Bio Pharma Dive
SEPTEMBER 19, 2023
AIRNA is one of several biotechs to debut plans for target alpha-1 antitrypsin deficiency in recent years, with competitors such as AlveoGene, Wave Life Sciences and Arrowhead Pharmaceuticals.
Pharmaceutical Technology
SEPTEMBER 19, 2023
The company will suspend the development of three assets, considering strategic alternatives for two clinical programmes.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
SEPTEMBER 19, 2023
Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second hearing on the PBM industry.
Pharmaceutical Technology
SEPTEMBER 19, 2023
Pelican Technology has combined business with Primordial Genetics under a deal to create a private biotechnology company Primrose Bio.
Bio Pharma Dive
SEPTEMBER 19, 2023
The company is restructuring its workforce and discontinuing programs, including its monotherapy combination of its drug exarafenib with Pfizer’s Mektovi.
Pharmaceutical Technology
SEPTEMBER 19, 2023
European Commission has approved the oral combination drug for treating newly diagnosed acute myeloid leukaemia.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 19, 2023
BioNTech has entered a strategic collaboration with the CEPI to develop mRNA-based vaccine candidates for monkeypox (Mpox ) prevention.
Bio Pharma Dive
SEPTEMBER 19, 2023
All but two employees will be gone by Sept. 30 as the company seeks shareholder approval for a dissolution plan.
Pharmaceutical Technology
SEPTEMBER 19, 2023
We interviewed Datwyler’s Gabrielle Gehron to understand the best sourcing strategies for primary packaging.
Fierce Pharma
SEPTEMBER 19, 2023
Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality control lapses, according to a Form 483 seen by Fierce Pharma.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
SEPTEMBER 19, 2023
Orexo has submitted a new drug application (NDA) to the US FDA for its high-dose rescue medication, OX124, for opioid overdose
XTalks
SEPTEMBER 19, 2023
The US Food and Drug Administration (FDA) has issued warning letters to eight companies manufacturing or marketing unapproved eye products that violate federal law. The FDA said the warning letters are part of the agency’s ongoing effort to protect Americans from potentially harmful ophthalmic products. Companies that the FDA sent the letters to include Walgreens, CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA and TRP Company Inc.
Pharmaceutical Technology
SEPTEMBER 19, 2023
The company plans to refile the IND after assessing the feasibility of US FDA-suggested trial modifications.
FDA Law Blog
SEPTEMBER 19, 2023
By Sara W. Koblitz & Kurt R. Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. On the heels of its powerful (and unprecedented) amicus brief in Paragraph IV litigation between Jazz and Avadel concerning a patent covering a Risk Evaluation and Mitigation Strategy (“REMS”) listed in the Orange Book, the Federal Trade Commission (“FTC”) is gearing up to tackle anticompetitive Orange Book listing practices.
Advertisement
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
Pharmaceutical Technology
SEPTEMBER 19, 2023
UK-based Pharmanovia has announced the acquisition of 11 central nervous system (CNS) brands from Sanofi.
Pharma Times
SEPTEMBER 19, 2023
The platform identifies antigens to fight against bacterial infectious disease - News - PharmaTimes
Intouch Solutions
SEPTEMBER 19, 2023
There was a lot of apologizing at this year’s Digital Pharma East conference. Apologies from companies not being further along in their omnichannel efforts, apologies that only 32% of patients describe pharma ads as relevant to them (Deep Intent), and even apologies that panel discussions still began with a debate about what definitions of omnichannel we should be using!
BioSpace
SEPTEMBER 19, 2023
The Japanese biopharma will receive $40 million upfront from Genetech for R&D of its macrocyclic peptide-radioisotope drug conjugates, with another $1 billion on the line in milestone payments.
Advertisement
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.
Fierce Pharma
SEPTEMBER 19, 2023
Novartis has ended its major cancer immunotherapy collaboration with BeiGene more than two years after touting the benefits of having a PD-1 inhibitor. | Novartis has ended its major cancer immunotherapy collaboration with BeiGene more than two years after touting the benefits of having a PD-1 inhibitor.
BioSpace
SEPTEMBER 19, 2023
Though it received backing from the Pulmonary-Allergy Drugs Advisory Committee in May, the FDA on Tuesday rejected ARS Pharmaceuticals’ neffy as a nasal spray for allergic reactions.
BioPharma Reporter
SEPTEMBER 19, 2023
The contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies has completed a UK manufacturing facility for the production of advanced therapies including viral gene therapies, oncolytic viruses and viral vaccines for use in clinical trials.
Outsourcing Pharma
SEPTEMBER 19, 2023
Qunaterix' LucentAD test could reveal whether a person is likely to have Alzheimer's Disease or not. In an interview with company CEO, Masoud Toloue, he explains the science and motivation behind the test.
Advertisement
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.
Pharma Times
SEPTEMBER 19, 2023
BeiGene will utilise Nona’s Harbour Mice platform as part of the agreement - News - PharmaTimes
Fierce Pharma
SEPTEMBER 19, 2023
Gaining FDA approval last month for its geographic atro | Astellas reported results of a phase 3 trial that assessed Izervay’s effectiveness and safety over a 24-month period. While the company said that the study met its primary objective of reducing the rate of geographic atrophy growth compared to a sham therapy, it offered little else about the results.
BioSpace
SEPTEMBER 19, 2023
The company has dropped its gene therapy candidate TSHA-120 for giant axonal neuropathy after the FDA reiterated the need for a randomized, double-blind, placebo-controlled trial.
Outsourcing Pharma
SEPTEMBER 19, 2023
An advanced wearable headband with integrated machine learning algorithms has achieved The US Food and Drug Administrationâs 510(k) clearance.
Advertisement
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.
BioSpace
SEPTEMBER 19, 2023
The consent agreement struck between the FTC and Amgen and Horizon Therapeutics could have significant implications for ongoing and future M&A challenges, experts told BioSpace.
Fierce Pharma
SEPTEMBER 19, 2023
Novo Nordisk, following a similar move by its diabetes rival Eli Lilly, is teaming up with Aspen Pharmacare to shore up insulin supplies in Africa, which currently imports more than 80% of its medi | Novo Nordisk is teaming up with Aspen Pharmacare to shore up insulin supplies in Africa, which currently imports more than 80% of its medicine.
BioSpace
SEPTEMBER 19, 2023
Bringing in an additional $50 million in a Series B extension, ReCode Therapeutics’ total haul for the funding round totaled $260 million, which it will use to further its experimental mRNA therapies.
Cloudbyz
SEPTEMBER 19, 2023
Introduction Clinical research is a complex and highly regulated field where meticulous attention to detail is paramount. The process of building a clinical study can be both time-consuming and error-prone, as it involves extracting essential data from protocol documents and translating it into electronic data capture (EDC) systems like Cloudbyz EDC.
Advertisement
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.
Expert insights. Personalized for you.
300 
Let's personalize your content