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FDA grants second orphan drug designation to Priothera’s mocravimod

The US Food and Drug Administration (FDA) has granted an orphan drug designation to Priothera’s mocravimod for leukaemia patients undergoing a stem cell transplant. The drug is indicated to help improve the outcome of patients with haematologic malignancies following a haematopoietic stem cell transplantation, according to a 27 November press release. Following the designation, the Dublin, Ireland-headquartered biotech will now be in line for tax credits for US-based clinical trials and, if the therapy is approved, have seven years of market exclusivity in the designated indication. Haematopoietic stem cell transplantation, also known as blood and bone marrow transplantation, is used to treat a wide range of blood cancers. There are nearly 60,000 new cases of leukaemia in the US each year. This is the second orphan drug designation for Priothera’s mocravimod. The first, granted in March 2022, was for the treatment of acute myeloid leukaemia (AML) in patients undergoing hematopoietic ...
- Source: drugdu
- 206
- November 29, 2023
Sanofi/Regeneron’s Dupixent shows promise in chronic obstructive pulmonary disease

Sanofi and Regeneron have shared positive results from a late-stage trial of Dupixent (dupilumab) in chronic obstructive pulmonary disease (COPD). The phase 3 NOTUS trial has been evaluating the investigational use of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled COPD and evidence of type 2 inflammation. The trial met its primary endpoint, with Dupixent shown to reduce moderate or severe acute COPD exacerbations by 34% compared to placebo. Results from the interim analysis also demonstrated that Dupixent improved lung function from baseline by 139ml at 12 weeks compared to 57ml for placebo, with this benefit sustained at week 52. COPD is a chronic respiratory disease that causes lung function to progressively decline. Approximately 300,000 people in the US live with uncontrolled cases of the condition and evidence of type 2 inflammation. The positive readout from NOTUS builds on the previous results from the ...
- Source: drugdu
- 104
- November 29, 2023
AbbVie’s epcoritamab gets one step closer to follicular lymphoma approval

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to the investigational therapy epcoritamab to treat follicular lymphoma. The European Medicines Agency (EMA) has validated a Type II application for epcoritamab for the same indication. Co-developed by AbbVie and Genmab, the subcutaneous IgG1-bispecific antibody, marketed as Epkinly in the US and Tepkinly in the EU, is being evaluated as a new therapy for follicular lymphoma. It has regulatory approval for treating certain large B-cell lymphomas (LBCL). AbbVie had entered into the $750m cancer therapeutics deal with Genmab to develop and commercialise antibody therapies back in 2020. In May 2023, the FDA granted an accelerated approval to Epkinly to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. Epkinly has generated $14m in sales so far this year, according to AbbVie’s Q3 2023 financial results. According to GlobalData’s Pharma Intelligence Center, the drug ...
- Source: drugdu
- 96
- November 29, 2023
British biopharma applies for BLA for T-cell cancer therapy

British biopharmaceuticals company Autolus Therapeutics has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for its chimeric antigen receptor T cell therapy (CAR-T therapy), which treats a persistent form of leukaemia. The therapy, obe-cel, targets relapsed/refractory adult B-cell acute lymphoblastic leukaemia (ALL), a blood cancer that currently has survival rates ranging from <10% to around 25% across all age groups. These rates are even lower for adults in older life. According to Phase II trial data, Autolus’ treatment had an overall response rate of 76%, with 97% of responders becoming minimal residual disease (MRD)-negative, meaning they entered a complete remission. After a median follow-up of nine and a half months, 61% of responders remained in remission without subsequent anti-cancer therapies. These results have allowed the drug to obtain Orphan Drug Designation from the FDA and Orphan Medical Product Designation from the European Medicines Agency (EMA). ...
- Source: drugdu
- 93
- November 29, 2023
EirGenix’s Breast Cancer Biosimilar Receives Marketing Authorization by EC

TAIPEI, Nov. 22, 2023 /PRNewswire/ — EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission (EC). The marketing authorization in the EU will cover the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, which are the same indications approved by the EC for the reference biologic, Herceptin®. Sandoz AG and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix Inc. will remain responsible for the development and manufacturing of trastuzumab while Sandoz will hold the rights to commercialize the medicine upon approval in the global market (excluding Taiwan, China, Russia, and some Asian countries). Breast and gastric cancers are among the most frequently occurring in Europe, and combined, are responsible for nearly 200,000 deaths ...
- Source: drugdu
- 112
- November 28, 2023
What 4 Execs Want People To Know About the Intersection Between the Justice System and Behavioral Health

