Mon.Mar 04, 2024

article thumbnail

Bayer pays $310M to buy into BridgeBio heart drug

Bio Pharma Dive

The deal gives the German pharma partial rights to a closely watched medicine for transthyretin amyloidosis cardiomyopathy that analysts expect to become a multibillion-dollar product.

Medicine 299
article thumbnail

Oncology emerges as dominant therapy area for CRISPR technology

Pharmaceutical Technology

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

Medicine 278
Insiders

Sign Up for our Newsletter

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

article thumbnail

Nocion, chasing GSK, pulls in $62M for chronic cough drug

Bio Pharma Dive

Nocion will use the cash to start a mid-stage trial testing its medicine, a potential rival to a drug GSK acquired last year in a $2 billion deal.

Drugs 182
article thumbnail

EMA awards double validation for Daiichi Sankyo and AstraZeneca’s cancer ADC

Pharmaceutical Technology

The EMA has validated the jointly developed TROP2-directed therapy for patients with breast or lung cancer following positive Phase III data.

article thumbnail

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

article thumbnail

Akero strengthens MASH drug’s case with new study data

Bio Pharma Dive

The updated results show that responses to the drug, which is currently in late-stage testing, deepened with time, helping the company rebound from an earlier setback.

Drugs 182
article thumbnail

FDA doubles down on patient engagement to support rare disease research

Pharmaceutical Technology

For Rare Disease Day, several panels organised by the FDA discussed the importance overcoming accessibility barriers during drug development.

Research 195

More Trending

article thumbnail

Sandoz strengthens US biosimilar market with CIMERLI acquisition

Pharmaceutical Technology

Sandoz has concluded the acquisition of the US biosimilar CIMERLI from Coherus BioSciences, bolstering ophthalmology and biosimilar expertise.

Marketing 147
article thumbnail

Using knowledge graphs to drive drug discovery

Bio Pharma Dive

How are knowledge graphs changing the path of drug discovery?

Drugs 147
article thumbnail

Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

article thumbnail

Pfizer stops buildout of $350M Seagen plant, leaving 120 workers' roles in question

Fierce Pharma

When Pfizer completed its $43 billion buyout of Seagen in December | Less than three months after completing its $43 billion acquisition of Seagen, Pfizer has confirmed a report that it is shutting down construction of a $350 million manufacturing facility in Everett, Washington. The decision will affect 120 employees working on the initial setup of the site, the company said.

article thumbnail

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

article thumbnail

F. Hoffmann-La Roche in advanced materials: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to advanced materials last quarter, and how many were granted? Discover the latest information here.

130
130
article thumbnail

Researchers reveal two different subtypes of prostate cancer using AI

Pharma Times

In the UK alone, the aggressive form of cancer affects around 52,000 men every year

Research 128
article thumbnail

CARsgen’s CAR-T therapy for multiple myeloma gains NMPA approval

Pharmaceutical Technology

The China's NMPA has granted approval for CARsgen Therapeutics' NDA for zevorcabtagene autoleucel to treat multiple myeloma.

130
130
article thumbnail

Poor spatial navigation could predict Alzheimer’s before symptom onset

Pharma Times

Around 900,000 people in the UK are affected by the progressive neurodegenerative disease

125
125
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

FogPharma secures $145m to develop cancer therapy

Pharmaceutical Technology

FogPharma has secured $145m in a Series E financing round to support the clinical development of its cancer therapy, FOG-001.

article thumbnail

Q&A: How AI and ML are reshaping the research landscape

Bio Pharma Dive

Panalgo’s Meg Richards and Mike Munsell discuss how AI and ML are transforming the healthcare research landscape.

Research 124
article thumbnail

FDA approves J&J’s RYBREVANT for NSCLC treatment

Pharmaceutical Technology

The US FDA has granted full approval for Johnson & Johnson's (J&J) RYBREVANT for types of NSCLC.

article thumbnail

Perrigo's over-the-counter birth control launch takes flight in the US

Fierce Pharma

A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.” | A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.

116
116
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Dark factories for a bright future

pharmaphorum

Explore the future of drug manufacturing with dark factories, robotic and automated facilities that promise efficiency and innovation. Learn how these advancements are shaping a bright future for the pharmaceutical industry.

article thumbnail

RSV vaccines may raise risk of Guillain-Barré syndrome, FDA preliminary analysis finds

Fierce Pharma

After decades of research into respiratory syncytial virus (RSV), Pfizer and GSK’s groundbreaking vaccines made waves as the first immunizations against the common respiratory illness. | After a preliminary analysis found a potentially higher risk of Guillain-Barré syndrome following RSV vaccination in older adults, GSK and Pfizer said they will conduct further safety studies.

Vaccine 115
article thumbnail

F. Hoffmann-La Roche in robotics: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to robotics last quarter, and how many were granted? Discover the latest information here.

113
113
article thumbnail

EMA starts twin reviews of AZ, Daiichi’s Dato-DXd

pharmaphorum

The clock has started ticking in the EU on two marketing applications for AstraZeneca and Daiichi Sankyo’s TROP2-targeting antibody-drug conjugate datopotamab deruxtecan in breast and lung cancer. The EMA has validated the two parallel applications for the drug, also known as Dato-DXd, in adults with previously treated non-small cell lung cancer (NSCLC) and hormone receptor-positive, HER2-negative breast cancer.

Hormones 113
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

F. Hoffmann-La Roche in internet of things: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to internet of things last quarter, and how many were granted? Discover the latest information here.

113
113
article thumbnail

After multiple wrist-slaps, Aurobindo unit Eugia receives another manufacturing write-up

Fierce Pharma

Aurobindo subsidiary Eugia is back in hot water with the FDA after a recent plant inspection yielded yet another Form 483—this time in India. | Following an inspection of Eugia's injectables facility in Telangana, India, the FDA issued a formal rebuke laying out seven manufacturing observations, parent company Aurobindo said in a recent filing.

article thumbnail

F. Hoffmann-La Roche in cybersecurity: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to cybersecurity last quarter, and how many were granted? Discover the latest information here.

113
113
article thumbnail

Pharma Pulse 3/4/24: Local Pharmacies on the Brink, People in MA Plans Experienced Delays in Accessing Care & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharmacy 105
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

With Takeda out of the picture, J&J’s Rybrevant moves into first line in lung cancer subtype

Fierce Pharma

Johnson & Johnson continues to grow its oncology franchise with a new FDA approval that opens the lung cancer drug Rybrevant to treating certain newly diagnosed patients. | Johnson & Johnson continues to grow its oncology franchise with a new FDA approval that opens the lung cancer drug Rybrevant to treating certain newly diagnosed patients.

article thumbnail

Bayer pays $310m for Euro rights to ATTR therapy acoramidis

pharmaphorum

Bayer licenses European rights to BridgeBio's acoramidis, putting some big pharma muscle behind the ATTR cardiomyopathy treatment

Licensing 104
article thumbnail

Bayer in robotics: theme innovation strategy

Pharmaceutical Technology

How many patents did Bayer submit related to robotics last quarter, and how many were granted? Discover the latest information here.

100
100
article thumbnail

As Medicare price negotiations roll on, drugmakers counter HHS' initial offers

Fierce Pharma

After the U.S. | With the counteroffers, the IRA-mandated negotiations period has begun and will continue through August.

98
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.