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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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Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Veopoz (pozelimab-bbfg) injection, a complement inhibitor, for the treatment of adult and pediatric patients aged one year and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease. 19 August 2023
Biotechnology
Flagship Pioneering company Alltrna, which is unlocking transfer RNA (tRNA) biology and pioneering tRNA therapeutics to regulate the protein universe and resolve disease, has appointed Chris Henderson, as chief scientific officer and promoted William (Will) Kiesman, to the post of chief technology officer. 19 August 2023
Pharmaceutical
Although Latin America has a broad portfolio of innovative medicines to treat orphan diseases and cancer, only 13% of patients who would benefit from these therapies have access to them. 18 August 2023
Pharmaceutical
Daewoong Pharmaceutical has already won approvals for its indigenous therapies—sodium–glucose linked transporter-2 (SGLT-2) inhibitor Envlo (enavogliflozin) and its metformin combination drug Envlomet—in South Korea. 18 August 2023
Pharmaceutical
New Jersey, USA-based Merck & Co has reported positive top-line data from a trial of its oral HIF-2α blocker Welireg (belzutifan). 18 August 2023
Generics
There has been a substantial backlash from major pharmaceutical trade associations and companies to the European Commission’s (EC) feedback initiative on the introduction of a pan-European compulsory license, which would allow for the invalidation of existing drug patents across the European Union (EU) in emergency situations. 18 August 2023
Pharmaceutical
The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Danish dermatology specialist LEO Pharma’s delgocitinib cream. 18 August 2023
Biotechnology
US healthcare giant Johnson & Johnson subsidiary Janssen today revealed that the European Commission (EC) has granted the approval of a Type II variation application for Tecvayli (teclistamab). 18 August 2023
Biotechnology
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submitted by US biotech Regeneron Pharmaceuticals for its odronextamab. 18 August 2023
Biotechnology
US biotech Selecta Biosciences is to freeze investment on all pipeline assets except SEL-212, which is being developed for the treatment of chronic refractory gout. 18 August 2023
Pharmaceutical
The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP), an investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), Astellas Pharma announced today. 18 August 2023
Pharmaceutical
Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF, UK Pharma major AstraZeneca announced this morning. 18 August 2023
Pharmaceutical
Across the globe, tense relationships between countries are on the rise. The PwC 25th Annual Global CEO Survey showed that 32% of executives cited geopolitical conflict as a top threat to growth, while 71% said it could inhibit their ability to deliver products or services. 17 August 2023
Pharmaceutical
Humanitarian organization Médecins Sans Frontières/Doctors Without Borders (MSF) revealed today that it has requested ViiV Healthcare to withdraw conditions in negotiations for a purchase agreement for an important HIV treatment. 17 August 2023
Biotechnology
UK-based Ashington Innovation has agreed to acquire in Cell Therapy Limited in a £135 million ($172 million) reverse takeover, resulting in its own shares being suspended from trading in London. 17 August 2023
Biotechnology
US drugmaker AbbVie has won approval from the European Commission (EC) for Aquipta (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month. 17 August 2023
Biotechnology
Massachusetts, USA-based cell therapy specialist Abcuro has raised $155 million in a series B financing round co-led by Redmile Group and Bain Capital Life Sciences. 17 August 2023
Biotechnology
The US Food and Drug Administration (FDA) has told bluebird bio that an advisory committee (AdCom) meeting will not be scheduled for lovotibeglogene autotemcel (lovo-cel). 17 August 2023
Biotechnology
US clinical stage biotech Day One Biopharmaceuticals has entered into an exclusive, global license agreement and research collaboration with Sweden’s Sprint Bioscience for rights to the latter’s VRK1 program. 17 August 2023
Pharmaceutical
The USA’s Fifth Circuit Court of Appeals on Wednesday rejected an extraordinary decision blocking the US Food and Drug Administration's (FDA) decades-old approval of the widely used abortion medication mifepristone, but also upheld the decision's reinstatement of restrictions on access to the medication. 17 August 2023
All news
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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