R/R AML) and other types of cancer. . Olutasidenib, an investigational agent, is an oral, small molecule inhibitor of mutant isocitrate dehydrogenase 1 (mIDH1) that attaches to and hinders mutated IDH1 enzymes.

Marketing 147
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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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AbCellera inks another venture partnership, this time with Atlas

Bio Pharma Dive

One week after striking a deal with Versant, the antibody specialist is teaming up with Atlas to provide drug candidates to an undisclosed startup backed by the biotech investor.

Antibody 299
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Gilead reports 1% rise in revenue for Q2 2022

Pharmaceutical Technology

Gilead Sciences has reported a 1% growth in revenue to $6.3bn in the second quarter (Q2) of 2022 as against $6.2bn in the year-ago quarter. The company attributed the revenue rise to enhanced sales in HIV and oncology products, which was offset partially by reduced sales of Veklury (remdesivir) and hepatitis C virus (HCV) medicines. For the three months ended on 30 June 2022, diluted earnings per share (EPS) declined to $0.91 from $1.21 in Q2 2021.

Sales 130

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Internet of things hiring levels in the pharmaceutical industry rose in July 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for internet of things related positions rose in July 2022 compared with the equivalent month last year, with 18.2% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 14.6% of companies who were hiring for internet of things related jobs a year ago but a decrease compared to the figure of 19.7% in June 2022.

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Coherus wins FDA approval for second Lucentis biosimilar, its third drug

Bio Pharma Dive

The biotech company secured a valuable interchangeable designation for the copycat medicine, which it plans to launch later this year.

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Overdose reversal drugs gain support at music festivals, but not fentanyl test strips

NPR Health - Shots

Festival promoters are allowing lifesaving medication as fentanyl deaths surge, but volunteers are often left to distribute it, and more controversial forms of harm reduction aren't openly allowed.

Drugs 131
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Connecting EHR to clinical trials: How to embrace the promise of real-world data

pharmaphorum

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Co

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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STAT+: ‘How can you not be excited?’: AI experts share enthusiasm about its future in health care

STAT News

While the adoption of artificial intelligence in health care has been slow and bumpy at times, three academic AI experts, from Emory, Stanford, and the University of Michigan, spoke optimistically about its future applications in medicine, during a virtual panel discussion Wednesday with STAT’s National Technology Correspondent Casey Ross. They discussed how to integrate AI into clinical workflows with shifting patient populations, and strategies to ensure the technology’s performa

Medicine 119
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Gilead Sciences’ push into oncology is paying off, as Veklury falters

pharmaphorum

Gilead Sciences’ investment in oncology has started to provide a solid return, with sales of cancer therapies breaching the $500 million threshold for the first time in the second quarter. Cell therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) for lymphoma and leukaemia together brought in $368 million, up 68%, while antibody drug conjugate Trodelvy (sacituzumab govitecan) rose 79% to $159 million thanks to increased uptake in triple-negative breast canc

Sales 105
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Monoclonal antibody treatment for malaria shows encouraging results

STAT News

An experimental antibody treatment prevented malaria in the majority of participants in a small but important new study , providing a measure of hope in the effort to lower the burden of the disease worldwide. Only two of 17 participants in the Phase 1 clinical trial contracted malaria after being given the monoclonal antibody treatment, known as L9LS, according to results of the trial, which were published Wednesday in the New England Journal of Medicine.

Antibody 105
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Roche adds to pipeline with Poseida, Kiniksa deals

pharmaphorum

Roche has announced a pair of licensing deals with Poseida Therapeutics and Kiniksa Pharmaceuticals that bolster its pipeline in cancer and inflammatory diseases. The agreement with Poseida is by far the larger of the two, with Roche paying $110 million upfront to license rights to off-the-shelf CAR-T therapies aimed at haematological cancers, including one targeting BCMA on phase 1 testing and another targeting CD19 and CD20 that is due to start trials in 2023 – known as the tier 1 candidates.

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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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The trust-builder: a cancer center director’s try-it-all strategy for breaking the barriers between research and Black patients

STAT News

TRIALS AND TRUST: This is the second part of a series on health equity and diversity in clinical trials and cancer research. R ICHMOND, Va. — The residents agreed: Nobody like Robert Winn — director of the Virginia Commonwealth University Massey Cancer Center — had ever visited the neighborhood before. This development on the outskirts of Richmond, more parking spots and asphalt than trees and lawn, was “the hood,” after all, they said.

Research 105
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Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy

Pfizer

Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. deliesschef. Wed, 08/03/2022 - 15:35. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Wednesday, August 03, 2022 - 05:00pm. Decision follows results of interim futility analysis which indicate Phase 3 REALM-DCM trial unlikely to meet primary endpoint.

