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Generics
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
Generics
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
Pharmaceutical
Switzerland-based Idorsia today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aprocitentan, the firm’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with difficult-to-control hypertension. 20 December 2022
Generics
In what could well be India's biggest pharma deal, China's Fosun Pharma-owned Gland Pharma is on the block. A number of private equity firms have been approached, including Baring Private Equity, Bain Capital, Blackstone, Carlyle, and KKR. 19 December 2022
Pharmaceutical
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted eight to three that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction (HFrEF). 14 December 2022
Pharmaceutical
Drugmakers Novo Nordisk, Daiichi-Sankyo, Lundbeck, AstraZeneca, UCB and Biogen have been named and shamed by the UK pharma trade group. 12 December 2022
Pharmaceutical
US pharma company Esperion has presented compelling new data on its cholesterol drug Nexletol (bempedoic acid). 8 December 2022
Biotechnology
Just a week after securing an historic US approval for its one-time hemophilia B treatment, Hemgenix (etranacogene dezaparvovec-drlb), Dutch gene therapy company uniQure has less positive news to announce. 30 November 2022
Pharmaceutical
A Phase II miss for CinCor Pharma has sent the firm’s stock falling precipitously. Shares are now changing hands for around $14, 45% lower than last week. 29 November 2022
Biotechnology
US pharma giant Merck & Co has recently presented positive top-line results from the Phase III STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc fusion protein being evaluated as an add-on to stable background therapy for pulmonary arterial hypertension (PAH). 21 November 2022
Biotechnology
Novartis has presented new data on Leqvio (inclisiran), an siRNA product approved in primary hyperlipidemia as an adjunct to diet and maximally tolerated statin therapy to reduce low-density lipoprotein cholesterol (LDL-C). 8 November 2022
Pharmaceutical
Continued growth in the giant and growing market for heart failure treatments looks assured for British pharma major AstraZeneca, with more positive data for its glucose lowering blockbuster Farxiga (dapagliflozin). 8 November 2022
Pharmaceutical
US drug developer Ionis Pharmaceuticals saw its shares close down 8.5% at $40.98 on Friday, after it revealed that its licensing partner, Germany’s Bayer, had pulled out of a deal for the development of fesomersen. 5 November 2022
Pharmaceutical
Privately-held German drugmaker Boehringer Ingelheim has appointed a new chief medical officer, Lykke Hinsch Gylvin. 4 November 2022
Biotechnology
US biotech major Amgen reported its quarterly financial results late Thursday. 4 November 2022
Biotechnology
Australia’s CSL Limited has sought to shed light on the promise of its pipeline at its annual R&D investor briefing. 3 November 2022
Biotechnology
Shares of French biotech Quantum Genomics were decimated on Friday after its revealed efficacy results for firibastat in its Phase III study FRESH in treatment-resistant hypertension (TRH), are non-significant versus placebo. The stock plunged 90% to 0.33 euros. 31 October 2022
Biotechnology
Australia’s largest biotech CSL Limited today revealed it has entered into a strategic option and license agreement with Arizona, USA-based Translational Sciences for rights to its enhanced thrombus (blood clot) dissolving drug candidate, TS23. 26 October 2022
Pharmaceutical
Sales and income were both down at Swiss pharma giant Novartis for the third quarter of 2022, with the company missing analyst estimates on both measures. 25 October 2022
Biotechnology
Among important research news last week, US pharma giant Merck & Co released positive Phase III results for the pulmonary arterial hypertension (PAH) candidate sotatercept, validating its $11.5 billion acquisition of Acceleron last year. Also, Sino-American biotech BeiGene announced new Phase III showing that its blood cancers drug Brukinsa scored superiority to Johnson & Johnson’s Imbruvica in chronic lymphocytic leukemia (CLL). After several delays, the US Food and Drug Administration (FDA) has at last approved scPharmaceuticals at-home heart failure treatment Furosix. Last week Merck & Co also excercised its option to jointly develop Moderna’s personalized cancer vaccine mRNA-4157. 17 October 2022
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Biotechnology
Anthos Therapeutics has presented data at the American Heart Association (AHA) Scientific Sessions from its landmark AZALEA-TIMI 71 study showing that abelacimab led to consistent and substantial reductions in bleeding for patients on or off antiplatelet (APT) therapy, compared to rivaroxaban. 18 November 2024
Pharmaceutical
Life science investors can be divided into two groups: those who bought Novo Nordisk stock before GLP-1s hit the big time, and those who wish they had. 10 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Biotechnology
Ascendis Pharma has granted fellow Denmark-based Novo Nordisk an exclusive worldwide license to the TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary products in metabolic diseases (including obesity and type 2 diabetes) and a product-by-product exclusive license in cardiovascular diseases. 4 November 2024
Pharmaceutical
Swiss pharma giant Novartis revealed rising sales and earnings in its third-quarter financial results on Tuesday. 29 October 2024
Pharmaceutical
Denmark-based Novo Nordisk’s oral semaglutide, marketed as Rybelsus for type 2 diabetes, has not gained much presence in the GLP-1 receptor agonists (GLP-1RAs) market despite its approval in 2019, as its injectable alternatives prove to have higher efficacy and results both in diabetes and obesity patients. 28 October 2024
Pharmaceutical
Germany’s Bayer has entered into an exclusive licensing agreement with privately-held Dewpoint Therapeutics for a heart disease program to treat dilated cardiomyopathy (DCM) patients, who are characterized through carrying specific mutations. 25 October 2024
Pharmaceutical
Philadelphia, USA-based SERB Pharmaceuticals has announced the acquisition of Aurlumyn (iloprost), the only FDA-approved treatment for severe frostbite in the USA. 22 October 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). 22 October 2024
Pharmaceutical
Novo Nordisk today announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomized trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). 21 October 2024
Generics
Lexicon Pharmaceuticals announced that Viatris has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the USA and Europe in all indications. 18 October 2024
Pharmaceutical
Johnson & Johnson has reported revenue of $22.5 billion for the third quarter of 2024, a 5.2% increase year-over-year. 15 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Pharmaceutical
Cardiopulmonary diseases specialist Liquidia Corporation closed Monday’s trading 11% higher following a favorable court ruling. 8 October 2024
Pharmaceutical
AstraZeneca has entered into an exclusive license agreement with China’s CSPC Pharmaceutical to advance the development of an early stage, novel small molecule lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidemia. 7 October 2024
Pharmaceutical
Privately-held metabolic health specialist Rivus Pharmaceuticals has announced new clinical data from the Phase IIa HuMAIN study of HU6 in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) 1 October 2024
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