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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
- 130
- August 1, 2023
Inflationary pressure causes drop-off in contract manufacturing M&A

AGlobalData analysis found that the total number of deals involving contract manufacturing organisations (CMO) peaked in 2021, but has declined considerably since then. In GlobalData’s “M&A in the Pharmaceutical Contract Manufacturing Industry” webinar, PharmSource editor Fiona Barry highlighted a drop-off in the volume of contract manufacturing mergers and acquisitions (M&As) in 2023 so far but remained optimistic that more activity would happen in the near future. A GlobalData analysis found that from 2021 to 2022, active pharmaceutical ingredient (API) manufacturers made up 45% of acquisition targets, involving both small molecule and biologic. In the last five years, Thermo Fisher Scientific’s $20.9bn acquisition of pharmaceutical clinical research organisation PPD ranked the highest in value. Barry also identified Cambrex Corp, Catalent, Charles River Laboratories and Recipharm, as the most active CMO acquirers. However, Barry reported that since late 2022, M&As in pharmaceutical manufacturing have steadily dropped off. “The amount we saw was ...
- Source: drugdu
- 101
- August 1, 2023
NS Pharma scores breakthrough therapy status for DMD therapy

The US Food and Drug Administration (FDA) has granted NS Pharma’s NS-089/NCNP-02 breakthrough therapy designation in a move that will help ramp up the future treatment options for Duchenne Muscular Dystrophy (DMD). The news follows another recent FDA win for NS Pharma, which is owned by Japanese pharmaceutical company Nippon Shinyaku, after its therapy was awarded a rare paediatric disease (RPD) designation earlier in July. A first-in-human clinical trial (NCT04129294) in six Japanese patients with DMD amenable to exon 44 skipping showed that the therapy increased dystrophin protein expression, and improved the motor function of patients as measured by The North Star Ambulatory Assessment. NS-089/NCNP-02 is an antisense nucleotide that helps cells skip over a particular exon. In the case of DMD patients, this is the mutated – and therefore dysfunctional – exon 44 in the DMD gene. Nippon Shinyaku discovered NS-089/NCNP-02 in a joint research project with the National ...
- Source: drugdu
- 209
- August 1, 2023
Merck’s Pneumococcal Shot Claims Back-to-Back Phase III Wins

By Tristan Manalac Pictured: Merck sign at its office in California/iStock, hapabapa Merck’s investigational pneumococcal vaccine V116 aced two Phase III trials, eliciting strong immune responses in both the Phase III STRIDE-3 and STRIDE-6 trials, the company announced Thursday. Without providing specific data, the drugmaker said that in STRIDE-3, V116 significantly outperformed the standard 20-valent pneumococcal conjugate vaccine at eliciting an immune response in adults who had not been immunized before. Meanwhile, STRIDE-6 showed that Merck’s investigational shot could prime immunity against all 21 targeted pneumococcal serotypes in adults aged 50 years and above who had been vaccinated at least a year prior. Both STRIDE-3 and STRIDE-6 also demonstrated that V116’s safety profile was comparable to the standard vaccine comparator used in these studies. “Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older,” Merck Chief Medical Officer Eliav Barr ...
- Source: drugdu
- 126
- August 1, 2023
Biogen Boosts Neuro Pipeline with $7.3B Reata Buy Amid Layoffs

Published: Jul 28, 2023 By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is dropping $7.3 billion in cash to acquire Texas-based Reata Pharmaceuticals aimed at bolstering its neurological and rare disease businesses, the companies announced Friday. Reata, whose shares soared 51% in premarket trading following the buyout news, recently won the FDA’s approval for Skyclarys (omaveloxolone), the first and so far only authorized treatment for Friedrich’s ataxia in the U.S. Reata is currently working on launching Skyclarys, which it will price at $370,000 per year. Under the terms of the agreement, Biogen will pay a per-share price of $172.50, which represents an approximately 58% premium to Reata’s closing price Friday. Biogen will make the payment in cash, supplemented by the issuance of term debt. The companies expect to close the deal in the fourth quarter of 2023, though it must first pass the heightened scrutiny ...
- Source: drugdu
- 100
- August 1, 2023
FDA Adopts New Sterilization Standard to Support Switch From Ethylene Oxide

