The first 10 drugs selected for Medicare price negotiations now have new prices set to take effect in 2026. Industry observers note that most of these drugs are older products facing generic competition soon, so greater industry impact will come as the program expands to more drugs in years to come. By Frank VinluanMedicare has unveiled prices for the first 10 drugs selected for its negotiation program, resulting in discounts of as much as 79% off of list prices. Taxpayers will save an estimated $6 billion, the White House said in a Thursday announcement of the new prices. The savings won’t happen right away. New pricing for these products won’t take effect until Jan. 1, 2026 for those with Medicare Part D prescription drug coverage. But these 10 widely used products in therapeutic areas such as diabetes and autoimmune disorders represent the first of many drugs on a path to ...
Novo Nordisk Education Foundation (NNEF), a non-profit organisation set up by Novo Nordisk India, signed a Memorandum of Understanding (MoU) with Rabindranath Tagore (RNT) Medical College, Udaipur to establish a ‘Sickle Cell Wellness Hub’ dedicated to people living with sickle cell disease (SCD). The MoU was signed between Dr Vipin Mathur – Principal & Controller, RNT Medical College and Vikrant Shrotriya – Managing Trustee, Novo Nordisk Education Foundation. Also present at the occasion were Dr R L Suman – Medical Superintendent, MB Government Hospital, Udaipur and Dr Lakhan Poswal – Senior Professor & HOD, Pediatrics and Nodal Officer, SCD Centre of Excellence, RNT medical College, Udaipur. This public-private partnership is aligned to the Government of India’s commitment of eradicating SCD from India by 2047 as part of its National Sickle Cell Anaemia Elimination Mission 2023 [1]. According to the statement released, the Sickle Cell Wellness Hub will offer holistic care ...
By Mike Hollan Abrams discusses how both new pharma and big pharma are reacting to each other and the current market.The last few years have been a rollercoaster ride for the pharma industry. Michael Abrams, managing partner at Numeroff & Associates, spoke with Pharmaceutical Executive about the current state of the industry and what factors are driving M&A and layoffs at the moment. Pharmaceutical Executive: What is driving layoffs in the Pharma sector? Michael Abrams: Despite hopes that the wave of layoffs in 2023 would mark the peak industry pain point, they have continued well into 2024. For big pharma companies, the language used in press releases varies, but the underlying causes are similar: growing pressure on price from government and private sector payers, combined with patent expirations that threaten to cut into revenue. While these are the main real issues, there is, after the surprise passage of the IRA, ...
Current trends are driven by various strategic and financial considerations from both established pharmaceutical companies and development-stage biotech firms. Understanding the valuation and accounting implications of these transactions are crucial for stakeholders to navigate the complex landscape effectively. By Kristen SeaverThe biotechnology industry has witnessed significant shifts in recent years, particularly in the realm of both mergers and acquisitions (M&A) and collaborative agreements. These trends are driven by various strategic and financial considerations from both established pharmaceutical companies and development-stage biotech firms. Understanding the valuation and accounting implications of these transactions are crucial for stakeholders to navigate the complex landscape effectively. Trends in biotech transactions One of the prominent trends in the biotech sector is the acquisition of clinical-stage companies with compelling clinical development programs. Established pharmaceutical companies are increasingly acquiring development stage companies with promising clinical stage programs to bolster their drug development pipelines and mitigate the risks associated ...
In its recently released research note, rating agency ICRA highlighted the encouraging growth prospects of the Indian active pharmaceutical ingredients (API) industry. ICRA expects the revenues of its sample set of companies to expand at a CAGR of 7-8 per cent between CY2023 and CY2029 from an estimated size of USD 13-14 billion in CY2023. This will be driven by a steady ramp-up in the pharmaceutical formulations industry, which in turn, will be aided by an increasing geriatric population, higher prevalence of chronic diseases, and rising demand for contract manufacturing with global customers looking to diversify their supply chain along with greater focus on domestic sourcing. ICRA forecasts the operating profit margin (OPM) of its sample set of companies to improve mildly in FY2025. Indian API industry players faced considerable volatility in earnings over FY2021-FY2023 on account of multiple headwinds such as rising raw material costs due to elevated crude ...
