Pfizer to pull sickle cell drug from market, shut down trials
BioPharma Drive: Drug Pricing
SEPTEMBER 26, 2024
The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S.
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Poor Trial Results May Prompt Maker to Pull ALS Drug, Relyvrio, From Market
Drugs.com
MARCH 11, 2024
MONDAY, March 11, 2024 -- Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market. In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a.
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Maker Is Pulling Controversial ALS Drug Relyvrio Off the Market
Drugs.com
APRIL 4, 2024
THURSDAY, April 4, 2024 (HealthDayNews) -- Following disappointing trial results, the maker of a controversial ALS drug said it is pulling the medication off the market. In a statement issued Thursday, Amylyx Pharmaceuticals said that Relyvrio.
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The AI model that is changing clinical trial design
Drug Target Review
JULY 1, 2025
Clinical trials are expensive, slow and often limited by outdated design constraints. These digital twins are created for each trial participant using their baseline data – regardless of whether they are assigned to the placebo or treatment arm – and simulate how that individual would have responded under control conditions.
GSK cancer drug Blenrep gets surprise trial win
BioPharma Drive: Drug Pricing
NOVEMBER 27, 2023
drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch. One year after the U.K.
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Lilly’s Zepbound beats Novo’s Wegovy in high-stakes obesity drug trial
BioPharma Drive: Drug Pricing
DECEMBER 4, 2024
Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.
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Leveraging AI Solutions for Clinical Trial Efficiencies
PPD
JANUARY 15, 2025
As clinical trials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinical trial management. Get in touch.
How AI will reshape pharma by 2025
Drug Target Review
DECEMBER 20, 2024
Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drug development has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drug development.
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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities
FDA Law Blog: Drug Discovery
JANUARY 30, 2025
However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.
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Redefining Acceleration of the Drug Development Journey
PPD
NOVEMBER 11, 2024
It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drug development. As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients.
Poor Trial Results May Prompt Maker to Pull ALS Drug From Market
Drugs.com
MARCH 11, 2024
MONDAY, March 11, 2024 -- Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market.In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a.
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Amylyx to pull ALS drug from market in rare move
BioPharma Drive: Drug Pricing
APRIL 4, 2024
In the wake of a major trial failure, the company is withdrawing Relyvrio and cutting costs with a restructuring that involves laying off 70% of its employees.
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AI in drug discovery: faster, smarter, better
Drug Target Review
APRIL 30, 2025
In the rapidly evolving field of cell and gene therapy (CGT), the ability to manage complex biological data, optimise manufacturing processes, and accelerate drug discovery is crucial. It involves a dynamic and often unpredictable process where every stage, from target identification to clinical trials, generates vast amounts of data.
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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing
Drug Patent Watch
DECEMBER 12, 2024
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies.
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Partnering for success in early phase clinical development
BioPharma Drive: Drug Pricing
FEBRUARY 24, 2025
Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.
USA Clinical Trial Market Size and Opportunities
ProRelix Research
DECEMBER 27, 2022
Clinical trials form the crux of all regulatory decisions regarding any new health intervention such as drugs and medical devices and thus require to be performed with the utmost care […]. The post USA Clinical Trial Market Size and Opportunities appeared first on ProRelix Research.
Future-proofing drug development with GenAI
Drug Target Review
JULY 3, 2025
It is becoming increasingly evident that generative artificial intelligence (GenAI) is a resourceful tool for helping pharmaceutical companies reduce manual tasks required by clinical trials. Given the full potential of future assets can’t be directly observed or measured, drug developers are often unaware of certain opportunities or risks.
What Clinical Trial Listings Say About Who’s Hiring Legal Help Next
Drug Patent Watch
JUNE 13, 2025
According to our analysis of clinical trial listings, the following industries are leading the charge in seeking legal counsel: Biotech: With a 25% increase in clinical trial listings over the past year, biotech companies are racing to secure patents and protect their intellectual property.
Lilly’s obesity pill scores in large diabetes trial
BioPharma Drive: Drug Pricing
APRIL 17, 2025
The drug, orforglipron, helped people with diabetes reduce their blood sugar levels while spurring significant weight loss, swelling Lilly's market value by more than $100 billion.
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Pharmacognosy and Drug Patents: Unveiling Nature’s Medicinal Treasures
Drug Patent Watch
DECEMBER 9, 2024
This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. But what exactly is pharmacognosy, and how does it relate to the complex world of drug patents? This approach has led to the discovery of numerous potential drug candidates. What is a Drug Patent?
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From siloed data to breakthroughs: multimodal AI in drug discovery
Drug Target Review
JUNE 11, 2025
Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates.
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Understanding the Regulatory Environment in Japan for Generic Drug Development
Drug Patent Watch
DECEMBER 30, 2024
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.
Karuna submits schizophrenia drug for US approval
BioPharma Drive: Drug Pricing
SEPTEMBER 28, 2023
The drug’s success in two late-stage clinical trials has buoyed Karuna to a market valuation exceeding $6 billion.
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How long do clinical trials take?
