April, 2024

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Women want to participate in clinical trials. Lack of flexibility is still a problem.

Bio Pharma Dive

Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.

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Early Data Indicate Cell Therapies Could ‘Reset the Clock’ in Parkinson’s

BioSpace

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.

Marketing 129
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Moderna banks on OpenAI to accelerate mRNA research 

pharmaphorum

In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA drug development and manufacturing operations.

Research 110
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Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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

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FDA settles ivermectin lawsuit, removes contentious COVID-19 posts

BioPharma Reporter

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.

Doctors 145
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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

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More Trending

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5 Mid-Stage ALS Drugs to Watch

BioSpace

As the Phase III amyotrophic lateral sclerosis pipeline thins out, the ALS community is placing its hopes on earlier-stage trials sponsored by Denali Therapeutics, PTC Therapeutics and more.

Drugs 136
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Spotlight on kidney disease: Driving change for patients

pharmaphorum

Explore the latest advancements and initiatives in kidney disease research, driving change for patients with kidney conditions. Learn more about the current research landscape and potential breakthroughs in treatment from Kidney Research UK.

Research 126
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Outrun Therapeutics announces launch with $10m seed funding

Pharmaceutical Technology

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

Protein 323
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Pfizer accused of 'bringing discredit' on industry with 'unnecessary' vaccine tweet

BioPharma Reporter

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.

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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

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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

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.

Insulin 132
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Metsera, a well-funded obesity drug startup, sees chance to challenge Lilly, Novo

Bio Pharma Dive

It’s “early innings” in the obesity drug race, said Metsera CEO Clive Meanwell, whose company has acquired a portfolio of medicines it aims to test in combination.

Drugs 316
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Merck Snaps Up Small Startup in $208M Deal, Seeks to Improve Safety of ADCs

BioSpace

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.

Antibody 131
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FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

pharmaphorum

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

Drugs 122
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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.

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ESCMID 2024: Using AI in infection prevention and control

Pharmaceutical Technology

Artificial intelligence tools can be used for infection control through facial recognition systems designed to identify proper face mask use within hospitals.

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Could placenta-derived cells revolutionize age-related disease treatment?

BioPharma Reporter

Celularity, a biotech company specializing in placental-derived allogeneic cell therapies, will be showcasing data at the upcoming ASGCT Annual Meeting, showcasing the potential of their off-the-shelf natural killer (NK) cells to combat age-related diseases.

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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

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.

Drugs 130
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New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.

Bio Pharma Dive

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.

Medicine 316
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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AACR, Cancer Treatment and the Promise of Antibody-Drug Conjugates

BioSpace

This week’s American Association for Cancer Research annual meeting drove home the importance of antibody-drug conjugates as an emerging class of potential anti-cancer therapeutics.

Antibody 128
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Psychedelic treatments on cusp of approval, but questions remain

pharmaphorum

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.

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India sees insignificant revision to price ceiling in 2024

Pharmaceutical Technology

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.

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Has Pfizer brought discredit on the industry with misguided vaccine tweet? Industry weighs in

BioPharma Reporter

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.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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Number of ongoing US drug shortages reaches new high, pharmacist group says

Fierce Pharma

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.

Drugs 125
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Vertex begins bid for US approval of non-opioid painkiller

Bio Pharma Dive

The start of a so-called rolling review formally begins an FDA evaluation of a closely watched drug that’s important to the biotech’s future, but faces questions about its sales potential.

Sales 303
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FDA Rejects Abeona’s Epidermolysis Bullosa Cell Therapy, Asks for CMC Data

BioSpace

The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.

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12 Questions with Dr Jay Shah

pharmaphorum

Get to know Dr Jay Shah, a prominent figure in the field of cardiovascular medicine, as he answers 12 intriguing questions about his role as Chief Medical Officer at Aktiia and his insights into the field.

Medicine 124
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

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

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Norgine seeks approval for high-risk neuroblastoma treatment

Pharmaceutical Technology

Norgine has sought approval for eflornithine (DFMO) for the treatment of patients with high-risk neuroblastoma (HRNB).

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Eli Lilly under pressure: Can they solve GLP-1 supply squeeze?

BioPharma Reporter

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.

Drugs 119
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FTC targets Novo's Ozempic, others in crackdown on 300-plus 'junk' patent listings in FDA database

Fierce Pharma

The U.S. Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. | The U.S. FTC is not done with its crackdown on what it views as improper listing of patents in the FDA Orange Book. After an initial round of challenge launched in November against more than 100 patents, the FTC is back targeting another 300-plus patent listings by eight pharma firms.

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Ultragenyx says Angelman therapy is working, but safety questions remain

Bio Pharma Dive

Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time