Thu.Jun 30, 2022

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Crunching the numbers on the first half drought for biotech IPOs

Bio Pharma Dive

Data compiled by BioPharma Dive show a growing gap in the frequency and size of new stock offerings compared to prior years. Some analysts believe as many as a third of public biotechs must “go away” before the sector’s slump ends.

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Pfizer, BioNTech enter $3.2bn deal with US government for Covid-19 shots

Pharmaceutical Technology

Pfizer and BioNTech have entered a new vaccine supply agreement worth $3.2bn with the US government to supply further doses of their Covid-19 vaccine. As per the agreement, the government will procure 105 million 3µg, 10 µg and 30 µg doses of the vaccine. This deal might comprise Omicron-adapted Covid-19 vaccines for use in adults, contingent on obtaining the US Food and Drug Administration (FDA) authorisation.

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Pfizer seeks full FDA approval of Paxlovid as questions about its benefits grow

Bio Pharma Dive

Converting Paxlovid’s emergency authorization to a standard clearance could further broaden its use. But the drug may not meaningfully help people who are vaccinated, and concerns about its potency against emerging variants are growing.

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Neglected tropical diseases: non-profits lead the way as private sectors lags

Pharmaceutical Technology

Stagnating interest from private players and added pressure due to the Covid-19 pandemic has put the onus on academia and non-profits to drive new therapies for neglected tropical diseases (NTDs). New therapies and repurposed assets, could bring conditions like African trypanosomiasis closer to near extinction. Nonprofits like the Drugs for Neglected Diseases initiative (DNDi) and independent researchers are studying diseases such as river blindness, which are missing more targeted and effective

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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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US pays Pfizer $3.2B to increase vaccine supply ahead of omicron booster push

Bio Pharma Dive

The order will bolster the government stockpile of COVID-19 vaccines ahead of a booster rollout that the FDA now says should include shots tailored to the newest versions of omicron.

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HDT Bio receives Emergency Use Approval for Covid-19 vaccine in India

Pharmaceutical Technology

HDT Bio has received Emergency Use Approval from Indian regulators for its Covid-19 vaccine, Gemcovac. The vaccine leverages self-amplifying RNA (saRNA), which can replicate itself after administration and could be effective at very low doses. As against other existing messenger ribonucleic acid (mRNA) vaccines that need ultra-cold storage, the Gemcovac vaccine is stable at refrigerator temperatures.

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Eczac?ba?? to acquire Turkish pharma company Gensenta for $135m

Pharmaceutical Technology

The Eczac?ba?? Group has entered an agreement for the acquisition of a 99.96% stake in Turkish pharmaceutical company Gensenta from Amgen, in a deal worth $135m. Eczac?ba?? is the founder of the first modern pharmaceutical facility in Turkey. With the takeover of Gensenta, Eczac?ba?? will move a step closer to becoming a key healthcare player in Turkey and global markets.

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AstraZeneca, chasing immunotherapy rivals, claims study success in early lung cancer

Bio Pharma Dive

A regimen involving its drug Imfinzi improved tumor responses when given before surgery, building on evidence that immunotherapies, already mainstays for advanced disease, could become standard treatments earlier.

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From operator to API: how the future of micronisation means no more compromise

Pharmaceutical Technology

Despite industry investment in large molecule drugs, demand for small molecule active pharmaceutical ingredients (API) manufacturing remains high. Driven by the rise of oncology pipeline drugs coupled with small or virtual pharma companies being unable to acquire or access containment capabilities in-house, the increase in high potency small molecule APIs means that the demand for these innovative, specialised capabilities is likely to continue.

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FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects

Bio Pharma Dive

Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of Principia Biopharma.

Drugs 169
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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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June 30, 2022: BackInAction Is Back on Track After COVID-19 Delays

Rethinking Clinical Trials

Dr. Karen Sherman. In connection with the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, we asked Drs. Karen Sherman and Lynn DeBar to update us on the Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction) Demonstration Project. BackInAction is a pragmatic randomized trial to evaluate the safety and effectiveness of treatments for older adults with chronic low back pain.

Trials 179
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Merck launches accelerator programme for AI startups

pharmaphorum

Merck & Co is looking for startup companies applying artificial intelligence , machine-learning and other digital approaches to drug discovery and development for a new accelerator programme. The big pharma – known as MSD outside North America – is initially offering support to 12 companies though the newly-formed Merck Digital Sciences Studio (MDSS) and is now taking applications from would-be participants.

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New patent expiration for Eisai Inc drug LUSEDRA

Drug Patent Watch

Annual Drug Patent Expirations for LUSEDRA Lusedra is a drug marketed by Eisai Inc and is included in one NDA. There is one patent protecting this drug. This drug has…. The post New patent expiration for Eisai Inc drug LUSEDRA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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FDA rejection of Spero’s tebipenem ‘raises resistance threat’

pharmaphorum

The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resistance, according to a GlobalData analyst. The FDA delivered a blow to Spero’s hopes of bringing the carbapenem to market in a complete response letter (CRL) delivered this week, which said another trial would be required to support approval.

