Drug Discovery and Development Archives - Page 130 of 158

Meet the drugs and devices giving hope to millions of migraine patients

Photo by Liza Summer from Pexels

Migraines are an ancient condition. In about 400 B.C., Hippocrates described visual symptoms of migraine aura that precede headache onset.

But up until recently, neurologists had relatively few tools at their disposal to help migraine patients. The treatment landscape has evolved considerably in recent years, explains Alexander Feoktistov, a neurologist at the Synergy Integrative Headache Center in Chicago. “I’ve been in this field of headache medicine for probably over 20 years now, and I’ve never been as excited to work in this field as in the past few years,” he said.

The most recent article in a two-part interview with Dr. Feoktistov (the first part is here) discusses both drug and device treatments for migraine headaches, which affect roughly one billion people globally.

Get the full story from our sister site, MassDevice.

Pfizer expands COVID-19 vaccine trial involving children under 12

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

In related news, Pfizer and BioNTech must contend with concerns that their BNT162b2 could be linked to myocarditis in adolescents.

[Related: 50 of 2020’s best-selling pharmaceuticals]

A recently published preprint in the journal Pediatrics describes seven male adolescents who developed myocarditis after receiving the vaccine. All seven pa…

Indivior eyes cannabis disorder treatment

Billing itself as the “world leader in opioid addiction treatment,” Indivior (INDV.L) is looking to diversify into treating cannabis use disorder.

The North Chesterfield, Va.–The headquartered company will spend $30 million upfront to acquire Aelis Farma for development rights for AEF0117, an investigational drug that blocks the CB1 cannabinoid receptor in the brain. In addition to cannabis use disorder, the experimental drug could also potentially treat cannabis-induced psychosis.

AEF0117 has shown promise in Phase 1 and Phase 2 trials. AEF0117 is a first-in-class signaling-specific inhibitor, according to Indivior.

Aelis stands to rake in an additional $100 million if the drug candidate meets additional milestones, including succeeding in a planned Phase 2b study.

Indivior, like many other companies with opioid-based products, has faced significant legal pressures in the U.S. as the country grapples with an ongoing opioid epidemic.

In a s…

Bayer moves forward with cell and gene therapies for Parkinson’s disease

Bayer announced today that its BlueRock Therapeutics subsidiary successfully administered the first dose of its Parkinson’s disease therapies.

Berlin-based Bayer said in a news release that BlueRock successfully administered the dose of its investigational pluripotent stem cell-derived dopaminergic neruons, called DA01, to a Parkinson’s disease patient in an open-label Phase 1 clinical safety and tolerability study.

Additionally, Bayer said its wholly-owned, clinical-stage adeno-associated virus (AAV) gene therapy company, Asklepios BioPharmaceutical (AskBio), is currently recruiting and evaluating patients in an ongoing Phase 1b clinical study to assess the safety and preliminary efficacy of a parallel gene therapy program for Parkinson’s disease.

BlueRock will enroll 10 patients across the U.S. and Canada. Those enrolled will undergo surgical transplantation of the dopamine-producing cells into the putamen deep brain structure, with a…

What’s driving the natural language processing revolution in pharma and life sciences

Image courtesy of Pixabay

Pharmaceutical and life sciences companies are faced with a constant stream of new data flowing into often siloed information systems. About 80% of that information exists in unstructured text that is difficult to extract and use, despite its paramount importance in driving clinical and commercial outcomes.

As a result, these organizations find themselves increasingly overwhelmed with volumes of inaccessible data. At the same time, researchers and data scientists lack effective search tools to find the right information in this “big data” tsunami, causing them to miss opportunities to enhance patient safety, improve clinical trial design, identify previously undetected biomarkers and better understand the voice of the customer.

To overcome the limitations of time-consuming, manual searches through mountains of data, pharma and life sciences companies are looking to artificial…

Biogen’s stock pops nearly 40% after FDA’s Alzheimer drug approval, but questions remain

FDA has approved the Aduhelm (aducanumab) from Biogen, the first novel Alzheimer’s drug treatment, in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials.

The news caused Biogen’s share price to jump from $286.14 to $395.85 — a 38.34% increase.

It remains to be seen, however, just how big of a blockbuster Aduhelm will be. Some Alzheimer’s experts have stressed that they won’t prescribe aducanumab, citing a lack of convincing evidence that it is effective. Last November, an FDA advisory committee also expressed reservations about aducanumab’s clinical trial data. Three of those members explained their reasoning in a March editorial in JAMA.

But optimists stress that Aduhelm’s approval could also mark a turning point in treating Alzheimer’s disease (AD). “Aduhelm is the first therapy to target and affect the underlying disease process of AD,” said Alessio Brune…

A neurologist dishes on the migraine treatment landscape

Migraine image courtesy of Pixabay

Migraines are a prevalent condition, affecting about one billion people across the world. “In the U.S., about 13% of the population experiences migraine headaches regularly,” said Dr. Alexander Feoktistov, a neurologist at the Synergy Integrative Headache Center in Chicago.

