17 October 2024 The chronic obstructive pulmonary disease (COPD) market in the seven major markets (7MM) is set to grow from $11.5 billion in 2023 to $30.8 billion in 2033, driven by the launch of the first biologic for COPD and other pioneering pipeline agents.
In the UK, the medicines regulator has given a positive scientific opinion on Novartis’ investigational treatment asciminib, under the Early Access to Medicines Scheme (EAMS). 25 January 2022
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck & Co’s New Drug Application (NDA) for gefapixant, the orally administered selective P2X3 receptor antagonist, under development for refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. 25 January 2022
Protas, a UK-based independent not-for-profit organization, designing and delivering large, global randomized clinical trials of treatments for common and other life-threatening diseases, launches today and announces French pharma major Sanofi as its first strategic partner. 25 January 2022
The year 2022 promises to continue the upward trajectory of development for orphan drugs. Financial projections from the previous year are expected to remain on course this year, with growth in the orphan drug market anticipated to increase from $190.8 billion in 2021 to $248.2 billion in 2026.1 25 January 2022
The British pricing and reimbursement agency has updated its guidance for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate), broadening access to the therapy. 24 January 2022
Marking a milestone in the troubled development of novel RARγ agonist palovarotene, French drugmaker Ipsen has finally secured approval, in Canada, where the therapy will be marketed under the brand name Sohonos. 24 January 2022
Thousands of Hungarian patients may have better life prospects after a decision was made again to include new therapies to the social security subsidy system following a two-year pause. As a result, 31 new medicines or indications will now be available under regular subsidy thanks to a regulation published at the end of December. 24 January 2022
In Latin America as with across the globe, the pharmaceutical sector works to consolidate a solid scheme of protection of intellectual property (IP), incentivizing a virtuous ecosystem generating technology and innovation, based on principles of trust and security. 21 January 2022
Global regulators have published a report on the effectiveness of current vaccines against the COVID-19 Omicron variant based on a workshop held under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). 21 January 2022
Russian drugmaker Nanolek continues the production of CoviVac, the vaccine which was developed by the country’s Chumakov Federal Scientific Center, reports The Pharma Letter’s local correspondent. 21 January 2022
Once touted as a potential successor to Merck & Co’s former boss Kenneth Frazier, Frank Clyburn is to leave his post as the company’s executive vice president and president, Human Health, to take up a role elsewhere. 21 January 2022
The Russian government plans to stimulate the level of competition during public procurements of drugs for the domestic market, that will take place through the splitting of purchases and the introduction of limits on the volume of lots during state tenders. 21 January 2022
The European Parliament endorsed the provisional agreement reached with the Council last year on increasing the powers of the European Union’s medicines regulator with 655 votes in favour, 31 against and eight abstentions. 21 January 2022
The equity research team at US financial services firm Morningstar has published the Annual Drug Pipeline report, which looks at the large-cap biopharma groups and their position in the market. 20 January 2022
Japanese drug major Daiichi Sankyo edged up 1.6% to 2,608 yen after it revealed it has entered into an agreement with Cosette Pharmaceuticals, whereby it divested and Cosette acquired rights for manufacturing, commercialization, and certain other rights for the following products in the USA: 20 January 2022
The Russian Direct Investment Fund (RDIF) has revealed the results of a study on the Sputnik V vaccine for COVID-19 and its effectiveness against the Omicron variant. 20 January 2022
Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), today announced the granting of provisional approval for US biotech firm Novavax’ COVID-19 vaccine. 20 January 2022
A positive decision from the European medicine regulator’s scientific panel makes another approval for the vasculitis med Tavneos (avacopan) likely. 20 January 2022
As the European Parliament prepares for the confirmation hearings of the new Commissioners, the Open Trade Coalition is reiterating its call for a bold and open EU trade policy, according to a posting on the European Federation of Pharmaceutical Industries and Associations (EFPIA) website. 18 October 2024
After a couple of negative decisions, the US Food and Drug Administration (FDA) has approved Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). 18 October 2024
Gan & Lee Pharmaceuticals as reported that its three investigational drugs - GZR18, GZR4, and GZR101 - achieved positive results in Phase II diabetes trials. 17 October 2024
A new group of British Members of Parliament (MPs) and peers have written to the Chancellor urging her to protect and promote the UK’s world-leading life sciences sector in the government's first Budget, due on October 30. 17 October 2024
The US Food and Drug Administration (FDA) has updated the US label for French pharma major Sanofi’s Flublok (Influenza Vaccine) to include data from a new safety study involving pregnant women. 17 October 2024
Chengdu Baiyu Pharmaceutical yesterday announced that it has entered into an exclusive license agreement with Swiss pharma giant Novartis for a small molecule anti-tumor asset. 17 October 2024
Shionogi has announced new data at IDWeek 2024 from PROVE (Retrospective Cefiderocol Chart Review), the largest global real-world evidence study of Fetroja/Fetcroja (cefiderocol), an innovative siderophore cephalosporin. 17 October 2024
Sanofi has entered into an agreement with Orano Med, a subsidiary of the Orano Group, to advance the development of radioligand therapies for rare cancers. 17 October 2024
ViiV Healthcare, the specialist HIV company majority owned by GSK, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). 16 October 2024
Jaguar Health today announced the US launch of Gelclair, the only Food and Drug Administration (FDA)-approved mucoadhesive on the market indicated for the management of pain caused by oral mucositis 16 October 2024
Netherlands-based life sciences venture capital firm Forbion has raised more than 2 billion euros ($2.2 billion) across its two newest funds. 16 October 2024
The American Lung Association Research Institute has announced a $22 million research investment in 2024, marking one of the largest lung health research programs in the USA. 16 October 2024
US pharma major Eli Lilly has announced a strategic collaboration with two UK government departments and the devolved nations to tackle significant population health challenges, including exploring new models to better care for people living with obesity. 16 October 2024
TenNor Therapeutics, a Suzhou-based clinical-stage biotech company, has announced the initial closing of a series E financing round, raising over 300 million yuan ($41 million). 16 October 2024
Switzerland-based Novocure saw its shares rise 10% yesterday and leap a further 24% to $22.05 pre-market, after the company received a new US regulatory approval for its key product Optune Lua. 16 October 2024
Shares of Spanish drugmaker PharmaMar leapt more than 28% to 63.70 euros today, after it announced positive clinical trial findings for its combo lung cancer treatment, under development with USA-based Jazz Pharmaceuticals, which rose 4.2%. 15 October 2024
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Company Spotlight
Dewpoint is a biotech company pioneering the application of biomolecular condensate biology – the science studying the organization of biomolecules within membrane-less compartments – towards the development of a new generation of therapeutics to address diseases of high unmet need.