Drugs - Clinical Research Informer

Genentech takes up a deal to make ‘molecular glue’ drugs

Bio Pharma Dive

SEPTEMBER 20, 2023

Targeted protein degradation has emerged as one of the more competitive areas of pharmaceutical research in recent years as scientists develop new ways to reach difficult-to-drug targets.

Drugs

Drugs Protein Scientist Research

Medicare names first 10 drugs for price negotiations

Bio Pharma Dive

AUGUST 29, 2023

The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.

Drugs

Drugs Medicine

Eisai’s Alzheimer’s drug Leqembi approved in Japan

Bio Pharma Dive

SEPTEMBER 25, 2023

Eisai and Biogen’s anti-amyloid drug is still undergoing regulatory reviews in the EU, U.K. and elsewhere.

Drugs

FDA grants rare paediatric drug status for IPS HEART’s stem cell drugs

Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. The drug candidate received an orphan drug designation (ODD) from the FDA in February 2023.

Drugs

Drugs Clinical Trials Clinical Trials Trials

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

FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

Drugs

Drugs FDA Approval Trials Development

AstraZeneca, seeking new drug targets, taps a genomics biotech and its AI technology

Bio Pharma Dive

SEPTEMBER 8, 2023

Worth up to $840 million, the collaboration will give Alexion access to Verge Genomics’ platform, which uses human tissue data to find drug targets for diseases that degrade the nerve system.

Genome

Genome Genomics Drugs

CVS launches new venture in biosimilar drug experiment

Bio Pharma Dive

AUGUST 24, 2023

The subsidiary, called Cordavis, will work directly with manufacturers to market or co-produce low-cost biologic drugs, starting with Novartis’ Humira copy.

Drugs

Drugs Manufacturing Marketing

Artificial intelligence: The prime mover in drug discovery

Bio Pharma Dive

AUGUST 28, 2023

With its ability to process vast amounts of data and identify patterns, AI can significantly reduce the time and cost involved in developing new drugs.

Drugs

Drugs Development

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

Ethnopharmacology: traditional medicine and modern drug discovery

Pharmaceutical Technology

APRIL 24, 2023

However, the reality is that traditional medicine has been the source of lead identification in modern drug discovery. Ethnopharmacology has been an important basis for modern medicine The estimated percentage of pharmaceutical drugs available today that are sourced from natural products varies.

Medicine

Medicine Drugs Research Regulation

Boehringer sues to block US drug price program

Bio Pharma Dive

AUGUST 22, 2023

The pharma’s suit, which claims Medicare’s new power to negotiate certain drug prices is unconstitutional, comes days before the agency will reveal the first 10 medicines to be included under the plan.

Drugs

Drugs Medicine

Fentanyl: a horrifyingly disruptive drug

Pharmaceutical Technology

DECEMBER 22, 2022

The Drug Enforcement Administration (DEA) recently announced that it had seized 10,000 pounds of illicit fentanyl in 2022 and pointed out that this volume represented enough fentanyl to kill every American. Fentanyl was first synthesised in 1959 and introduced to markets in the 1960s as a pain relief drug.

Drugs

Drugs Manufacturing Marketing Production

J&J antibody drug combination shows promise in multiple myeloma

Bio Pharma Dive

MAY 25, 2023

A pair of dual-acting antibodies displayed early potential to become a new type of drug regimen for the blood cancer, but led to a high rate of side effects as well.

Antibody

Antibody Drugs

Lilly drug slows Alzheimer’s decline in large study

Bio Pharma Dive

MAY 3, 2023

approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab. The company plans to quickly submit an application for U.S.

Drugs

Drugs Trials

XtalPi announces $250m AI drug discovery collaboration with Eli Lilly

Pharmaceutical Technology

MAY 31, 2023

XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.

Drugs

Drugs Development Research

Amylyx’s ALS drug could face rejection in Europe

Bio Pharma Dive

MAY 30, 2023

The biotech said a committee advising the European Medicines Agency is “trending” toward issuing a negative opinion of its drug Relyvrio, which was approved in the U.S. last year.

Drugs

Drugs Medicine

AstraZeneca the latest pharma to challenge drug pricing law

Bio Pharma Dive

AUGUST 25, 2023

The drugmaker's lawsuit comes the week before the Biden administration is set to announce the first 10 drugs subject to negotiated prices in 2026.

Drugs

Roche’s surprise study results spur new optimism for TIGIT drugs

Bio Pharma Dive

AUGUST 23, 2023

Data inadvertently published from a closely watched lung cancer study suggest a drug blocking the protein TIGIT may help extend survival, a finding that boosted shares of other developers.

Drugs

Drugs Protein Development

FDA panel backs Alnylam drug despite doubts over benefit

Bio Pharma Dive

SEPTEMBER 13, 2023

“There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.

