PharmaFocus Today – Page 259 – media

Genentech, PeptiDream Ink Potential $1B Radiopharma Deal

By Kate Goodwin Pictured: Businessmen shaking hands/iStock, Tippapatt Japanese biopharma PeptiDream on Wednesday announced yet another licensing agreement with Roche’s Genentech, this time worth up to $1 billion. The latest deal builds on previous partnerships between the two companies starting in December 2015 with licensing in 2016 and an expansion deal in 2018. PeptiDream will receive $40 million upfront for R&D of its macrocyclic peptide-radioisotope drug conjugates. Going forward, another $1 billion is on the line in milestones plus tiered royalties of product sales to markets outside of Japan. PeptiDream will oversee preclinical activities to develop a peptide-RI drug conjugate and retain rights in Japan for any products developed. While a particular target was not disclosed, PeptiDream CEO Patrick Reid said in a statement that the company hopes to “bring innovative first-in-class peptide radiopharmaceuticals to patients worldwide.” The peptide-RI drug conjugates in the deal with Genentech are designed to use ...
- Source: drugdu
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- September 30, 2023
Medicaid/CHIP Coverage To Be Reinstated for 500K People

Thirty states have been conducting Medicaid and CHIP automatic renewals incorrectly, leading to many individuals being wrongly removed from coverage. Because of this, nearly 500,000 children and other individuals will have their coverage reinstated. By MARISSA PLESCIA After determining an issue in the way many states were handling Medicaid and CHIP redeterminations, the U.S. Department of Health and Human Services (HHS) announced Thursday that coverage will be reinstated for nearly 500,000 children and other individuals.“Thanks to swift action by HHS, nearly half a million individuals, including children, will have their coverage reinstated, and many more will be protected going forward. HHS is committed to making sure people have access to affordable, quality health insurance – whether that’s through Medicare, Medicaid, the Marketplace, or their employer,” said HHS Secretary Xavier Becerra in a statement. “We will continue to work with states for as long as needed to help prevent anyone eligible ...
- Source: drugdu
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- September 30, 2023
Meitheal partners with Chinese company for US licencing of insulin biosimilars

Meitheal Pharmaceuticals has signed an exclusive licensing agreement with the China-based Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars in the US. The insulin biosimilars include two rapid-acting insulins, namely insulin lispro and insulin aspart, and the long-acting insulin glargine. The rights were acquired by Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical. Eli Lilly reported global sales of $440.4m for the branded version of insulin lispro Humalog in n Q2 2023, while Sanofi’s Lantus (insulin glargine) had global sales of $353m in the same period, as per the company’s Q2 financials. Meitheal will have exclusive US marketing rights after the insulin biosimilars are approved by the US Food and Drug Administration (FDA), which is expected in 2026. As part of the agreement, both Tonghua Dongbao and Nanjing King-Friend Biochemical would be responsible for the development and supply of all three insulin biosimilars. All three companies will also share the royalties ...
- Source: drugdu
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- September 30, 2023
Evaxion partners with Afrigen Biologics to develop mRNA gonorrhea vaccine

The Danish artificial intelligence (AI) biotech Evaxion has announced plans to develop an mRNA vaccine against gonorrhea in partnership with Afrigen Biologics. Gonorrhea antigens identified through Evaxion’s EDEN platform have shown strong protective effects in preclinical trials, as per the company. The partnership will investigate the function of these antigens when presented in the mRNA form. After the validation phase, the partners will discuss an agreement for clinical development and commercialisation, with the opportunity to involve additional collaborators. Cape Town, South Africa-based Afrigen Biologics is set up as a specialised centre to support mRNA vaccine development and technology transfer, will take charge of developing the mRNA vaccine in low and middle-income countries and African territories. Gonorrhea is a sexually transmitted infection, caused by the bacteria Neisseria gonorrhoeae. It heightens the vulnerability to HIV, a prevalent health concern in many low and middle-income countries (LMICs). Birgitte Rønø, Evaxion’s Chief Scientific Officer ...
- Source: drugdu
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- September 30, 2023
NIH clinical trial for universal influenza vaccine begins

The universal vaccine could protect people against more strains of flu The National Institutes of Health (NIH) has announced that it has begun dosing patients in a phase 1 clinical trial of a new influenza (flu) vaccine candidate, FluMos-v2, to evaluate the vaccine for safety and its ability to elicit an immune response. Designed by researchers at the National Institute of Allergy and Infectious Diseases’s (NIAID) Vaccine Research Center (VRC), FluMos-v2 works to induce antibodies against various influenza strains by displaying part of the influenza virus haemagglutinin (HA) protein in repeating patterns on self-assembling nanoparticle scaffolds, preparing the immune system to recognise and fight the actual virus. Sponsored by NIAID, the trial is expected to enrol 24 healthy individuals, aged 18 to 50 years, to receive two intramuscular injections of the vaccine candidate, 16 weeks apart. The researchers aim to enrol 12 participants in a lower dose group (60mcg per ...
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- September 30, 2023
NICE recommends more genetic testing for links to ovarian cancer

