Wed.Aug 28, 2024

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Meet the Researcher: Dr Joanne Taylor

Drug Discovery World

DDW’s Megan Thomas looks at a day in the life of Dr Joanne Taylor , Senior Vice President and Head of Discovery Research at Gain Therapeutics. MT: Can you provide a top line summary of your research? JT: We are developing novel small molecule, disease-modifying, allosteric regulators to treat serious diseases such as Parkinson’s disease and other dementias.

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Bayer partners with RNA drugmaker to develop new cancer therapies

Bio Pharma Dive

Under a collaboration with NextRNA Therapeutics, Bayer will access the biotech’s platform to target long, non-coding RNA interactions with small molecule drugs.

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FABA’s life sciences innovation cluster works on global partnerships to propel novel biologics & diagnostics

AuroBlog - Aurous Healthcare Clinical Trials blog

Federation of Asian Biotech Associations’ (FABA) Life Sciences Innovation Cluster is now working to strengthen the global partnerships to propel an ecosystem for novel biologics and diagnostics.

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Neurocrine’s mixed schizophrenia data disappoint Wall Street

Bio Pharma Dive

Despite “positive” results, shares of the biotech slid by 20%. Analysts cautioned that Neurocrine shouldn’t get “the benefit of the doubt” with its data.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Pfizer launches digital healthcare platform to streamline access

Pharmaceutical Technology

Pfizer has launched a new digital platform, PfizerForAll, aimed at simplifying the process of accessing healthcare for millions of Americans.

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After an FDA rejection, here’s what’s next in the psychedelics pipeline

Bio Pharma Dive

By rejecting the first MDMA therapy this month, the FDA signaled to the psychedelic drug field that the road to approval isn’t easy.

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BioMarin cuts deeper with 225 layoffs under CEO's new corporate strategy

Fierce Pharma

The rightsizing at BioMarin continues to take its toll as CEO Alexander Hardy devises a new corporate strategy for the rare disease biotech. | The rightsizing at BioMarin continues to take its toll as CEO Alexander Hardy devises a new corporate strategy for the rare disease biotech.

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Eli Lilly’s Zepbound to be issued in single-dose vials for self-payers

Pharmaceutical Technology

Eli Lilly has announced the availability of Zepbound (tirzepatide) in 2.5mg and 5mg single-dose vials for self-pay for adults with obesity.

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Details emerge of £400m investment programme tied to VPAG

pharmaphorum

The £400m pledged by industry as part of the new VPAG voluntary scheme of pharma rebates will be used mainly to support the UK clinical research sector

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EC approves Astellas’ PADCEV for urothelial cancer

Pharmaceutical Technology

The European Commission has authorised Astellas Pharma's PADCEV regimen for the first-line treatment of advanced urothelial cancer.

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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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AI voice assistant can spot complications in heart patients

pharmaphorum

A virtual voice assistant used to contact patients after heart procedures can make early discharge possible and spot complications

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Soleno wins FDA priority review for Prader-Willi therapy

Pharmaceutical Technology

The FDA also plans to hold an advisory committee for the DCCR therapy for Prader-Willi syndrome, with a PDUFA date of 27 December 2024.

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Germany's Stada reports rosy earnings as CEO tempers expectations around possible sale, IPO

Fierce Pharma

As Stada Arzneimittel’s private equity owners continue to weigh their options around a potential sale or public offering, the German drugmaker gave a good indication Wednesday of exactly what it ca | As Stada Arzneimittel’s private equity owners continue to weigh their options around a potential sale or public offering, the German drugmaker gave a good indication Wednesday of exactly what it can bring to the table.

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Navigator gains $100m in Series A funding for antibody therapeutics

Pharmaceutical Technology

Navigator Medicines has secured $100m in a Series A financing round with the aim of advancing bispecific antibody therapeutics.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With phase 3 win, Novartis pads case for broader use of heart med Leqvio

Fierce Pharma

Three years after launching Leqvio in the U.S., Novartis is still steadily advancing its blockbuster ambitions for the cholesterol-lowering drug. | After a positive phase 3 readout, Novartis said it aims to apply cholesterol-lowering Leqvio across the "full spectrum" of atherosclerotic cardiovascular disease.