Drugs

Superluminal draws RA Capital, Nvidia as investors in GPCR drug hunt

Bio Pharma Dive

AUGUST 28, 2023

GPCRs, a ubiquitous family of proteins that are prime drug targets, have drawn the interest of companies like Structure Therapeutics, Septerna and now Superluminal Medicines.

Drugs

Drugs Protein Medicine

FDA panel backs full approval for Eisai, Biogen Alzheimer’s drug

Bio Pharma Dive

JUNE 9, 2023

In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

Drugs

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Synlogic’s SYNB1934 receives orphan drug status from US FDA

Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The orally administered, non-systemically absorbed drug candidate SYNB1934 has been designed for reducing blood phenylalanine (Phe) levels in PKU patients.

Drugs

Drugs Genetic Engineering Genetics Medicine

Repurposing the anthelmintic drug Niclosamide

Pharma Mirror

SEPTEMBER 8, 2023

This drug is present in the Model List of Essential Medicines from the World Health Organization, used since the 1960s for tapeworm infection. Niclosamide was approved by the US FDA in 1982 but it is not currently available for human The post Repurposing the anthelmintic drug Niclosamide appeared first on Pharma Mirror Magazine.

Drugs

Drugs Medicine

Sanofi strikes a $150M deal for Maze’s Pompe disease drug

Bio Pharma Dive

MAY 1, 2023

The cash influx extends Maze’s financial runway into 2025, giving the South San Francisco company time to advance other drug candidates into testing.

Drugs

FDA withdraws approval of preterm birth drug Makena

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

Drugs

Drugs FDA Approval Clinical Trials Clinical Trials

Medicare Drug Price Negotiations: First 10 Drugs Up for Negotiation Revealed

XTalks

SEPTEMBER 11, 2023

The Centers for Medicare & Medicaid Services (CMS) announced the first ten drugs that will be entering Medicare drug price negotiations. The drugs are covered under Part D of the Medicare program, which provides coverage for prescription drugs. Together, the drugs totalled $50.5 million Total Revenue 2022: $18.3

Drugs

Drugs Insulin Pharma Companies Sales

Novo Nordisk, Evotec partner in metabolic disease drug discovery pact

Bio Pharma Dive

SEPTEMBER 26, 2023

Hunting for more metabolic disease drugs, Novo plans to work with Evotec to shape early academic research into new development programs.

Drugs

Drugs Research Development

Dawn of a new indication: how to study drugs for aging

Pharmaceutical Technology

MARCH 6, 2023

Whether one refers to such research as “longevity”, “anti-aging” or “extending healthspan”, it is clear this area has evolved massively over the last few years with more scientists now eager to get drugs in this area from bench to bedside. This regulatory issue coupled with others has hindered the clinical development of drugs in the field.

Drugs

Drugs Clinical Trials Clinical Trials Trials

FDA withdraws approval of preterm birth drug Makena

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

Drugs

Drugs FDA Approval Clinical Trials Clinical Trials

HHS lays out timing for drug price negotiations

Bio Pharma Dive

JANUARY 11, 2023

The agency will kick off discussions on how it will negotiate Medicare drug prices in the spring and publish a list of the first 10 drugs selected by Sept.

Drugs

Teva puts rival to Prometheus, Pfizer drugs at center of turnaround plans

Bio Pharma Dive

MAY 18, 2023

At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth prospects.

Drugs

Drugs Protein

FDA partially halts leukemia studies of Gilead cancer drug

Bio Pharma Dive

AUGUST 21, 2023

The hold is the latest setback for a drug that was the center of Gilead’s $5 billion acquisition of biotech Forty Seven in 2020.

Drugs

Rationing strategies proliferate with cancer drugs in short supply

Pharmaceutical Technology

JULY 4, 2023

While drug shortages have been a major cause for concern over the past few years, medications to treat cancer are in particularly short supply.

Drugs

Signal: Novo Nordisk market cap higher than Danish GDP due to obesity drugs

Pharmaceutical Technology

SEPTEMBER 1, 2023

Novo Nordisk's obesity drugs are driving Danish growth as well as record profits as the company becomes second-most valuable in Europe.

Drugs

Drugs Marketing

Generative AI has the potential to revolutionise drug discovery

Pharmaceutical Technology

AUGUST 3, 2023

The impact of artificial intelligence has been profoundly felt in the drug discovery space, with increased interest in AI in recent years.

Drugs

Lilly drug Mounjaro succeeds in second weight loss study

Bio Pharma Dive

APRIL 27, 2023

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

Drugs

Drugs FDA Approval Trials

European regulators probe suicide risk to Ozempic, other Novo drug Saxenda

Bio Pharma Dive

JULY 10, 2023

Three reports from Iceland spurred the EMA to evaluate whether certain Novo Nordisk drugs, including Ozempic, might cause thoughts of self harm.

