UK Researchers developing new tetanus test to identify global immunity gaps
Pharma Times
JULY 12, 2024
The serious, rare condition is responsible for up to 7% of all neonatal deaths globally
Fri.Jul 12, 2024
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NHS rolls out “more convenient” Ocrevus injection for multiple sclerosis
Pharmaceutical Technology
JULY 12, 2024
The subcutaneous formulation of Roche’s blockbuster Ocrevus will cut hospital treatment time for patients.
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Leqembi sales inch higher; Spark’s pivot leads to layoffs
Bio Pharma Dive
JULY 12, 2024
Sales data suggest forecasts for the Alzheimer’s drug may be in reach. Elsewhere, Ipsen is licensing an ADC and Novartis is closing a San Diego site.
Ipsen gains global rights to Foreseen Biotech’s FS001 ADC
Pharmaceutical Technology
JULY 12, 2024
Ipsen has entered an exclusive global licensing agreement with Foreseen Biotech for FS001, a potentially first-in-class ADC.
Bristol Myers’ leukemia blockbuster set to face first generic rival
Bio Pharma Dive
JULY 12, 2024
Patent litigation has opened the door to generic copies of Bristol Myers’ Sprycel arriving in the U.S. as soon as September.
BARDA and Tiba Biotech link to develop ‘flu therapeutics
Pharmaceutical Technology
JULY 12, 2024
Preclinical biopharmaceutical company Tiba Biotech has announced a partnership with BARDA to develop therapeutics against influenza.
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Crossject secures funding from French Government for needle-free platform
Pharmaceutical Technology
JULY 12, 2024
The cash injection will accelerate the development of Crossject’s prefilled needle free platform to treat anaphylactic shock.
Senate Unanimously Passes Bill to Reduce Big Pharma Patent Thickets, Increase Competition
BioSpace
JULY 12, 2024
The Senate on Thursday unanimously passed a bill aimed at limiting the number of patents drugmakers can introduce and making it easier for generic and biosimilar competitors to enter the market.
Pan Cancer T raises funds through seed extension round
Pharmaceutical Technology
JULY 12, 2024
Pan Cancer T has announced a €4.25m ($4.62m) seed extension round to complete of preclinical studies for its leading product, PCT1:CO-STIM.
Abecma competition, Sotyktu pricing pressure and IRA: Analysts outline Bristol Myers’ top challenges
Fierce Pharma
JULY 12, 2024
Several challenges across Bristol Myers Squibb’s business have Leerink Partners analysts worried about the future—despite a few promising growth opportunities the team has identified. | Several challenges across Bristol Myers Squibb’s business have Leerink Partners analysts worried about the drugmaker—despite a few promising growth opportunities they identified.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Explainer: Labour has been elected in the UK – now what?
Pharmaceutical Technology
JULY 12, 2024
As Wes Streeting takes over the UK’s Department for Health and Social care, investors wait to see if the Labour government will will do.
Pfizer selects once-daily GLP-1 for its obesity push
pharmaphorum
JULY 12, 2024
Pfizer is advancing on a broad front in its attempt to catch up with Novo Nordisk and Eli Lilly in the obesity drug category – but has now decided on a lead candidate.The company said that, based on a pharmacokinetic study, it has plumped for a once-daily, modified-release formulation of GLP-1 agonist danuglipron that will start dose optimisation studies later this year.
MSD closes $1.3bn EyeBio acquisition, plans pivotal trial for lead asset
Pharmaceutical Technology
JULY 12, 2024
MSD (Merck & Co) plans to start a Phase IIb/III trial for EyeBio’s lead candidate, Restoret, in diabetic macular oedema in H2.
Proposed Medicare codes could lift digital health sector
pharmaphorum
JULY 12, 2024
A new payment policy proposal released by the Centers for Medicare and Medicaid Services (CMS) this week covers digital tools used for behavioural health, which could be a boost for the digital health sector.The Medicare Physician Fee Schedule (PFS) sets out the method of payment, rates, and codes for healthcare providers participating in Medicare, and is often used by the administration as an instrument to encourage some forms of healthcare intervention.
FDA grants fast track designation to AskBio’s AB-1005 for PD
Pharmaceutical Technology
JULY 12, 2024
Bayer and Asklepios BioPharmaceutical (AskBio) have announced FDA fast track designation for AB-1005, a gene therapy for PD.
Akebia Ends Deal With CSL Vifor, Unveils Hefty Price Tag for CKD Anemia Drug Vafseo
BioSpace
JULY 12, 2024
Akebia Therapeutics on Thursday said it regained full U.S. rights to its chronic kidney disease anemia drug Vafseo, which the biotech has priced at around $15,500 per year.
