Mon.Nov 20, 2023

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AstraZeneca creates digital health unit, with big-name partnerships already in place

Bio Pharma Dive

Called Evinova, the unit will operate as a separate business within AstraZeneca, which sees digital health solutions as a market primed for growth.

Marketing 284
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Takeda wins EU approval for paediatric use of Takhzyro in HAE

Pharmaceutical Technology

Takhzyro has been approved for the routine prevention of recurrent hereditary angioedema attacks in patients aged 2 years and older.

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Bristol Myers faces FDA delay on cancer cell therapy decision

Bio Pharma Dive

The regulator plans to convene an advisory panel to discuss an expanded indication for Abecma, presenting another hurdle for Bristol Myers and partner 2seventy bio.

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Are haemophilia gene therapies truly “one and done”?

Pharmaceutical Technology

The value of haemophilia gene therapies like Roctavian and Hemgenix hinge on long-term efficacy and innovative payment structures play a key role.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Data infrastructure excellence changing the shape of biopharma manufacturing

Bio Pharma Dive

Biopharma companies capture data across a variety of different fronts and, so this data must be managed effectively in order to unlock business efficiencies and drive improvements.

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AstraZeneca launches new digital health solutions business Evinova 

Pharmaceutical Technology

AstraZeneca has launched a new digital health solutions business, Evinova, to expedite innovation in the life sciences industry.

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Pfizer licenses small molecule drug delivery technology from Serina

Pharmaceutical Technology

Serina Therapeutics’ polymer aims to overcome certain limitations of the commonly used polyethylene glycol for drug delivery.

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Biohaven hopes to muscle in on Ozempic with a different type of weight loss drug

Bio Pharma Dive

Several biotech companies, Biohaven among them, are trying to develop medicines that could trim the waistline while building lean tissue.

Medicine 148
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Signal: Wegovy highlights UK’s complex relationship with private sector

Pharmaceutical Technology

Wegovy has made headlines recently in the UK, highlighting both its seismic impact and changes in health habits.

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Food Industry Influencers Warned by FTC for Inadequate Disclosure of Paid Promotions

XTalks

Food industry influencers were recently at the center of a controversy highlighted by the Federal Trade Commission (FTC). Last week, the FTC issued warning letters to two major groups in the food and beverage sector and several online food industry influencers. Their offense? Inadequate disclosure of paid social media posts that endorsed a sweetener and various sugary products.

Marketing 110
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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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Monash University team to receive funds for prostate cancer therapy

Pharmaceutical Technology

A team of researchers at Monash University received a $5m award from the government for developing CAR T cell therapy for prostate cancer.

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After protests, pharma industry reaches 'landmark' drug spending deal with UK government

Fierce Pharma

After blasting the U.K.’s drug pricing policy, the pharma industry has secured a new government spending deal featuring a higher revenue cap and an innovative drug-friendly rebate mechanism. | After blasting the U.K.’s drug pricing policy, the pharma industry has secured an improved government spending deal. The agreement will double the annual growth rate for prescription meds over the coming years.

Drugs 108
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Oxurion to file for bankruptcy following trial failure

Pharmaceutical Technology

Oxurion’s diabetic macular oedema drug, THR-149, failed to meet its primary endpoint in the Phase IIb trial.

Trials 147
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BHF and UKDRI announce first UK centre for vascular dementia research

Pharma Times

The centre will help discover new treatments to prevent, halt and cure the condition - News - PharmaTimes

Research 134
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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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NeoImmuneTech bags orphan drug tag for IL-7 acute radiation syndrome treatment

Pharmaceutical Technology

NeoImmuneTech is developing NT-17, an IL-7 treatment, to promote rapid T-cell recovery in patients with acute radiation syndrome.

Drugs 130
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What We’re Watching for 2024 – Top Trends in Market Access

Intouch Solutions

In the rapidly changing landscape of global markets, staying ahead of the curve is crucial for businesses aiming to expand and thrive. As we step into 2024, the realm of market access undergoes dynamic shifts influenced by technological advancements, policy changes, and evolving consumer behaviors. There are the usual suspects like evolving provider models, the continued transition to value-based care and pharma/biotech companies increased investment in “access,” but there are two trends that ar

Marketing 105
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EC approves BeiGene’s Brukinsa combo to treat follicular lymphoma

Pharmaceutical Technology

The EC has granted marketing authorisation to BeiGene’s Brukinsa plus obinutuzumab to treat follicular lymphoma (FL) in adults.

