Mon.Apr 01, 2024

article thumbnail

5 FDA decisions to watch in the second quarter

Bio Pharma Dive

The FDA could soon expand use of two multiple myeloma cell therapies as well as a top-selling medicine from Sanofi and Regeneron, while Pfizer’s years of gene therapy work might finally pay dividends.

article thumbnail

Merck gets grant for patent granted for tricyclic heterocycle compounds for treating HIV

Pharmaceutical Technology

Discover the groundbreaking patent by Merck & Co Inc for Tricyclic Heterocycle Compounds to combat HIV infection. Learn about the innovative formula and treatment methods for a potent solution in antiretroviral therapy.

246
246
Insiders

Sign Up for our Newsletter

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

article thumbnail

Breaking barriers: Advances and challenges in therapeutic cancer vaccines

Bio Pharma Dive

The development of cancer vaccines has provided some hope in the battle against cancer worldwide; however, there are still many challenges to overcome when developing these life-saving treatments.

article thumbnail

US FDA grants fast track status to LISCure’s LB-P8 drug for PSC

Pharmaceutical Technology

FDA has granted fast track designation to LISCure Biosciences’ investigational drug LB-P8, for the treatment of PSC.

Drugs 246
article thumbnail

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

article thumbnail

AstraZeneca gets FDA OK for rare disease drug acquired in Alexion buyout

Bio Pharma Dive

The clearance of Voydeya as an add-on therapy for an uncommon blood disease validates a bet Alexion made on original developer Achillion five years ago.

Drugs 169
article thumbnail

Jubilant Pharmova gets grant for radiopharmaceutical composition for diagnostic imaging with stable attributes

Pharmaceutical Technology

Discover the innovative patent by Jubilant Pharmova Ltd for a stable radiopharmaceutical composition of tetrofosmin, ensuring high purity and effectiveness in diagnostic imaging.

130
130

More Trending

article thumbnail

Redx Pharma gets grant for ROCK inhibitors for treating ROCK mediated diseases

Pharmaceutical Technology

Discover Redx Pharma's groundbreaking patent for novel compounds targeting ROCK1 and ROCK2 inhibitors. Learn about the formula, structural features, and pharmaceutical applications covered in this exclusive patent.

130
130
article thumbnail

European prosecutors take over investigation into deal for Pfizer COVID vaccines: Politico

Fierce Pharma

While the market for COVID-19 vaccines has been shrinking lately, an investigation into text messages between Pfizer CEO Albert Bourla and the European Commission’s President Ursula von der Leyen r | The European Public Prosecutor’s Office (EPPO) took over the investigation into COVID vaccine negotiations between the European Commission's president and Pfizer's CEO Albert Bourla, Politico reports.

article thumbnail

UCB gets grant for treatment of systemic lupus erythematosus with anti-CD154 antibody

Pharmaceutical Technology

Treat systemic lupus erythematosus effectively with UCB SA's patented method using a specific antibody to CD154. Significant improvements in SLE indices and outcomes. Explore the potential of this innovative treatment now!

Antibody 130
article thumbnail

Teva snares up to $150M in Abingworth funding to propel late-stage asthma rescue inhaler

Fierce Pharma

Shortly after Gilead Sciences teamed up with Carlyle’s Abingworth to fuel further research on its antibody-drug conjugate Trodelvy, Teva is following a similar pathway with an asthma resc | Shortly after Gilead Sciences teamed up with Carlyle’s Abingworth to fuel further research on its antibody-drug conjugate Trodelvy, Teva is following a similar pathway for an asthma rescue inhaler.

Antibody 118
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

Gilead Sciences gets grant for treatment of HIV infection with specific compounds

Pharmaceutical Technology

Discover the groundbreaking patent by Gilead Sciences Inc for compounds to treat HIV infection, including specific chemical formulas and pharmaceutical compositions. Learn more about this innovative approach to combating the virus.

130
130
article thumbnail

AstraZeneca CEO's 2024 pay proposal under fire from influential proxy advisers

Fierce Pharma

Like clockwork, AstraZeneca CEO Pascal Soriot’s pay is under fire again. | Like clockwork, AstraZeneca CEO Pascal Soriot’s pay is under fire again. The two most influential proxy advisory firms are rallying investors to vote against the 2024 pay proposal for Soriot at the company’s annual general meeting this month.

117
117
article thumbnail

Forma Therapeutics gets grant for USP30 inhibitor compounds for medical use

Pharmaceutical Technology

Discover how Forma Therapeutics Inc's patent for USP30 Inhibitor Compounds paves the way for innovative pharmaceutical treatments, targeting specific structural configurations for effective patient care.

130
130
article thumbnail

Eisai, Biogen's injectable Leqembi delayed as FDA asks for more data

Fierce Pharma

What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA. | What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA.

