Thu.Oct 05, 2023

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Apellis' stumbling GA drug Syfovre shows signs of recovery

Fierce Pharma

Five weeks removed from slashing 25% of its workforce amid problems wi | Five weeks removed from slashing 25% of its workforce amid problems with its groundbreaking geographic atrophy drug, Apellis is making progress in re-accelerating the launch of Syfovre. Ahead of its quarterly earnings presentation, Apellis estimated sales of approximately $74 million for the third quarter for Syfovre and a rekindling of demand in recent weeks as doctors get a better handle on the risk of vascular retinitis.

Drugs 111
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Orchard sells to Kyowa Kirin in gene therapy buyout

Bio Pharma Dive

Kyowa will pay nearly $400 million to acquire Orchard, which sells the gene therapy Libmeldy in Europe but has struggled to find paths to market for other experimental treatments.

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Lumicell co-founder wins Nobel Prize in Chemistry

Pharmaceutical Technology

Lumicell co-founder, Moungi Bawendi, has been awarded the accolade alongside two others for his research into quantum dots.

Research 258
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Apellis sales numbers show steady demand for new eye drug, despite safety worries

Bio Pharma Dive

The company says Syfovre prescriptions accelerated again in August after a rocky summer of side effect probes.

Sales 277
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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

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Rising Addiction to Milk Tea Linked to Depression in Adolescents

AuroBlog - Aurous Healthcare Clinical Trials blog

Milk teas – a variety of sweet drinks including bubble tea – have become phenomenally popular in China and other parts of Asia in recent years, and a new study has highlighted some worrying links between the beverage and mental health issues.

Research 238
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AbbVie acquires Parkinson’s drug in latest biotech buyout

Bio Pharma Dive

The company exercised an option to buy Mitokinin, a Pfizer-backed drugmaker built on work by scientific co-founders Nicholas Hertz and Kevan Shokat.

Drugs 195

More Trending

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Dana-Farber spinout Precede exits stealth with blood test technology and $57M

Bio Pharma Dive

Precede has used the money to develop a platform that reveals the activity of genes and pathways.

Gene 162
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Japanese Kyowa Kirin acquires Orchard to bolster gene therapy pipeline

Pharmaceutical Technology

Orchard's portfolio includes Libmeldy, which has been approved for a rare genetic disorder, metachromatic leukodystrophy.

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UniQure lays off 20% of staff, cuts research to ‘significantly’ lower costs

Bio Pharma Dive

All told, the biotech said it will discontinue more than half of its research and technology projects, including a Parkinson’s disease treatment.

Research 162
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October 5, 2023: GRACE Trial Featured on CBS News Chicago for Sickle Cell Awareness Month

Rethinking Clinical Trials

The GRACE trial, an NIH Pragmatic Trials Collaboratory Demonstration Project, was featured in a segment on CBS News Chicago. Co–principal investigator Ardith Doorenbos was interviewed for the segment as part of the news program’s observance of Sickle Cell Awareness Month. “Millions of people around the world with sickle cell disease really suffer from very serious chronic pain, which impacts all their life experiences,” Doorenbos said. “What the GRACE trial is doing is ta

Trials 147
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA issues draft guidance on stimulant use disorder drug development

Pharmaceutical Technology

The US FDA has issued a draft guidance to aid sponsors in developing biologics and drugs for stimulant use disorders.

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Signant Health launches Signant Biotech for emerging biopharma organisations

Pharma Times

The research approach will help small- to mid-sized organisations to advance their clinical studies - News - PharmaTimes

Research 136
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ADCs dominate with billion-dollar licensing agreements in 2022

Pharmaceutical Technology

Antibody-drug conjugates (ADCs) saw a 400% growth in total licensing agreement deal value from 2017 to 2022 and reached a peak of $16.6bn.

Licensing 130
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Evonetix installs first DNA synthesis development platform at ICL

Pharma Times

It will be the company’s first platform to be installed in an external scientific setting - News - PharmaTimes

DNA 134
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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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IMIDomics, WuXi to advance antibody development for IMIDs

Pharmaceutical Technology

IMIDomics and WuXi Biologics have signed an agreement to advance the development and manufacturing of the humanised antibody, IMB1001

Antibody 130
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Roche app relieves diabetes distress in clinical trial

pharmaphorum

Roche app relieves diabetes distress in clinical trial Phil.

