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Johnson & Johnson’s PARP combo nabs first global nod but faces tough fight against AZ, Merck’s Lynparza

Johnson & Johnson’s idea to carve out the prostate cancer indication from GSK’s PARP inhibitor Zejula has yielded its first global approval. Following a recommendation from the European Medicines Agency, the European Commission has officially approved J&J’s Akeega in metastatic castration-resistant prostate cancer (mCRPC), J&J said Friday. The drug is a fixed-dose combo of Zejula and J&J’s androgen-directed Zytiga, and it’s used alongside a corticosteroid. Under a 2016 deal with Zejula’s developer Tesaro, J&J specifically carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. Not all patients can get Akeega under the drug’s European label. To be eligible, a patient’s tumor must test positive for BRCA1/2 mutations, which account for 10% to 15% of all cases, J&J said. Akeega’s label in Europe is narrower than that of rival PARP inhibitor Lynparza from AstraZeneca and Merck. The European Commission in December cleared Lynparza and Zytiga for mCRPC ...
- Source: drugdu
- 127
- May 3, 2023
European paediatricians sound alarm over medicine shortage

Paediatricians from European countries have raised the alarm over a shortage of medicines for children including antibiotics and asthma treatment, warning it was endangering health. In a letter addressed to health ministers and seen by AFP on Saturday, the doctors stressed it was “urgent to find a fast, reliable and lasting solution” to the problems facing stocks in Europe. “The health of our children and our youngsters is in danger because of the lack of medicines throughout Europe,” they wrote. The letter was addressed to the health ministers of Austria, France, Germany, the Italian region of South Tyrol and Switzerland. It was co-signed notably by Andreas Werner, president of the French Association of Ambulatory Pediatrics, his German counterpart Thomas Fischbach and Laura Reali, head of the European Confederation of Primary Care Paediatricians. The doctors said it was the responsibility of political decision-makers to ...
- Source: drugdu
- 172
- May 2, 2023
WHO announces launch of new pandemic preparedness initiative

The guidance focuses on respiratory pathogens, including influenza and respiratory syncytial virus. The World Health Organization (WHO) has launched a new initiative to help countries better prepare for future pandemics. The new ‘Preparedness and Resilience for Emerging Threats Initiative’ incorporates the latest tools and approaches for shared learning and collective action established during the COVID-19 pandemic and other recent public health emergencies, according to WHO. The initiative’s first module focuses specifically on responding to the threat or arrival of respiratory pathogens, including influenza, COVID-19 and respiratory syncytial virus. This will enable countries to critically review, test and update their respiratory pandemic planning efforts to ensure they have the functional capacities and capabilities in place. A process is currently underway to identify the next group of pathogens, such as arboviruses, to be addressed under this initiative. Dr Tedros Adhanom Ghebreyesus, WHO director-general, said: “Preparedness, prevention, and ...
- Source: drugdu
- 158
- May 2, 2023
Pfizer CEO’s texts with European Commission chief trigger new NYT lawsuit

Twenty-two months after European Commission President Ursula von der Leyen admitted to The New York Times that she negotiated a COVID-19 vaccine deal with Pfizer CEO Albert Bourla, Ph.D., through text messages, the newspaper is suing the commission over its refusal to make the texts public. While the lawsuit was filed on Jan. 25 and listed on the European Court of Justice’s public website Monday, Feb. 13, none of the documents related to the case are available to the public. Two people familiar with the suit confirmed it to Politico. The NYT argues that the EC is required legally to turn over the messages. Last year—in response to a public information request—the commission wrote that text messages do not need to be stored because they are treated as “short-lived ephemeral documents.” Reference: https://www.politico.eu/article/new-york-times-sue-european-union-ursula-von-der-leyen-pfizer-texts/
- Source: drugdu
- 141
- May 2, 2023
Kite’s CAR-T therapies recommended by NICE for certain blood cancers

The two treatments could benefit up to 600 patients each year in England via the Cancer Drugs Fund. Kite – a Gilead company – has announced that two of its CAR T-cell therapies have been recommended by the National Institute for Health and Care Excellence (NICE) as options to treat certain aggressive blood cancers. The treatments, both given as one-off infusions, have been specifically recommended for use within the Cancer Drugs Fund (CDF), which pays for cancer treatments while further data is collected on their clinical effectiveness. Kite’s Yescarta (axicabtagene ciloleucel) has been recommended for adults with diffuse large B‑cell lymphoma (DLBCL) that returns within a year of, or is resistant to, first-line chemoimmunotherapy. It can also be used with a stem cell transplant in some cases. The treatment was previously available as standard care after two or more systemic therapies, with the updated guidance now making it available after ...
- Source: drugdu
- 148
- May 2, 2023
Seres’s Bacteria in a Pill Becomes First FDA-Approved Oral Microbiome Therapy

