Drug Discovery and Development Archives - Page 127 of 158

Europe orders another 150 million doses of Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) has announced that the European Commission has reserved an additional 150 million doses of its COVID-19 vaccine for delivery in 2022.

To date, the European Commission has reserved 460 million Moderna vaccine doses.

The new deal gives the European Commission the ability to purchase new COVID-19 vaccines.

The company is currently testing various booster options, including the use of its existing mRNA-1273 vaccine. In addition, it is developing a vaccine known as mRNA-1273.351 based on the B.1.351 variant that first emerged in South Africa.

Interim data from a Phase 2 trial in the U.S. found that both mRNA-1273 and mRNA-1273.351 led to increased neutralizing antibody titer levels in response to the B.1.351 and P.1 variants. The mRNA-1273.351 appears to be more effective at generating an immune response to those viral lineages. The P.1 variant is also known as the “Gamma Variant.”

Moderna also recently announced that the…

6 pharma firms rank among Glassdoor’s 2021 Best Places to Work

Glassdoor has released its latest list of the top 100 best places to work in 2021, and six pharmaceutical companies made the cut. One thread running across the entries in the entire list is the employers’ ability to empower and inspire workers in a time of continued challenges.

In addition to the pharma companies, a handful of medical device companies were featured as well including Stryker (14/100) and Intuitive Surgical (41/100)

Johnson & Johnson: 24 out of 100

J&J (NYSE:JNJ) has come up in the ranks since we published our list of the top pharma companies to work for in May. Employees praised the opportunities with various departments, the overall work environment and the work-life balance their roles afforded.

Johnson & Johnson was also the top-ranked pharmaceutical company in Gartner’s most recent list of top 25 supply chain companies, coming in at slot three. “J&J remains unparalleled in the life science industry, possessing enduring…

First oral blood thinner for children wins FDA approval

FDA has approved Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) oral pellets for children with venous thromboembolism who are between three months and under 12 years old.

The indication stipulates that children receiving Pradaxa have received prior treatment with an injectable blood thinner given by injection for at least five days.

FDA has also approved Pradaxa in capsule form to treat blood clots in patients eight years and older with venous thromboembolism. That approval also requires that the patients receive a prior injectable blood thinner for at least five days. FDA has also approved the use of Pradaxa to prevent recurrent clots in patients eight and older who finished treatment for their first venous thromboembolism.

Besides Pradaxa, there is no other approved oral blood thinner for children.

The drug first won FDA approval in 2010 to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation.

“The F…

Why Janssen believes next-gen drug Tremfya can meet unmet needs in psoriasis and beyond

Two decades ago, psoriasis was a poorly understood condition. Treatment options for severe psoriasis included powerful immunosuppressant agents such as methotrexate and cyclosporin that can have significant side effects.

But the fact those immunosuppressant drugs were effective at treating psoriasis helped pave the way to use biologics to treat the condition. The experience “really taught us that psoriasis was an immunologic disease,” said Dr. Lloyd Miller, vice president, immunodermatology at Janssen Research & Development (NYSE:JNJ).

After researchers determined that psoriasis, which affects some 125 million patients worldwide, results from excess inflammatory cytokines, drug developers began to test the potential of inhibitors of tumor necrosis factor (TNF) and interleukin 17 (IL-17) in treating the disease.

FDA approved TNF blockers such as Janssen’s Remicade (infliximab) for psoriasis and psoriatic arthritis in the mid-2000s. IL-17A antagonists …

Agios Pharmaceuticals files NDA for drug that would treat pyruvate kinase deficiency

The small-molecule therapeutics company Agios Pharmaceuticals (NSDQ:AGIO) has submitted a new drug application (NDA) with the FDA to use mitapivat to treat adults with pyruvate kinase (PK) deficiency, a rare condition in which the rapid breakdown of red blood cells occurs can trigger anemia. The condition is the result of an inherited lack of the enzyme PK.

Mitapivat is a novel oral, small molecule allosteric activator of wild-type and various mutated PKR enzymes.

“With this NDA filing, we are poised to deliver the first potentially disease-modifying therapy for people with PK deficiency, a chronic, lifelong hemolytic anemia characterized by serious complications affecting multiple organs,” said Dr. Chris Bowden, the chief medical officer at Agios.

There are currently no FDA-approved therapies for PK deficiency. While mild cases may not require treatment, physicians treat more severe forms of the disease with blood transfusions and splenectomy. PK defici…

Australia COVID-19 vaccine supply limited until August

Australia image from Pixabay.

As the U.S. sees demand plateauing for COVID-19 vaccines, Australia is facing a shortage of both vaccine supplies and healthcare workers.

Australian health officials project that the nation’s vaccination program will face delays from June to July. The slowdown is partly a result of limited shipments of the Pfizer vaccine. Australia expects to receive 1.7 million doses of the vaccine this month and another 2.8 million in July.

Australian officials are also aiming to enlist a greater number of general practitioners to help dispense vaccines later in the summer when supplies are likely to increase.

Like several other countries, Australia has also limited the use of the AstraZeneca (LON:AZN) vaccine over the risk of rare blood clots. Health officials there recently recommended the AstraZeneca vaccine only for adults 60 and older.