About 44% of people in jail and 37% of people in prison have a mental illness. In addition, 63% of people in jail and 58% of people in prison have a substance use disorder. Yet, support is often lacking for this population. This was the topic of discussion on a recent panel of behavioral health experts at the Behavioral Health Tech 2023 conference in Phoenix. When asked what the healthcare industry should know about the intersection between the justice system and mental health, one panelist said that numerous players work with the incarcerated population and there needs to be better collaboration. “There are so many organizations — city-based, state-based, nationally-based — that are assisting this community,” said Darren Webb, CEO of Mindset, which helps those with mental illness and their caregivers apply for Social Security Disability benefits. “We’ve gone to partner with jails and we wouldn’t even know that there ...
- Source: drugdu
- 97
- November 28, 2023
In Cardiology, AI Enables Me to Deploy Therapy Faster, and Can Make the Difference Between Life and Death

I work as a cardiologist for a multi-specialty group that sees patients both in capitated payer and fee-for-service environments. This diverse practice gives me the experience to know where insurance providers will find value or what they will likely pay for. As these protocols become more scientifically validated, AI is going to help the entire healthcare system to identify at-risk patients quickly and accurately. By DR. JONATHAN A. ALIOTA As a cardiologist, I see this kind of scenario play out on a daily basis. A patient comes in for a routine procedure and a heart murmur is detected. This murmur could have several different diagnoses. While they can be a sign of something more serious, many of the heart murmurs we hear on a routine basis are normal, physiologic murmurs, such as mild mitral regurgitation. In addition, a healthy heart that had too much caffeine and not enough water that ...
- Source: drugdu
- 98
- November 28, 2023
AWS, Hoppr Launch Model to Accelerate Generative AI Tools in Medical Imaging

At RSNA 2023, AI startup Hoppr announced that it teamed up with AWS to launch a new foundation model. The product, named Grace, is a B2B model designed to help application developers build better AI solutions for the medical imaging field — and to build them more quickly. By KATIE ADAMS AI startup Hoppr teamed up with AWS to launch a new foundation model to help bring more generative AI solutions into medical imaging, the companies announced on Sunday at RSNA 2023, the annual radiology and medical imaging conference in Chicago. The new product, named Grace, is a B2B model designed to help application developers build better AI solutions for medical images — and to build them more quickly. Along with the launch of Grace, Hoppr also announced that it received “a multi-million dollar investment” from Health2047, the American Medical Association’s venture studio. Chicago-based Hoppr, which was founded in 2019, ...
- Source: drugdu
- 119
- November 28, 2023
Novo Nordisk announces $2.3bn investment to expand production site in France

Novo Nordisk has said it will be investing more than $2.3bn to expand its existing production site in France “for the current and future product portfolio within serious chronic diseases”. The investment will “significantly increase” the capacity of the Chartres manufacturing facility, Novo said, including for its GLP-1 products in the cardiometabolic disease space. The site in Chartres was first established in 1961 and currently employs around 1,600 people, with more than 500 new jobs expected to be created as a result of the expansion. Lone Charlotte Larsen, corporate vice president of Novo Nordisk Production Chartres, said: “This significant investment… confirms the importance of our French manufacturing site, one of our strategic production sites, as a cornerstone of the growth we are experiencing as a company. “By maximising the skills and infrastructure we already have on the site, we are expanding our capacity in an efficient way.” The expansion is ...
- Source: drugdu
- 103
- November 28, 2023
AstraZeneca plans to exit ‘beating heart’ of Indian operations in Bangalore

Amid a corporate review of AstraZeneca’s global manufacturing and supply network, the company’s Indian subsidiary is planning to close up shop at the “beating heart” of its India operations in Bangalore. AstraZeneca Pharma India will exit its production plant in Bangalore, India, “in due course,” the company said in a filing on the Bombay Stock Exchange Thursday. AZ plans to auction off the site “in a fully operational manner” to a buyer who can also serve as a contract manufacturer for the AstraZeneca drugs made and packaged in Bangalore, AZ’s Indian subsidiary said. In the filing, AZ said it is “fully cognizant of the impact this change can bring,” adding that the company’s “first responsibility will be towards its employees and meeting the needs of its patients by ensuring an uninterrupted supply of medicines.” AstraZeneca has operated in India since 1979, the company says on its website. Aside from its ...
- Source: drugdu
- 104
- November 28, 2023

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