Latest Pharma and Biotech News
Pharmaceutical
7 January 2025 Unquestionably, US drugmaker Vertex Pharmaceuticals is the dominant drug developer in the cystic fibrosis (CF) space.
How has the company achieved this — on the R&D and patient access side — and what is the company doing to help the remaining patients? Vertex’s Andrew Wilfin, Senior Country Medical Director, UK and Ireland, took part in a Q&A with The Pharma Letter to reveal all.
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Pharmaceutical
Metsera today announced positive data from a 12-week Phase IIa clinical trial of MET-097i, its potential once-monthly, ultra-long acting, subcutaneously injectable, fully-biased, GLP-1 receptor agonist (RA). 7 January 2025
Pharmaceutical
Central nervous system (CNS) specialist Neuraxpharm Group has acquired Provigil (modafinil) and Nuvigil (armodafinil), both of which are indicated for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy. 7 January 2025
Pharmaceutical
Japan-based FUSO Pharmaceutical Industries and Australia’s Dimerix Limited have entered into an exclusive development and license agreement for the development and commercialization of Dimerix’ Phase III drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease in Japan. 7 January 2025
Pharmaceutical
The heart failure market is projected to grow at a compound annual growth rate of 9.6% over the next decade, increasing from $13.5 billion in 2022 to $33.7 billion in 2032 across seven major markets, according to a report from analytics firm GlobalData. 7 January 2025
Pharmaceutical
A late-stage trial failure has dented Denali Therapeutics stock, with an announcement Monday revealing the HEALEY ALS study missed all endpoints. 7 January 2025
Pharmaceutical
Unquestionably, US drugmaker Vertex Pharmaceuticals is the dominant drug developer in the cystic fibrosis (CF) space.
How has the company achieved this — on the R&D and patient access side — and what is the company doing to help the remaining patients? Vertex’s Andrew Wilfin, Senior Country Medical Director, UK and Ireland, took part in a Q&A with The Pharma Letter to reveal all. 7 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. 7 January 2025
Pharmaceutical
Sentynl Therapeutics, wholly owned by Zydus Lifesciences, has announced that the US Food and Drug Administration has accepted its New Drug Application for CUTX-101, a potential first treatment for Menkes disease. The application has been granted priority review, with a target action date set for June 30, 2025. 7 January 2025
Pharmaceutical
rug Administration (FDA) approved an update to the US Prescribing Information (USPI) for Pyrukynd (mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, Agios Pharmaceutical revealed in a Security and Exchange Commission (SEC) notice. 7 January 2025
Pharmaceutical
A team of Chinese researchers has identified a promising candidate for glaucoma treatment using artificial intelligence tools. 6 January 2025
Pharmaceutical
Patrick Branch, head of Japan and APAC business development at Nxera Pharma,
Japan’s most innovative and nimble biopharma company, provides a summary of the year in the important eastern market. 6 January 2025
Pharmaceutical
Immedica Pharma, a Swedish company specializing in rare diseases, has announced its acquisition of Marinus Pharmaceuticals in a deal valued at $151 million. The agreement, finalized through a cash tender offer, marks a significant expansion of Immedica’s presence in the US market. 6 January 2025
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca has announced that new, positive, long-term results from the pivotal ALPHA Phase III trial have appeared in the journal Blood, which is published by the American Society of Hematology. 6 January 2025
Pharmaceutical
Alon Natanson, a business leader and alumnus of the Hebrew University of Jerusalem, has been appointed chief executive officer (CEO) of Yissum, the Israeli Hebrew University Tech Transfer company. 6 January 2025
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for the hereditary angioedema(HAE) drug candidate donidalorsen. 6 January 2025
Pharmaceutical
Switzerland’s Santhera Pharmaceuticals has entered an exclusive deal with Clinigen Group to manage the supply and distribution of Agamree (vamorolone) in regions where the drug is not yet commercially available. 6 January 2025
Pharmaceutical
Full mergers and acquisitions in the pharmaceutical and biotechnology in 2024 fluctuated throughout the year with hardly any in some months and a significant number in other. But one thing was clear – buyers were shying away from big bets on commercially ready medicines in favor of earlier stage drug developers. 3 January 2025
