Fri.Jun 07, 2024

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Beyond one-size-fits-all: How compounding pharmacies address allergies with precision

pharmaphorum

Discover how compounding pharmacies use genetic information to create precision medications tailored to individual allergies. Learn how personalised treatments can benefit you.

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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next

Bio Pharma Dive

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

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FDA admonishes Jiangsu Hengrui’s manufacturing site following inspection

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has criticised the state of Chinese pharma company Jiangsu Hengrui’s facilities in a newly released 483 form.

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Geron wins long-sought drug approval; Califf talks China, GLP-1s at BIO

Bio Pharma Dive

After 34 years, Geron finally has an approved medicine in Rytelo. Elsewhere, Shionogi disclosed disappointing obesity drug data and AbbVie got some good trial news.

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

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Curevac gets grant for pharmaceutical composition for rsv vaccine with modified fusion protein

Pharmaceutical Technology

Discover Curevac NV's groundbreaking patent for an mRNA-based RSV vaccine, targeting prophylaxis and treatment. Learn about the innovative pharmaceutical composition and method for stimulating a robust immune response against RSV.

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After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

Fierce Pharma

Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.

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MASH Clash Between Lilly and Boehringer-Zealand Takes Center Stage at EASL24

BioSpace

Both Eli Lilly and the partnered companies Boehringer Ingelheim and Zealand Pharma have mid-stage data readouts this week, fueling the race in metabolic dysfunction-associated steatohepatitis.

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Syndax Pharmaceuticals gets grant for inhibitors of menin-mll interaction for cancer treatment

Pharmaceutical Technology

Discover the groundbreaking patent by Syndax Pharmaceuticals Inc for compounds targeting menin-MLL interaction in leukemia treatment. Learn more about this innovative approach to fighting cancer.

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Vanda Gets $466M Unsolicited Offer from Cycle Amid Ongoing Row with FDA

BioSpace

After rejecting a previous takeover offer from Future Pak, Vanda Pharmaceuticals is now fielding another acquisition proposal from Cycle Pharmaceuticals, which values the biotech at $8 per share.

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Heidelberg Pharma gets grant for amanitin derivative conjugates for treating cancer

Pharmaceutical Technology

Discover Heidelberg Pharma AG's groundbreaking patent for synthesizing amanitin derivatives to treat breast, pancreatic, and colorectal cancer. Learn more about this innovative method now!

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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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FDA Approves Geron’s First-in-Class Telomerase Inhibitor for Blood Disorder

BioSpace

Approved for patients with low- to intermediate-risk myelodysplastic syndromes, Geron’s Rytelo is the first telomerase inhibitor to hit the market and the company’s first approved drug after 34 years in business.

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CSPC Pharmaceutical Group gets grant for pharmaceutical formulation for treating inflammatory or neurodegenerative diseases

Pharmaceutical Technology

Discover the groundbreaking patent by CSPC Pharmaceutical Group Ltd for a pharmaceutical composition targeting Cx43 hemichannels to treat inflammatory and neurodegenerative diseases like spinal cord injury. Explore the specific antibodies and stabilizing agents within a defined pH range.

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Biomea’s Stock Nosedives More Than 60% as FDA Puts Clinical Hold on Diabetes Candidate

BioSpace

Biomea Fusion’s early-stage investigational diabetes treatment BMF-291 has been slapped with a full FDA clinical hold on its Phase I/II trials due to concerns over liver toxicity.

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Amneal Pharmaceuticals gets grant for patent granted for floating gastroretentive composition with sustained release

Pharmaceutical Technology

Discover the innovative patent by Amneal Pharmaceuticals for a floating gastroretentive composition delivering sustained release of liothyronine. Revolutionizing hypothyroidism treatment with unique design and effective drug delivery.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Boehringer, Zealand Heat Up MASH Race With Strong Phase II Data

BioSpace

The companies announced Friday that their candidate survodutide, which is licensed to Boehringer Ingelheim from Zealand Pharma, improved fibrosis in more than 50% of treated patients with metabolic dysfunction-associated steatohepatitis.

