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Integra warns impact of plant closure will continue into 2024, with delays possible

Dive Brief Integra LifeSciences is aiming to restart manufacturing at its Boston tissue product plant in the fourth quarter and resume commercial sales in the second quarter of next year, CEO Jan De Witte said in a Thursday earnings call. The forecast, which follows the recall of all devices made at the plant over the past five years, confirms that the problem will continue to drag on Integra’s results into next year. Further delays are possible. Integra expects the quality situation to wipe $60 million from its revenues this year, and predicts that it will take another $50 million sales hit next year. Dive Insight Integra disclosed the problems at its Boston plant in May. After discovering endotoxin testing deviations, the company recalled SurgiMend collagen matrix and other tissue devices made over a five-year period. Integra lowered its second quarter revenue forecast by $24 million and told ...
- Source: drugdu
- 137
- August 2, 2023
Non-profit receives FDA approval to supply cheaper OTC naloxone

The US Food and Drug Administration (FDA) approved the second over-the-counter (OTC) naloxone nasal spray product, RiVive (3mg) by non-profit pharmaceutical company Harm Reduction Therapeutics, for the emergency treatment of known or suspected opioid overdose. This approval follows the agency’s approval of Emergent BioSolutions’ Narcan in March 2023, as the agency has recently increased efforts to address the opioid crisis. The FDA also approved the first generic non-prescription naloxone drug in July 2023. Naloxone reverses opioid overdoses by blocking opioid receptors, thus preventing the drugs’ addictive effects. Harm Reduction Therapeutics has announced that the drug will be available by early 2024 and be primarily supplied to state governments and US harm organisations at “costs lower than other opioid antagonist nasal sprays”. The US-based non-profit organisation has said that the first 200,000 doses (10% of projected initial annual product production) of RiVive will be available free of charge. ...
- Source: drugdu
- 128
- August 2, 2023
Searchlight licenses Mithra’s menopause drug Donesta for Canadian market

Mithra Pharmaceuticals and Searchlight Pharma have entered a licensing agreement for Donesta, an investigational drug for treating menopausal symptoms. The agreement grants Searchlight exclusive sales and marketing rights in Canada. As per the agreement, Searchlight is responsible for regulatory approval of Donesta in Canada while Mithra would be entitled to licensing fees, Canadian sales royalties, and milestone-based payments totalling up to €17.05m ($18.8m). Donesta is an orally administered estetrol (E4) hormone therapy that targets nuclear estrogen receptor alpha (ERα) and can potentially avoid the common side effects associated with hormonal therapies. Mithra’s first estertrol (E4) therapy was a combination therapy Estelle (15mg estetrol and 3mg drospirenone), which is currently marketed in the US, Canada, and Europe. The data from the two multicentre, randomised Phase III trials (C301 – NCT04209543, and C302 – NCT04090957) evaluating Donesta, demonstrated a reduction in vasomotor symptoms from baseline and compared ...
- Source: drugdu
- 224
- August 2, 2023
GSK beats Merck to first PD-1 approval in newly diagnosed endometrial cancer

GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation. The FDA has cleared Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer, GSK said Monday. To be eligible for the therapy, the patient’s tumor must be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), both terms that describe a type of genetic abormality. The approval comes nearly two months ahead of schedule and puts Jemperli ahead of Merck & Co.’s rival PD-1 inhibitor Keytruda, which is also gunning for the first-line endometrial cancer use. But the dMMR/MSI-H restriction comes as a bit of a disappointment for the GSK drug. By GSK’s estimate, about 15% to 20% of the roughly 60,000 new cases of endometrial cancer each year in the U.S. will be diagnosed at an advanced ...
- Source: drugdu
- 106
- August 2, 2023
Human senescent fibroblasts trigger fibrogenic reaction in the lungs of immunodeficient mice

A new research paper was published on the cover of Aging (listed by MEDLINE/PubMed as “Aging (Albany NY)” and “Aging-US” by Web of Science) Volume 15, Issue 14, entitled, “Human senescent fibroblasts trigger progressive lung fibrosis in mice.” Cell senescence has recently emerged as a potentially relevant pathogenic mechanism in fibrosing interstitial lung diseases (f-ILDs), particularly in idiopathic pulmonary fibrosis. In a new study, researchers Fernanda Hernandez-Gonzalez, Neus Prats, Valentina Ramponi, José Alberto López-Domínguez, Kathleen Meyer, Mònica Aguilera, María Isabel Muñoz Martín, Daniel Martínez, Alvar Agusti, Rosa Faner, Jacobo Sellarés, Federico Pietrocola, and Manuel Serrano from Hospital Clinic Barcelona, The Barcelona Institute of Science and Technology (BIST), Instituto de Investigaciones Biomédicas August Pi i Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red Enfermedades Respiratorias (CIBERES), University of Barcelona, Karolinska Institute, Catalan Institution for Research and Advanced Studies (ICREA), and Altos Labs hypothesized that senescent human fibroblasts may suffice to ...
- Source: drugdu
- 126
- August 2, 2023
Apellis Eye Injection Treatment Flagged for Safety Issues