At the Breaking Point: The Unsustainable Future of Government Drug Discount Programs
Drug Channels
JULY 12, 2024
Today’s guest post comes from Gavin Magaha, Senior Director of External Affairs and Policy at Kalderos. Gavin discusses the three key reasons for duplicate discounts between the 340B Drug Pricing Program and the Medicaid Drug Rebate Program. He then explains Oregon’s novel approach to fixing the problem. To learn more, register for Kalderos’ August 21, 2024, webinar: Revolutionizing Government Discount Programs: Why Traditional Methods Fail.
AbbVie’s Humira Continues to Lose Market Share as Biosimilars Gain Ground: Report
BioSpace
JULY 12, 2024
CVS Caremark’s recent decision to take AbbVie’s Humira off its major formularies has caused the blockbuster to lose more market share to biosimilars, according to the latest report from Samsung Bioepis.
The New Age of Decentralized Clinical Trials
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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.
AbbVie's Humira loses some ground in high-stakes battle against biosimilars: report
Fierce Pharma
JULY 12, 2024
Even through an onslaught of biosimilar launches that began early last year, AbbVie’s big-selling Humira has been able to retain most of its lucrative market. | With ten biosimilar options in play, AbbVie's star immunology drug lost 13% of its total market share since March, according to a new Samsung Bioepis report.
DNA sequencer Element Bio raises $277m to take on Illumina
pharmaphorum
JULY 12, 2024
Element Bio’s bid to take on Illumina in the DNA sequencing market has been helped by an impressive $277m financing round
Innovate UK grants £4m to four companies to evaluate biomarkers for dementia
Pharma Times
JULY 12, 2024
The progressive neurodegenerative disease affects more than 55 million people globally
Streeting orders “raw and frank” investigation of NHS
pharmaphorum
JULY 12, 2024
New UK Health Secretary Wes Streeting orders a 'raw and frank' review of NHS to inform a new 10-year plan to fix it
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Immutep Aces Phase IIb in First-Line Head and Neck Cancer, Eyes Regulatory Pa.
BioSpace
JULY 12, 2024
Immutep shares jumped nearly 20% on Friday after data showed its LAG-3 therapy—plus Keytruda—elicited strong response rates in head and neck squamous cell carcinoma patients in the front-line setting.
CDMO Rentschler eyes more production projects as it revs up manufacturing line at new MA facility
Fierce Pharma
JULY 12, 2024
With a new production line up and running at its latest facility in the greater Boston area, family-owned German CDMO Rentschler Biopharma is eager to court new clients. | Rentschler this week revealed that the production line at its site in Milford, Massachusetts (formerly known as the Rentschler Biopharma Manufacturing Center), is now fully operational.
PBMs and Big Pharma Play Blame Game for Inflated Prescription Drug Prices
BioSpace
JULY 12, 2024
The Federal Trade Commission criticized the business practices of pharmacy benefit managers this week, but drugmakers are also at fault for the high costs of medicines.
New tentative approval for Alembic drug dabigatran etexilate mesylate
Drug Patent Watch
JULY 12, 2024
Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.
How Machine Learning Drives Clinical Trial Efficiency
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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.
US and UK fast track designations for Parkinson’s gene therapy
Drug Discovery World
JULY 12, 2024
The US Food and Drug Administration (FDA) has granted Fast Track Designation for Asklepios BioPharmaceutical’s (AskBio) AB-1005 which is being developed for moderate Parkinson’s disease. AB-1005 has also been awarded the innovative medicine designation, the Innovation Passport by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of Parkinson’s disease.
Coming soon: New EU Artificial Intelligence Act
pharmaphorum
JULY 12, 2024
Stay informed about the upcoming EU Artificial Intelligence Act, which will regulate AI use in compliance with EU standards. Learn how this legislation may impact your organisation's AI initiatives.
Increase in diabetes research fuelled by GLP-1s like Ozempic
Drug Discovery World
JULY 12, 2024
Covid-19 is no longer in the top five most studied indications, replaced by type 2 diabetes, according to Phesi’s mid-year analysis of clinical trials. The analysis of 66,935 clinical trials reveals that the top five most studied diseases are now breast cancer, solid tumours, stroke, prostate cancer and type 2 diabetes. The mid-year analysis indicates breast cancer could be the most researched disease area for four-years running, after topping the table last year.
Celebrating the 2024 PharmaTimes MSEA and NIEA awards
Pharma Times
JULY 12, 2024
The awards celebrated both medical affairs and nursing professionals in the industry
Roles and Responsibilities of Specialized Clinical Supply Experts
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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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