Drugs - Clinical Research Informer

India takes centre-stage in clinical trials for HIV/AIDS drug

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 5, 2024

India has taken centre-stage in clinical trials for HIV/AIDS drug as there are several ongoing clinical trials in India focused on advancing HIV treatment. These trials are investigating new drug candidates, therapies, and approaches to manage HIV more effectively and potentially cure it.

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 21, 2024

Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.

Manufacturing

Manufacturing Development Compliance Drugs

SEC recommends approval for MSN Laboratories’ sleep disorder drug

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 14, 2024

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.

Drugs

Drugs Clinical Trials Clinical Trials Branding

Lilly drug for Alzheimer’s approved by FDA

Bio Pharma Dive

JULY 2, 2024

The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.

Drugs

Commercial Drug Sourcing for Clinical Trials

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Watch this video to learn more about what to look for when selecting a commercial drug sourcing specialist, as well as Catalent’s approach to this process.

Clinical Trials

Investors put $400M into biotech licensing obesity drugs from China

Bio Pharma Dive

MAY 16, 2024

The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.

Licensing

Licensing Licensing Drugs

After rejections, AbbVie secures approval for Parkinson’s drug

Bio Pharma Dive

OCTOBER 17, 2024

Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.

Drugs

Amgen talks obesity drug ‘differentiation’; Servier brain cancer drug approved by FDA

Bio Pharma Dive

AUGUST 7, 2024

Executives at Amgen had few updates on their drug MariTide, but defended what they see as the once-monthly shot’s competitive profile.

Drugs

NVIDIA champions Innophore partnership to model drug dynamics with AI

Pharmaceutical Technology

JANUARY 21, 2025

Innophore will launch the CavitOmiX AI tool to screen for new drugs, predict side effects, and repurpose existing molecules.

Drugs

Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and (..)

Clinical Supply

Summit lung cancer drug shows ‘striking’ benefit over Keytruda

Bio Pharma Dive

SEPTEMBER 8, 2024

Study results provide much-anticipated details to Summit’s claim earlier this year that its drug “decisively beat” Merck’s dominant immunotherapy.

Drugs

Vertex’s non-opioid pain drug gets FDA approval in milestone for company and research

Bio Pharma Dive

JANUARY 30, 2025

Despite high demand for an option like Journavx, doctors fear the drug’s price could be a major hangup for insurers, potentially limiting patients’ ability to access it.

FDA Approval

FDA Approval Doctor Doctors Drugs

Drug patents protect pharma profits. Track when they’ll expire here.

Bio Pharma Dive

MAY 8, 2024

Intellectual property is the foundation of the drug industry’s business model. This database will track key patent expiry dates for 30 top-selling medicines.

Drugs

Drugs Medicine

Digital transformation expected to shorten drug development timelines

Pharmaceutical Technology

NOVEMBER 27, 2024

Pharmaceutical professionals expect digital solutions to solve drug development headaches, with AI already proving disruptive.

Development

Development Drugs

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.

Clinical Supply

Biogen, Ionis shelve ALS drug following study failure

Bio Pharma Dive

MAY 16, 2024

While results indicated the drug works as intended, it didn’t have enough of an effect on a protein that’s become integral to many ALS research programs.

Drugs

Drugs Protein Research

A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology

Bio Pharma Dive

SEPTEMBER 4, 2024

But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes. Over the past 10 years, PD1-blocking medicines have transformed cancer care.

Drugs

Drugs Medicine

AstraZeneca director says AI must be a “thought partner” in drug discovery

Pharmaceutical Technology

MARCH 14, 2025

AstraZenecas senior director in oncology data science outlined how the company uses AI for drug discovery at a recent talk.

Drugs

Medicare reveals results of drug price negotiations

Bio Pharma Dive

AUGUST 15, 2024

The agency said the first round of pricing talks, which involved drugs like the blood thinners Eliquis and Xarelto, will result in $6 billion in savings for taxpayers.

Drugs

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

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development?

Clinical Research

Bristol Myers schizophrenia drug, the first of its kind, approved by FDA

Bio Pharma Dive

SEPTEMBER 26, 2024

In testing, Cobenfy eased schizophrenia symptoms without some of the disruptive side effects typical of existing drugs. The results have been met with excitement, as well as caution.

