Tue.Jan 10, 2023

article thumbnail

JPM23: Califf on accelerated approvals, biotech startups’ looming cliff and an explanation from Editas

Bio Pharma Dive

The FDA commissioner shared advice for drugmakers at the J.P. Morgan Healthcare conference, while venture investors cautioned of a coming funding crunch for young biotechs.

356
356
article thumbnail

AstraZeneca to buy US-based CinCor Pharma for $1.8bn

Pharmaceutical Technology

AstraZeneca has signed a definitive agreement to buy US-based biopharmaceutical company CinCor Pharma in a deal valued at about $1.8bn. Under the deal, the company will initiate a tender offer to purchase all the outstanding shares of CinCor Pharma for $26 per share in cash. The transaction also includes a non-tradable contingent value right of $10 per share in cash which will be paid after a specified regulatory submission of CinCor’s lead drug candidate, baxdrostat (CIN-107).

Insiders

Sign Up for our Newsletter

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

article thumbnail

5 questions facing emerging biotech in 2023

Bio Pharma Dive

Investors expect another lackluster year in IPOs, while company restructurings look set to continue as biotech executives try to conserve cash.

339
339
article thumbnail

FDA Approves New Alzheimer’s Drug Designed to Slow Cognitive Decline

AuroBlog - Aurous Healthcare Clinical Trials blog

The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease. The FDA approval of the drug, Leqembi, also known as lecanemab, comes just days after the regulatory agency was harshly criticized in a congressional report […].

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

JPM23: Vaccine developers as dealmakers, Gilead’s trial tea leaves and building platform companies

Bio Pharma Dive

Moderna’s Stéphane Bancel and Pfizer’s Albert Bourla hinted Monday at greater dealmaking to come for their companies, while Gilead gave investors an update on an important cancer drug trial.

Trials 285
article thumbnail

NPPA looks into fixation of retail price of drugs under phase IV clinical trials

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Pharmaceutical Pricing Authority (NPPA) may fix the retail price of formulations which are under phase IV clinical trials based on the company’s application submitted to the central drug regulator for conducting the phase of clinical trials and other documents along with the relevant form. The Authority deliberated the issue of retail price fixation […].

More Trending

article thumbnail

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

Pharmaceutical Technology

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India). The leading blockbuster franchises, from 2019, such as Victoza in the glucagon-like peptide-1 (GLP-1) space, Januvia for dipeptidyl peptidase-4 inhibitors (DPP-4Is), and Lantus in the insulin ma

Insulin 130
article thumbnail

Mistakes happen in research papers. But corrections often don’t

STAT News

Mistakes happen — in life, in the lab, and, inevitably, in research papers, too. Journals use corrections and retractions to resolve those mistakes. But one particularly high-profile case is now drawing fresh attention to the problems with journals’ process for addressing concerns about research integrity. Late last year, Stanford University announced that it was opening an investigation into its president, neuroscientist Marc Tessier-Lavigne, over allegations of research misconduc

Research 138
article thumbnail

Boehringer Ingelheim partners with 3T Biosciences for cancer therapies

Pharmaceutical Technology

Boehringer Ingelheim has entered a strategic partnership and licensing agreement with 3T Biosciences for the discovery and development of next-generation cancer immunotherapies. The collaboration will combine 3T Biosciences’ 3T- T-Cell Receptor Antigen and Cross-Reactivity Engine (TRACE) discovery platform with Boehringer Ingelheim’s two-pronged research strategy combining compounds that are directed towards cancer cells and target immune cells. 3T Biosciences’ platform uses diverse target libra

article thumbnail

MacKenzie Scott is shaking up philanthropy's traditions. Is that a good thing?

NPR Health - Shots

Donations often come with rigorous applications and reporting requirements. Billionaire MacKenzie Scott, who divorced Jeff Bezos in 2019 and vowed to give away most of her fortune, does it her way.

137
137
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

STAT+: An FDA pathway to clear medical devices is putting patients at risk, research suggests

STAT News

The Food and Drug Administration’s approach to evaluating some new medical devices might actually increase the risk that those devices will later be recalled over safety concerns. For some medical devices, the FDA requires data from studies in people to show that the device, including things like implantable heart defibrillators or stents, is safe and effective.

Research 135
article thumbnail

BioNTech to acquire AI specialist InstaDeep: ‘Our aim is to be a technology company where AI is seamlessly integrated into all aspects of our work’

BioPharma Reporter

German mRNA pioneer BioNTech will acquire InstaDeep, an artificial intelligence and machine learning specialist, for around Â362m ($439m): pledging to incorporate rapidly evolving AI capabilities into its research, drug discovery, manufacturing and deployment processes.

article thumbnail

BioNTech buys UK-based AI startup InstaDeep in £562m deal

pharmaphorum

mRNA specialist BioNTech has driven its partnership with UK artificial intelligence InstaDeep into top gear, agreeing to buy the company outright in a cash and equity deal that values it at up to £562 million ($683 million). The deal , billed as BioNTech’s largest to date and unveiled at the JP Morgan healthcare conference today, includes $362 million upfront with another £200 million on offer if performance targets are met.

article thumbnail

A child or youth died every 4.4 seconds in 2021. That number could get worse

NPR Health - Shots

A new U.N. report shows that child mortality rates are declining, but the yearly improvements have slowed. And the drop-off in childhood vaccinations during the pandemic causes concern for the future.

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

JPM23: Pfizer entering the 'most important' 18-month stretch in company history, CEO says

Fierce Pharma

JPM23: Pfizer entering the 'most important' 18-month stretch in company history, CEO says. esagonowsky. Tue, 01/10/2023 - 08:51.

