Sat.Nov 14, 2020 - Fri.Nov 20, 2020

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Pfizer strikes a deal with newly formed China biotech

Bio Pharma Dive

The deal, which has Pfizer paying as much as $70 million, is the latest in a series of moves by big pharma companies to forge a stronger position in the world's second-largest drug market.

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Pharma’s golden handcuffs

World of DTC Marketing

People who stay with a company just because of their salary and benefits are not the kind of people that are needed to make the leap from good to great. This week a friend and colleague I have known for over ten years decided to leave her current position where she was a top performer for a position where her expertise would be more valued. No one tried to stop her from leaving or asked if there was anything they could do to keep her.

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J&J launches Phase 3 trial for 2-dose COVID-19 vaccine

BioPharma Reporter

Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial explores a 1-dose regimen).

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NHS launches 40 ‘long COVID’ clinics

Pharma Times

It is hoped that the move will help to tackle the persistent symptoms – such as fatigue and brain fog – suffered by people who have developed the condition

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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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Stem cell therapy for ALS fails a large clinical trial

Bio Pharma Dive

The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however.

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Lilly’s baricitinib granted US emergency use in COVID-19

pharmaphorum

Doctors in the US are to get another option to treat COVID-19 after the FDA granted an Emergency Use Authorization (EUA) for Eli Lilly’s baricitinib. Baricitinib is the active ingredient in Lilly’s rheumatoid arthritis drug Olumiant and is the latest example of a drug being repurposed to combat COVID-19. Most of the drugs attempt to tackle the inflammation that can cause complications in patients with severe disease.

Doctors 119

More Trending

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W.H.O. Rejects Antiviral Drug Remdesivir as a Covid Treatment

NY Times

In a review of several trials, the World Health Organization found that Gilead’s drug did not improve survival rates for patients nor did it help them recover.

Drugs 124
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UniQure's gene therapy for hemophilia B meets first goal in key study

Bio Pharma Dive

The results are first to emerge from a late-stage test of a hemophilia B gene therapy, and show UniQure's treatment can restore clotting protein levels to mild or even near normal levels.

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What will the digital health ecosystem look like post-COVID?

pharmaphorum

COVID-19 has turned the world on its head and healthcare systems have had to respond rapidly to match the sudden changes created by lockdown. Digital health had already been building a presence before the pandemic, but the tools it offers have been essential to counter the disruption caused by the coronavirus, reports Richard Staines. COVID-19 isn’t going away any time soon but when, and if, this crisis subsides the healthcare systems that are left behind will have changed radically.

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Moderna’s COVID-19 vaccine reports 94.5% efficacy: Phase 3 interim analysis

BioPharma Reporter

Modernaâs mRNA COVID-19 vaccine candidate has reported vaccine efficacy of 94.5% in the first Phase 3 interim analysis, released this morning. "This is a pivotal moment," says Moderna's CEO.

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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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Researchers Create Nasal Spray for COVID-19 That May Already Be Safe for Humans

BioSpace

Researchers from the University of Birmingham, UK, announced today that they have developed a nasal spray that can potentially provide protection against COVID-19. Additionally, it is formulated using materials that have already been cleared for use in humans.

Research 120
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Hospitals scramble to get ready for coronavirus vaccines

Bio Pharma Dive

Facilities are preparing ultra-cold storage capabilities and reviewing secruity plans as they brace for their role in distributing potentially multiple shots.

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Increasing patient engagement with UK clinical trials

pharmaphorum

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. It can help address well established issues with studies, such as patient recruitment and retention, as well as reducing the need for additional trial protocol amendments.

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New Pfizer Results: Coronavirus Vaccine Is Safe and 95% Effective

NY Times

The company said it planned to apply for emergency approval from the Food and Drug Administration “within days.

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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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£12.2m boost for coronavirus genomic surveillance

Pharma Times

The funds will help expand the scale of SARS-CoV-2 virus sequencing in the hope of revealing new opportunities for intervention

Genome 129
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Moderna's vaccine can last for weeks in a refrigerator, expanding an edge on rivals

Bio Pharma Dive

Pharmacies and doctor's offices should be able to store Moderna's shot on site, a crucial advantage for the mass immunization challenge that lies ahead.

