Japan's Ministry of Health, Labor and Welfare (MHLW) has granted manufacturing and marketing approval for Andembry (garadacimab) subcutaneous (SC) injection 200mg pens, developed by Australia’s CSL Limited and to be marketed by its CSL Behring unit. 21 February 2025
Danish pharma major Novo Nordisk has sued KBP Biosciences and its founder and executive chairman, Huang Zhenhua, for $830 million in an application to the Singapore International Commercial Court. 19 February 2025
Significant research news last week included a setback for Pliant Therapeutics, when it paused a Phase IIb trial of its bexotegrast in idiopathic pulmonary fibrosis (IPP). Also, US biotech AnaptysBio released positive new Phase II data on its rosnilimab in rheumatoid arthritis that attracted attention. On the regulatory front, US drug developer BridgeBio Pharma last week gained European Commission (EC) approval for its Beyonttra (acoramidis) for cardiomyopathy (ARRR-CM). The EC also granted approval for Kostaive, an mRNA COVID-19 vaccine developed by US firm Arcturus Therapeutics and licensed to CSL Limited for European marketing. 16 February 2025
An interview with Bayer's Bernardo Kanahuati, senior vice president, global head cardiorenal and product team lead, Kerendia, and Katja Rohwedder, senior medical affairs physician, global medical affairs heart and kidney. 14 February 2025
The European Commission has granted marketing authorization in the European Union (EU) for acoramidis, under the brand name Beyonttra, for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). 11 February 2025
Novartis today announced that it has entered into an agreement to acquire privately-held Anthos Therapeutics, which the Swiss pharma giant helped launch in 2019, granting it rights to abelacimab, a late-stage medicine in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation. 11 February 2025
Affinia Therapeutics, a US biotech with a pipeline of rationally designed adeno-associated virus (AAV) gene therapies for cardiovascular and neurological diseases, has announced the appointment of Hideo Makimura as its chief medical officer (CMO). 5 February 2025
Russia plans to significantly expand the geography of the export of its drugs this year, paying attention both to emerging nations and developed countries, reports The Pharma Letter’s local correspondent. 3 February 2025
Novartis’ results show the firm humming along nicely in 2024, with sales driven by continued strong performance from its cardiovascular and immunology products. 31 January 2025
US pharma giant Merck & Co today revealed an early stop to the Phase III HYPERION study evaluating Winrevair (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) II or III at intermediate or high risk of disease progression. 30 January 2025
Swiss pharma giant Novartis has expressed its satisfaction at a decision by the US Court of Appeals for the Federal Circuit (CAFC) that affirms the validity of the Entresto (sacubitril/valsartan) combination patent. 14 January 2025
Chinese metabolic diseases specialist Hangzhou Sciwind Biosciences has announced details of a deal with Verdiva Bio for the global development and commercialization of a portfolio of therapies in territories outside of China and South Korea. 10 January 2025
European biotech start-ups Numab Therapeutics and AnaCardio have raised new funding to advance their pipelines, adding positive momentum to the sector at the start of the new year. 10 January 2025
UK headquartered Verdiva Bio Limited today announced its launch as a clinical-stage biopharmaceutical company focused on developing innovative therapies for obesity and other cardiometabolic disorders. 9 January 2025
Denmark’s Novo Nordisk and Valo Health today announced they have entered into an expanded agreement to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease based on Valo’s extensive human dataset and computation powered by artificial intelligence (AI). 8 January 2025
Privately-held US biotech Alloy Therapeutics has announced a target specific collaboration and license agreement for the use of its novel and proprietary anticlastic antisense platform with French pharma major Sanofi for a central nervous system (CNS) target. 8 January 2025
The past year has been a very busy one for privately-held Dewpoint Therapeutics, a Boston firm founded in 2018 that focuses on the application of biomolecular condensate biology towards the development of a new generation of therapeutics to address diseases of high unmet need. 7 January 2025