Marketing 130
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Merck Drops Up to $610M on Neuro Disease-Focused Caraway Therapeutics

BioSpace

The buy brings three small molecules in preclinical development for Parkinson’s disease, amyotrophic lateral sclerosis and lysosomal storage diseases into Merck’s pipeline.

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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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Chiesi partners with Haisco to commercialise bronchiectasis drug  

Pharmaceutical Technology

The partners will develop, manufacture, and commercialise the candidate outside China and adjacent territories.

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NHS expands COVID-19 research platform for other major diseases

Pharma Times

The OpenSAFELY platform will support the discovery of new treatments - News - PharmaTimes

Research 132
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FDA Delays Decision on BMS, 2seventy bio’s Push for Earlier Line Abecma Treatment

BioSpace

The regulator has decided to hold an advisory committee meeting regarding BMS and 2seventy bio’s bid to move the CAR-T cell therapy into earlier lines of treatment, missing its previous target action date of Dec. 16.

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After FDA no, Almirall’s eczema drug gets EU okay

pharmaphorum

The European Commission has approved Almirall’s lebrikizumab as Ebglyss for the treatment of moderate-to-severe atopic dermatitis (AD), with an EU rollout set to start in Germany next year.

Drugs 95
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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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Flagship Pioneering Launches First UK Biotech with $50M Investment

BioSpace

Quotient Therapeutics, co-located in Cambridge, Mass. and Cambridge, U.K., will receive $50 million over two years from Flagship to study somatic genomics with an eye to finding new targets for gene therapies.

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Using AI to Become Pharma's Next Superhero

Fierce Pharma

“AI is becoming part of the pharma fabric, and it really is set to disrupt the industry.” | Viz.ai’s Nina Binetti is joined by colleagues at CrowdPharm and Remedy Product Studio to explore the various ways in which AI is being used among pharma companies – from improving patient diagnoses and treatments to unlocking operating efficiencies.

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Demystifying Patient Advocacy in Clinical Research

XTalks

Today’s healthcare landscape is rapidly shifting, with an emphasis on the need for patient-centered care. Xtalks’ recent discussion with Rebekah Angove, PhD, Executive VP of Research and Evaluation at the Patient Advocate Foundation (PAF), offers a deeper understanding of incorporating patient narratives into clinical trials. Established over 25 years ago, the PAF has been dedicated to providing direct services to patients experiencing access and affordability challenges, especially those with c

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BeiGene Inks Potential $1.3B Deal with Ensem for Early-Stage CDK2 Inhibitor

BioSpace

The biotech company has bought the global rights to an investigational oral CDK2 inhibitor from Ensem Therapeutics in a licensing agreement valued at up to $1.33 billion if all milestones are met.

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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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FDA pushes back decision date on BMS, 2seventy bio's Abecma in earlier line of treatment

Fierce Pharma

It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. | It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. The company’s effort to gain approval for the CAR-T in an earlier line of treatment—previously set for an FDA decision on Dec. 16—will have to be pushed back pending an advisory committee meeting.

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People on the move: New appointments in the pharma industry in November

BioPharma Reporter

IO Biotech, Quotient Sciences and Terumo Blood and Cell Technologies are among the key companies welcoming new colleagues.

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Bayer pulls batch of cancer med Vitrakvi over bacterial contamination concerns

Fierce Pharma

The threat of microbial contamination has triggered yet another drug recall, this time from German pharma bigwig Bayer. | Bayer is recalling one lot of Vitrakvi oral solution in the U.S. after routine stability testing discovered the presence of microbial contamination identified as Penicillium brevicompactum.

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Unlocking the potential of synthetic DNA 

Drug Discovery World

Raquel Sanches-Kuiper , Vice President of Science and Applications at Evonetix, and Clare Whitewoods , Marketing Communications Manager at Evonetix, look at the benefits synthetic DNA brings to pharmaceutical development. Engineering biology is reshaping the world, from enabling the rapid development of vaccines to providing alternatives to petroleum fuels.

DNA 69
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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.