BMS: Delayed new drug to avoid paying billions?

World of DTC Marketing

billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Food and Drug Administration approval for the non-Hodgkin lymphoma drug by a Dec.

US FDA grants Orphan Drug status to Avacta’s drug for soft tissue sarcoma

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’s safety, tolerability and efficacy.

Can we get healthcare right?

World of DTC Marketing

Patients on Medicare who don’t qualify for low-income subsidies could see out-of-pocket costs for the drug of over $12,000. A bill to lower drug prices via negotiations with Medicare is finally moving forward, but PhRMA has bought some politicians. Administration on Aging.

Hope is not a reason to approve a drug

World of DTC Marketing

GOOD MORNING: The future of Biogen’s potential blockbuster Alzheimer’s treatment was thrown back into doubt on Friday when an unusually combative scientific panel contradicted the positive conclusions of staff at the US drug regulator. ” Biogen is desperate for approval of this drug.

Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients.

The current pricing of cancer treatments is unsustainable

World of DTC Marketing

needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S.

Lilly has a new blockbuster

World of DTC Marketing

Food and Drug Administration approved Eli Lilly’s novel treatment for diabetes. The drug led to impressive blood sugar and body weight drops in clinical trials. Some of the epidemiologists I spoke to are concerned about the drug’s side effects.

A perfect storm for biotech stocks

World of DTC Marketing

Meanwhile, the Food and Drug Administration has delayed several drug approvals, and Sen. introduced sweeping drug-pricing legislation. 1ne: More scrutinization by the FDA on new drug applications. Business of the drug industry Biotech M&A

CMO Moves: Regulatory catalysts for drug manufacturing-September

Pharmaceutical Technology

This month’s edition covers news events from late July to early September on regulatory decisions by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), along with reimbursement authorities like the UK’s National Institute of Health and Care Excellence (NICE).

Pharma is in acquisition mode but small biotechs hurting for money

World of DTC Marketing

It seems that pharma is only interested in drugs that have the potential to sell hundreds of millions as opposed to small products that may only sell to a limited audience. billion, which was much lower than previous studies, which have placed the average cost of drug development as $2.8

FDA grants Orphan Drug status to AceLink’s Fabry disease treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AceLink Therapeutics’ AL01211 to treat Fabry disease. The post FDA grants Orphan Drug status to AceLink’s Fabry disease treatment appeared first on Pharmaceutical Technology.

FDA grants Orphan Drug status to Ocelot’s hepatorenal syndrome therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Ocelot Bio’s OCE-205 to treat hepatorenal syndrome. Currently, there exist no therapies approved by the Food and Drug Administration for treating HRS-AKI.

Avrobio receives orphan drug designation for Hunter syndrome gene therapy

Pharmaceutical Technology

Avrobio has received orphan drug designation for its gene therapy, AVR-RD-05, from the US Food and Drug Administration (FDA) to treat mucopolysaccharidosis type II (MPSII) or Hunter syndrome.

FDA grants Orphan Drug status to Maze’s Pompe disease treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Maze Therapeutics’ investigational product, MZE001, to treat Pompe disease.

A scientific approach to irrational consumer choices

World of DTC Marketing

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Subsequent research has indicated that people go online to learn more about an advertised drug.

Three biggest threats to healthcare

World of DTC Marketing

Launch prices of new cancer drugs in the U.S. Food and Drug Administration (FDA). billion estimated cumulative spending on the new oral targeted cancer drugs by the end of 2018. Drug Prices Healthcare costs

To insource or outsource drug commercialisation? Flexibility is the answer

Pharmaceutical Technology

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. De-risking drug launch.

Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

Pharmaceutical Technology

Most, if not all, of these therapies used the FDA’s Orphan Drug Designation to aid their development plans. So far this year, 176 drugs have already received this designation. Have orphan drug designations increased in recent years?

CMO Moves: Regulatory catalysts for drug manufacturing—August

Pharmaceutical Technology

In this ongoing series , Pharmaceutical Technology takes alook at recent regulatory rulings that will likely impact the manufacturing volumes of drugs and biologics. NICE decisions from mid-June to late July for biopharmaceutical drugs and the CMOs contracted to manufacture them.

Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Another benefit is that fewer patients are required in clinical trials using HCs, thereby reducing time to trial completion and speeding drug approval.

Antibody drug conjugates and bispecifics seize the spotlight at ASCO 2022

Clarivate

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting.

FDA grants Orphan Drug status to Aro Biotherapeutics’ Pompe disease therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for Aro Biotherapeutics’ ABX1100 to treat Pompe disease. The post FDA grants Orphan Drug status to Aro Biotherapeutics’ Pompe disease therapy appeared first on Pharmaceutical Technology.

CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.

Can Hepatitis C drugs reduce symptoms of PTSD?

European Pharmaceutical Review

Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus. There are two current medications – sertraline and paroxetine – approved by the US Food and Drug Administration (FDA) for treating PTSD symptoms.

Nitrosamine drug substance-related impurities (NDSRIs)

European Pharmaceutical Review

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. It has also outlined the various issues impacting on the drug product.

Digital Thread Solutions Can Speed Scale-up and Shorten Time to Market for Pharma

PM360

Food and Drug Administration (FDA) and their international peers protect us all from ineffective, substandard, and even dangerous compounds, whether produced willfully by shady actors or by accident by those of high repute.

Rensselaer team receives NIAID grant to develop antiviral drug for Covid-19

Pharmaceutical Technology

grant from the National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) for developing a Covid-19 oral antiviral drug. The antiviral will be a low-dose drug which can be taken in the at-home setting.

New Mayo Clinic program helps four new AI startups get market ready

MedCity News

Mayo experts work with the companies to understand AI model requirements, check for fairness and bias in their AI models, help them understand the Food and Drug Administration clearance process and more.

Eli Lilly launches citrate-free Taltz formulation

Pharma Leaders

The latest move comes after the receipt of the US Food and Drug Administration (FDA) approval in May this year for the new formulation, which includes the same.

Pharma dodges a bullet, for now

World of DTC Marketing

Medicare’s innovation center may be the best avenue for lowering drug costs if provisions empowering government price negotiation don’t’ make it into a sweeping domestic spending package. For now, drug companies are free to overcharge Medicare for prescription drugs.

Pharma 199

Is it too late for Biogen?

World of DTC Marketing

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and Drug Administration on Biogen Inc.’s

You can’t afford to get cancer

World of DTC Marketing

Monthly drugs costs may reach $100,000, causing many Americans to struggle with the physical and emotional effects of high out-of-pocket medical costs. Some cancer patients may face out-of-pocket costs of nearly $12,000 a year for one drug.

The current pharma business model is unsustainable

World of DTC Marketing

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it.

FDA and NIH partner for neurodegenerative disease treatment development

Pharmaceutical Technology

The US Food and Drug Administration (FDA) and the US National Institutes of Health (NIH) have unveiled a public-private partnership (PPP) to understand and develop treatments for neurodegenerative diseases.

Pfizer to deliver up to six million courses of Paxlovid to Global Fund

Pharmaceutical Technology

It has obtained emergency use authorization from the US Food and Drug Administration for treating mild-to-moderate Covid-19 patients aged 12 years and above who are at increased disease progression risk.

Gilead’s Veklury receives WHO recommendation to treat severe Covid-19

Pharmaceutical Technology

In April, the US Food and Drug Administration approved the supplemental new drug application for Veklury as a treatment for paediatric Covid-19 patients aged more than 28 days.

Turmoil at FDA or just another day?

World of DTC Marketing

PBS.org) Nuplazid, a drug for hallucinations and delusions associated with Parkinson’s disease, failed two clinical trials. Patients on Uloric, a gout drug, suffered more heart attacks, strokes, and heart failure in two out of three trials than their counterparts on standard or no medication.

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Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.

FDA grants Fast-Track status for Relmada’s major depressive disorder therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD).

China NMPA grants IND clearance for Ascletis’ Covid-19 therapy

Pharmaceutical Technology

The China National Medical Products Administration (NMPA) has granted clearance for Ascletis Pharma’s Investigational New Drug (IND) application of its drug candidate, ASC10, for Covid-19.