Wed.Nov 15, 2023

article thumbnail

A gene editing biotech’s struggles end with reverse merger

Bio Pharma Dive

Since halting work on a sickle cell treatment early this year, Graphite Bio has laid off staff, shed assets and, now, agreed to be subsumed via a merger with Lenz Therapeutics.

article thumbnail

NHS sets sights on ending cervical cancer by 2040 with HPV vaccine drive

Pharmaceutical Technology

Chief executive Amanda Pritchard says vaccination and screening could make eliminating cervical cancer a reality in the next two decades.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Gilead expands Arcellx cancer cell therapy deal

Bio Pharma Dive

The deal gives Gilead an estimated 13% ownership in Arcellx and extends the company’s cash runway into 2027.

280
280
article thumbnail

Signal: Pfizer cuts 500 UK jobs in restructuring after posting Q3 loss

Pharmaceutical Technology

The company has struggled this year on the back of reduced Covid-19 medication sales and is now streamlining costs.

Sales 246
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Mastering Your Body’s Internal Clock Could Be The Key to Success

AuroBlog - Aurous Healthcare Clinical Trials blog

Timing is everything. For early risers and late-nighters alike, listening to your internal clock may be the key to success. From the classroom to the courtroom and beyond, people perform best on challenging tasks at a time of day that aligns with their circadian rhythm.

article thumbnail

Alkermes separates cancer drug business as new company Mural

Bio Pharma Dive

Now independent Mural Oncology will focus on advancing a pipeline of engineered cytokines for cancer, while Alkermes has recast itself as a “pure-play” neuroscience company.

Engineer 171

More Trending

article thumbnail

NIMHANS ties up with Liverpool Univ to accelerate pace of research in mental health & neurosciences

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Institute of Mental Health and Neuro Sciences (NIMHANS) in partnership with the University of Liverpool along with a £1.5 million fund support from Pratiksha Trust, will now accelerate the pace of research in mental health & neurosciences. This includes Japanese Encephalitis which requires early detection and neurocysticercosis, another serious brain infection.

Research 148
article thumbnail

UK JCVI recommends chickenpox vaccine in early childhood

Pharmaceutical Technology

The UK JCVI has recommended the addition of chickenpox vaccine to the country's routine immunisation programme for children.

article thumbnail

Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity

Fierce Pharma

In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival. | In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.

Trials 142
article thumbnail

Evaluating the top five sterilisation techniques for parenteral packaging

Pharmaceutical Technology

The use of validated methods for sterilising primary packaging before aseptic fill-and-finish plays a critical role in patient safety.

Packaging 147
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

Vertex, CRISPR Win World’s First Approval for CRISPR-Edited Therapy from UK

BioSpace

The U.K.’s Medicines and Healthcare products Regulatory Agency on Thursday provided conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel.

article thumbnail

Cambridge University spinout raises £48m to advance T-cell therapies

Pharmaceutical Technology

T-Therapeutics plans to use the Series A funds to develop T-cell therapies for cancer and auto-immune disorders.

article thumbnail

Germany considers banning the export of Novo Nordisk's Ozempic

Fierce Pharma

How popular have Novo Nordisk’s semaglutide drugs become for weight loss in Europe? | How popular have Novo Nordisk’s semaglutide drugs become for weight loss in Europe? The craze is such that Germany’s drug regulator is considering banning the export of Ozempic, according to a report in Der Spiegel magazine.

article thumbnail

Atreca downsizes again to focus on antibody-drug conjugate programmes

Pharmaceutical Technology

Atreca has made significant cuts to its workforce (by 40%) for the second consecutive quarter in 2023 in an effort to cut costs.

Antibody 147
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

Study shows how congenital heart disease affects blood supply before birth

Pharma Times

CHD is a common birth defect that affects the development of the heart and brain - News - PharmaTimes

article thumbnail

Kesin Pharma expands antibiotic reach with liquid suspension approval

Pharmaceutical Technology

The liquid suspension requires no preparation or refrigeration and treats bacterial infections such as rosacea and pelvic inflammatory disease.

130
130
article thumbnail

2seventy suffers sales slump on high production charges for BMS-partnered CAR-T med Abecma

Fierce Pharma

If you’re curious about the pitfalls of CAR-T drug commercialization, look no further than Bristol Myers Squibb’s Abecma partner 2seventy bio. | After reporting a sizable revenue decline for its BMS-parntered multiple myeloma cell therapy in 2023’s third quarter, 2seventy stands out as a prime example of the dangers of scaling up a process before suffering lower-than-expected demand, one group of analysts contends.