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Bayer teams up with lncRNA-focused NextRNA in $547m deal

Pharmaceutical Technology

The deal included an undisclosed upfront payment and NextRNA can get up to $547m if all the milestones are reached.

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Novartis taps Lindy to turn biologic drugs into at-home injectables, puts nearly $1B on the line

Fierce Pharma

Novartis has formed a strategic collaboration with drug delivery specialist Lindy Biosciences to develop self-administered versions of the Swiss pharma’s innovative drugs. | Novartis has formed a strategic collaboration with drug delivery specialist Lindy Biosciences to develop self-administered versions of the Swiss pharma’s innovative drugs.

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myTomorrows and Pancreatic Cancer Europe partner on clinical trials

Pharma Times

The partnership will improve care for patients with pancreatic cancer

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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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In key win for GSK, Delaware court will review decision to allow expert testimony in Zantac cases

Fierce Pharma

Delaware's Supreme Court has upheld a GSK appeal, deciding to review the state’s Superior Court decision to allow expert testimony in Zantac lawsuits.

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Acelyrin’s izokibep for hidradenitis suppurativa reveals positive results

Pharma Times

However the company will not continue developing the candidate

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HDA 2024 Traceability Seminar: What to Expect From FDA Inspections

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA Traceability Seminar.

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Flagship and Quotient partner on cardiovascular and renal disease therapies

Drug Discovery World

Pfizer has expanded its strategic partnership with Flagship Pioneering, adding two new research programmes with Flagship-founded Quotient Therapeutics. Under the collaboration, the companies will analyse somatic mutations that occur in diseased patient tissue to inform the discovery and development of therapies for cardiovascular and renal diseases.

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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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HDA 2024 Traceability Seminar: DSCSA Implementation and Readiness

Pharmaceutical Commerce

Session uncovers distributors’ experiences with the Waiver, Exception, or Exemption request process, and how these affect the overall supply chain.

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Regulatory Considerations for API Manufacturing in the EU: Ensuring Compliance and Supply Chain Resilience

Drug Patent Watch

The European Union (EU) has implemented a robust regulatory framework to ensure the quality and safety of active pharmaceutical ingredients (APIs) used in medicines. The EU’s Good Manufacturing Practice (GMP) guidelines provide the minimum standards for API manufacturing, and compliance with these guidelines is mandatory for all manufacturers and importers of APIs intended for the EU market.

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UK drug discovery companies receive share of £17.8M fund

Drug Discovery World

Therapeutics companies developing immunotherapies, mRNA vaccines and anti-inflammatory therapies have been chosen to receive funding from Innovate UK Biomedical Catalyst. In total, thirty projects will receive a share of £17.8 ($23.5) million from Biomedical Catalyst, Innovate UK’s flagship grant funding mechanism. Biomedical Catalyst was created to help small and medium-sized businesses test and develop innovative health and care solutions across health and life sciences, including therapeutics

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Novartis builds case for Leqvio with monotherapy data

pharmaphorum

Novartis builds case for fast-growing cholesterol drug Leqvio, as V-MONO trial shows benefit as a monotherapy in patients at lower risk of heart disease

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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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EU okays new first-line treatment for advanced urothelial cancer

Drug Discovery World

The European Commission has granted marketing authorisation for antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) in combination with PD-1 inhibitor Keytruda (pembrolizumab) for urothelial cancer. It is approved for the first-line treatment of adult patients with unresectable or metastatic cancer, who are eligible for platinum-containing chemotherapy.

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Shifting the paradigm in pharma marketing with content transformation

pharmaphorum

Join the EVERSANA webinar to discover how content transformation is revolutionising pharma marketing strategies. Learn how to shift the paradigm and stay ahead in the industry.

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Pharma Pulse 8/28/24: AI Regulation Is Coming, A Case for Payer Engagement/Participation in Clinical Research & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Changing Faces – Board of Directors appointments from July 2024

pharmaphorum

Changing Faces announces new board of directors appointments from July 2024 for Immatics, Memo Therapeutics, Scancell, Abcuro and more. Stay updated on the latest developments in the biotech industry.

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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.