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.
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Pharma AI is Changing Clinical Trials by Optimizing Patient Selection
Reprocell
NOVEMBER 27, 2024
In recent years, the pharmaceutical industry has increasingly harnessed artificial intelligence (AI) to make clinical trials more efficient and effective. One of the most powerful applications of AI in this space is its ability to help researchers identify patient groups most likely to benefit from specific drugs.
CMC and the Critical Path to NDA: The Journey from Molecule to Market
The Premier Consulting Blog
DECEMBER 10, 2024
Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Within the NDA, the chemistry, manufacturing, and controls (CMC) section plays a pivotal role in demonstrating drug quality, safety, and efficacy. Drug product (finished dosage form).
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Post-Marketing Surveillance Strategies
ProRelix Research
NOVEMBER 2, 2023
Although clinical trials provide useful information regarding the efficacy and safety of new drugs, biological products, and medical devices, the information captured through them is not all-encompassing. Limited patient populations, […] The post Post-Marketing Surveillance Strategies appeared first on ProRelix Research.
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Key factors shaping the future of clinical services organizations in the APAC market
BioPharma Drive: Drug Pricing
SEPTEMBER 30, 2024
Clinical services organizations can help pharma with global drug development and clinical trial challenges.
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Antibody Drug Conjugates: windows of opportunity
Drug Target Review
JULY 4, 2023
Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.
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The Real Cost of Complexity: What Every Drug Developer Needs to Know
PPD
DECEMBER 16, 2024
Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Pressure and requirements to engage diverse patient populations in trials have become more challenging and expensive, requiring tailored strategies that can stretch both resources and budgets.
Asahi Kasei Pharma Launches Global Phase III Trial of ART-123 for CIPN Prevention
The Pharma Data
JULY 2, 2025
Asahi Kasei Pharma Initiates Phase III Clinical Trial of ART-123 to Combat Chemotherapy-Induced Peripheral Neuropathy Asahi Kasei Pharma Corporation has officially commenced drug administration in a pivotal Phase III clinical trial of ART-123, a recombinant human thrombomodulin (rTM), in Japan.
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New tRNA tech aims to rewrite rare disease treatment
Drug Target Review
JUNE 9, 2025
A personal journey to Alltrna Michelle Werner’s career has spanned over 20 years in the pharmaceutical industry, where she developed her expertise in oncology drug development at leading companies such as Bristol Myers Squibb, AstraZeneca, and Novartis.
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The rising impact of biomarkers in early clinical development
Drug Target Review
APRIL 7, 2025
A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinical trials.
Eisai says new data could support more convenient form of Alzheimer’s drug Leqembi
BioPharma Drive: Drug Pricing
OCTOBER 25, 2023
An under-the-skin injection of Leqembi performed about the same as the already marketed intravenous form, according to trial results presented Wednesday. A new approval application is expected by the end of March.
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How FSP Models Help Biotech Companies Augment Their Clinical Development Needs
PPD
JANUARY 2, 2025
Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.
Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence
PPD
MARCH 11, 2025
Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.
Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025
FDA Law Blog: Biosimilars
APRIL 13, 2025
By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). As a single-arm trial (i.e., Join us as we break down what went wrong this time. The problem?
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UCB’s GEMZ Phase 3 Trial Shows Promising Results for Fenfluramine in Treating CDKL5 Deficiency Disorder
The Pharma Data
JUNE 27, 2025
The trial met both its primary and key secondary endpoints, signaling a potential breakthrough in a condition with few, if any, effective treatment options. It is marketed under the brand name Fintepla® and has shown considerable success in significantly reducing seizure frequency while improving quality of life in these populations.
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Key Strategies Central Labs Use to Fast-Track Time to Market
Reprocell
NOVEMBER 14, 2024
The journey of drug discovery is notoriously long; from initial discovery and development to clinical assessment and final approval, the process can take anywhere from 10 to 30 years and cost billions of dollars 1, 2.
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The rise of GLP-1 drugs: Transforming weight loss treatment
BioPharma Drive: Drug Pricing
JUNE 23, 2025
Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss. Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite.
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Emerging Trends in Clinical Trial Design
PPD
AUGUST 16, 2023
The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs.
Virtual Support Improves Patient, Site and Sponsor Experiences in Clinical Trials
PPD
AUGUST 14, 2024
Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. One of the top reported challenges facing drug developers today is recruiting, enrolling and retaining the right patients for studies. The increase in complexity isn’t just creating challenges for patients.
Time for change: non-human primates in drug research
Drug Target Review
JULY 7, 2025
Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Conventional models often fail to predict cardiac side effects, especially with biologics.
Viatris Announces Success in Second Pivotal Phase 3 Trial of MR-141 Targeting Presbyopia
The Pharma Data
JUNE 26, 2025
Details of the VEGA-3 Phase 3 Trial The VEGA-3 study is part of Viatris’ broader clinical development program to evaluate MR-141 for presbyopia. The trial was conducted as a randomized, placebo-controlled, double-blind study and enrolled a total of 545 adult participants.
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