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Red Cross beginning to screen blood donors for monkeypox

STAT News

As monkeypox continues its relentless spread around the globe, organizations in the U.S. are taking steps to safeguard the nation’s blood supply. In addition to temperature checks that are part of standard health screens for prospective donors, the American Red Cross is now checking for the distinctive lesions that are  a hallmark of the disease  as part of routine arm examinations.

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Criminalization of pregnancy has already been happening to the poor and women of color

NPR Health - Shots

The symbol of the post-Roe era might not be coat hangers. It may instead be prison bars.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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STAT+: Lilly is ordered to pay $61 million for shortchanging the Medicaid drug rebate program

STAT News

After nearly a decade of legal squabbling, Eli Lilly was ordered by a federal court jury to pay $61 million for shortchanging the Medicaid drug rebate program, the latest instance in which a drug company was accused of skimping on payments. The company had been accused of failing to pay rebates from 2005 to 2016 and, consequently, making false statements to the U.S.

Drugs 98
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New life sciences development destined for Paddington

Pharma Times

The sites will maximise local and global benefits of NHS, research, industry and community partnerships

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Opinion: Inching closer to an essential global pandemic treaty

STAT News

World Health Organization Director-General Tedros Adhanom Ghebreyesus recently declared monkeypox a public health emergency of international concern (PHEIC). The world is now simultaneously fighting three global health emergencies that are currently designated as PHEIC’s — Covid-19, monkeypox, and polio — a poignant reminder of the catastrophic threat posed by pathogens.

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Quantro and Boehringer Ingelheim collaborate on inhibitors

Pharma Times

Deal represents part of Boehringer Ingelheim’s strategy to provide breakthrough cancer therapies

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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.

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Opinion: Lack of diversity in clinical trials costs billions of dollars. Incentives can spur innovation

STAT News

The lack of diversity in clinical trials unfairly skews American medicine and costs billions of dollars a year in early deaths and poor health. Proven economic incentives to recruit more diverse participants can dramatically change the picture — if the will exists to employ them. The scope of the problem was laid out in a new report that Congress requested from the National Academies of Sciences, Engineering, and Medicine, which we as committee members helped write.

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Chinese biotech Sironax raises $200m for RIPK1 pipeline

pharmaphorum

Beijing biotech Sironax has closed a whopping $200 million second-round financing that shows investors still have a desire to back companies working on RIPK1 inhibitors despite setbacks for GSK in the class. The five-year-old Chinese company – which is developing drugs for age-related degenerative diseases – said it will use the proceeds of the Series B to support the clinical development of its RIPK1 inhibitors as well as to expand its pipeline of drug candidates in other classes.

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STAT+: Civica Rx begins selling its first generic drug as it tries to overhaul the pharmaceutical supply chain

STAT News

In the latest bid to address high prescription drug costs, a nonprofit plans to sell a cheaper generic version of an expensive cancer medicine in the U.S. Civica Rx, which was formed four years ago, is working with a generic manufacturer to supply pharmacies with the abiraterone prostate cancer treatment for $160 for a month’s supply. And the nonprofit is suggesting pharmacies sell the medicine to consumers for $171, which is considerably less than what most consumers currently pay for br

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HERBAL / NATURAL INGREDIENTS FOR SKIN NOURISHMENT FROM A TO Z

Pharma Tutor

HERBAL / NATURAL INGREDIENTS FOR SKIN NOURISHMENT FROM A TO Z. About Authors. Avdesh Thassu. MPharm (Nat. Chem.); MBA(Mkt.). admin. Wed, 08/03/2022 - 15:44. Tags. Articles.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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STAT+: Alnylam therapy for increasingly common heart disease succeeds in closely watched trial

STAT News

Alnylam Pharmaceuticals’ treatment for an increasingly common heart disease succeeded in a closely watched clinical trial, the company said Wednesday, clearing the path to approval and affirming the promise of a drug analysts expect to reap blockbuster sales. Patients treated with the intravenous drug, called patisiran, did significantly better than those taking a placebo on a test of how far they could walk over the course of six minutes, meeting the study’s primary goal.

Trials 98
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New patent for Cmp Dev drug CAROSPIR

Drug Patent Watch

Annual Drug Patent Expirations for CAROSPIR Carospir is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from two suppliers. There are five…. The post New patent for Cmp Dev drug CAROSPIR appeared first on DrugPatentWatch - Make Better Decisions.

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Virtual Event: Creating AI That Improves Health

STAT News

Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET. Artificial intelligence could play a role in the future of patient care — managing everything from office visits to surgery and radiology. A look at how researchers aim to create a “data economy” to ensure that these new technologies live up to their potential.

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New patent for Gilead Sciences drug VEKLURY

Drug Patent Watch

Annual Drug Patent Expirations for VEKLURY Veklury is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are ten…. The post New patent for Gilead Sciences drug VEKLURY appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.