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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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Pharmaceutical
The US Supreme Court is to hear a challenge from the Biden administration to the settlement agreed by Purdue Pharma that would protect owners the Sackler family from civil lawsuits over their role in the opioid epidemic. 11 August 2023
Biotechnology
Following the approval of toripalimab, the drug is expected to get a first-mover advantage in the first-line treatment setting within the PD-1 market in RCC for China, says data and analytics company GlobalData. 11 August 2023
Biotechnology
USA-based American Gene Technologies International (AGT) and 10X Capital Venture Acquisition Corp III (10X III; (NYSE: VCXB), a special purpose acquisition company (SPAC), have entered into a merger agreement for a business combination that would result in the combined company being a publicly listed company following the business combination to be renamed Addimmune, which is expected to trade under the ticker symbol “HIV”. 11 August 2023
Biotechnology
Building on lessons learned during the coronavirus pandemic, the UK government is to open a major new vaccine research center aimed at combating future threats. 10 August 2023
Pharmaceutical
Danish drugmaker Novo Nordisk is emerging alongside Eli Lilly (NYSE: LLY) as an early frontrunner in the market for obesity treatments. 10 August 2023
Pharmaceutical
Danish drugmaker Novo Nordisk has reported sales in line with expectations at 108 billion Danish krone ($15.98 billion) for the first six months in 2023, up 30% from the same period a year earlier. 10 August 2023
Pharmaceutical
San Diego, USAbased cancer specialist Mirati Therapeutics is to replace its chief executive, David Meek, with former CEO Charles Baum taking over on an interim basis. 10 August 2023
Biotechnology
Anglo-Swedish pharma major AstraZeneca’s research into mRNA vaccines is to be aided by the use of Chinese biotech firm CanSino Biologics' manufacturing platform. 10 August 2023
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday issued a Complete Response Letter (CRL) regarding US drug developer Galera Therapeutics New Drug Application (NDA) for avasopasem manganese for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment. 10 August 2023
Biotechnology
US hearing loss treatment specialist Decibel Therapeutics (Nasdaq: DBTX) saw its share rocket 77% to $4.95 pre-market on Wednesday, on the news that it has agreed to be acquired by US biotech major Regeneron Pharmaceuticals. 10 August 2023
Biotechnology
First granted US accelerated approval in 2020, the Food and Drug Administration on Wednesday converted this to regular approval of Gavreto (pralsetinib) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 10 August 2023
Biotechnology
Positive data for a new kind of medicine, a BTK inhibitor developed by Novartis, could pave the way to improved treatment options for people with chronic spontaneous urticaria. 9 August 2023
Biotechnology
San Diego, USA-based next generation RNA therapeutics company ADARx Pharmaceuticals today revealed it has closed an oversubscribed Series C financing of $200 million. 9 August 2023
Pharmaceutical
Emergent BioSolutions has announced that it is reducing investment in and de-emphasizing focus on growth in its contract development and manufacturing organization (CDMO) services business. 9 August 2023
Biotechnology
The prevalence of non-alcoholic steatohepatitis (NASH), a more advanced stage of nonalcoholic fatty liver disease (NAFLD), continues to increase. 9 August 2023
article
Japanese drug major Astellas Pharma has announced a strategic investment to support the advancement of Poseida Therapeutics’ commitment to redefining cancer cell therapy. The news pushed Poseida’s shares up as much as 24% to $2.69. 9 August 2023
Biotechnology
South Korean vaccine developer SK bioscience’s shares were up 4.6% at 84,500 won, after it announced its decision to make an equity investment of around $85 million in US biotech Novavax. 9 August 2023
Biotechnology
Sino-American biotech Terns Pharmaceuticals yesterday revealed positive top-line results from the Phase IIa DUET clinical trial of TERN-501, both alone and in combination with TERN-101, for the treatment of non-alcoholic steatohepatitis (NASH). 9 August 2023
Pharmaceutical
The competition to address two areas of huge unmet medical need is heating up, and Eli Lilly has a chance of being the leader in both. 8 August 2023
Pharmaceutical
Germany’s Bayer might have a new chief executive in Bill Anderson, but many of the challenges faced by his predecessor Werner Baumann remain. 8 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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