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
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today announced that Dr Thomas Schinecker, chief executive (CEO) of Swiss pharma giant Roche (ROG: SIX), will take up the post as president of the trade association effective January 1, 2025. 26 November 2024
Pharmaceutical
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Pharmaceutical
Shares in US biotech major Amgen were 11% lower early on Tuesday. 26 November 2024
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
Biotechnology
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
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
All news
Generics
As part of an initiative to reduce global dependence on China for the supply of crucial pharmaceutical and active pharmaceutical ingredient (API) requirements, India and the USA have agreed to collaborate on the development of APIs and vaccine materials. 28 June 2023
Pharmaceutical
Research from industry analyst GlobalData suggests that Pfizer’s newly-approved PARP inhibitor-based combo could achieve sales of around $650 million by the end of the decade. 28 June 2023
Pharmaceutical
Adding to strong data released earlier this year form the SKYLIGHT 2 and SKYLIGHT 4 studies, Japanese drug major Astellas today announced positive top-line results from the Phase IIIb DAYLIGHT clinical trial for fezolinetant. 28 June 2023
Pharmaceutical
US pharma giant Pfizer says the US Food and Drug Administration (FDA) has approved Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. 28 June 2023
Biotechnology
US drug major Bristol Myers Squibb’s Sotyktu (deucravacitinib), a once-daily oral tablet, has been recommended for use on the National Health Service (NHS) in England as an option for treating certain adults with moderate to severe plaque psoriasis. 28 June 2023
Pharmaceutical
The UK has recently announced a two-year pilot scheme aimed at tackling obesity, which has become a significant financial burden on the National Health Service (NHS). 28 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), solely due to an ongoing review of inspection findings at a third-party filler. 28 June 2023
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical has announced positive results from a Phase III trial in its home country for brexpiprazole in the treatment of agitation associated with Alzheimer's dementia. 28 June 2023
Biotechnology
German biotech TME Pharma saw its shares rise more than 7% to 1.44 euros in early trading today, as it announced a positive clinical update on the survival of first-line glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, TME Pharma's CXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab. 28 June 2023
Biotechnology
Top-line Phase III data from Bavarian Nordic reflect the difficulties of targeting COVID-19, with a constantly mutating viral threat and an equally changeable regulatory landscape. 28 June 2023
Biotechnology
The Russian biotech company Biocad has begun a Phase III of clinical trial of its new, original drug for the treatment of melanoma, bringing it a step closer to launching a second product for this disease. 28 June 2023
Pharmaceutical
The race to provide obesity treatments on Monday seems have raised the bar, as an experimental weight-loss compound from US pharma major Eli Lilly yielded the strongest results of any treatment seen so far. 27 June 2023
Pharmaceutical
Mounjaro (tirzepatide) has not been recommended in draft guidance issued by the National Institute for Health and Care Excellence (NICE) on Tuesday for treating type 2 diabetes in adults alongside diet and exercise. 27 June 2023
Generics
AstraZeneca has called on the Russian Ministry of Health to change the conditions for registering prices for generics in Russia, as the current rules, according to the company, prevent original drugmakers from participating in public procurements, reports The Pharma Letter’s local correspondent. 27 June 2023
Pharmaceutical
Mid-size French drugmaker Ipsen is hoping to be lucky third time around in its bid to gain US Food and Drug Administration (FDA) approval for palovarotene for the prevention of heterotopic ossification in patients with fibrodysplasia ossificans progressiva (FOP). 27 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B, said US pharma giant Pfizer. 27 June 2023
Biotechnology
A new Pompe disease therapy has been approved by the European Medicines Agency, with Amicus Therapeutics picking up authorization for the enzyme stabilizer Opfolda (miglustat). 27 June 2023
Pharmaceutical
Bristol Myers Squibb has announced that the European Commission (EC) has approved Camzyos (mavacamten) to treat symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM). 27 June 2023
Biotechnology
Shares Avalo Therapeutics plummeted almost 89% to $0.50 by close of trading yesterday, after the US clinical-stage biotech released disappointing clinical trial results asthma candidate. 27 June 2023
Pharmaceutical
China’s National Medical Products Administration (NMPA) has approved Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycemic control, from UK pharma major AstraZeneca. 27 June 2023
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