Drugs

Eisai wins over European regulators on Alzheimer’s drug Leqembi

Bio Pharma Dive

NOVEMBER 14, 2024

A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.

Regulation

Regulation Drugs Marketing

On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned

Bio Pharma Dive

NOVEMBER 11, 2024

Negative drug results cost AbbVie billions of dollars in market value and convinced analysts that Bristol Myers had placed a better bet in buying Karuna Therapeutics.

Drugs

Drugs Marketing

Lilly obesity drug shows heart benefit in late-stage trial

Bio Pharma Dive

AUGUST 1, 2024

The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.

Drugs

Drugs Trials

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Clinical Trials

CG follows big IPO with new results for bladder cancer drug

Bio Pharma Dive

MAY 3, 2024

Newly disclosed Phase 3 results presented Friday match findings the biotech disclosed last year, while offering a more comprehensive look at how its drug stacks up to rival therapies.

Drugs

GSK builds case for return of multiple myeloma drug Blenrep

Bio Pharma Dive

JUNE 2, 2024

Study results showed the antibody-drug conjugate helped stave off disease progression better than a standard treatment. But eye-related side effects remained common.

Drugs

Drugs Antibody

Madrigal wins FDA approval of first drug for MASH

Bio Pharma Dive

MARCH 14, 2024

But its sales potential is unclear, and competition could emerge from popular weight loss drugs. Rezdiffra’s clearance is a turning point in the fight against the liver disease.

FDA Approval

FDA Approval Drugs Sales

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

Bio Pharma Dive

APRIL 18, 2024

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

Drugs Medicine

Panel recommends programme for uniform high standard drug regulation nationwide

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2025

A Parliamentary Panel has recommended implementation of a comprehensive, nationwide and phased Medicines Regulatory Maturity Enhancement Programme on the lines of World Health Organisation’s (WHO) vaccine benchmarking process to ensure a consistently high standard of drug regulation across the country.

Regulation

Regulation Drugs Vaccine Vaccination

Diabetes advocacy group discourages use of compounded GLP-1 drugs

Bio Pharma Dive

DECEMBER 2, 2024

The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.

Pharmacy

Pharmacy Doctor Doctors Drugs

Ionis plots next steps for Angelman drug Biogen passed on

Bio Pharma Dive

JULY 22, 2024

The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.

Drugs

Drugs Trials

ALS drugs from Denali, Calico come up short, marking more failures for Healey trial

Bio Pharma Dive

JANUARY 7, 2025

Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the tally of failed drugs in the innovative “Healey platform trial” to seven.

Life Science

Life Science Trials Drugs Medicine

New research could ease concerns over suicide risk of obesity drugs

Bio Pharma Dive

SEPTEMBER 3, 2024

While results from two after-the-fact analyses were “reassuring,” outside experts urged “continued vigilance” to ensure GLP-1 drugs don’t worsen problems in people with preexisting mental health conditions.

Drugs

Drugs Research

Versant startup sets out to make a new type of obesity drug

Bio Pharma Dive

NOVEMBER 21, 2024

The startup, Pep2Tango, is combining four methods of accelerating weight loss into one medicine in the hopes of developing a treatment that can improve upon drugs like Wegovy and Zepbound.

Drugs

Drugs Medicine Development

Amazon joins forces with Memorial Sloan Kettering for AI-powered drug discovery

Pharmaceutical Technology

FEBRUARY 19, 2025

MSK plans to speed up early-stage drug development by using AWS Drug Discovery Workbench to screen potential candidates.

Drugs

Drugs Development

Nura Bio gets another $68M, new CEO to advance ‘neuroprotective’ brain drugs

Bio Pharma Dive

SEPTEMBER 17, 2024

The funding will support mid-stage testing of a drug the company believes to have the potential to treat a range of neurodegenerative conditions.

Drugs

Alector turns to layoffs as Alzheimer’s drug fails

Bio Pharma Dive

NOVEMBER 26, 2024

The brain drug developer is letting go of around 41 of its 238 employees, in a move the company says will help “align resources” with its strategic priorities.

