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.
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
Novartis has discontinued an early Phase II trial of LTP001 in idiopathic pulmonary fibrosis (IPF). The company confirmed that the decision was not related to safety, with no issues emerging in the study. 15 October 2024
The US Biotechnology Innovation Organization (BIO) has signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to the ‘morning after’ abortion pill mifepristone (marketed under the trade name Mifeprex) that would create regulatory barriers and potentially upend the US Food and Drug Administration’s (FDA) authority to approve life-saving and life-enhancing therapies to patients. 13 April 2023
US medicines cost watchdog the Institute for Clinical and Economic Review (ICER) has posted a Protocol outlining how it will conduct its third annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards. 13 April 2023
A newly-published cost effectiveness analysis for Tarpeyo (budesonide) could help developer Calliditas Therapeutics increase sales in the USA, where the therapy was approved at the end of 2021. 12 April 2023
India’s Delhi High Court has refused to grant an interim injunction to German family-owned pharma major Boehringer Ingelheim in patent litigation concerning its patent-protected diabetes drug linagliptin, which is marketed under the brand names Trajenta and Trajenta Duo. 12 April 2023
Australian drug developer Paradigm Biopharmaceuticals (ASX PAR) saw its shares gain 4% to A$1.27 in early trading, as it announced that analysis of six-month trial data shows injectable pentosan polysulfate sodium (iPPS) may slow the progression of osteoarthritis of the knee. 11 April 2023
US pharma major Eli Lilly has become the second American drugmaker, after Bristol-Myers Squibb, that has decided to exit the Russian market, reports The Pharma Letter’s local correspondent. 11 April 2023
Pharma manufacturers will be challenged by the effects of high inflation and declining US Food and Drug Administration (FDA) drug approvals in 2023. 11 April 2023
China’s National Medical Products Administration (NMPA) has announced that China will downgrade its COVID-19 insurance reimbursement management level to a Class B infectious disease in line with its management of the disease starting Saturday, April 8. 11 April 2023
A Texas federal judge on Friday ruled that the US Food and Drug Administration (FDA) "stonewalled judicial review" of its decades-old approval of the ‘morning after’ abortion pill mifepristone (marketed by Danco Laboratories under the trade name Mifeprex) and agreed to stay the effective date of the drug's approval. 11 April 2023
The US Food and Drug Administration announced the final decision to withdraw approval of Makena (hydroxyprogesterone caproate injection) - a drug that had been approved under the accelerated approval pathway and marketed by privately-held Swiss drugmaker Covis Pharma. 7 April 2023
There have been huge changes in the way highly regulated markets operate in recent years – caused by new regulations, technologies and demands. 6 April 2023
In what is being seen as a double blow to UK pharma major AstraZeneca's non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib mesylate), the Indian Patent Office has granted a patent to the National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, for its nano-formulation of drug osimertinib mesylate. 6 April 2023
US immunology focussed biotech Immunic saw its shares soar more than 23% to $1.80 in early trading today, as it reported positive data from the maintenance phase of its Phase IIb CALDOSE-1 trial of its lead asset, vidofludimus calcium (IMU-838), in patients with moderate-to-severe ulcerative colitis (UC). 5 April 2023
UK-based iron deficiency specialist Shield Therapeutics today revealed that Andy Hurley will be joining the firm’s executive team as chief commercial officer (CCO), effective April 10, 2023. 5 April 2023
The value of treatments for obesity is set to grow considerably in the next decade, with industry analyst GlobalData forecasting a market value of around $37 billion by 2031. 5 April 2023
A Citizen Petition (CP) has been filed on behalf of Swiss biotech Idorsia Pharmaceuticals, urging the USA’s Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data. 5 April 2023
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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.