Wed.Apr 24, 2024

article thumbnail

Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

article thumbnail

Moderna turns to AI to change how its employees work

Bio Pharma Dive

An expanded partnership with OpenAI is helping Moderna embed custom-built AI chatbots in a wide range of research and business processes.

Research 294
Insiders

Sign Up for our Newsletter

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

article thumbnail

For The First Time, Scientists Showed Structural, Brain-Wide Changes During Menstruation

AuroBlog - Aurous Healthcare Clinical Trials blog

The constant ebb and flow of hormones that guide the menstrual cycle don’t just affect reproductive anatomy. They also reshape the brain, and a study has given us insight into how this happens.

Scientist 190
article thumbnail

Biogen to invest more in launch of Alzheimer’s drug Leqembi

Bio Pharma Dive

Growing demand has convinced Biogen that it's worth expanding the sales force around Leqembi by 30%.

Sales 304
article thumbnail

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

article thumbnail

Incyte signs deal to acquire Escient Pharmaceuticals

Pharmaceutical Technology

Incyte has agreed to acquire US-based Escient Pharmaceuticals and its assets including two first-in-class small molecule antagonists targeting Mas-related G protein-coupled receptor X2 (MRGPRX2) for the treatment of various mast cell-mediated disorders.

Protein 147
article thumbnail

CureVac to cut costs in restructuring

Bio Pharma Dive

The mRNA vaccine maker, which has lost most of its value since early 2021, is undergoing an “organizational redesign” that will involve the elimination of 150 positions.

More Trending

article thumbnail

Biogen: Don’t expect any big acquisitions this year

Bio Pharma Dive

While the company is eager to diversify, CEO Chris Viehbacher said that in the near-term any dealmaking would likely focus on collaborations and early-stage assets.

171
171
article thumbnail

MacroGenics gets grant for patent granted for compounds targeting IL23a and BAFF

Pharmaceutical Technology

Discover how MacroGenics Inc's patent for compounds targeting IL23A and BAFF can suppress inflammatory responses in subjects in need. Learn about the unique polypeptide compositions and methods outlined in the patent.

130
130
article thumbnail

Biogen sees ‘encouraging’ trends for postpartum depression drug

Bio Pharma Dive

First quarter sales of Zurzuvae doubled consensus estimates, though analysts are skeptical whether the better-than-expected launch will continue.

Sales 177
article thumbnail

Seres Therapeutics gets grant for composition of isolated bacteria in capsule for dysbiosis treatment

Pharmaceutical Technology

Discover the groundbreaking patent by Seres Therapeutics Inc for a unique composition targeting dysbiosis in mammals. Learn how specific bacterial species in a capsule can inhibit pathogenic bacteria growth.

Bacteria 130
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

Endeavor pulls in $132M to back cancer, lung disease drugs

Bio Pharma Dive

Led by the founder of a biotech Celgene acquired for $7 billion, the startup is developing two prospects that originated in the labs of other drugmakers.

Drugs 171
article thumbnail

Ipsen gets grant for treatment of diseases with specific benzothiazepine and benzothiadiazepine derivatives

Pharmaceutical Technology

Discover how Ipsen SA's patented compounds can treat cardiovascular, metabolic, gastrointestinal, and liver diseases. Learn about the method and specific compounds outlined in the recently granted patent.

130
130
article thumbnail

[Podcast] Partner for Progress: Strategies for Biotech Success

Bio Pharma Dive

In this three-part podcast series, hear from seasoned experts from Allucent as they discuss a range of topics, including how small and mid-sized companies can take a more strategic approach to pharmacovigilance, a regulatory & development roadmap for ADCs and RDCs, and pre-MAA/NDA inspection readiness.

article thumbnail

Sanofi gets grant for optical decoding system for determining medicament dose in drug delivery device

Pharmaceutical Technology

Enhance medication dosing accuracy with Sanofi's patented optical decoding system for drug delivery devices. Improve efficiency and precision in dispensing with this innovative technology.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

April 24, 2024: Developments in Waivers and Alterations of Informed Consent in Minimal-Risk Research, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Lauren Milner, Dr. Jonathan Casey, and Dr. Matthew Semler In this Friday's PCT Grand Rounds, Lauren Milner of the US Food and Drug Administration (FDA) and Jonathan Casey and Matthew Semler of Vanderbilt University will present "Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – FDA Regulation Development and Research Landscape.

article thumbnail

Bicycle Therapeutics gets grant for high affinity binders of nectin-4 for treating diseases

Pharmaceutical Technology

Discover the groundbreaking patent by Bicycle Therapeutics Plc for high affinity binders of Nectin-4, including drug conjugates and pharmaceutical compositions. Learn about the detailed method for synthesizing compound BCY8245.