Pharmacy 325
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Vertex Pharma’s vision for reimbursement innovation

pharmaphorum

As regional vice president for Northern Europe & Australia, Simon Lem led the digital launch of Vertex Pharma’s novel cystic fibrosis drug Kaftrio. He tells pharmaphorum about embracing digital change and the need for innovative reimbursement solutions. For Vertex, COVID-19 accelerated a digital transformation much needed for the patients they serve.

Medicine 117
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Warren Buffett Makes Big Bets on Pharma Stocks

BioSpace

Warren Buffett, one of America’s best-known investors, is backing multiple pharmaceutical companies developing therapies aimed at curbing the ongoing global COVID-19 pandemic.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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The Steady Rise of Plant-Based Fast Food Offerings

XTalks

For the majority of fast-food restaurants, the only vegan items on the menu have tended to be the shredded lettuce and sliced tomatoes that topped a hamburger. That is, until now. Recently, the fast-food industry has embraced the growing demand for plant-based meat, with many popular chains beginning to offer vegan menu items that go beyond burger toppings.

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Moderna says vaccine prevents COVID-19 in large study, adding to hopes for several protective shots

Bio Pharma Dive

Several effective vaccines will likely be needed to end the pandemic. Moderna's study results, which are equally strong as those reported by Pfizer and BioNTech last week, make that outcome more likely.

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COVID-19: Helping to support momentum on antimicrobial innovation

pharmaphorum

To mark World Antimicrobial Awareness Week NovaBiotics’s Deborah O’Neil tells us why 2021 might be the year anti-infective drugs finally demonstrate their economic value. . COVID-19 has reminded the world how critical infectious disease is, from both a societal and economic standpoint. Cancer is rightly seen as one of the most pressing challenges of our time: but it has not yet caused a multi-trillion hole in the world’s finances.

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Former MiMedx CEO Parker Petit Found Guilty of Fraud

BioSpace

Parker H. “Pete” Petit, the former chief executive officer of wound care company MiMedx was convicted of fraud and making false statements to the U.S. Securities and Exchange Commission, following a months-long investigation into the company’s financial records. William Taylor, the company’s form.

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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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Early Data Show Moderna’s Coronavirus Vaccine Is 94.5% Effective

NY Times

Moderna is the second company to report preliminary results from a large trial testing a vaccine. But there are still months to go before it will be widely available to the public.

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New coronavirus vaccine data back up Pfizer, BioNTech claims of strongly effective shot

Bio Pharma Dive

Reaching the main goal of their large trial, Pfizer and BioNTech reported 162 cases of COVID-19 among participants who received a placebo, and just 8 for those who were vaccinated.

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Six new medicines leap towards EU approval

Pharma Times

The recommendations include new treatments for cancer and intraocular pressure and prevention of uncomplicated flu.

Medicine 129
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Mouse Seeking Elephant: Innovators Address Unmet Needs in Biotech and Analytics

BioSpace

The 2020 Virtual Texas Life Science Forum, sponsored by BioHouston November 10-12, showcased dozens of innovative, early stage companies seeking partners to reach the next level.

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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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FDA to expedite development of two Sanofi rare disease drugs

pharmaphorum

The FDA has agreed to expedite development of two rare disease drugs from Sanofi. The most significant of the two announcements is the Priority Review for avalglucosidase alfa, a potential new therapy for Pompe disease. The review period will be shortened from the standard ten months to six months or less, and the French pharma said the FDA will make the regulatory decision before May 18th.

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FDA unexpectedly rejects Alkermes schizophrenia drug, citing manufacturing concerns

Bio Pharma Dive

Though Alkermes believes it can quickly resolve the issues cited by the agency, the complete response letter nonetheless delays approval of a drug that's critical to the company's hopes of a turnaround.

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Moderna’s COVID-19 Vaccine Candidate Shows Almost 95 Percent Effectiveness in Interim Analysis

XTalks

Moderna announced today that its highly anticipated COVID-19 vaccine candidate appears to be 94.5 percent effective. This is according to preliminary trial data from the company’s ongoing study that involves 30,000 people in the US. The news comes shortly after Pfizer and BioNTech’s mega announcement last week of their COVID-19 vaccine having shown 90 percent efficacy in an ongoing large-scale Phase III trial.

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One Step Forward for Hemophilia Patients – an Even Bigger Step for Gene Therapy

BioSpace

Positive top-line data from UniQure’s Phase III HOPE-B gene therapy trial of etranacogene dezaparvove, an investigational AAV5-based gene therapy, point to a potentially curative treatment for patients with moderate to moderately severe hemophilia B.

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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.