Marketing 119
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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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New patent expiration for NOVO drug SAXENDA

Drug Patent Watch

Annual Drug Patent Expirations for SAXENDA Saxenda is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are twenty-three patents protecting…. The post New patent expiration for NOVO drug SAXENDA appeared first on DrugPatentWatch - Make Better Decisions.

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Continuing Transformation, Bayer Opens Genetown Research and Innovation Center

BioSpace

Cambridge, Massachusetts’ Kendall Square just got a little more crowded following the announcement that life sciences giant Bayer opened its new Research and Innovation Center.

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Study reveals an unprecedented change in Europe’s fire regime

Scienmag

A study reveals an unprecedented change in the fire regime in Europe which is related to climate change. The affected areas are in Southern, Central and Northern Europe but this historical change in Europe’s fire regime is more intense in the Mediterranean area. The study, published in the journal Scientific Reports, is led by Jofre […].

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Amarin, Secura Bio Face Disappointing Data, FDA Warning

BioSpace

???????Amarin released disappointing post hoc data from a sub-study of the REDUCE-IT trial, showing that its fish oil-derived Vascepa had little impact on serum biomarkers.

Trials 102
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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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Study shows HIV speeds up body’s aging processes soon after infection

Scienmag

HIV has an “early and substantial” impact on aging in infected people, accelerating biological changes in the body associated with normal aging within just two to three years of infection, according to a study by UCLA researchers and colleagues. Credit: National Institute of Allergy and Infectious Diseases (NIAID) HIV has an “early and substantial” impact […].

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Atos opens Life Science Centre of Excellence

Pharma Times

Centre will accelerate drug development and enable precision health solutions

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Laser creates a miniature magnetosphere

Scienmag

Osaka, Japan – Magnetic reconnections in laser-produced plasmas have been studied to understand the microscopic electron dynamics, which is applicable to space and astrophysical phenomena. Osaka University researchers, in collaboration with researchers at the National Institute for Fusion Science and other universities, have reported the direct measurements of pure electron outflows relevant to magnetic reconnection […].

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How to Overcome the Healthcare Talent Shortage

BioSpace

Forrester Consulting partnered with Sterling and found that, while the pandemic is the top concern for healthcare employers, overcoming the healthcare talent shortage is a close second.

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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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Aging-US | Time makes histone H3 modifications drift in mouse liver

Scienmag

BUFFALO, NY- June 30, 2022 – A new research paper was published in Aging (Aging-US) on the cover of Volume 14, Issue 12, entitled, “Time makes histone H3 modifications drift in mouse liver.” Credit: Hillje et al. BUFFALO, NY- June 30, 2022 – A new research paper was published in Aging (Aging-US) on the cover […].

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Akebia Regains Rights to Anemia Drug After Otsuka Partnership Dissolves

BioSpace

Otsuka Pharmaceutical terminated a deal with Akebia Therapeutics, which ends the U.S. and ex-U.S. vadadustat Collaboration and License Agreements.

Licensing 102
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Research reveals structure of a human endogenous reverse transcriptase

Scienmag

The crystal structure of a human endogenous reverse transcriptase has similarities to HIV reverse transcriptase, a well-known tractable drug target, which will help design drugs to treat cancer and other diseases, according to a study co-authored by a Rutgers researcher. The study, published in The Proceedings of the National Academy of Sciences (PNAS), describes the […].

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Provention Bio Announces FDA Extension of Diabetes Drug Review

BioSpace

Provention Bio announced the FDA extended its review period by three months for the Biologics License Application (BLA) of its diabetes prevention drug, teplizumab to Nov. 17.

Drugs 98
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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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Scientists unravel the key to colon cancer relapse after chemotherapy

Scienmag

Approximately 1 in 25 people will develop colon cancer during their lifetime and nearly 2 million cases new cases are diagnosed worldwide each year. Chemotherapy is commonly used to treat colon cancer. While this treatment is initially effective in most cases, many patients relapse after treatment. Credit: IRB Barcelona Approximately 1 in 25 people will […].

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After Layoffs, Big Companies Advance and Small Firms Retrench

BioSpace

After the spring reductions in the workforce that left thousands of biotech employees searching for jobs, larger companies are, for the most part, moving forward.

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Gemini North spies ultra-faint fossil galaxy discovered on outskirts of Andromeda

Scienmag

An unusual ultra-faint dwarf galaxy has been discovered on the outer fringes of the Andromeda Galaxy thanks to the sharp eyes of an amateur astronomer examining archival data processed by NSF’s NOIRLab’s Community Science and Data Center. Follow-up by professional astronomers using the International Gemini Observatory, a Program of NSF’s NOIRLab, revealed that the dwarf […].

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NYU Researchers Create Synthetic Versions of Hox Genes

BioSpace

A team of researchers at New York University has successfully created synthetic versions of the Hox genes that control biological development in humans.

Gene 98
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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.