In the following interview, Feoktistov shed light on the prevalence of the condition and shares his thoughts on the overall treatment landscape. A forthcoming article will touch on how migraine treatments have evolved over the past two decades, focusing on the impact of recently introduced therapies.

Could you briefly summarize how you diagnose migraines?

Feoktistov: Migraine headaches typically start in childhood or during adolescence and frequently continue throughout most of the patient’s life. We sometimes see outliers when people start experiencing headaches later …

Activist shareholder aims to drive shakeup at immunotherapy firm IMV

Dr. Michael Gross, a disgruntled shareholder of immunotherapy specialist IMV (NSDQ:IMV), has launched an offensive intended to cause a leadership shakeup at the company.

Gross released a press release on June 1 announcing his plans to oust the company’s board chair Andy Sheldon and the chair of the board’s compensation committee, Julia Gregory.

The director must receive a majority of shareholder votes to retain his role.

IMV will hold an annual general meeting on June 18.

On June 4, Gross released a new press release stating that he had the support of approximately 25% of the outstanding common shares of IMV.

Gross also stressed that he believes in IMV’s potential.

An IMV spokesperson said the company’s management is aware of the concerned shareholder but had no further comment. The company has made recent changes to its board, installing Dr. Michael Kalos and Kyle Kuvalanka. Kalos is an expert in T-cell therapy and immunotherapy…

FDA approves Novo Nordisk’s semaglutide for weight management

FDA has approved Wegovy, the weekly semaglutide treatment for obesity from Novo Nordisk (CPH:NOVO-B).

The agency approved the use of semaglutide for type 2 diabetes in 2017. FDA approved an oral formulation for diabetes in 2019.

Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist (RA) that continues to find wider use.

In clinical trials, Novo Nordisk people led to an average weight loss of 15% to 18% of body weight over 68 weeks in patients with obesity without diabetes.

In a clinical trial published in JAMA and The New England Journal of Medicine, semaglutide tripled weight loss for participants who received lifestyle management coaching.

Novo Nordisk continues to research new potential uses of the drug. It has launched clinical trials to test its use for conditions ranging from atherosclerosis to Alzheimer’s and Parkinson’s disease. A posthoc analysis involving three cardiovascular clinical trials found that participants recei…

How AI technology can democratize clinical trials in oncology

While drug developers continue to develop promising investigational cancer drugs, conducting clinical research in oncology remains difficult. Here’s how AI-enabled software can help.

AI image courtesy of Pixabay

The statistics on inadequate trial recruitment and endemic challenges in oncology clinical trials are well known. They have only gotten worse over the past 20 years. While the number of cancer treatments has nearly quadrupled in that time period from 421 to 1,489, cancer drugs take 30–40% longer than other indications to gain approval and 80% of oncology clinical trials fail to meet enrollment timelines. Over this period, trial complexity has also increased due to more comprehensive trial designs (e.g., multi-cohort, basket and umbrella studies), precision medicine studies requiring gene, RNA or protein biomarker assays and the increasing quantity and sophistication of desired endpoints.

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FDA authorizes lower dose of REGEN-COV COVID-19 antibody cocktail

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200 mg of Imdevimab.

The initial EUA for REGEN-COV did not include the option for a subcutaneous dose of the antibody cocktail. The option to make the product available via injection makes it easier for doctors or nurses to administer. The use of SARS-CoV-2 monoclonal antibodies has lagged behind vaccines, with only a fraction of eligible patients receiving such antibodies in the past year.

FDA came to its decision after reviewing data from a pivotal Phase 3 study that showed that the drug reduced the risk of hospitalization or death by 70%. The efficacy of the reduced dose is similar to the 2,400 mg dose.

REGEN-COV appears to be …

Olaparib improved survival rates in patients with breast cancer subtype

AstraZeneca (LON: AZN) announced that its oncology drug olaparib (Lynparza) led to clinically meaningful improvements in a Phase 3 study. The study focused on patients with germline BRCA-mutated high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Some 5% of breast cancer patients have BRCA1 and BRCA2 mutations.

Clinical trial investigators have repeatedly demonstrated that olaparib is effective against BRCA-related cancer.

NEJM recently published a summary of the study, known as OlympiA, whose primary endpoint was disease-free survival. The study had 1,836 participants.

After a median follow-up period of 2.5 years, the 3-year invasive survival-free survival rate for olaparib recipients was 85.9% compared with 77.1% in the placebo group.

For patients who had received local treatment and standard neoadjuvant or adjuvant chemotherapy, olaparib led to a 42% reduction in invasive breast can…