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Roche CEO Thomas Schinecker revealed that the company is considering selling all of its prescription medicines in the U.S. through a direct-to-patient (DTP) modelDuring the company’s half-year financial results meeting, Schinecker told reporters that the decision would totally cut out pharmaceutical middlemen like pharmacy benefit managers (PBMs) and could save up to 50% of the money currently spent on drugs in the U.S.However, Schinecker did not provide additional details around how the new model might work
Eli Lilly is set to become the first company in Germany to agree on a confidential reimbursement price under the 2024 Medical Research Act (MFG), according to Süddeutsche Zeitung (SZ)The company plans to sign a contract next week with health insurers for its diabetes and obesity treatment Mounjaro (tirzepatide), as detailed in a letter sent to German doctors and obtained by SZ, NDR, and WDRAlthough Germany is a key reference country where rebated prices are typically public, the Medical Research Act now permits confidential pricing agreements under specific conditions since January 1, 2025
The U.S. Food and Drug Administration (FDA) has opened its new Commissioner's National Priority Voucher (CNPV) pilot program to manufacturer applicantsThe agency will accept no more than five participants during the initial year of the program and has officially added “increasing affordability” consistent with Most Favored Nation pricing as a priority of the pilotSpecifically, the FDA states that increasing affordability "could include a company that lowers the U.S. price of a drug or drugs consistent with Most Favored Nation pricing or reduces other downstream medical utilization to lower overall healthcare costs"
The European Commission has confirmed that six oncology medicines are now undergoing Joint Clinical Assessment (JCA) under the EU HTA Regulation, following the addition of three new drugsNewly added to the list are Novartis’ Onasemnogene abeparvovec, PharmaMar’s Lurbinectedin, and AstraZeneca’s Camizestrant, with EMA validation dates in May and June 2025Among the six ongoing JCAs, two are advanced therapy medicinal products (ATMPs) and three carry orphan drug designations
Sarepta Therapeutics will pause shipments of its gene therapy for Duchenne muscular dystrophy (DMD), Elevidys (delandistrogene moxeparvovec), to the U.S. following a request from the U.S. Food and Drug Administration (FDA)Although Sarepta initially refused the FDA’s request, the company has since decided to temporarily pause all shipments of the gene therapy as of July 22, 2025. Sarepta notes that this step will allow the company the necessary time to respond to any requests for information and allow Sarepta and FDA to complete the Elevidys safety labeling supplement processThe FDA notes that it will continue to investigate the safety concerns associated with gene therapies using Sarepta’s AAVrh74 Platform Technology and will evaluate the need for further regulatory actions
India had saved approximately ₹1,362 crore (around USD 163 million) in pharmaceutical raw material imports due to the government’s push for local manufacturing under the Production-Linked Incentive (PLI) Scheme for bulk drugsIn a written reply to the Rajya Sabha, Minister of State for Chemicals and Fertilisers Anupriya Patel said that the import savings were achieved by creating domestic manufacturing capacity for 25 key pharmaceutical ingredients that were previously largely imported. These include Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs)Patel added that the scheme has generated cumulative sales of ₹1,817 crore (nearly USD 217 million), including exports worth ₹455 crore (around USD 54 million)
The UK’s new Life Sciences Sector Plan wants to make the country a top global hub for life sciences by 2035, backed by £2 billion in government funding. The plan focuses on attracting investment and simplifying NHS pathways to adopt new innovations The U.S. Food and Drug Administration (FDA) will consider drug affordability as part of its new Commissioner’s National Priority Voucher (CNPV) program. The program is intended to speed up drug review timelines for drugmakers “supporting U.S. national interests In a recent release, the Federal Joint Committee (G-BA) has taken a step towards aligning the EU Health Technology Assessment Regulation (EU HTAR) with Germany’s national early benefit assessment of new medicines
According to Biocon's CEO, Siddharth Mittal, the company is gearing up to launch a generic version of the weight-loss drug Wegovy (semaglutide) in India and Canada within the next two yearsIn an email interview with Reuters, the CEO said the company plans to file for approval with India’s drug regulator by the end of 2026 and hopes to launch the product in 2027 through a partner. Late-stage trials are expected to be completed within 12 to 18 months“We are progressing with filings for semaglutide in Canada and other emerging markets,” said Mittal
The UK’s new Life Sciences Sector Plan wants to make the country a top global hub for life sciences by 2035, backed by £2 billion in government funding. The plan focuses on attracting investment and simplifying NHS pathways to adopt new innovations Under the plan, the MHRA and NICE will work together to streamline drug and device approvals. The MHRA will use AI for faster reviews, while NICE will speed up appraisals, update methods, and enable real-time updates to care pathways. The plan includes many other measures like scaling up clinical trials through VPAG funding, introducing a single National Formulary, and introducing a new and proportionate approach to NICE appraisals and NHS indication-specific based pricing agreements for some medicinesHowever, the Association of the British Pharmaceutical Industry (ABPI) worries that that the plan is not enough to reverse the decline of the UK’s standing as a center for life sciences
ViiV Healthcare has expanded its licensing deal with the Medicines Patent Pool (MPP) to include injectable cabotegravir long-acting (CAB LA) for HIV treatment. This move enables access to the treatment in 133 countries, including low-income and sub-Saharan nations, aiming to improve care for those facing challenges with daily oral regimensThe deal allows generic drugmakers like Aurobindo, Cipla, and Viatris to develop and supply CAB LA combined with rilpivirine for HIV-1 treatment, pending regulatory approval Dr. Meg Doherty, Director of Global HIV, Hepatitis and Sexually Transmitted Infections Programs at WHO, said, “This agreement aligns with our global goals to ensure equitable access to essential medicines and improve health outcomes for all. We are committed to supporting countries in implementing these new guidelines and ensuring no one is left behind”
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