Pictured: Healthcare worker checking the eye of an elderly woman patient/iStock, peakSTOCK Apellis’ recently approved eye injection Syfovre (pegcetacoplan injection) has been linked to several cases of retinal vasculitis, a rare complication involving eye inflammation, according to the American Society of Retina Specialists’ Research and Safety in Therapeutics Committee, as reported by several media outlets. In a press statement posted Saturday, Apellis confirmed seven retinal vasculitis cases, two of which arose in April 2023 following Syfovre injections, while two others were detected in May and three in June. The company has also received a report of one other retinal vasculitis event, but has yet to confirm this. Apellis has carried out a comprehensive investigation of these complications, including a review of Phase III safety data from Syfovre’s development program, as well as of its manufacturing process. However, “there is no indication that the drug product or manufacturing issues contributed to these events,” the ...
- Source: drugdu
- 110
- August 2, 2023
Sumitomo, Otsuka’s Schizophrenia Candidate Fails Phase III Trials

Pictured: Woman in mental anguish/iStock, Marina Demeshko Sumitomo Pharma and Otsuka Pharmaceutical announced Monday that two Phase III studies of ulotaront failed to meet primary endpoints for acutely psychotic adults living with schizophrenia. The studies, DIAMOND 1 and DIAMOND 2, pitted the trace amine-associated receptor 1 (TAAR1) agonist against a placebo. After six weeks, the studies showed improvement on the Positive and Negative Syndrome Scale (PANSS), but results were not superior to placebo. A “large placebo effect” was present in both studies “which may have masked the molecule’s therapeutic effect,” according to the press release. While placebo responses are frequently higher in psychiatric studies, Sumitomo CEO Hiroshi Nomura pointed to COVID-19 as a potential culprit for the high placebo effect as the studies were conducted throughout the pandemic. The molecule was part of a four-compound deal forged between Otsuka and Sunovion, a subsidiary of Sumitomo, nearly two years ago. The former made an upfront payment of ...
- Source: drugdu
- 99
- August 2, 2023
FDA approves second over-the-counter naloxone nasal spray for opioid overdose

The US Food and Drug Administration (FDA) has approved the over-the-counter (OTC), non-prescription use of Harm Reduction Therapeutics’s RiVive, a 3mg naloxone hydrochloride nasal spray, for the emergency treatment of known or suspected opioid overdose. The FDA’s decision means that RiVive stands as the second non-prescription, OTC naloxone nasal spray product that the agency has approved. FDA commissioner, Robert Califf, said: “We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. “Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health.” Prescription opioids, such as morphine, codeine and fentanyl, are used as treatments to relax the body and relieve pain. However, misuse of opioids can lead to several harmful effects, including slowed breathing, and hypoxia, which can ultimately lead to death. In the US, drug ...
- Source: drugdu
- 102
- August 2, 2023
Biogen, amid layoffs, ponies up $7.3B for rare disease specialist Reata and potential blockbuster Skyclarys

On Monday during a quarterly earnings call, when Biogen CEO Chris Viehbacher was asked about the company’s potential to execute M&A, he randomly offered “we’ve got, I think, about $7.3 billion in cash?” Four days later, Biogen has revealed a proposal to acquire Reata Pharmaceuticals. The Massachusetts biotech will pay $172.50 per share for the Plano, Texas-based rare disease specialist in a deal that comes to—you guessed it—$7.3 billion. With the purchase—which is a 59% markup on Reata’s shares from close of the market on Thursday—Biogen gains Skyclarys, the first treatment for the rare, inherited neurologic disorder Friedreich’s ataxia. It was approved by the FDA in February of this year and carries sales potential of $1.5 billion in 2030, according to analysts. On a conference call Friday to bookend the busy week, Viehbacher called Biogen “the natural owner for Skyclarys.” When the deal is done, Biogen will be able to ...
- Source: drugdu
- 130
- August 1, 2023
UKHSA data reveals a 45% decline in hepatitis C prevalence in England

The UK Health Security Agency (UKHSA) has published new data showing that there were an estimated 70,649 people living in England with hepatitis C in 2022, marking a 45% decrease from the number recorded in 2015. Since 2015, NHS England has treated over 80,000 people for the infection as part of its national elimination programme. Of those treated, more than 80% were from the most deprived areas in England, which the UKHSA says highlights “the role of eliminating hepatitis C as a key driver of reducing health inequalities”. Hepatitis C is a blood-borne virus that can cause life-threatening liver disease, including cancer. However, those infected often have no symptoms until years later when their liver has already been badly damaged. Spread through blood-to-blood contact, the virus is commonly contracted through sharing needles contaminated with the infection, but it can also be contracted through the sharing of razors or toothbrushes. Dr ...
- Source: drugdu
- 127
- August 1, 2023

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