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Allscripts Healthcare Solutions gets grant for optimizing patient overview in user interface for medical processing device

Pharmaceutical Technology

Discover how Allscripts Healthcare Solutions Inc's patented technologies optimize patient overviews in a user-friendly interface. Enhance workflow efficiency with customizable patient data displays.

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FDA Raises Concerns About Lilly’s Donanemab Alzheimer’s Candidate Ahead of Adcomm

BioSpace

In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes.

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Zydus Lifesciences gets grant for oral suspension of mycophenolate mofetil

Pharmaceutical Technology

Discover the innovative patent by Zydus Lifesciences Ltd for a pharmaceutical oral suspension with mycophenolate mofetil, xanthan gum, and more. Revolutionizing immunosuppressive treatment methods.

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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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Why commercialisation is the next frontier for digital innovation in pharma

pharmaphorum

Explore how commercialisation is the new frontier for digital innovation in the pharmaceutical industry, with a focus on GLP-1 drugs, digital strategies, and reducing patient acquisition costs.

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Avadel Pharmaceuticals gets grant for patent granted for modified release formulation of gamma-hydroxybutyrate

Pharmaceutical Technology

Discover Avadel Pharmaceuticals' innovative patent for modified release formulations of gamma-hydroxybutyrate, enhancing dissolution and pharmacokinetic properties. Learn about the unique composition designed for oral administration.

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AbbVie Sees Early ROI on $10B Immunogen Buy in Phase II Ovarian Cancer Win

BioSpace

AbbVie’s antibody-drug conjugate Elahere, developed by ImmunoGen, elicited a nearly 52% objective response rate in heavily pretreated patients with folate receptor-alpha-positive, platinum-sensitive ovarian cancer.

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ASCO24: Another win for Opdivo/Yervoy in first-line HCC despite uncertainties

Pharmaceutical Technology

The prognostic factor(s) driving outcomes at the initial stages of hepatocellular carcinoma remain unclear, complicating the treatment choice.

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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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Cycle Pharma makes $466m takeover bid for Vanda

pharmaphorum

UK group Cycle Pharma has made an unsolicited takeover bid to buy Vanda Pharma, which is already fending off an overture from Future Pak.

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FDA AdCom to question efficacy and safety concerns with Eli Lilly’s Alzheimer’s drug

Pharmaceutical Technology

The FDA is looking to ask questions about a change of primary endpoint, treatment cessation and mortality reporting from the donanemab trial.

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Nestle bids to take control of Seres’ C diff drug Vowst

pharmaphorum

Nestle Health Science bids to take control of Seres Therapeutics’ oral microbiome product Vowst for preventing C. diff infections.

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ChromaDex wins orphan designation for rare ataxia drug

Pharmaceutical Technology

The company will be filing an IND for nicotinamide riboside chloride (NRC), which has received both orphan and rare pediatric designations.

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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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Building resilience in cancer trials

pharmaphorum

Learn how building resilience can positively impact cancer trials in the field of oncology. Learn more about CancerEngage.

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Agomab wins FDA orphan drug status for idiopathic pulmonary fibrosis asset

Pharmaceutical Technology

Agomab Therapeutics has now secured a US Food and Drug Administration (FDA) orphan drug designation for IPF treatment AGMB-447.

Drugs 130
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Ex-staffer pleads guilty to scamming Takeda out of $2.3M through fake consulting firm

Fierce Pharma

After fessing up to wire fraud charges, a former Takeda employee will be preparing for a sentencing hearing rather than walking down the aisle with $2.3 million garnered through a scheme to defraud | Priya Bhambi, 40, pled guilty to wire fraud charges after running a detailed scheme to scam Takeda into paying for non-existent services from a fake consulting firm.

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Orano Med unveils radiopharma manufacturing plant in Indianapolis 

Pharmaceutical Technology

The facility is expected to allow Orano Med to produce 5,000 doses of lead-212 based radioligand therapies by 2025.

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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.