Drugs

Drugs Development

Fulcrum shares collapse as Sanofi-partnered muscular dystrophy drug fails key test

Bio Pharma Dive

SEPTEMBER 12, 2024

The biotech will now suspend development of a drug prospect that Sanofi acquired partial rights to just four months ago.

Drugs

Drugs Development

IGM’s autoimmune pivot backfires as top drug disappoints in testing

Bio Pharma Dive

JANUARY 9, 2025

The biotech will stop developing two drugs and lay off nearly three-quarters of its staff after its lead therapy wasn’t as potent in early testing as the company expected.

Drugs

Drugs Development

Judo Bio debuts with $100M and a plan to take RNA drugs to the kidney

Bio Pharma Dive

OCTOBER 7, 2024

The Cambridge, Massachusetts-based biotech is using what it calls ligand-siRNA conjugates to reach drug targets in the kidney, which historically have been difficult to reach with RNA therapies.

RNA

RNA Drugs

Novo, with new results, to seek approval for obesity drug in MASH

Bio Pharma Dive

NOVEMBER 1, 2024

The Phase 3 findings position semaglutide to become the first drug of its kind for the liver disease. But they also confirm GLP-1s aren't a "silver bullet" for MASH, one analyst argued.

Drugs

Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?

Bio Pharma Dive

JUNE 26, 2024

Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.

Hormones

Hormones Drugs

Egyptian Drug Authority approves Lilly and EVA’s insulin injection

Pharmaceutical Technology

DECEMBER 18, 2024

Eli Lilly and EVA Pharma have announced approval from the Egyptian Drug Authority for the human insulin glargine injection.

Insulin

Insulin Drugs

India takes centre-stage in clinical trials for HIV/AIDS drug

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

Trending Sources

SEC recommends approval for MSN Laboratories’ sleep disorder drug

Lilly drug for Alzheimer’s approved by FDA

Commercial Drug Sourcing for Clinical Trials

Investors put $400M into biotech licensing obesity drugs from China

After rejections, AbbVie secures approval for Parkinson’s drug

Amgen talks obesity drug ‘differentiation’; Servier brain cancer drug approved by FDA

NVIDIA champions Innophore partnership to model drug dynamics with AI

Clinical Supply Strategies for CROs

Summit lung cancer drug shows ‘striking’ benefit over Keytruda

Vertex’s non-opioid pain drug gets FDA approval in milestone for company and research

Drug patents protect pharma profits. Track when they’ll expire here.

Digital transformation expected to shorten drug development timelines

Accelerating Clinical Supply Through Integrated Drug Development

Biogen, Ionis shelve ALS drug following study failure

A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology

AstraZeneca director says AI must be a “thought partner” in drug discovery

Medicare reveals results of drug price negotiations

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

Bristol Myers schizophrenia drug, the first of its kind, approved by FDA

Eisai wins over European regulators on Alzheimer’s drug Leqembi

On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned

Lilly obesity drug shows heart benefit in late-stage trial

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

CG follows big IPO with new results for bladder cancer drug

GSK builds case for return of multiple myeloma drug Blenrep

Madrigal wins FDA approval of first drug for MASH

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

Panel recommends programme for uniform high standard drug regulation nationwide

Diabetes advocacy group discourages use of compounded GLP-1 drugs

Ionis plots next steps for Angelman drug Biogen passed on

ALS drugs from Denali, Calico come up short, marking more failures for Healey trial

New research could ease concerns over suicide risk of obesity drugs

Versant startup sets out to make a new type of obesity drug

Amazon joins forces with Memorial Sloan Kettering for AI-powered drug discovery

Nura Bio gets another $68M, new CEO to advance ‘neuroprotective’ brain drugs

Alector turns to layoffs as Alzheimer’s drug fails

Fulcrum shares collapse as Sanofi-partnered muscular dystrophy drug fails key test

IGM’s autoimmune pivot backfires as top drug disappoints in testing

Judo Bio debuts with $100M and a plan to take RNA drugs to the kidney

Novo, with new results, to seek approval for obesity drug in MASH

Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?

Egyptian Drug Authority approves Lilly and EVA’s insulin injection

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