Recurrent Clostridioides difficile infection can be treated with fecal microbiota transplants. FDA approval of Seres Therapeutics’ Vowst makes it the first oral microbiome therapy. A capsule filled with bacteria is now FDA approved for treating a serious and potentially deadly type of gut infection, making the Seres Therapeutics drug the first oral microbiome therapy to receive the regulatory go-ahead for patients. The infection is caused by Clostridioides difficile (C. difficile or C. diff), a bacterium that’s part of the diverse microbial community in the intestines. When the gut microbiome is disrupted, C. diff can proliferate, releasing toxins that cause frequent diarrhea, abdominal pain, and fever. In severe cases, the infection leads to organ failure and death. Antibiotics can treat C. diff infection, but these bacteria can develop resistance, leading to a recurrence of the infection. When that happens, patients have limited treatment options. According to Centers for Disease Control and Prevention data cited by Seres, about 156,000 cases of ...
- Source: drugdu
- 176
- May 2, 2023
‘Eat, sleep, console’ reduces hospital stay and need for medication among opioid-exposed infants

Researchers have found the “Eat, Sleep, Console” (ESC) care approach to be more effective than using the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess and manage opioid-exposed newborns, according to a national, randomized controlled clinical trial. Newborns cared for with ESC were medically ready for discharge approximately 6.7 days earlier and 63% less likely to receive medication as part of their treatment, compared to newborns cared for with FNAST. ESC prioritizes non-pharmacologic approaches to care, such as a low-stimulation environment, swaddling, skin-to-skin contact and breastfeeding. ESC also encourages parental involvement in the care and assessment of their infants. These findings are based on the hospital outcomes of a large and geographically diverse group of opioid-exposed infants. A two-year follow-up study of a subset of infants is ongoing. The current findings are published in the New England Journal of Medicine. “Medical care for newborns who were ...
- Source: drugdu
- 135
- May 2, 2023
Moderna says it expects up to $15 billion in sales of Covid, RSV, flu vaccines in 2027

Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added. The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially available product. ...
- Source: drugdu
- 123
- May 2, 2023
New Blood Test May Reduce Invasive Surgeries for Bladder Cancer

By LabMedica International staff writers One of the methods for treating bladder cancer involves the use of chemotherapy and/or radiation therapy, followed by a radical cystectomy only for patients who do not achieve a complete response. Those who do achieve a complete response are closely monitored following chemotherapy and/or radiation and undergo radical cystectomy if cancer reoccurs. However, radical cystectomy is a significant operation that necessitates urinary diversion, leading to life-altering consequences. Now, a new blood test may enable bladder cancer patients to avoid a precautionary cystectomy after immunotherapy treatment. Scientists at the Netherlands Cancer Institute (NKI, Amsterdam, Netherlands) in collaboration with Inivata (Cambridge, UK) have demonstrated that a novel technique can improve the prediction of tumor recurrence. In the study, the scientists examined the blood of bladder cancer patients who had undergone immunotherapy. These patients were part of a high-risk group with an increased likelihood of disease recurrence, placing ...
- Source: drugdu
- 122
- May 2, 2023
Addressing the much-needed development of effective pneumococcal vaccination policies for long-term care settings

The International Federation on Ageing (IFA) is proud to release findings from a recent study entitled Driving the Agenda of Pneumococcal Pneumonia Vaccination in At-risk Populations in Community and Long-term Care. The COVID-19 pandemic has exposed the brutal nature and impact of respiratory infections on people of all ages and particularly amongst those at-risk of serious complications, such as older adults in long-term care (LTC) settings. Though several respiratory infections and other vaccine-preventable diseases (VPDs) can be prevented, or their severe symptoms reduced through receiving vaccines, current vaccination uptake rates for pneumococcal disease among older adults in LTC are below national targets. This study conducted by the IFA looked at the status of existing public health policies and campaigns on pneumococcal disease in Canadian LTC settings and investigated the policy gaps that have resulted in poor vaccine uptake. One of the main findings from this study is that within LTC ...
- Source: https://www.news-medical.net/news/20230429/Addressing-the-much-needed-development-of-effective-pneumococcal-vaccination-policies-for-long-term-care-settings.aspx
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- May 1, 2023
pneumococcal vaccination policies

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