Drug Discovery and Development Archives - Page 129 of 158

Top J&J exec moves to Moderna

Moderna (NSDQ:MRNA) announced today that former Johnson & Johnson executive Dr. Paul Burton will join as chief medical officer.

Cambridge, Mass.-based Moderna said in a news release that Burton assumes the role of CMO effective July 6, 2021, and he will serve on the company’s executive committee and report to CEO Stéphane Bancel.

“Paul’s extensive medical experience in the global pharmaceutical and biotech industry will be important to Moderna as we expand internationally and continue our journey as a commercial company,” Bancel said in the release. “As we work to deliver on the promise of mRNA science to create a new generation of transformative medicines for patients, Paul’s expertise across multiple therapeutic areas and his proven track record leveraging data science and digital technologies to reimagine medical engagement will be invaluable. I look forward to working with Paul and re-inventing how medical affairs should be built and run i…

Prioritizing translational research is changing drug development for patients and doctors, for good

Photo by Edward Jenner from Pexels

Twelve years. That’s the average amount of time it takes for a viable therapeutic to make it from the research stage to approval for market. In that time, 2.4 million Americans will suffer the effects of severe acute pancreatitis, many of which can be long-lasting and debilitating. Roughly 240,000 of these patients will die as a result of the illness. This is from just one potentially treatable disease.

With more Americans falling ill to preventable diseases each year, the pressure has never been greater for researchers and developers to find ways to create higher-quality therapeutics in less time to save and improve lives. Surprisingly, the way forward is not to change the approval process but to improve the research and development methods applied at each pipeline stage.

The logjam isn’t the approval process — it’s the methods

At first glance, it is easy to assume …

Pfizer’s Prevnar 20 vaccine wins FDA approval

Pfizer’s (NSE:PFE) pneumococcal 13-valent conjugate vaccine Prevnar 13 is one of pharma’s bestsellers, earning nearly $6 billion last year.

Now, the company has scored FDA approval for its Prevnar 20 vaccine for adults 18 and older.

The vaccine is the first to offer protection against 20 serotypes of pneumococcal disease that cause the majority of pneumonia and invasive pneumococcal disease. In addition to the capsular polysaccharide conjugates already included in Prevnar 13, the new vaccine adds conjugates for seven different serotypes linked with invasive pneumococcal disease, antibiotic resistance and meningitis.

“With a single injection, Prevnar 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world,” said Kathrin U. Jansen, senior vice president and head of vaccine research and development at Pfizer, in a statement.

Pfizer oversaw Phase 1 and…

Recent study finds Pfizer vaccine effective against Delta variant

The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) leads to a strong neutralizing antibody response to the B.1.617 variant, according to a recent study published in Nature.

The study focused on the B.1.617.2 subtype of the virus. Two others exist, known as B.1.617.1 and B.1.617.3.

The study did acknowledge that the antibody response to the B.1.617 was less robust than it was for the USA-WA1/2020 strain.

The study concluded that mass immunization with the BNT162b2 vaccine should be a central strategy to end the pandemic.

Researchers first identified the B.1.617 variant in India. The so-called Delta variant now accounts for approximately 6% of COVID-19 infections in the U.S. It is also the dominant variant in the U.K. Various subtypes of B.1.617 exist.

The predominance of B.1.617 in the U.K. underscores its potential to outcompete against B.1.1.7, the so-called “U.K. strain” that became dominant in …

Daiichi Sankyo’s valemetostat fares well in lymphoma and leukemia study

Valemetostat, a potential first-in-class drug from Daiichi Sankyo, led to durable tumor response in patients with peripheral T-cell lymphoma (PTCL) and adult T-cell leukemia/lymphoma (ATL) in a Phase 1 study.

The company presented highlights from the trial at the European Hematology Association (EHA) 2021 Virtual Congress today.

In the study, the objective response rate was 54.5% in 44 patients with PTCL. That tally included 12 complete responses and 12 partial responses. The median duration of response was 56 weeks.

[Related: View the 50 largest pharmaceutical companies of 2020]

Valemetostat inhibits two enzymes known as enhancer of zeste homolog 1 and 2 (EZH1/EZH2).

Researchers have observed altered EZH2 expression in the development and progression of blood cancers such as non-Hodgkin lymphomas (NHLs) and adult T-cell leukemia/lymphoma (ATL). EZH1 also plays a role in hematologic cancer progression.

Daiichi Sankyo has noted …

How lupus clinical trials are evolving

A high magnification micrograph of histomorphologic changes in a lymph node resulting from systemic lupus erythematosus (SLE). Image from Wikipedia.

In the past half-century, scores of investigational drugs for lupus have seemingly failed in clinical trials. GSK’s Benlysta (belimumab) is unique in winning approval from the FDA and European regulatory authorities.

Anifrolumab from AstraZeneca, which would be a first-in-class type I interferon inhibitor, is one of the most promising investigational drugs for treating systemic lupus erythematosus (SLE). SLE is the most common form of lupus. The PDUFA date for anifrolumab is September 30, 2021, according to the Antibody Society.

A fully human monoclonal antibody, anifrolumab binds to subunit 1 of the type I interferon receptor, potentially calming the impact of pro-inflammatory cytokines involved in lupus.