Drugs 130
article thumbnail

Sanders Launches Probe of ‘Outrageously High Prices’ of Novo’s Ozempic, Wegovy

BioSpace

Sen. Bernie Sanders (I-Vt.) on Wednesday launched an investigation into the exorbitant prices of Novo Nordisk’s Ozempic and Wegovy blockbusters, and has asked the Danish drugmaker to justify their price tags.

114
114
article thumbnail

Pfizer gets grant for treatment of cancer using engineered immune cells targeting bcma

Pharmaceutical Technology

Discover how Pfizer's patented CARs targeting BCMA offer a groundbreaking method for treating cancer. Learn about the unique ligand-binding and signaling domains for effective treatment.

Engineer 130
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

BMS to Cut 2,200 Jobs in $1.5B Restructuring as Opdivo Sales Drop in Q1

BioSpace

Bristol Myers Squibb announced Thursday it is implementing major cost-cutting measures including thinning out its management layers. The pharma also reported modest revenue growth despite taking a 6% sales hit for lung cancer therapy Opdivo.

Sales 112
article thumbnail

EC approves Astellas’ Xtandi for high-risk prostate cancer treatment

Pharmaceutical Technology

The EC has granted approval for label extension to Astellas’ Xtandi to be used as monotherapy or in combination with androgen deprivation therapy to treat adult men with high-risk BCR nmHSPC who are not suitable for salvage-radiotherapy.

130
130
article thumbnail

Roche's Vabysmo shows no sign of slowdown after Regeneron and Bayer's launch of Eylea HD

Fierce Pharma

It’s been eight months since Regeneron secured approval for a high-dose version of its powerhouse macular degeneration treatment Eylea in the U.S. | How much impact has the approval of high-dose Eylea had on the upward trajectory of Roche’s Vabysmo? Not much, according to sales figures released by Roche.

Sales 111
article thumbnail

Apellis Pharmaceuticals gets grant for treatment of complement-mediated eye disorder with long-acting compstatin analog

Pharmaceutical Technology

Discover how Apellis Pharmaceuticals' patented method using long-acting compstatin analogs can effectively treat complement-mediated eye disorders like geographic atrophy.

130
130
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

FDA initiative puts AR/VR at heart of home health drive

pharmaphorum

A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system

121
121
article thumbnail

BioCryst Pharmaceuticals gets grant for inhibitors of the complement system for disease treatment

Pharmaceutical Technology

Discover how BioCryst Pharmaceuticals' patent for complement system inhibitors offers targeted treatment options for diseases like paroxysmal nocturnal hemoglobinuria.

130
130
article thumbnail

Regeneron Pays Mammoth $100M to Access CRISPR Enzymes for AAV Delivery

BioSpace

Regeneron will use Mammoth Biosciences’ tiny Cas enzymes to deliver in vivo CRISPR-based gene editing therapies to tissues and cell types beyond the liver, the companies announced Thursday.

article thumbnail

Novartis reports 25% increase in net income in Q1 2024

Pharmaceutical Technology

Novartis has reported net income from continuing operations of $2.68bn for the first quarter (Q1) of 2024, marking a 25% increase from $2.15bn in Q1 2023.

130
130
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

Sanofi and AstraZeneca Scrap Several Early-Stage Programs in Q1

BioSpace

Sanofi is dropping its Sjögren’s syndrome candidate due to disappointing Phase II efficacy data, while AstraZeneca is stopping work on some early-stage assets amid a portfolio reprioritization.

109
109
article thumbnail

Novartis bags paediatric FDA label expansion for Lutathera

Pharmaceutical Technology

Lutathera is approved by the US FDA to treat patients aged 12 years and older with rare gastroenteropancreatic neuroendocrine cancer.

130
130
article thumbnail

Elevating Equity: Why National Minority Health Month Matters

XTalks

April marks not only the blossoming of spring and the onslaught of my allergies but also a pivotal moment for raising awareness and advocating for equitable healthcare access. National Minority Health Month, observed annually throughout April, serves to emphasize the recognition of the unique health challenges faced by minority communities. This month-long observance is not just a symbolic gesture; it’s a critical opportunity to take a deeper dive to open up dialogue and cast our focus on

Research 105
article thumbnail

GSK, Lundbeck, ROVI: Three Journeys of Unified Pharma Events Management 

Pharmaceutical Technology

GSK, Lundbeck, and ROVI share how their events strategies contribute to higher-value engagement with healthcare professionals (HCPs).

130
130
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.