Sales 106
article thumbnail

Almirall and Absci link for AI-driven dermatological drug development

Pharmaceutical Technology

Almirall has entered into a collaboration with Absci for the development and commercialisation of new treatments for dermatological ailments.

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

Astellas Sees Path Forward for Gene Therapy Despite Four Patient Deaths

BioSpace

The Japanese pharma contends that an analysis of the four deaths in its AT132 gene therapy clinical trial shows it is still viable as a potential treatment for a fatal, rare genetic disease.

article thumbnail

A new era for pMDI propellants

Pharmaceutical Technology

Is the pharmaceutical industry prepared to phase out HFAs used in pressurised metered-dose inhalers (pMDI) for the treatment of asthma?

130
130
article thumbnail

Starry Soda: PepsiCo’s Lemon-Lime Soda Nears Its First Birthday

XTalks

Starry soda, Pepsi’s innovative entry in the lemon-lime soda market, has nearly completed its first year on the market. Introduced in January 2023, this strategic move was aimed at competing with Sprite, Coca-Cola’s dominant lemon-lime beverage, which boasts a seven percent share in the $82 billion US soda market. Sierra Mist, Pepsi’s previous contender, only managed to secure about 0.1 percent of this market share.

Marketing 104
article thumbnail

COP27: Have we committed to our goals?

Pharmaceutical Technology

Despite negotiations being ongoing since COP27, they have been slowed down by a lot of disagreements on how the fund will work.

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.

article thumbnail

CorMedix gains hard-fought approval for combo drug that reduces risk of catheter infection during dialysis

Fierce Pharma

CorMedix went through a lot to secure its FDA approval for DefenCath. | CorMedix went through a lot to secure its FDA approval for DefenCath. There was a reorganization, a CEO change, an exit from Europe, two complete response letters and a switch of manufacturers and suppliers. And it took a novel pathway for the approval to finally come through on Wednesday.

article thumbnail

Autifony and Jazz enter $770.5m drug development deal

Pharmaceutical Technology

Autifony Therapeutics and Jazz Pharmaceuticals have signed a $770.5m deal for the discovery and development of drug candidates.

article thumbnail

BMS Drug Augtyro Gets FDA Approval to Treat ROS1-Positive NSCLC

BioSpace

After Bristol Myers Squibb picked up Augtyro as part of its $4.1 billion takeover of Turning Point Therapeutics last year, the ROS1-positive non-small cell lung cancer drug reached the regulatory finish line on Wednesday.

article thumbnail

BIO-Europe 2023: Pharma balances on shaky financial and legislative footing

Pharmaceutical Technology

At BIO-Europe 2023, experts highlighted challenges in fundraising and concerns about impending EU legislative changes.

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

Jefferies Healthcare Conference: How CDMOs are embracing the obesity drugs craze

BioPharma Reporter

Weight loss drugs known as GLP-1s have caused a stir among patients and investors, with many CDMOs now looking to tap into the booming market.

Drugs 105
article thumbnail

Novo Takes Aim at Lilly’s Zepbound in Head-to-Head Trial Versus Wegovy Combo

BioSpace

Just a week after it secured FDA approval, Eli Lilly’s Zepbound now faces a challenge from Novo Nordisk’s investigational next-generation weight-loss candidate CagriSema in a Phase III trial.

article thumbnail

JCVI advises UK government on gonorrhoea and mpox vaccinations

Pharma Times

Both programmes will be offered to those most at risk of developing STIs - News - PharmaTimes

article thumbnail

Medicare Part D in 2024: Mapping Large Chains' Position in 2024’s Preferred Pharmacy Networks

Drug Channels

In Medicare Part D in 2024: The Seven Largest Companies' Preferred Pharmacy Networks and the Coming Collapse of the PDP Market , I documented how those networks now dominate stand-alone Medicare Part D prescription drug plans (PDPs) and have become a major presence in Medicare Advantage prescription drug (MA-PD) plans. Today, I examine the seven largest retail chains’ participation in the 20 major 2024 Part D networks that the eight largest plan sponsors will offer.

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.