Australia’s Chief Medical Office…

Athira Pharma faces shareholder rights investigations

A growing number of law firms are investigating claims of securities fraud associated with Athira Pharma (NSDQ:ATHA), a clinical-stage biopharma focused on small molecules targeting neurodegeneration. Its lead therapeutic candidate, ATH-1017, targets dementia associated with Alzheimer’s and Parkinson’s.

Law firms investigating potential securities fraud claims involving the company include the following:

Ademi (Milwaukee). Block & Leviton (Boston). Johnson Fistel (San Diego). Portnoy (Los Angeles). Wolf Popper (New York City).

The Bothell, Wash.–based company’s stock fell 39% on June 18 after announcing it was putting Leen Kawas, the firm’s CEO, on temporary leave.

Its share price had stabilized in mid-day trading, edging up 1% to $11.27. E

arlier this month, Jefferies predicted thath Athira shares would rise as much as 50% after FDA decided to approve the Alzheimer’s drug aducanumab from Biogen (NSDQ:BIIB).

An Athira Pharma spo…

Athira Pharma’s stock falls 39% after placing its CEO on leave

The Bothell, Wash.–based clinical-stage biopharma Athira Pharma (NSDQ:ATHA) is in a tailspin after the company’s board put Leen Kawas, the firm’s CEO, on temporary leave.

The company’s stock closed the day at an all-time low of $11.15. The stock was valued as high as $34.25 on Dec. 31, 2020.

Washington State University has launched an independent review of Kawas’s doctoral research in molecular pharmacology and toxicology, which she completed a decade ago.

The university is investigating reports that Kawas authored several papers with altered images.

Several papers Kawas had co-authored now appear on PubPeer, which cites possible problems with published research. PubPeer authors have pointed out that specific images in those papers appear to have duplicated portions and other irregularities. Some of the anomalies could have led to incorrect research findings or at least the interpretability of those findings.

In the interim, the company has…

Moderna to expand its Massachusetts manufacturing capabilities

Cambridge, Mass.–headquartered Moderna (NSDQ:MRNA) will hire at least 155 new manufacturing employees for manufacturing jobs at its plant in Norwood, Mass.

A $2.33 million tax incentive from the Massachusetts Life Sciences Center helped bankroll the expansion. The investment will enable the company to double the size of its manufacturing site in Norwood, Mass., which became operational in 2018.

With limited manufacturing capability, Moderna has had to rely on partners with contract manufacturers such as Lonza(SWX:LONN), Catalent (NYSE: CTLT), Baxter BioPharma Solutions (NYSE: BAX), Recipharm and Laboratorios Farmacéuticos Rovi (BME:ROVI).

Get the full story from our sister site, Pharmaceutical Processing World.

mRNA vaccines do not negatively affect sperm county, study finds

One of the many urban legends related to COVID-19 vaccines is that they cause infertility. Researchers at the University of Miami set out to disprove that claim with a recent single-center prospective study. Unsurprisingly, the study that indicated the mRNA vaccines have no negative impact on male fertility. In fact, the researchers found that after the second vaccine dose, participants exhibited a significant increase in median sperm concentration and sperm motility.

In the study published in JAMA, the researchers stopped short of claiming that mRNA COVID-19 vaccines could boost fertility in men. “While these results showed statistically significant increases in all sperm parameters, the magnitude of change is within normal individual variation,” the study authors concluded.

The study only evaluated the BNT162b2 and mRNA-1273 vaccines from Pfizer-BioNTech and Moderna, respectively.

The study tracked participants approximately 70 days after administering…

CureVac marches on after announced disappointing study results

After CureVac (NSDQ:CVAC) revealed that its first-generation vaccine candidate has an interim efficacy of 47% in a pivotal trial, its stock lost about half its value. The company, however, is undeterred.

Speaking in a call with investors and analysts, CureVac CEO Franz-Werner Haas said the company would continue to seek the authorization of its CVnCoV vaccine and continue developing its next-generation CV2CoV vaccine.

One difference between the vaccine from CureVac and those from Moderna and Pfizer-BioNTech lies in the dose of mRNA. The CureVac vaccine contains 12 µg of mRNA per dose. The Pfizer-BioNTech vaccine uses 30 µg per shot, while the Moderna vaccine contains 100 µg.

Haas, however, stressed the role of virus variants in the 47% interim efficacy figure. The Phase 2b/3 study “provides important insights into a dramatically transformed variant environment, suggesting that we are virtually fighting a different virus — a different pandemic” than six m…

U.S. buys 200 million more Moderna vaccine doses for potential boosters and use in children

Health experts remain divided over the need for COVID-19 vaccine boosters in the coming months, but the U.S. government is preparing for that possibility by purchasing 200 million additional doses of the COVID-19 vaccine from Moderna (NSDQ:MRNA).

The purchase of additional doses will also enable the U.S. government to inoculate children aged 12 to 17 in coming months, assuming FDA authorizes that use. Two doses of the vaccine were 100% effective in that age group, according to a recent Phase 2/3 trial.

In May, FDA amended its EUA for the Pfizer-BioNTech vaccine to include adolescents aged 12 to 15.

The U.S. has committed to buying 500 million doses of Moderna’s vaccine to date. The company expects to deliver 110 million doses in the fourth quarter of 2021 and another 90 million in the first quarter of 2022.

To date, Moderna has provided 217 million doses to the U.S.

The NIH has launched a clinical trial involving fully vaccinated participan…