By Don Tracy, Associate Editor UGN-102 has the potential to be the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer, UroGen says. UroGen has completed its New Drug Application (NDA) submission for UGN-102 (mitomycin) for intravesical solution, suggesting that it has the potential to become the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The NDA submission is supported by results from the Phase III ENVISION trial, which demonstrated that patients treated with UGN-102 had a 79.6% complete response (CR) rate at three months following the first instillation.1 “The completion of the NDA submission for UGN-102 marks a crucial milestone for UroGen and underscores our dedication to advancing this groundbreaking treatment for patients with LG-IR-NMIBC,” said Liz Barrett, president, CEO, UroGen, in a press release. “By providing a viable alternative to repeated surgeries, if approved UGN-102 may offer patients quality of life benefits and clinically ...
Livdelzi is now FDA-approved for treating the rare liver disease primary biliary cholangitis. Gilead Sciences added the drug to its pipeline via the $4.3 billion acquisition of CymaBay Therapeutics earlier this year. By Frank Vinluan A Gilead Sciences drug acquired earlier this year in a multi-billion dollar deal is now FDA approved as new treatment for primary biliary cholangitis (PBC), a rare liver disease that can lead to liver failure. The approval announced Wednesday for the drug covers the treatment of adults whose disease is inadequately managed by the standard of care PBC drug as well as those who cannot tolerate that drug. The Gilead therapy, seladelpaar, will be marketed under the brand name Livdelzi. PBC is a rare, progressive autoimmune condition that leads to inflammation and scarring of the liver’s bile ducts. The chronic disorder, which impairs liver function, mainly strikes women over 40 years of age. Gilead estimates that ...
Researchers from King’s College London’s (KCL) School of Biomedical Engineering and Imaging sciences, along with partners at the University of Michigan, the Institut national de la santé et de la recherche médicale in Paris, Norway and Germany, are using shear waves to map blood vessel structures to improve treatments for tumours and other medical conditions. Findings published in Science Advances could improve cancer treatment and potentially improve drug delivery while helping researchers better understand tumours. Michigan and KCL experts developed a new theory using MRI-based elastography imaging to study how shear waves travel through tissue. By analysing them, researchers are able to measure the architecture of blood vessels non-invasively using readily available clinical imaging devices. Shear waves store information about the materials they pass through, including tissue stiffness, which can help diagnose diseases. The method allows researchers to see tiny blood vessels that are usually too small to detect and ...
Drugdu.com expert’s response: When foreign trade enterprises do not possess import and export rights, there are indeed alternative methods to achieve exports. These methods primarily encompass: I. Export Under Billing This refers to units without import and export rights using the name of another import and export company for export purposes. The specific operational process is as follows: 1.Purchase of Export Documents: Acquire a set of export customs declaration documents, which will be used for customs clearance procedures. 2.Submission of Customs Declaration Materials: Submit the purchased customs declaration materials to a customs broker or freight forwarder for customs clearance. Once the goods are successfully declared and released, the process of export under billing is completed. 3.Handling of Customs Clearance Documents: The information used for customs declaration may differ from the header company for customs clearance documents provided to the recipient at the destination port, but documents must be consistent, meaning ...
The CMT Research Foundation (CMTRF) has invested in a research project based at Nationwide Children’s Hospital, US, to develop new vehicles for delivering gene therapies to treat several types of Charcot-Marie-Tooth disease (CMT). The new project aims to improve the treatment efficacy and safety of gene therapies for forms of CMTs, including CMT1A, the most prevalent form, which accounts for 50% of all patients with nerve-damaging disorder. Recognised as a rare peripheral neuropathy disease that affects nearly three million people globally, CMT is a group of inherited conditions that damage the peripheral nerves, which are found outside the main central nervous system. The development of safe and effective gene therapies for CMT requires the delivery of a therapeutic genetic payload into the peripheral nervous system, which specifically targets Schwann cells, a type of glial cells that help form the myelin sheath around the nerve fibres, for types of CMT including ...
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