PharmaFocus Today – media

EMA recommends approval of Lencanermab

After four months of deliberation, the European Medicines Agency (EMA) has “changed its mind” on Lencanermab. On November 14, the EMA Committee for Medicinal Products for Human Use (CHMP) announced that after re-examining Lencanermab, it recommended approval of Lencanermab for the treatment of mild cognitive impairment or mild dementia caused by Alzheimer’s disease, suitable for apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. According to regulations, the European Commission is expected to make a final ruling on the marketing authorization application for Lencanermab within the next 67 days. Of course, the European Commission is not in a good position to raise objections, so it is equivalent to approval. Although we had expected this result four months ago, it can be imagined that there were a lot of discussions in the middle. Foreign media commented that “EMA’s attitude towards Lencanermab has reversed 180 degrees.” This time, after Eisai/Biogen submitted the subgroup ...
- Source: drugdu
- 21
- November 21, 2024
AstraZeneca’s new dual anti-cancer drug approved for clinical trials in China

On November 15, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that AstraZeneca’s Class 1 new drug AZD0486 was approved for two clinical trials with implicit approval, which are intended to be used for the treatment of previously untreated follicular lymphoma in adults; and relapsed and refractory follicular lymphoma in adults who have received at least 2 lines of systemic treatment or more. Public information shows that AZD0486 is a CD19/CD3-targeted bispecific T cell adaptor protein under development by AstraZeneca, which is a next-generation T cell adaptor. This is the first time that a drug has been approved for clinical trials in China for the indication of follicular lymphoma (FL). In a clinical study recently published by AstraZeneca, the product showed an overall response rate (ORR) of up to 96% when used to treat patients with relapsed/refractory FL (R/R FL). ...
- Source: drugdu
- 22
- November 21, 2024
Novo Nordisk’s weekly weight loss formulation is officially launched

On November 17, Novo Nordisk announced that its weekly formulation of glucagon-like peptide-1 receptor agonist (GLP-1RA) semaglutide (trade name: Novowin) for long-term weight management was officially launched in China, providing a weight loss option for Chinese overweight and obese patients. It is understood that with the official commercialization of Novowin, the first prescription of semaglutide for weight loss indications in public hospitals will be issued in Shanghai next week. Regarding the pricing of Novowin, Novo Nordisk responded: “We have begun to apply for Novowin provincial bidding network, and the sales price will refer to the provincial online price.” Previously, Novo Nordisk’s semaglutide for the treatment of type 2 diabetes, Novotai, has been included in the medical insurance, and the cost of a 3 ml dose is less than 800 yuan. In addition, Novowin has previously entered the private hospital channel and can be booked through the Internet platform, with a ...
- Source: drugdu
- 24
- November 21, 2024
Commercial raw liquid and formulation workshop of Altruist Biologics ADC has been officially put into operation

On November 15, 2024, Altruist Biologicstech, a leading domestic biopharmaceutical CDMO company, announced that its antibody conjugated drug (ADC) raw liquid and formulation production workshop (M3) located at its Hangzhou production base has officially started production! Becoming one of the few companies in China that can provide one-stop services from antibody and antibody conjugate drug stock solutions to formulations. This powerful production capacity will be able to meet the growing demand for ADC drugs in the market, accelerate the process of partner product launch, and enhance competitiveness. On that day, Altruist Biologicstech Hangzhou Base welcomed a visiting delegation composed of outstanding founders and executives from the domestic biopharmaceutical industry, who visited the ADC commercial raw material and preparation workshop, as well as four 20000 liter antibody raw material factories and preparation factories. The delegation expressed high interest and appreciation for the design layout, advanced hardware facilities, and automated production lines ...
- Source: drugdu
- 42
- November 20, 2024
Barco showcases new products at CCR2024, adding momentum to precision medicine

The 31st Radiology Academic Conference of the Chinese Medical Association (CCR2024) was held at the Shanghai World Expo Center from November 14th to 17th. Barco showcased its new Coronis OneLook 32MP multimodal diagnostic imaging display, integrated reading center, and multiple radiology displays at the booth, bringing cutting-edge technology and outstanding products to the Chinese precision medicine market with updated and more comprehensive solutions. New product One Look 32MP unveiled, showcasing higher standards in the medical display field The display is a bridge connecting radiologists and medical imaging, and its performance directly affects the accuracy of doctors’ capture, interpretation, and diagnosis of image details. At this conference, Barco unveiled its new Coronis OneLook 32MP multimodal fusion display, bringing more refined solutions to the Chinese medical market. The Coronis OneLook 32MP multimodal fusion display is Barco’s industry-leading medical display solution, featuring a 32MP ultra high definition resolution and a 33 inch large ...
- Source: drugdu
- 42
- November 20, 2024
Prepayment system can speed up hospital payments to suppliers

