Wed.May 26, 2021

article thumbnail

Lyell aims to follow Juno, Sana as Wall Street cools to biotech IPOs

Bio Pharma Dive

The ambitious cell therapy developer, which has already raised nearly $1 billion from investors, will test the IPO market just as the pace and performance of recent biotech offerings have slowed considerably.

Marketing 317
article thumbnail

470% price increases

World of DTC Marketing

SUMMARY: Sometimes there are just no words to express my outrage. Here is the executive summary of the Government’s report on AbbVie. I’m disgusted, sad , and angry. Mostly I’m angry because this reflects badly on all the good people within our industry who are trying to do great work and help people. Here is the executive summary from the report.

Drugs 180
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

UK drug contractor to be sold to private equity firm in $1.4B deal

Bio Pharma Dive

Through a subsidiary, The Carlyle Group will pay a 27% premium to acquire Vectura, a CDMO that specializes in inhaled medicines.

Medicine 152
article thumbnail

Legend Biotech’s CEO Ying Huang on Cilta-cel’s High PFS in Myeloma Patients

BioSpace

Legend Biotech and its partner Janssen are presenting six abstracts at the ASCO meeting in June detailing ciltacabtagene autoleucel (cilta-cel) CAR-T studies in multiple myeloma.

138
138
article thumbnail

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

article thumbnail

Campaigners challenge NHS England’s latest plan to share patient data

pharmaphorum

Remember the Care.data debacle? Now, a new move by NHS England to move the records of 55 million patients into a database that will be accessible by third-party companies is under fire by privacy campaigners, who claim it could be unlawful. . The new General Practice Data for Planning and Research (GPDPR) service was unveiled earlier this month by NHS Digital, which described it as a way to “improve” the collection of patient information that would allow better planning of healthcare

Research 116
article thumbnail

Will COVID-19 Vaccines Need a Booster? CDC Will Meet to Decide

BioSpace

Drug companies have been suggesting that booster shots will be needed. However, it is up to the CDC's recommendation if booster shots are necessary.

More Trending

article thumbnail

Relief for Women: FDA Approves Heavy Menstrual Bleeding Drug

BioSpace

The U.S. FDA has granted approval to MYFEMBREE, Myovant Sciences, and Pfizer’s once-daily treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

article thumbnail

Real-world flight data shows continued need for social distancing

Scienmag

Credit: Dr. Islind REYKJAVIK, Iceland 26 May 2021 – Current vaccination programmes alone will have a limited effect in stopping the second wave of COVID infections in the US, according to a study conducted by scientists from Reykjavik University, University of Lyon, University of Southern Denmark and University of Naples Federico II, and published in […].

article thumbnail

Belgium halts dosing of J&J COVID vaccine in under 41s after death

pharmaphorum

Belgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s one-shot COVID-19 vaccine, following the death of a woman from what appeared to be a blood clot-related condition. . The unnamed woman – who was under the age of 40 – died on 21 May after being admitted to hospital with severe thrombosis and low blood platelets, according to a statement from the Interministerial Conference on Public Health (CIM), which brings together national an

article thumbnail

Keeping more ammonium in soil could decrease pollution, boost crops

Scienmag

Credit: Egan Jimenez, Princeton University Modern-day agriculture faces two major dilemmas: how to produce enough food to feed the growing human population and how to minimize environmental damage associated with intensive agriculture. Keeping more nitrogen in soil as ammonium may be one key way to address both challenges, according to a new paper in the […].

97
article thumbnail

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

article thumbnail

Moderna’s vaccine ‘highly effective’ at preventing COVID-19 in adolescents

Pharma Times

Phase II/III TeenCOVE study met primary endpoint of non-inferior immunogenicity versus adult comparator group

article thumbnail

Significant otter helps couples communicate from the heart

Scienmag

CMU, snap researchers develop smartwatch app that uses heartrate to communicate Credit: Significant Otter Even though people stayed in touch during the pandemic’s stay-at-home orders and social distancing, it was easy to feel out of touch with loved ones. Technology and the internet have expanded the way humans communicate and added much to that communication […].

article thumbnail

Digital health firm Hello Tomo snapped up by ICAS World

pharmaphorum

A UK tech firm with an NHS-commissioned mental health app – Hello Tomo – has been acquired by ICAS World, a company specialising in providing employee health and wellbeing services. . Hello Tomo is described as a behaviour change tool for mental health and wellbeing that aims to help users maintain healthy habits, and according to ICAS is the first of a series of acquisitions underpinning a new digital health strategy at the group.

Trials 94
article thumbnail

HKUST’s meta-analysis shows SARS-CoV-2 variants unlikely to affect T cell responses

Scienmag

Credit: HKUST In a new study, scientists at The Hong Kong University of Science and Technology (HKUST) have revealed that most T cell epitopes known to be targeted upon natural infection are seemingly unaffected by current SARS-CoV-2 variants. In their latest research, the team compiled and analysed data from 18 immunological studies of T cell […].

article thumbnail

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.

article thumbnail

Abivax’s ABX464 shows ‘impressive’ efficacy in severe ulcerative colitis patients

Pharma Times

Once-daily oral treatment was well-tolerated and demonstrated a good safety profile in Phase IIb study

118
118
article thumbnail

To sting or not to sting?

