Bio Pharma Dive
APRIL 8, 2024
Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.
Pharmaceutical Technology
APRIL 18, 2024
Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.
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Fierce Pharma
APRIL 17, 2024
One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.
BioPharma Reporter
APRIL 2, 2024
The FDA has agreed to permanently remove several social media posts urging people not to take ivermectin for the treatment of COVID-19, after a lawsuit brought by three doctors accused the regulatory body of interfering with their ability to practice medicine.
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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
pharmaphorum
APRIL 15, 2024
Psychedelic treatments for conditions like PTSD using substances like MDMA are on the brink of approval, but there are still unanswered questions surrounding their effectiveness and potential risks. Learn more here.
BioSpace
APRIL 21, 2024
A one-time treatment for Parkinson’s disease could be a ‘market changer,’ experts told BioSpace, adding that cell therapies could limit the adverse effects seen with current drugs.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
APRIL 22, 2024
Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.
Fierce Pharma
APRIL 18, 2024
Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.
BioPharma Reporter
APRIL 9, 2024
Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.
pharmaphorum
APRIL 15, 2024
Regeneron has formed a corporate venture capital unit with $100 million a year to invest over the next five years in “biopharmaceutical, healthcare, and health technology” start-ups.
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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
Drug Discovery World
APRIL 8, 2024
The latest sponsored DDW Sitting Down With vodcast features Dr Adriano Flora, Director of Business Development at The Jackson Laboratory (JAX). He discusses alternatives to non-human primates, the key benefits of this, and what impact will they have on the future of drug development. Moreover, he answers questions on the key breakthroughs in recent years in this field and how have these impacted future success, as well as challenges in the clinic that must be overcome to ensure this success is a
Bio Pharma Dive
APRIL 10, 2024
The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.
Pharmaceutical Technology
APRIL 22, 2024
Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.
Fierce Pharma
APRIL 11, 2024
As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.
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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.
BioPharma Reporter
APRIL 9, 2024
Pfizer has been accused of âbringing discreditâ on the pharma industry after senior employees promoted its âunlicensedâ COVID-19 vaccine through social media at the height of the pandemic.
pharmaphorum
APRIL 17, 2024
Sage Therapeutics has suffered another disappointment after deciding that it will have to drop the Parkinson’s programme for key pipeline drug dalzanemdor after it showed no benefit in a phase 2 trial. The oral positive allosteric modulator (PAM) of the NMDA receptor is being investigated to see if it can counteract mild cognitive impairment in neurodegenerative disorders, and the PRECEDENT trial in Parkinson’s is the first major readout from the drug programme.
BioSpace
APRIL 8, 2024
As the antibody-drug conjugate space continues to heat up, Merck has acquired preclinical startup Abceutics—spun out of the University at Buffalo—and its novel platform that aims to make ADC therapeutics safer.
Bio Pharma Dive
APRIL 15, 2024
Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharmaceutical Technology
APRIL 16, 2024
The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.
Fierce Pharma
APRIL 8, 2024
With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s (ADC's) reach in the U.S.< | With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s reach in the United States.
BioPharma Reporter
APRIL 11, 2024
Specific doses of Eli Lillyâs GLP-1 blockbuster drugs Mounjaro and Zepbound are currently facing a supply shortage, and frustrated patients are urging the pharma giant to act â fast.
pharmaphorum
APRIL 22, 2024
Pharmaceutical companies stand to gain significant benefits from technological innovation in the form of improved data analytics, streamlined healthcare processes, and enhanced patient outcomes. Explore the potential advantages for the pharma industry.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Antidote
APRIL 4, 2024
Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.
Bio Pharma Dive
APRIL 18, 2024
Analysts had low expectations for Cerevel’s drug tavapadon, which was something of an afterthought in AbbVie’s proposed buyout of the biotech.
Pharmaceutical Technology
APRIL 19, 2024
The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).
Fierce Pharma
APRIL 18, 2024
During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. | During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. A spokesperson said the company would offer affected employees a chance to apply for new roles, plus "outplacement services.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Pharma Times
APRIL 12, 2024
NSCLC is the most common type of lung cancer and is responsible for up to 85% of all cases
pharmaphorum
APRIL 11, 2024
Discover effective strategies to overcome barriers to healthcare providers (HCP) and patients adopting digital health initiatives like apps. Learn how to increase engagement and improve outcomes.
Drug Patent Watch
APRIL 21, 2024
Annual Drug Patent Expirations for SOOLANTRA Soolantra is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from three suppliers.
Bio Pharma Dive
APRIL 19, 2024
The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.
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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.
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