An obesity drug biotech gets buy-in from Eli Lilly, venture firms
Bio Pharma Dive
NOVEMBER 7, 2023
Startup OrsoBio raised $60 million in a Series A round co-led by Longitude Capital and Enavate Sciences, and joined by the pharma’s venture arm.
Tue.Nov 07, 2023
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Millions of Women Feel Severe Pain From This Condition. Why Don’t We Talk About It?
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 7, 2023
Endometriosis causes physical, sexual and emotional pain. About 190 million people around the globe have endometriosis, including one in 10 American women, but there has historically been a deafening silence about the disease and the pervasive impact it can have on a person’s life.
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Biogen, Sage set price of postpartum depression pill at $15,900
Bio Pharma Dive
NOVEMBER 7, 2023
The price is below what some analysts had predicted and significantly less than $34,000 Sage initially set for its earlier postpartum infusion, Zulresso.
TN DCA initiates action against use of diclofenac & aceclofenac in veterinary treatments to control death of vultures
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 7, 2023
The Tamil Nadu Drug Control Administration (TN DCA) has initiated action against the use of analgesic and anti-inflammatory drugs, diclofenac and aceclofenac, in veterinary treatments on account of sharp decline in vulture population in the forest areas of the state.
Flagship expands into Asia-Pacific with new Singapore hub
Bio Pharma Dive
NOVEMBER 7, 2023
The biotech company creator hopes its new office will help its portfolio companies grow and strike partnerships in the region.
Navigating Regulatory Compliance in the Pharmaceutical Industry
Pharma Mirror
NOVEMBER 7, 2023
Navigating regulatory compliance in the pharmaceutical industry is crucial to ensure the safety, efficacy, and quality of pharmaceutical products. The pharmaceutical industry is heavily regulated in most countries to protect public health and to maintain the integrity of the products. Here are some key aspects to consider when navigating regulatory compliance in the pharmaceutical industry: Understanding Regulatory Authorities: Identify the regulatory authorities that govern pharmaceuticals in y
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AAO 2023: Allgenesis Biotherapeutics presents Phase IIa data of AG-73305 for DME
Pharmaceutical Technology
NOVEMBER 7, 2023
At AAO 2023, results were presented from the Phase IIa trial of Allgenesis’ AG-73305, evaluating its application for the treatment of DME.
Ventyx revises TYK2 drug plans after lackluster study data
Bio Pharma Dive
NOVEMBER 7, 2023
The biotech will terminate studies of its drug in psoriasis and psoriatic arthritis after the “magnitude of efficacy” reported in one was less than Ventyx’s target.
Cell and gene therapy biotechs face access hurdles in Europe
Pharmaceutical Technology
NOVEMBER 7, 2023
At BIO-Europe 2023, experts said competition from the US and China and proposed European legislation are hurdles for this sector.
AbbVie, AstraZeneca, Boehringer and more face FTC's ire for 'improper' patent listings
Fierce Pharma
NOVEMBER 7, 2023
Pharma, you were warned. | Only two months after the Federal Trade Commission said it was eying a crackdown on improper patents listed by the FDA, the agency has filed challenges against more than 100 patents in the agency's Orange Book. The companies have 30 days to respond.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
EU pharma legislation may bring ‘more harm than good’ to the region
Pharmaceutical Technology
NOVEMBER 7, 2023
The new incentives to improve access to medication across Europe are seen as innovation-stifling measures by the industry.
Pfizer cost-savings campaign reaches Ireland, where 100 production workers will lose jobs
Fierce Pharma
NOVEMBER 7, 2023
Pfizer’s $3.5 billion cost-savings drive has made its way overseas. | The layoffs at Pfizer's Newbridge, Kildare, manufacturing site are the latest in the company's effort to save $3.5 billion by 2024 amid declining demand for its COVID-19 products.
AAO 2023: PULSAR and PHOTON studies provide promising results for AMD and DME
Pharmaceutical Technology
NOVEMBER 7, 2023
These studies evaluated the effectiveness of HD Eylea (aflibercept 8mg) in patients with AMD and patients with DME.
Frontiers Health 2023 Day One
pharmaphorum
NOVEMBER 7, 2023
Frontiers Health 23 - Day 1 from the marvellous Auditorium della Tecnica in Rome, where we are set to bring you the biggest news stories, trends, and industry insights
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
BIO-Europe 2023: Small oncology biotechs require creative financing approaches
Pharmaceutical Technology
NOVEMBER 7, 2023
At the BIO-Europe conference, experts said smaller oncology biotechs need to explore alternate financing strategies for pipeline development.