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued draft guidance, saying that it has not recommended the diabetes drug Jardiance (empagliflozin) for the treatment of adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction for use on the National Health Service (NHS). 8 February 2023
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) to expand the use of Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged two to 6 February 2023
French privately-held pharma company Servier has announced its financial results for the 2021/22 financial year, highlighting the major steps of its ongoing transformation. 3 February 2023
US drugmaker Bristol Myers Squibb was trading 2% higher at lunchtime Thursday after presenting its fourth quarter and full year 2022 financial results. 2 February 2023
US biotech giant Amgen released mixed financial results for the fourth quarter and full year 2022 versus comparable periods in 2021, after markets closed on Monday. 1 February 2023
In a sudden turn of events, Novartis' Entresto (sacubitril/valsartan) patent has been reinstated in India, after a two-judge bench stayed a previous order that invalidated it. 24 January 2023
As a blockbuster heart failure drug by Swiss pharma giant Novartis goes off-patent, several Indian drug majors are rushing to market with their generic applications. The patent loss of Entresto (sacubitril/valsartan) has brought on significant disruptions in India’s cardiology sector. High courtroom drama ensued a few days before the patent loss and had everyone on tenterhooks, reports The Pharma Letter’s India correspondent. 20 January 2023
California, USA-based clinical-stage biopharmaceutical company 89bio’s pegazofermin has potential to become one of the major players in the dyslipidemia space if it is successful in Phase III clinical trials, says analyst. 17 January 2023
The cardiomyopathies market in the 68 major world markets (68M) is set to grow from $3.07 billion in 2021 to $9.63 billion in 2031 at a compound annual growth rate (CAGR) of 12.1%. 16 January 2023
The past week kicked off with several M&A deals being announced. The largest of these was by UK pharma major AstraZeneca revealing that is acquiring CinCor Pharma for up to $1.8 billion, with the aim of expanding it cardiorenal portfolio and pipeline as well as blood pressure drug baxdrostat. Also, French drugmaker Ipsen announced a takeover bid for USA-based Albireo in a deal worth almost $1 billion, bringing with it rights to liver disease drug Bylvay. Arecor Therapeutics reached a key milestone in the development of the ready-to-use injectable AT307 in its partnership with Hikma Pharmaceuticals but the latter also returned rights to another candidate, AT282. Privately-held US mRNA specialist Anima Biotech entered into a collaboration with US pharma major AbbVie to develop cancer and immune disorder therapies. 15 January 2023
US neuromuscular and cardiac diseases specialist Solid Biosciences and privately-held Dutch biotech Phlox Therapeutics have announced a strategic collaboration focused on genetic cardiac diseases. 12 January 2023
Research from industry analyst GlobalData finds that western companies are likely to play an important role in providing new cardiovascular disease (CVD) management options in China. 12 January 2023
Presentations from German group Bayer at the JP Morgan Healthcare Conference have rallied investors’ confidence in the company’s mid-term prospects. 11 January 2023
After an active M&A year in 2022, UK pharma major AstraZeneca kicked off 2023 with an agreement to acquire USA-based clinical stage biotech CinCor Pharma. 9 January 2023
A growing number of key starting materials (KSMs) and active pharmaceutical ingredients (APIs) coming into India have become 25% to 35% more expensive as reports of Covid infections spiral out of control in China, squeezing margins and increasing drug prices. The Indian government's production linked incentive (PLI) scheme for the promotion of domestic manufacturing of critical KSMs, drug intermediates (DIs) and APIs is soon set to come to the aid of many domestic players, reports The Pharma Letter’s India correspondent. 29 December 2022
Indian generics major Zydus Lifesciences, formerly known as Cadila Healthcare, subsidiary Zydus Worldwide has received final approval from the US Food and Drug Administration (FDA) to market Selexipag Tablets, 200mcg, 400mcg, 600mcg, 800mcg, 1,000mcg, 1,200mcg, 1,400mcg, and 1,600mcg. 22 December 2022