126
126
article thumbnail

The sports world is still built for men. This elite runner wants to change that

NPR Health - Shots

Champion distance runner Lauren Fleshman says too many coaches assume — falsely — that what works for male athletes also benefits female athletes. Her memoir is Good for a Girl.

105
105
article thumbnail

Opinion: Is the golden age of biotech stocks over?

STAT News

Much of the last decade felt like the golden age of biotechnology investing. Money — lots of money — was poured into new gene therapies that replaced defective genes with healthy ones, immunotherapies that were game changers for people with cancer, innovative medicines for rare diseases and HIV, and more. The returns on biotech stocks were phenomenal.

article thumbnail

A Holiday Surprise; FTC Published Its Health Products Compliance Guidance

FDA Law Blog

By Riëtte van Laack & Ricardo Carvajal — On Dec. 20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). FTC staff prepared the new Guidance to update and replace Dietary Supplements: An Advertising Guide for Industry , issued in 1998 (“1998 Guidance”). The new Guidance provides the first update in 25 years on FTC’s thinking regarding substantiation and disclosures for health-related claims.

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.

article thumbnail

STAT+: FDA scolds Sun Pharmaceutical for serious quality control problems at a key plant in India

STAT News

Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S. Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems. In a Dec. 15 warning letter posted on Tuesday on the FDA website, Sun was cited for several notable failures, such as not following appropriate procedures to prevent contamination; establishing an adequ

article thumbnail

JP Morgan 2023 – Day 2

pharmaphorum

Tuesday brings the on-site part of Fierce’s JPM event as well as day 2 of the Informa Biotech Showcase. We’ll do our best to surf between the two, as well as providing remote updates where we can from the main event. Fierce’s event “The long haul: How pharma and healthcare can survive in 2023” will feature guests from Bayer, Takeda, Genentech, and more.

103
103
article thumbnail

The pandemic showed the power of viral sequencing. Now the U.K. plans to decode other respiratory bugs

STAT News

Building on the global boom in viral surveillance during the pandemic, U.K. scientists on Tuesday unveiled an initiative to expand sequencing of the common seasonal respiratory bugs that have received comparatively little attention. The Respiratory Virus & Microbiome Initiative, launched and funded by the Wellcome Sanger Institute, will track the evolution not just of SARS-CoV-2, the coronavirus that causes Covid-19, but also other coronaviruses, different flu families, RSV, and other pathog

Scientist 105
article thumbnail

How Damar Hamlin's collapse fueled anti-vaccine conspiracy theories

NPR Health - Shots

In the absence of information about why the Buffalo Bills player collapsed during a game, misleading claims about COVID vaccines quickly spread online.

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

STAT+: Illumina, the DNA sequencing giant, gives Wall Street bad news

STAT News

Illumina, the largest maker of DNA sequencing technology, told investors exactly what they didn’t want to hear on Monday. For years, Illumina shares rose steadily as the company led the way on pushing down the costs involved in doing genetic research. Its new machines were must-haves for genetic researchers, who bought the new devices as quickly as Apple enthusiasts snapping up new iPhones.

DNA 105
article thumbnail

Lack of medicines in Greece and the solution of Generics

Pharma Tutor

Lack of medicines in Greece and the solution of Generics. admin. Tue, 01/10/2023 - 15:46. Georgios-Marios Bolmpasis. MPharm Student University of Athens. Vice President of Pharmacy Students Association(Athens).

Medicine 100
article thumbnail

STAT+: Hospitals say peak labor costs are behind them

STAT News

SAN FRANCISCO — Rising labor costs have been the main financial concern for hospitals over the past year, but those costs have peaked and are now a lot lower, according to hospital system executives who presented during the J.P. Morgan Healthcare Conference. During the Omicron surge at the beginning of 2022, Covid patients flooded hospitals, which didn’t have enough staff to treat everyone.

Nurses 105
article thumbnail

JPM23: Novavax hopes end of COVID emergency—and open vaccine market—will help it grow market share

Fierce Pharma

JPM23: Novavax hopes end of COVID emergency—and open vaccine market—will help it grow market share. aarmstrong. Tue, 01/10/2023 - 10:24.

Marketing 114
article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

article thumbnail

STAT+: People hate drug ads on TV. Here’s what they complain about most

STAT News

In the United States, pharmaceutical advertising seems inescapable. Since the first prescription drug ad ran in the early 1980s, the business of pharmaceutical advertising has exploded. Drug companies spent $7 billion on advertising last year, according to Statista , with most of that going to television ads; more than $287 million was spent on TV advertising for Sanofi and Regeneron’s anti-inflammatory drug Dupixent alone.

Drugs 98
article thumbnail

Connected customer data: a golden opportunity for pharma marketers

pharmaphorum

Data is transforming life sciences, but many organisations are not using its full potential. Life sciences and the pharmaceutical industry are awash with data. It flows from every direction in torrents to create huge opportunities to address the world’s mounting health issues. Approximately 30% of global data volume is generated by the healthcare industry and it will continue to expand with a compound annual growth rate predicted to reach 36% by 2025, according to research by RBC Capital Markets

article thumbnail

Callers keep flooding 988 mental health, suicide line

STAT News

HYATTSVILLE, Md. — When Jamieson Brill answers a crisis call from a Spanish speaker on the newly launched national 988 mental health helpline, he rarely mentions the word suicide, or “suicidio.” Brill, whose family hails from Puerto Rico, knows that just discussing the term in some Spanish-speaking cultures is so frowned upon that many callers are too scared to even admit that they’re calling for themselves.

98
article thumbnail

SIFI and Avanzanite announce AKANTIOR agreement

Pharma Times

Partnership offers treatment access to hundreds of patients across several European countries

133
133
article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.