Pharmaceutical
Regeneron Pharmaceuticals has acquired UK-based biotech Oxular, enhancing its gene therapy development program with the firm’s specialized ocular delivery tech. 3 January 2025
Pharmaceutical
One of the most promising areas of medical innovation in the next five years is immuno-oncology (I-O)/cancer therapeutics represent, fundamentally transforming how cancer is treated. 3 January 2025
Pharmaceutical
Massachusetts, USA-based based brain disease biotech Neumora Therapeutics shares tumbled 81.4% to 1.97 after it revealed that its experimental depression treatment failed in the first of three studies planned by the biotech company. 3 January 2025
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Pharmaceutical
Swedish exports of pharmaceuticals reached a peak of 152.2 billion kronor (~$15 billion), which corresponds to 7.3% of the country’s total export value, and means an almost 10% p increase since 2022. 14 March 2024
Pharmaceutical
Two privately-held American firms, Allumiqs and Prolytix, have announced a long-term, strategic partnership focused on: “optimizing drug development pipelines.” 13 March 2024
Pharmaceutical
A private share placement should see Regulus Therapeutics swell its coffers by around $100 million. 13 March 2024
Pharmaceutical
Spanish dermatology giant Almirall has entered into an agreement with USA-based Eloxx Pharmaceuticals related to the asset ZKN-013. 13 March 2024
Pharmaceutical
Pfizer has won European Commission (EC) approval for Prevenar 20 for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in children aged from six weeks to less than 18 years. 13 March 2024
Pharmaceutical
French hearing specialist Sensorion has announced that a Phase IIa trial of SENS-401 has met its primary efficacy endpoint. 12 March 2024
Pharmaceutical
Following discussions with the US regulator, Texan drugmaker Lexicon Pharmaceuticals now plans to resubmit a New Drug Application (NDA) for sotagliflozin. 12 March 2024
Pharmaceutical
New Zealander Guy Oliver has left his role as Ipsen’s general manager for the UK and Ireland, to take up the same position at Bristol Myers Squibb. 12 March 2024
Pharmaceutical
USA-based rare disease company Applied Therapeutics closed nearly 9% lower after Monday’s trading. 12 March 2024
Pharmaceutical
Swiss drugmaker Basilea Pharmaceutica announced yesterday that the continued strong sales performance of the antifungal Cresemba (isavuconazole) by its license partner Pfizer in the Asia Pacific region and China exceeded the sales threshold triggering a $1.25 million milestone payment. 12 March 2024
Pharmaceutical
Shares in San Diego, USA-based Acadia Pharmaceuticals fell around 20% ahead of the opening bell on Tuesday, following poor results from the ADVANCE-2 trial. 12 March 2024
Pharmaceutical
USA-based Viatris said in a website posting that it has been informed by its partner, Israel-based Mapi Pharma, that it has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40mg from the US Food and Drug Administration (FDA). 12 March 2024
Pharmaceutical
Danish firm Novo Nordisk has announced positive results from the kidney outcomes trial FLOW, in which Ozempic (semaglutide) 1mg reduced the risk of kidney disease progression and the risk of kidney and cardiovascular deaths by 24%. 12 March 2024
Pharmaceutical
A final report for KarXT (xanomeline tartrate/trospium chloride) has been published by influential US pricing watchdog The Institute for Clinical and Economic Review (ICER). 12 March 2024
Pharmaceutical
India's Department of Pharmaceuticals introduced the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme aimed at enhancing the technological prowess of the country's pharmaceutical sector to meet global standards. 12 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. 12 March 2024
Pharmaceutical
On Monday, the US Food and Drug Administration (FDA) issued a revised draft guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. 12 March 2024
Pharmaceutical
Israel-based RedHill Biopharma has announced the issuance of a new US patent related to Talicia (omeprazole/amoxicillin/rifabutin). 11 March 2024
Pharmaceutical
The ACTION3 Phase III trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) was successful in the pre-specified interim analysis of the proteinuria (efficacy) endpoint from the trial’s first 72 randomized patients, Melbourne, Australia-based Dimerix Limited revealed today. 11 March 2024
Pharmaceutical
In a new report, The World Health Organization (WHO) has warned of growing resistance to certain HIV medications, while the overall picture on combating the disease remains positive. 11 March 2024
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