Gilead Q3 Revenue Stagnates, Drops Late-Stage COVID-19 and AML Trials
BioSpace
NOVEMBER 7, 2023
The third-quarter growth of Gilead’s HIV, oncology and cell therapy businesses was completely offset by declining COVID-19 and liver disease sales, with revenue flat compared to the same period last year.
NICE introduces revamped support service for life sciences sector
Pharmaceutical Technology
NOVEMBER 7, 2023
The UK National Institute for Health and Care Excellence (NICE) unveils refreshed support service, NICE Advice, for the life sciences sector.
The ‘elegant science’ in achieving the promise of ADCs
pharmaphorum
NOVEMBER 7, 2023
In this week’s episode of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Raquel Izumi, chief operating officer and co-founder of Vincerx Pharma, who is on a mission to improve antibody drug conjugate (or ADC) drug development, aiming to conquer cancer with safe, well-tolerated, and paradigm-shifting therapeutics.
The New Age of Decentralized Clinical Trials
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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.
UK’s MHRA grants authorisation for breast cancer prevention drug
Pharmaceutical Technology
NOVEMBER 7, 2023
The UK MHRA has granted authorisation for Anastrozole, previously a breast cancer treatment for post-menopausal women, to prevent the cancer.
Bayer Eyes Break-Up, Management Cuts on Disappointing Q3 Results
BioSpace
NOVEMBER 7, 2023
The company on Wednesday reported nearly 50 billion euros, or $53.3 billion, in revenue with zero cash flow. Several layers of management will be eliminated as structural split-off strategies are considered.
FDA warns of hidden drug ingredients in Dr Ergin’s SugarMD
Pharmaceutical Technology
NOVEMBER 7, 2023
Patients who have used the products should consult their healthcare provider and properly discard the product.
Activist Investor Takes $1B Stake in BioMarin Amid CEO Change, Disappointing Sales
BioSpace
NOVEMBER 7, 2023
Activist hedge fund investor Elliott Investment Management has bought over a $1 billion stake in BioMarin as the biotech grapples with a leadership change and disappointing sales of its hemophilia A gene therapy.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
US FDA approves Zydus’ Zituvimet for type 2 diabetes mellitus
Pharmaceutical Technology
NOVEMBER 7, 2023
The US Food and Drug Administration (FDA) has granted approval for Zydus Lifesciences’ NDA for Zituvimet for type 2 diabetes mellitus.
Eisai Sees ‘Dramatic’ Increase in Leqembi Uptake Following Full FDA Approval
BioSpace
NOVEMBER 7, 2023
After winning traditional approval from the U.S. regulator, Eisai’s Alzheimer’s disease therapy Leqembi has seen a sharp increase in patient uptake, with a target of 10,000 patients by March 2024.
Leading innovators in transdermal drug delivery for the pharmaceutical industry
Pharmaceutical Technology
NOVEMBER 7, 2023
GlobalData uncovers the leading innovators in transdermal drug delivery for the pharmaceutical industry.
With Amgen's biosim on the scene, J&J's Stelara looks poised to sidestep Medicare negotiations: HHS
Fierce Pharma
NOVEMBER 7, 2023
There might just be a silver lining for Johnson & Johnson in the FDA's recent approval of Amgen’s Stelara biosimilar. | There might just be a silver lining for Johnson & Jonhson in the FDA's recent approval of Amgen’s Stelara biosimilar. That’s because the coming entry of a cheaper copycat presents J&J with an opportunity to elude Medicare price negotiations outlined in the Inflation Reduction Act.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Immuno-oncology: the leading companies in cancer immunotherapy revealed
Pharmaceutical Technology
NOVEMBER 7, 2023
GlobalData uncovers the leading innovators in cancer immunotherapy for the pharmaceutical industry.
Bluebird won't play off Vertex in deciding price for its lovo-cel gene therapy, exec says
Fierce Pharma
NOVEMBER 7, 2023
Two long-awaited treatments for sickle cell disease (SCD) are on the docket for FDA decisions next month. Vertex and CRISPR Therapeutics are up first with a Dec. | Two long-awaited treatments for sickle cell disease (SCD) are on the docket for FDA decisions next month. One potential advantage for bluebird, giving the timing, could be a chance to view its rival's pricing before deciding itself.
Landmark Bio and Galapagos sign deal for oncology CAR-T cell therapy
Pharmaceutical Technology
NOVEMBER 7, 2023
Landmark Bio and Galapagos have signed an agreement for the manufacture of the latter’s oncology CAR T-cell therapy
Biopharma’s Q3 Earnings Season Sees Mixed Results as Challenges Remain
BioSpace
NOVEMBER 7, 2023
With headwinds in the wider biotech sphere, the third quarter showed continuing vulnerabilities in the COVID space while the weight-loss drugs drove blockbuster sales.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
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