Novartis is upbeat about the future of CAR-Ts and TCRs 

The life sciences industry has just scratched the surface in terms of chimeric antigen receptor (CAR) T-cell therapy’s potential, according to a session at the Novartis Breakthrough Science media event held on November 10.

CAR-T therapy, which has emerged as one of the most promising new treatments for multiple myeloma, certain lymphomas and B-cell acute lymphoblastic leukemia, has found growing use in recent years. The treatment, however, is often expensive.

Manufacturing of CAR-Ts continues to improve, however. And in recent years, researchers have made progress in enhancing the fitness of CAR-T cells so that they have more potential for proliferation and “hopefully, overall, better benefit and higher response rates,” said Jennifer Brogdon, executive director, head of cell therapy research, department of exploratory immuno-oncology at the Novartis Institutes for BioMedical Research.

Manufacturing breakthroughs have enabled the therapy to be used …

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Novartis to continue manufacturing Pfizer/BioNTech vaccine

Novartis (NYSE:NVS) has announced that it has reached an agreement with BioNTech (NSDQ:BNTX) and Pfizer (NYSE:PFE) to produce their popular COVID-19 BNT162b2 vaccine.

The companies reached a new production agreement that will leave Novartis responsible for fill-and-finish operations related to the mRNA-based vaccine from Pfizer and BioNTech.

Under the agreement, Novartis will produce at least 24 million doses of the vaccine in 2022 in its facilities in Ljubljana, Slovenia.

This year, Novartis had an agreement for the fill and finish of more than 50 million doses.

For the agreement pertaining to 2022, Novartis intends to obtain bulk mRNA from BioNTech to fill into vials under sterile conditions. The company will return the vaccine doses to BioNTech for distribution.

In related news, Pfizer recently announced data from a Phase 3 study, which found that a booster dose of its vaccine was 95.6% effective against COVID-19 in a period when the Del…

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Tremfya bests Cosentyx in psoriasis study 

Janssen’s Tremfya (guselkumab) generally had higher efficacy in treating moderate-to-severe psoriasis than Cosentyx (secukinumab) from Novartis, according to recent data published in the Journal of Dermatological Treatment. 

In the 48-week Phase 3 ECLIPSE study, a greater number of guselkumab recipients achieved at least a 90% and 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 90 and PASI 100). Guselkumab recipients also had higher rates of clear or almost clear skin based on the Investigator’s Global Assessment scores of IGA 0 and IGA 0/1, respectively

The difference in performance between the two drugs was especially pronounced in patients weighing more than 100 kg (220 pounds). For instance, 62.3% of guselkumab recipients weighing 100–110 kg had IGA 0/1 responses at week 48, while 44.4% of secukinumab recipients did. 

The findings are significant because people with psoriasis have a higher prevalence and incidence of obesity…

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Novartis wins FDA fast track designation for investigational osteoarthritis drug

Novartis (NYSE:NVS) has received FDA fast track designation for LNA043, a potential treatment for osteoarthritis of the knee.

LNA043 is a modified version of the human angiopoietin-like 3 (ANGPTL3). The drug would be a potential first-in-class disease-modifying osteoarthritis therapy.

Osteoarthritis is a common joint disorder. In 2017, more than 300 million people internationally had either hip or knee osteoarthritis, according to an article in the Annals of the Rheumatic Diseases.  

At present, drugs play a supporting role in treating osteoarthritis. Patients primarily use them to reduce pain and swelling.

Several organizations, including Merck (NYSE:MRK), Novartis and a number of smaller companies, have launched clinical trials to test various investigational disease-modifying therapies for the condition.

LNA043 is an angiopoietin-like 3 (ANGPTL3) agonist targeting damaged cartilage. In a proof-of-concept study, the drug regenerated damag…

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FDA to prioritize review of Novartis STAMP inhibitor asciminib for chronic myeloid leukemia

Novartis (NYSE:NVS) has announced that the FDA has granted priority review for its application for allosteric inhibitor asciminib (ABL001) in chronic myeloid leukemia (CML).

The drug targets the ABL myristoyl pocket (STAMP).

The priority review status could trim four months off the review time, dropping the review period to eight months from 12 months under a standard review.

Novartis won the status after sharing positive data from its Phase 3 ASCEMBL trial, which pitted asciminib against Pfizer’s Bosulif (bosutinib) in participants with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP). Patients in the trial had received prior treatment with two or more tyrosine-kinase inhibitors (TKIs).

The prognosis for chronic myeloid leukemia has improved considerably since 2001, when promising treatments for the blood cancer began to emerge. Nevertheless, many people with CML face a risk of disease progression.