Scienmag

Credit: Morgane Nouvian When do bees sting and how do they organise their collective defence behaviour against predators? An interdisciplinary team of researchers from the Universities of Constance and Innsbruck has provided new insights into these questions. Their study, published in BMC Biology, combined behavioural experiments with an innovative theoretical modelling approach based on “Projective […].

article thumbnail

Roche UK launches renewable energy initiative with E.ON

Pharma Times

Scheme will enable Roche's supply chain partners to purchase 100% renewable energy

122
122
article thumbnail

Good bacteria can temper chemotherapy side effects

Scienmag

Naturally occurring gut bacteria can clean up chemo toxins in the body, study finds Credit: Northwestern University In the human gut, good bacteria make great neighbors. A new Northwestern University study found that specific types of gut bacteria can protect other good bacteria from cancer treatments — mitigating harmful, drug-induced changes to the gut microbiome. […].

article thumbnail

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.

article thumbnail

Once in a Lifetime: Customer Experience at Momentous Moments

Pharma Marketing Network

Some moments in life are profoundly important. Perhaps you’ve saved carefully for years to take your family on a special vacation. Or perhaps you’ve just been given a life-changing diagnosis that’s left you in a state of shock. Whether positive or negative, in a moment that important, you’re living in an altered state. Things might seem overwhelming, with the world moving too fast for you to understand what’s going on; or you may freeze, and it may feel like reality has slowed to a crawl.

Nurses 87
article thumbnail

Resetting the biological clock by flipping a switch

Scienmag

Credit: Issey Takahashi The biological clock is present in almost all cells of an organism. As more and more evidence emerges that clocks in certain organs could be out of sync, there is a need to investigate and reset these clocks locally. Scientists from the Netherlands and Japan introduced a light-controlled on/off switch to a […].

article thumbnail

DOJ Looks Into Employee Allegation of Rewriting Findings at Lilly Facility

BioSpace

Lilly said it is cooperating fully with the DOJ and is in the process of conducting its own investigation into the allegations made against the company.

86
article thumbnail

Study of promising photovoltaic material leads to discovery of a new state of matter

Scienmag

McGill University researchers gain new insight into the workings perovskites that could lead to more efficient and cheaper solar cells Credit: Colin Sonnichsen Researchers at McGill University have gained new insight into the workings of perovskites, a semiconductor material that shows great promise for making high-efficiency, low-cost solar cells and a range of other optical and electronic devices. […].

article thumbnail

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.

article thumbnail

Singapore Biopharma Manufacturer Raises $200 Million Series A

BioSpace

The funds will enable Esco that provides life sciences tools and services, to expand its toehold in China and the United States.

article thumbnail

Deep oceans dissolve the rocky shell of water-ice planets

Scienmag

Credit: S. Speziale/ GFZ What is happening deep beneath the surface of ice planets? Is there liquid water, and if so, how does it interact with the planetary rocky “seafloor”? New experiments show that on water-ice planets between the size of our Earth and up to six times this size, water selectively leaches magnesium from […].

84
article thumbnail

3 Skills That Make Introverts Excellent Leaders

BioSpace

It is true that many introverts might consider themselves to be reserved, shy, or aloof, but that doesn’t mean that they won’t take the lead on areas that are important to them.

79
article thumbnail

Report reveals impact of over £1.8 billion on UK science and economy by Diamond

Scienmag

Invite to Launch webinar of Diamond’s Socio-Economic Impact Study: 26 May 2021 14:00-16:00 BST Credit: Technopolis/Diamond Light Source A recent study by Technopolis and Diamond estimates a cumulative monetised impact of at least £1.8 billion from the UK’s synchrotron, Diamond Light Source, reflecting very favourably with the £1.2 billion investment made in the facility to […].

article thumbnail

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.

article thumbnail

Global Roundup: Abivax Eyes Phase III Following Positive UC Data

BioSpace

Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.

article thumbnail

Study finds ongoing evolution in Tasmanian Devils’ response to transmissible cancer

Scienmag

U of I-led study finds ongoing evolution in Tasmanian Devils’ response to transmissible cancer Credit: Photo courtesy of Menna Jones. MOSCOW, Idaho — May 26, 2021 — University of Idaho researchers partnered with other scientists from the United States and Australia to study the evolution of Tasmanian devils in response to a unique transmissible cancer. […].

article thumbnail

Sanofi and GSK Launch Late-Stage Trial for COVID-19 Vaccine Candidate

BioSpace

A two-stage Phase III clinical trial by Sanofi and GSK, is studying a COVID-19 vaccine candidate targeting the original SARS-CoV-2 strain as well as the South African B.1.351 variant.

article thumbnail

EU asks court to fine AstraZeneca over missing COVID jab shipments

pharmaphorum

Lawyers for the European Commission asked a court in Brussels today to fine AstraZeneca millions of euros for its “obvious” failure to meet the terms of its contract to supply COVID-19 vaccines to the EU. Rafael Jafferali. Counsel for the Commission – Rafael Jafferali – insisted during the hearing at the Brussels Court of First Instance that AZ had made no attempt to respect the terms of the contract, and accused the company of “diverting” around 50 million doses made wi

article thumbnail

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.