Latest Pharma and Biotech News
Pharmaceutical
25 November 2024 In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards.
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Biotechnology
French drugmaker Ipsen has won a landmark US approval of Sohonos (palovarotene) for an ultra-rare bone disease, having been rebuffed last month in its efforts to do so in Europe. 17 August 2023
Pharmaceutical
Translational science is intended to bring predictivity and efficacy to the development and dissemination of interventions that improve human health, turning science discoveries into therapeutic applications.1 17 August 2023
Pharmaceutical
A new report from British market research firm Deep Pharma Intelligence provides a profile of the use of artificial intelligence in the drug discovery industry. 17 August 2023
Generics
The UK’s Competition and Markets Authority (CMA) has welcomed the landmark judgment, which endorses all the main elements of the CMA’s decision in respect of liothyronine tablets – an essential medicine to treat thyroid hormone deficiency. 17 August 2023
Biotechnology
Privately-held drugmaker Chiesi has secured approval from the British medicines regulator for Elfabrio (pegunigalsidase alfa) in Fabry disease (FD). 16 August 2023
Biotechnology
US biotech Seagen has revealed results from the Phase III HER2CLIMB-02 clinical trial of Tukysa (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Roche’s Kadcyla), showing that it met its primary endpoint of progression-free survival (PFS). 16 August 2023
Biotechnology
Singapore-listed healthcare company Medi Lifestyle has announced a collaboration involving its subsidiaries, HealthPro Pharma and Healthpro Marketing, with FIOR Bioscience and Shine Bioscience. 16 August 2023
Biotechnology
The US Food and Drug Administration (FDA) has a revised Prescription Drug User Fee Act (PDUFA) action date from August to November 2023 for French company Valneva’s chikungunya vaccine. 16 August 2023
Pharmaceutical
Chiesi Global Rare Diseases, a business unit of privately-held Italian drugmaker Chiesi Farmaceutici established to deliver innovative therapies and solutions for people living with rare diseases, has announced a co-development agreement with Aliada Therapeutics. 16 August 2023
Pharmaceutical
According to the official website of the China State Drug Administration the application for marketing authorization of Feisumei (benaglutide) injection for obesity or overweight indications declared by Benemae Pharmaceuticals/Renhui Biotech was approved for weight management of adults. 16 August 2023
Pharmaceutical
Danish CNS specialist Lundbeck has announced a 13% rise in its revenue for the first half of the year. 16 August 2023
Biotechnology
US-incorporated clinical-stage biotech Galecto saw its shares close down more than 71% at $0.67 yesterday, after it revealed disappointing clinical trial results for a lead investigational drug. 16 August 2023
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval to Elrexfio (elranatamab-bcmm). 15 August 2023
Biotechnology
US biotech major Gilead Sciences has entered into three, multi-year, collaborations with San Diego-based start-up Tentarix Biotherapeutics. 15 August 2023
Generics
STADA Arzneimittel announced impressive sales growth for the first half of 2023 on Tuesday. 15 August 2023
Biotechnology
US rare diseases focused biotech Amicus Therapeutics today revealed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for adults living with late-onset Pompe disease (acid α glucosidase [GAA] deficiency). 15 August 2023
Biotechnology
Shares of Australia’ leading biotech firm CSL Limited closed with a 3.7% rise at A$272.80 today as it posted financial results for the full year ended June 2023. 15 August 2023
Pharmaceutical
Swedish biopharma Calliditas Therapeutics continues to press for full approval of Nefecon/Tarpeyo (budesonide) delayed release capsules/Kinpeygo. 15 August 2023
Biotechnology
US biotech Cytokinetics is seeking to develop medicines that treat cardiovascular and neuromuscular diseases of impaired muscle function. 15 August 2023
Pharmaceutical
US developer of rare neurological drugs Harmony Biosciences on Monday revealed it has reached a definitive agreement to acquire Zynerba Pharmaceuticals
. 15 August 2023
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Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
Biotechnology
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Biotechnology
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Pharmaceutical
Spanish HIV focused immunotherapies company AELIX Therapeutics, a spin-off of IrisCaixa, has announced the acquisition of its investigational assets related to the HTI therapeutic HIV vaccine by US antiviral specialist Gilead Sciences. 26 November 2024
Biotechnology
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Pharmaceutical
Positive top-line results from the Phase III ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality, were released today by US pharma giant Merck & Co. 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Pharmaceutical
Specialist pre-clinical contract research organization (CRO) and ion channel screening company Metrion Biosciences has announced the appointment of Lee Patterson as its new chief executive. 25 November 2024
Pharmaceutical
Levothyroxine, a widely prescribed treatment for hypothyroidism, may contribute to bone loss in older adults, according to new research presented at the Radiological Society of North America’s (RSNA) annual meeting. 25 November 2024
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Biotechnology
A patient in Neurogene’s ongoing Phase I/II trial for Rett syndrome—who was dosed on November 5 with 3E15 vg of NGN-401—has now died from a treatment-related serious adverse event (SAE). 25 November 2024
Generics
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
UK pharma major AstraZeneca today released positive high-level results from the CAPItello-281 Phase III trial showing that its Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT). 25 November 2024
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