101
101
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

Lonza Group gets grant for patent granted for capsule composition with pullulan, setting system, surfactant

Pharmaceutical Technology

Discover Lonza Group Ltd's patented capsule composition with pullulan, a unique setting system, and surfactant system. This innovative capsule includes specific mineral content and is made using an organic fermentation process. Explore the details in US Patent Publication Number: US11878079B2.

130
130
article thumbnail

AstraZeneca's rare disease add-on therapy Voydeya scores FDA nod

Fierce Pharma

With AstraZeneca’s dominance in the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) threatened by the recent approval of the first pill on the market for the condition, Novartis’ Fabha | With AstraZeneca’s dominance in the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) threatened by the recent approval of the first pill on the market for the condition, Novartis’ Fabhalta, AstraZeneca has answered in the United States for its add-on oral treatment in the indication.

article thumbnail

Yuhan gets grant for high-speed, precise temperature control for gas chromatography columns

Pharmaceutical Technology

Revolutionize your gas chromatography analysis with Yuhan Corp's patented heater integrated GC column device. Achieve precise temperature control and rapid changes for efficient compound separation and analysis.

130
130
article thumbnail

FDA clears first DTx for depression from Otsuka, Click

pharmaphorum

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder

111
111
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

A. Menarini Industrie Farmaceutiche Riunite gets grant for method of generating massively parallel sequencing library

Pharmaceutical Technology

Discover the innovative method patented by A. Menarini for generating massively parallel sequencing libraries, ensuring efficient and accurate DNA sequencing. Explore the detailed process now!

DNA 130
article thumbnail

Bavarian Nordic begins commercial launch of mpox vaccine Jynneos in US

Fierce Pharma

After years relying on the U.S. government to stockpile and distribute Jynneos, Bavarian Nordic is launching the mpox vaccine into the commercial market. | After years relying on the U.S. government to stockpile and distribute Jynneos, Bavarian Nordic is launching the mpox vaccine into the commercial market.

article thumbnail

Novartis gets grant for treatment of cocaine use disorder using mavoglurant

Pharmaceutical Technology

Reduce cocaine use and prevent relapse with Novartis AG's mavoglurant patent. Administering 200mg twice daily shows promising results in treating symptoms of depression and anxiety in patients with cocaine use disorder.

130
130
article thumbnail

Empowering Women and Celebrating Women’s History Month

Intouch Solutions

March is a month of empowerment, reflection, and celebration as we recognize Women’s History Month. It’s a time to honor the remarkable achievements, resilience, and contributions of women throughout history. During the month we hosted a variety of activities led by women including the popular “Coffee Break Speaker Series: Women’s History Month” edition featuring discussions facilitated by Joanna Derma, SVP, Head of Client Service and PMO, EVERSANA INTOUCH ® , and Kate Joy, Senior Partner, EVERS

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

Eisai and Biogen move to bring IV dosing for Leqembi to the US

Pharmaceutical Technology

Eisai is pursuing FDA authorisations for both its monthly IV maintenance and weekly subcutaneous regimens of Leqembi.

Drugs 130
article thumbnail

Leqembi maintenance dose filed in US, but SC form delayed

pharmaphorum

Eisai has filed to extend the label for its Alzheimer’s drug Leqembi to include a once-monthly maintenance regimen

Drugs 111
article thumbnail

Understanding CVS Health/McKesson and Why Pharmacies Lose Money on GLP-1s (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. Click here to see the original post from December 2023. Consider two apparently unrelated drug channel anomalies: In McKesson’s 2023 fiscal year, CVS bought $75 billion in pharmaceuticals from McKesson’s wholesale business—a jump of more than 35% compared with the previous year.

article thumbnail

FDA clears AZ’s new PNH therapy Voydeya

pharmaphorum

AstraZeneca’s Voydeya has been approved by the FDA as an add-on to treatment with Soliris or Ultomiris for rare disease PNH

104
104
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

How Dobbs v Jackson Women’s Health Organization Decision Influenced Self-Management Medication Use

Pharmaceutical Commerce

Cross-sectional study explores the impact of this monumental Supreme Court ruling.

101
101
article thumbnail

Study of different autism types reveals common underlying mechanism

Drug Discovery World

An analysis of how brains with different forms of autism develop has revealed common underlying mechanisms that may respond to existing medications. For the study, Rutgers Health researchers used induced pluripotent stem cells to transform the blood cells of people with both genetic and idiopathic autism spectrum disorder (ASD) into early brain cells called neural precursor cells.

Protein 59
article thumbnail

Fail-First Policies Are Harming Patients

Pharmaceutical Commerce

Patients should not have to wait to access the medication they need.

104
104
article thumbnail

New tentative approval for MYLAN drug efavirenz, emtricitabine and tenofovir alafenamide

Drug Patent Watch

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

Drugs 52
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.