Wed.Aug 28, 2024

article thumbnail

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.

RNA 298
article thumbnail

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.

Insiders

Sign Up for our Newsletter

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

article thumbnail

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.

283
283
article thumbnail

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.

130
130
article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

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.

Drugs 147
article thumbnail

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.

130
130

More Trending

article thumbnail

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.

130
130
article thumbnail

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.

article thumbnail

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.

Antibody 130
article thumbnail

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

article thumbnail

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

article thumbnail

Oesophageal cancer: the global clinical trials landscape in 2024

Pharmaceutical Technology

With new oesophageal cancer cases annually projected to increase by 80% before 2050, find out more about current and developing treatments.

article thumbnail

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

115
115
article thumbnail

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.

130
130
article thumbnail

myTomorrows and Pancreatic Cancer Europe partner on clinical trials

Pharma Times

The partnership will improve care for patients with pancreatic cancer

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

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.

130
130
article thumbnail

Acelyrin’s izokibep for hidradenitis suppurativa reveals positive results

Pharma Times

However the company will not continue developing the candidate

article thumbnail

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.

Drugs 113
article thumbnail

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.

104
104
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

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.

111
111
article thumbnail

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.

article thumbnail

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.

Sales 98
article thumbnail

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.

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

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.

article thumbnail

Lilly launches single-dose Zepbound to ease self-pay access

pharmaphorum

Lilly launches single-dose Zepbound to ease self-pay access Phil.

91
article thumbnail

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.

article thumbnail

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

Trials 89
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

Pharmacovigilance Software Solutions for CROs: What to Consider

Cloudbyz

Contract Research Organizations (CROs) play a vital role in the life sciences industry, acting as the bridge between pharmaceutical companies and regulatory bodies. They are tasked with managing clinical trials, collecting data, and ensuring that new drugs are safe and effective before they reach the market. Given their critical responsibilities, CROs must have robust pharmacovigilance (PV) systems to monitor and manage adverse events effectively.

article thumbnail

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.

article thumbnail

Bayer, NextRNA Therapeutics Agree to Strategic Collaboration to Develop Small Molecule Therapeutics

Pharmaceutical Commerce

The joint venture aims to disrupt pathological lncRNA interactions with RNA-binding proteins using NextRNA’s platform.

RNA 52
article thumbnail

MSD starts second phase 3 of Imago drug for blood cancers

pharmaphorum

MSD starts phase 3 trial of oral LSD1 inhibitor bomedemstat as a first-line option for blood cancer essential thrombocythaemia

Drugs 85
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.