Drugs

Drugs Regulation

Astellas to build drug production facility in Ireland

Pharmaceutical Technology

SEPTEMBER 14, 2023

Astellas Pharma is submitting a planning application for the construction of a new drug production facility in Ireland.

Drugs

Drugs Production

NVIDIA invests $50m in AI-enabled drug discovery

Pharmaceutical Technology

JULY 13, 2023

NVIDIA signed an investment and collaboration agreement with Recursion to create AI models to accelerate drug discovery.

Drugs

Maximizing Drug Patents’ Value: Strategies for Biomedical Companies

Drug Patent Watch

SEPTEMBER 18, 2023

The article “Maximizing the Value of Drug Patents Before Losing Exclusivity” discusses strategies for biomedical companies to maximize the value of their drug patents before the exclusivity period expires.

Drugs

Pharmacists Can Play Key Role in Drug Repurposing

Drug Patent Watch

SEPTEMBER 5, 2023

Pharmacists play a crucial role in drug repurposing due to the vast amount of opportunities that exist in this innovative approach. Drug development and registration can be costly, time-consuming, and… The post Pharmacists Can Play Key Role in Drug Repurposing appeared first on DrugPatentWatch - Make Better Decisions.

Drugs

Drugs Development

Study Highlights PBMs’ Role in Drug Prices

Pharmaceutical Commerce

SEPTEMBER 22, 2023

An analysis by 3 Axis Advisors has found that there is a large variability in pharmacy reimbursement of prescription drugs depending on PBM contracts with insurers. This creates a system with huge inconsistencies on the prices of both generics and branded products.

Drugs

Drugs Pharmacy Branding Production

CMS Names First 10 Drugs for Medicare Drug Price Negotiations

BioSpace

AUGUST 28, 2023

The Biden administration on Tuesday released a much-anticipated list of the first 10 medicines included in Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.

Drugs

Drugs Medicine

Genentech takes up a deal to make ‘molecular glue’ drugs

Medicare names first 10 drugs for price negotiations

Trending Sources

Eisai’s Alzheimer’s drug Leqembi approved in Japan

FDA grants rare paediatric drug status for IPS HEART’s stem cell drugs

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

FDA extends review of GSK’s myelofibrosis drug

AstraZeneca, seeking new drug targets, taps a genomics biotech and its AI technology

CVS launches new venture in biosimilar drug experiment

Artificial intelligence: The prime mover in drug discovery

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Ethnopharmacology: traditional medicine and modern drug discovery

Boehringer sues to block US drug price program

Fentanyl: a horrifyingly disruptive drug

J&J antibody drug combination shows promise in multiple myeloma

Lilly drug slows Alzheimer’s decline in large study

XtalPi announces $250m AI drug discovery collaboration with Eli Lilly

Amylyx’s ALS drug could face rejection in Europe

AstraZeneca the latest pharma to challenge drug pricing law

Roche’s surprise study results spur new optimism for TIGIT drugs

FDA panel backs Alnylam drug despite doubts over benefit

Superluminal draws RA Capital, Nvidia as investors in GPCR drug hunt

FDA panel backs full approval for Eisai, Biogen Alzheimer’s drug

Synlogic’s SYNB1934 receives orphan drug status from US FDA

Repurposing the anthelmintic drug Niclosamide

Sanofi strikes a $150M deal for Maze’s Pompe disease drug

FDA withdraws approval of preterm birth drug Makena

Medicare Drug Price Negotiations: First 10 Drugs Up for Negotiation Revealed

Novo Nordisk, Evotec partner in metabolic disease drug discovery pact

Dawn of a new indication: how to study drugs for aging

FDA withdraws approval of preterm birth drug Makena

HHS lays out timing for drug price negotiations

Teva puts rival to Prometheus, Pfizer drugs at center of turnaround plans

FDA partially halts leukemia studies of Gilead cancer drug

Rationing strategies proliferate with cancer drugs in short supply

Signal: Novo Nordisk market cap higher than Danish GDP due to obesity drugs

Generative AI has the potential to revolutionise drug discovery

Lilly drug Mounjaro succeeds in second weight loss study

European regulators probe suicide risk to Ozempic, other Novo drug Saxenda

Astellas to build drug production facility in Ireland

NVIDIA invests $50m in AI-enabled drug discovery

Maximizing Drug Patents’ Value: Strategies for Biomedical Companies

Pharmacists Can Play Key Role in Drug Repurposing

Study Highlights PBMs’ Role in Drug Prices

CMS Names First 10 Drugs for Medicare Drug Price Negotiations

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