Dive Brief The U.S. Food and Drug Administration has adopted an international sterilization standard to give medical device manufacturers another alternative to ethylene oxide (EtO). Manufacturers can now make declarations of conformity to the International Organization for Standardization’s recommendations on low-temperature vaporized hydrogen peroxide in submissions to the FDA. The FDA framed the addition of the ISO test to its Recognized Consensus Standards database as a response to pressure to reduce EtO use and the need to support supply chain resiliency. Dive Insight In April, the U.S. Environmental Protection Agency proposed limiting EtO emissions from sterilization facilities by 80% to minimize the risk of people developing cancer from exposure to the gas. AdvaMed has warned the limit could halve capacity at commercial sterilizing plants, and the FDA has cautioned that there is a lack of viable alternatives to EtO for many devices. The ...
- Source: drugdu
- 149
- July 28, 2023
Study Shows 82% of Child Deaths in Low-Income Countries Could Be Prevented

Eighty-two percent of child deaths in low-income countries could be prevented, according to a study from the international CHAMPS network published in JAMA Network Open. The study, which used the minimally invasive autopsy technique developed by the Barcelona Institute for Global Health (ISGlobal), found an infectious agent in 87% of cases and identified malnutrition as the most common underlying cause of death. Ninety-nine percent of deaths in children under five years of age occur in low- and middle-income countries. “If we want to prevent these deaths, we need to know the causes, but the problem is that we lack reliable data,” says Quique Bassat, ICREA researcher at ISGlobal, an institution supported by the “la Caixa” Foundation. Clinical data and family or caregiver testimonies (verbal autopsies) are often used to determine the causes in low-resource areas, but they are not detailed enough. In addition, it is important to ...
- Source: drugdu
- 146
- July 28, 2023
Merck, Moderna Launch Pivotal Cancer Vaccine Trial for High-Risk Melanoma

Merck and Moderna announced Wednesday the initiation of a pivotal Phase III high-risk melanoma trial combining the companies’ mRNA-based personalized cancer vaccine with Merck’s blockbuster Keytruda checkpoint inhibitor. After a successful Phase IIb in stage III/IV melanoma patients with high risk of recurrence after surgery, Phase III is expanding the population to include stage IIb-IV patients. The study will enroll around 1,089 patients at more than 165 sites and in over 25 countries. The primary endpoint is recurrence-free survival. Secondary endpoints include distant metastasis-free survival and overall survival. Patients will receive either V940 (mRNA-4157), being co-developed and commercialized by Merck and Moderna, in combination with Keytruda or Keytruda alone for comparison. Phase IIb results shared earlier this year showed the cancer vaccine combined with Keytruda reduced risk of recurrence or death by 44% compared to Keytruda alone. Additional data in June 2023 showed the vaccine combo reduced risk of distant metastasis or death by 65% over ...
- Source: drugdu
- 142
- July 28, 2023
UK Probes Weight Loss, Diabetes Drugs for Suicidal Ideation and Self-Harm Risk

The UK’s Medicines and Healthcare products Regulatory Agency said Wednesday that it is reviewing a class of drugs used for obesity and diabetes treatment after reports of self-injury and suicidal thoughts in patients. The probe by the MHRA comes shortly after the European Medicines Agency (EMA) expanded its own investigation into the GLP-1 receptor agonist class of drugs. This includes medications like Saxenda (liraglutide), Wegovy (semaglutide) and Ozempic (semaglutide) produced by Danish pharma company Novo Nordisk. According to reporting by Reuters, the MHRA also confirmed AstraZeneca’s Bydureon (exenatide), Sanofi’s lixisenatide, and Eli Lilly’s dulaglutide were also being included in the review. Novo Nordisk told Reuters that it had received a request from the MHRA about the investigation. “The review is ongoing and a response will be provided within the requested timelines,” Novo Nordisk said in a statement. The MHRA review kicked off July 12, though the agency could not specify when it would ...
- Source: drugdu
- 120
- July 28, 2023
Trial Investigating Peanut Allergy Immunotherapy Hits Final Milestone

A trial investigating desensitisation immunotherapy delivered as toothpaste for adults with peanut allergy reached a final milestone after Intrommune Therapeutics completed the last patient’s last visit. The Phase I OMEGA clinical trial (NCT04603300) is a multi-centre, randomised, placebo-controlled double-blind study involving splitting 32 participants with peanut allergy into two groups to receive either an escalating dose of the company’s candidate INT301 or placebo. The primary outcome is the safety of the drug compared to placebo. Safety is measured by the percentage of participants able to tolerate the highest dose and incidence of adverse reactions. Intrommune Therapeutics’ candidate utilises the company’s oral mucosal immunotherapy (OMIT) platform to deliver the therapy in fully functional toothpaste. OMIT’s simple administration allows for improved adherence, which is important for desensitising a patient to a specific allergy. Allergy immunotherapy requires consistent exposure. Peanut allergy is one of the most common allergies that ...
- Source: drugdu
- 125
- July 28, 2023

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