Around 340,000 to 444,000 people in the UK carry one of nine pathogenic gene variants The National Institute for Health and Care Excellence (NICE) has recommended that more people get tested for genes linked to ovarian cancer. The new guideline aims to raise awareness and increase the availability of genetic testing, allowing people to take preventive measures, including surgery, to prevent the development of ovarian cancer. Anyone can carry a gene linked to ovarian cancer, including women, men, transgender people, and non-binary people, which can be passed on to their children. In the UK, around 340,000 to 440,000 people carry one of the nine pathogenic variants – BRCA1, BRCA2, MLH1, MSH2, MSH6, RAD51C, RAD51D, BRIP1 and PALB2 – that cause cancer, 3% of whom know they have a high-risk gene. NICE has recommended that genetic services should test and assess the likelihood of people carrying the genes, including those who ...
- Source: drugdu
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- September 30, 2023
Over half of world’s population not covered by essential healthcare services

The World Health Organization (WHO) and the World Bank have published the 2023 Universal Health Coverage (UHC) Global Monitoring Report, which revealed some alarming statistics concerning out-of-pocket (OOP) health expenditure and the global health service coverage rate. The report showed that only 42 out of 138 countries have achieved progress in expanding UHC service coverage since 2000 while also reducing OOP spending for the population. Alternatively, 108 countries reported worsening to no significant changes in health coverage since 2015, the year when Sustainable Development Goals (SDGs) were adopted. All 108 countries that experienced slow progress in UHC service coverage are low-income countries (LICs) and lower-middle-income countries (LMICs). Despite that, the overall global UHC Service Coverage Index (SCI) score increased from 45 to 68 out of 100 between 2000 and 2021, but no change was reported in the global SCI score between 2019 and 2021. Notably, a significant variation in country-level ...
- Source: drugdu
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- September 29, 2023
Oxford Biodynamics launches prostate screening test

EpiSwitch is designed for men with prostate cancer risk in the UK and is 94% accurate Oxford BioDynamics – a company developing precision medicine tests – has announced that its EpiSwitch Prostate Screening (PSE) blood test will be available to UK patients. The existing PSA test is 55% accurate, and is considered an unreliable test by many doctors, including those in the NHS. The new PSE test has been designed to run alongside the standard PSA test, and combines the PSA score with five proprietary epigenetic biomarkers to predict – with 94% accuracy – the presence (or absence) of prostate cancer. The PSE test has emerged after nearly a decade’s long collaboration between OBD, Imperial College London, University of East Anglia, Imperial College NHS Trust and leading prostate cancer experts across the UK. The development was also part of the wider PROSTAGRAM screening pilot. Mathias Winkler, Consultant Urologist and Surgeon ...
- Source: drugdu
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- September 29, 2023
Will Big Pharma engage in Medicare price negotiations? AZ, BMS say they will

After the Centers for Medicare & Medicaid Services revealed the list of drugs set to face the first round of price negotiations under the Inflation Reduction Act (IRA), the drugmakers responsible for marketing them are confronting a series of deadlines. First up, the companies need to tell CMS by Sunday whether they’ll participate in the process or exit the Medicare and Medicaid programs entirely. In a statement to Fierce Pharma, an AstraZeneca representative said the company plans to “participate in the process outlined by CMS to communicate the value of Farxiga to people covered by Medicare” as part of its commitment to ensuring access. BMS plans to begrudgingly participate in the process, a spokesperson told Fierce Pharma in an emailed statement. “If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid,” the spokesperson said. “That is ...
- Source: drugdu
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- September 29, 2023
As chemotherapy shortage ebbs and flows, attention shifts to long-term solutions

It’s been about 10 months since FDA inspectors rebuked a production plant in India that made popular platinum-based chemotherapies, kicking off a chain reaction of drug shortages that continues to jeopardize cancer care in the U.S.While the White House recently announced that overseas importations and other efforts have increased U.S. supplies of carboplatin and cisplatin, not all clinics are able to access the drugs, according to the American Society of Clinical Oncology’s (ASCO’s) chief medical officer Julie Gralow, M.D. Even as supplies recover around the country, a “certain set” of cancer clinics are still unable to get their hands on the medicines, Gralow said in an interview. The disparity in availability reflects the disproportionate impact the shortage has had on patients based on factors such as location or socioeconomic status, Gralow added. It’s often smaller sites that can’t secure the drugs. While bigger hospitals may have them, those sites often ...
- Source: drugdu
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- September 29, 2023

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