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.
Responding to the urgent public health needs of the most vulnerable and ensuring its ‘experiment in innovation’ bears fruit depend entirely on the dedication, commitment, and resolve of its partners, supporters, and staff, said Drugs for Neglected Diseases initiative (DNDi). 15 July 2022
In the USA, a new approval for Xalkori (crizotinib) will extend the first-generation ALK inhibitor’s use to include certain people with myofibroblastic tumors. 15 July 2022
The US Food and Drug Administration yesterday issued a final guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format.” 15 July 2022
Shares of US drug developer Theravance Biopharma were up more than 17% at $10.14 pre-market, following the announcement late Wednesday that it has entered into a definitive agreement to sell all of its units in Theravance Respiratory Company, representing its 85% economic interest in the sales-based royalty rights on worldwide net sales of UK pharma major GSK's (LSE: GSK) Trelegy (fluticasone furoate/ umeclidinium/vilanterol) Ellipta to Royalty Pharma. 14 July 2022
Family-owned drugmaker Grünenthal today announced an agreement with fellow Germany-based Bayer to acquire Nebido, a long-acting depot preparation of testosterone undecanoate and a well-known brand for the treatment of male hypogonadism, and its associated brands. 14 July 2022
SIGA Technologies saw its shares gain almost 8% to $14.05 today, after it announced around $28 million of procurement orders for oral TPOXX (tecovirimat). 13 July 2022
South Korean firm SK bioscience has announced that SKYCovione, the Asian country’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, has been authorized by the Korean Ministry of Food and Drug Safety. 13 July 2022
Shares of Finnish drugmaker Orion Corporation jumped 7.6% to 47.60 euros by mid-morning, as it announced an important collaboration with US pharma giant Merck & Co. 13 July 2022
Early research conducted at the University of Birmingham, UK, shows that the novel ATM blocker AZD1390 can promote regeneration of damaged nerve cells, potentially restoring sensory and motor function after a spinal injury. 12 July 2022
As part of its efforts to keep up with changing technologies and to eliminate obsolete laws and regulations, the Indian government has unveiled a draft of the New Drugs, Medical Devices, and Cosmetics Bill 2022. 12 July 2022
The European Medicines Agency (EMA) has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorization applications (MAAs) for new medicines as well as post-authorization applications and to explore the practical aspects of the submission and analysis of such data. 12 July 2022
The pandemic revolutionized data collection and patient engagement in clinical trials. Although the life sciences industry has been historically cautious to adopt emerging technology trends, the sudden shutdown of in-person trial sites in adherence to safety protocols left sponsors and researchers with no choice but to adapt with more agile tools for remote data collection. 12 July 2022
New-York, USA-based Inspirna, a clinical stage biopharmaceutical company developing first-in-class small molecule therapeutics, has raised $50 million in a Series D financing round, co-led by new investors Sands Capital and Vivo Capital, with additional participation from new investor Dreavent 6. 12 July 2022
US drugmaker Vertex Pharmaceuticals (Nasdaq: VRTX) yesterday announced that the company has entered into a definitive agreement under to acquire ViaCyte, a privately held biotechnology company focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320 million in cash. 12 July 2022
German central nervous system (CNS) specialist Neuraxpharm is to buy two product portfolios within its main therapeutic focus area from French vaccines major Sanofi. 12 July 2022
US drugmaker La Jolla Pharmaceuticals Company saw its shares rocket 81.7% to $6.16 in early trading, after it was revealed that it has received a takeover approach from Innoviva. 11 July 2022
Shares of Dublin, Ireland-incorporated Perrigo Company were up 2.2% at $42.00 pre-market today, after it announced that its subsidiary HRA Pharma has submitted its application to the US Food and Drug Administration (FDA) for the first-ever over-the-counter (OTC) birth control pill in the USA. 11 July 2022
US pharma giant Merck & Co, known as MSD outside of the USA and Canada, has stopped its supplies of vaccines against chickenpox, rubella, measles and mumps to Russia but will continue sales of its drugs that do not have Russian analogues, reports The Pharma Letter’s local correspondent. 9 July 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.