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UK launches national full-body scan platform to accelerate drug discovery

Pharmaceutical Technology

The initiative was created in partnership with Medicines Discovery Catapult, the Medical Research Council, and Innovate UK.

Medicine 130
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At Viatris' request, US agency will review Novo Nordisk patent on semaglutide

Fierce Pharma

In Viatris' attempt to become the first company to reach the market with generic versions of Novo Nordisk’s diabetes and obesity juggernauts Ozempic and Wegovy, the company received good and bad ne | After hearing a petition from Viatris, the U.S. Patent and Trademark Office will conduct a review to determine the validity of a patent held by Novo Nordisk.

Marketing 125
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Shorla raises funds to advance oncology drug candidates

Pharmaceutical Technology

Shorla Oncology has received $35m in Series B funding to boost the oncology portfolio growth by advancing its pipeline of drug candidates.

Drugs 130
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Merck eyes new bladder cancer space with positive Keytruda trial in muscle-invasive disease

Fierce Pharma

Merck’s Keytruda is riding a winning streak in bladder cancer. | Merck’s Keytruda is riding a winning streak in bladder cancer. Following FDA approvals in the metastatic and non-muscle invasive settings, the anti-PD-1 therapy has delivered a positive readout in muscle-invasive urothelial carcinoma.

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Advanz Pharma to license Dimerix’s DMX-200 drug candidate

Pharmaceutical Technology

Advanz Pharma has signed an agreement to licence Dimerix’s DMX-200 for marketing in the UK, Australia and New Zealand among others.

Licensing 130
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Sanofi weighs Mirati buy as KRAS cancer drug battle enters new phase: Bloomberg

Fierce Pharma

Mirati Therapeutics enjoyed a stock-price spike Thursday after rumors started swirling about a potential buyout by French drug giant Sanofi. | Mirati Therapeutics saw its stock price spike Thursday at the possibility of a buyout from Sanofi. The French pharma has been evaluating a potential acquisition of the KRAS drug developer, Bloomberg reports, citing unnamed sources.

Drugs 124
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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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Inhibikase’s risvodetinib wins FDA orphan drug designation

Pharmaceutical Technology

Inhibikase is planning a Phase II trial to investigate its Abelson Tyrosine Kinase inhibitor in MSA.

Drugs 130
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LogiPharma USA 2023: Tracy Nasarenko Provides a Synopsis of “DSCSA—Final Checks to Have Before Deadlines.”

Pharmaceutical Commerce

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.

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EMA endorses Calliditas’ Alport syndrome drug for orphan designation

Pharmaceutical Technology

EMA gives positive opinion for granting Calliditas Therapeutics’ Alport syndrome drug an orphan designation.

Drugs 130
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UK Biobank study “will shape drug discovery”

pharmaphorum

UK Biobank study “will shape drug discovery” Phil.

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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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AstraZeneca’s Forxiga meets primary endpoint for T2D

Pharmaceutical Technology

Forxiga has approval for adult use in 122 countries and in the EU to treat paediatric patients for T2D above the age of ten.

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How AI and omnichannel are transforming pharma marketing

pharmaphorum

How AI and omnichannel are transforming pharma marketing Mike.

Marketing 116
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Lonza expands antibody-drug conjugate production pact, plots 180 new hires

Fierce Pharma

The abrupt departure of Lonza’s CEO last month clearly hasn’t dampened the Swiss CDMO’s dealmaking prowess. | Lonza has extended a long-term collaboration with an unnamed “major global biopharmaceutical partner” to crank up commercial supply of antibody-drug conjugates at its site in Visp, Switzerland. The deal is set to boost Lonza’s current bioconjugation capacity fourfold, thanks to the addition of two new bioconjugation suites.

Antibody 116
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LogiPharma USA 2023: Navigating the E2E Global Pharma Supply Chain Using Digital Transformation

Pharmaceutical Commerce

Panel discusses how digital transformation can best impact supply chains.

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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.