Recently, the National Medical Insurance Administration and the Ministry of Finance jointly issued the “Notice on Prepayment of Medical Insurance Funds” (hereinafter referred to as the “Notice”) to further standardize the prepayment system and clarify the scope of use and allocation of prepayments. conditions and expenditure standards, and standardizes the process management, accounting and fund supervision of advance payments. The prepayment system effectively relieves the financial pressure on medical institutions. By allocating medical insurance funds in advance, the prepayment system significantly reduces the cash flow pressure of medical institutions waiting for reimbursement settlement, helps hospitals better manage operating funds, and ensures the continuity and stability of medical services. Prepayments can be used to transfer funds for medical expenses such as the purchase of drugs and medical consumables, allowing hospitals to pay suppliers faster, reducing the pressure on financing in the medical and pharmaceutical industry, and improving the cash flow level ...
- Source: drugdu
- 28
- November 20, 2024
Atropine that “does not adapt to local conditions”

Pharmaceutical companies around the world have high hopes for atropine. After all, the demand for myopia prevention is very clear and huge. The most critical thing is the extremely large demand group. According to Eyenovia’s estimates, myopia is estimated to affect about 25 million children in the United States, of which up to 5 million are considered to be at high risk of progressive myopia. The same is true in China. According to Guosheng Securities’ estimate, the size of the myopia group of children and young people aged 6-16 is about 78 million. For this group of people, there are currently two major problems: some groups have no effective means of delay, and those with means of delay need solutions with better compliance and lower costs. At present, among the main measures to control and delay myopia, wearing frame glasses is convenient but has poor effects; optical correction (wearing orthokeratology ...
- Source: drugdu
- 31
- November 20, 2024
Refusal to adjust prices, a number of pharmaceutical companies “out”

On November 18, at the 44th China Pharmaceutical Industry Development Summit Forum, Geng Hongwu, executive deputy director of the Medical and Health Research Center of the Tsinghua University Association of Senior Scientists, pointed out that the basic ideas of my country’s medical insurance drug price management at this stage mainly include: management scope, quality-price matching, reasonable price difference, medical insurance guidance, strict supervision, etc. “Exerting the effectiveness of drug price governance” is one of the key tasks of the National Medical Insurance Administration this year. That is, to promote special governance of online drug prices, explore new mechanisms for drug price formation, and increase the disclosure of price procurement credit evaluation. Recently, the Shanxi Provincial Drug and Equipment Centralized Bidding and Procurement Center issued the “Notice on the Adjustment and Disposal of the Centralized Procurement Prices of Amoxicillin and Other Drugs of the Guangdong Alliance”. The relevant companies of 20 ...
- Source: drugdu
- 30
- November 20, 2024
Celltrion expands European market, acquires iQone Healthcare for 30 billion

On Friday, South Korean biosimilar giant Celltrion said it had completed the acquisition of iQone Healthcare Switzerland for approximately 30 billion won (about 155 million yuan) as part of its European expansion strategy. After the acquisition, iQone Healthcare Switzerland will become a wholly-owned subsidiary of Celltrion Healthcare Hungary Kft. The transaction will also provide Celltrion with the opportunity to obtain authorizations, further enhancing its pipeline of innovative therapies. In 2022, iQone’s annual revenue was 18.9 billion won (about 18.9 million US dollars), and sales increased by 57% to 29.6 billion won in 2023. Celltrion said the acquisition will further accelerate the expansion of its prescription drug business in Switzerland. According to IQVIA data, sales performance in the country remains strong, with the Ramsima series (IV and SC) accounting for 61% of the market share in the second quarter of this year. The company noted that its follow-up products are expected ...
- Source: drugdu
- 31
- November 20, 2024
Pumis announces equity acquisition agreement with BioNTech

According to the terms of the agreement, BioNTech will acquire 100% of Pumis’ issued share capital for a prepayment of $800 million (approximately RMB 5.781 billion) (subject to customary adjustment of the acquisition price), primarily in cash and a portion of American Depositary Shares (ADS). In addition, BioNTech will pay an additional milestone payment of up to $150 million (approximately RMB 1.084 billion) when Pumis meets the milestone conditions agreed upon by both parties. The transaction is expected to be completed in the first quarter of 2025, subject to customary delivery conditions and regulatory approvals. After the completion of this transaction, BioNTech will acquire full rights to the Pumis candidate drug pipeline and its bispecific antibody drug development platform, further expanding its business scope in China; Pumis Zhuhai will serve as the BioNTech China R&D center to conduct related R&D research; The Pumis Nantong production base, which meets international standards, ...
- Source: drugdu
- 42
- November 19, 2024

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