Anifrolumab has shown promise in SLE patie…

AstraZeneca’s TULIP trials highlight role of interferon in lupus

A recent post hoc analysis from AstraZeneca (LON:AZN) found that the monoclonal antibody anifrolumab (Saphnelo) led to consistent improvements in skin rash and arthritis in patients with systemic lupus erythematosus (SLE), which is the most common lupus type. A pooled analysis of the Phase 3 TULIP-1 and TULIP-2 clinical trials investigating anifrolumab showed the drug led to a sustained reduction in SLE symptoms based on the British Isles Lupus Assessment Group (BILAG)–based Composite Lupus Assessment (BICLA).

Anifrolumab binds to the type I interferon receptor subunit 1 and blocks all type I interferons.

If approved, anifrolumab would be a first-in-class lupus treatment. Researchers have known for decades that inflammation-causing signaling proteins known as interferons were involved in lupus. It was, however, unclear whether inhibiting interferons would provide relief to lupus patients. The TULIP clinical trial series, which draws its name from an acronym of …

Preliminary data point to possible link between myocarditis and mRNA COVID-19 vaccines

Image courtesy of Wikipedia

The theme of myocarditis and pericarditis following mRNA vaccination emerged in today’s Vaccines and Related Biological Products Advisory Committee meeting, which reviewed preliminary safety data of Pfizer-BioNTech vaccine in children aged 12 to 15. The risk, however, appears to be small.

As of May 31, there were 116 reports of myocarditis or pericarditis after the first dose of Pfizer-BioNTech vaccine. There were 100 for the first dose of Moderna vaccine. The problem, however, appears to be more common after the second dose. The government has collected 372 reports of myocarditis or pericarditis after the second dose of Pfizer-BioNTech vaccine and 201 for the Moderna vaccine.

Early data suggests a connection between the mRNA vaccines and myocarditis and pericarditis. Out of 2.3 million doses administered to 16-to-17-year-olds, the VAERS database lists 79 cases of myocardit…

Three members of FDA advisory committee resign after aducanumab approval

FDA’s decision to conditionally approve Biogen’s Aduhelm (aducanumab) continues to cause controversy.

Three members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee have resigned. The most recent include David S. Knopman, a neurologist at the Mayo Clinic (Rochester, Minn.) and Aaron Kesselheim, a professor at Harvard University (Cambridge, Mass.)

Last November, eight committee members disagreed that there was sufficient clinical trial evidence to suggest that the drug was effective against Alzheimer’s. Another was undecided.

The first to resign was Joel Perlmutter, a neurologist at Washington University (St. Louis).

The three have not gone quietly.

In a letter to acting FDA Commissioner Janet Woodcock, Kesselheim called the aducanumab approval the “worst drug approval decision in recent U.S. history.”

Knopman told The Washington Post that he did not “wish to be part of a sham process.”

Perlmutter was mor…

‘Good’ viruses? Tapping human viruses to address untreatable diseases

Electron microscopic image of two Epstein-Barr virus virions. Image courtesy of Wikipedia.

After living through the COVID-19 pandemic over the past year, it’s understandable that most people consider viruses to be our enemies causing illness and harm to humans. However, this outlook fails to consider the many surprising advantages these submicroscopic collections of genetic code afford scientists in pushing the boundaries of medicine.

Viruses have honed advantageous skills over billions of years of evolution to invade and hijack the cellular machinery of living organisms, including bacteria, fungi, animals and, importantly, humans. As such, this ability to manipulate life has enabled researchers to gain insights into how best to exploit this advantage for good. This effort has already yielded new biological therapies to treat a wide range of diseases, including rare, inherited disorders treated with gene and…

FDA advisory committee member reportedly resigns over Alzheimer’s therapy approval

A member of the FDA’s expert panel for nervous system therapies reportedly resigned over the decision to authorize an Alzheimer’s therapy.

The FDA controversially authorized Aduhelm (aducanumab) from Biogen on Monday, making it the first novel Alzheimer’s drug treatment in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials.

STAT News reported yesterday that Joel Perlmutter, a neurologist at Washington University (St. Louis) and a member of the FDA’s expert panel for nervous system therapies, told the outlet that he quit the committee on Monday “due to this ruling by the FDA without further discussion with our advisory committee.”

In March, three FDA advisory committee members — none of them Perlmutter — published an editorial in JAMA expressing reservations about aducanumab’s clinical trial data. The FDA’s approval of the drug is conditional, with Biogen required to run a confirmatory clinical…

The top pharma stories of early 2021

Image courtesy of Nataliya Vaitkevich via Pexels.

COVID-19 vaccines dominated pharma industry news during the first half of this year.

It’s little wonder, too, since vaccines are the best hope to return the world to some kind of post-pandemic “normal.”

As with any new medical treatments — especially ones authorized amid an emergency — there have been questions about side effects. Drug Discovery & Development delved into what experts and scientific studies are saying. The overall conclusion is clear: While reactogenicity is a valid concern, the benefits of COVID-19 vaccines greatly outweigh the risks for the vast majority of patients.

Here are eight stories of our stories that delved into potential COVID-19 vaccine side effects:

Dizziness among common COVID-19 vaccine side effects Tinnitus reports grow amid COVID-19 vaccinations Moderna COVID-19 vaccine might cause facial swelling for p…