Sequential therapy with…

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Novartis’s Kymriah fails in study focused on aggressive B-cell non-Hodgkin lymphoma

Novartis (SWX:NOVN) has announced that the genetically modified autologous T cell immunotherapy Kymriah (tisagenlecleucel) failed to meet the primary endpoint in its Phase 3 BELINDA trial. That endpoint involved event-free survival for people with aggressive B-cell non-Hodgkin lymphoma compared to standard of care. To qualify for the study, patients needed to have primary refractory disease or have relapsed within 12 months of receiving first-line treatment. 

Two other companies, Bristol Myers Squibb (NYSE:BMY) and Gilead Sciences (NSDQ:GILD), recently announced successful data in similar studies involving Breyanzi and Yescarta, respectively.

Bristol Myers Squibb received FDA approval for Breyanzi as third-line therapy in February. 

FDA granted accelerated approval to Yescarta for relapsed or refractory follicular lymphoma in March. 

The standard of care in the treatment was salvage chemotherapy. Also known as rescue therapy, salvage chemotherapy …

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FDA grants orphan drug designation to investigational Novartis drug NIS793

FDA has granted orphan drug designation for Novartis’s (SWX:NOVN) NIS793, an anti-TGF-β IgG2 monoclonal antibody.

Specifically, the designation covers the use of NIS793 in conjunction with standard-of-care chemotherapy to treat pancreatic cancer.

NIS793 has been the subject of eight clinical trials for indications ranging from solid tumors to myelofibrosis.

NIS793 would be a first-in-class antibody specific for transforming growth factor-beta (TGFβ), which is implicated in several tumors. Inhibiting TGFβ can reduce fibrosis associated with pancreatic cancer, according to Novartis.

The prognosis for pancreatic cancer tends to be poor. The five-year survival rate for the cancer ranges from 5% to 10%, according to Johns Hopkins Medicine. Part of the reason for the low survival rate is the generally late diagnosis of the cancer.

Novartis is also testing NIS793 in conjunction with the novel immunotherapy PDR001 in breast and lung cancers trials.

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34 of the most innovative pharmaceutical products

Photo by Myriam Zilles on Unsplash

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to make its selections.

The organization will announce final winers in the competition at ceremony in New York City on October 28, 2021. 

In terms of pharmaceutical agents, the organization selected the following 34 nominees:

Company Drug name

AbbVie Inc.

Rinvoq (upadacitinib)

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma 

Adhansia XR (methylp…

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Novartis refiles paperwork to FDA for novel cholesterol drug inclisiran

Novartis (NYSE: NVS) has resubmitted paperwork to the FDA for inclisiran, a subcutaneously-delivered drug candidate for treating hyperlipidemia in adults whose low-density lipoprotein cholesterol (LDL-C) remains elevated after taking a maximum tolerated dose of statin therapy.

In Dec. 2020, FDA issued a complete response letter (CRL) for inclisiran. A CRL indicates that the agency has decided not to approve a new drug application. In this case, FDA had expressed concern over unresolved inspection-related conditions at an Italian contract development and manufacturing organization (CDMO).

In a statement, Novartis announced that it plans to shift inclisiran production to its facility in Schaftenau, Austria. The company said it planned to move production of the drug to that plant before it received the CRL.

In its CRL, FDA did not relay concerns related to the safety or efficacy of inclisiran.

Novartis won EU approval for the drug in December.

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10 of the best pharma companies to work for

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research.

The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries.

To get a sense of which pharmaceutical companies in the sector were the best employers, we sifted through data on company reviews sites Glassdoor and Comparably, and other sources.

Here are the 10 companies that came in on top:

Get the full story from our sister site, Drug Discovery & Development.

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10 of the best pharma companies to work for

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research.

The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries.

To get a sense of which pharmaceutical companies in the sector were the best employers, we sifted through data on company reviews sites Glassdoor and Comparably, and other sources.

Here are the 10 companies that came in on top.

Get the full story from our sister site, Drug Discovery & Development.

And browse data on all the Pharma 50 companies here.

Read more
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10 of the best pharma companies to work for

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research.

The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries.

To get a sense of which pharmaceutical companies in the sector were the best employers, we sifted through data on company reviews sites Glassdoor and Comparably, and other sources.

Below are the 10 companies that came in on top. (And browse data on all the Pharma 50 companies here.)

1. Sage Therapeutics

Glassdoor rating: 4.4/5 83% would recommend to a friend

Pros: Workers at Sage Therapeutics applauded the company’s work-life balance and culture. Just under three-quarters (74%) had a positive business outlook for the firm. One recent reviewer found meaning in “doing the toughest job in the world by developing CNS drugs.” The company’s brain health p…

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