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
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
All news
Biosimilars
South Korea’s Samsung Bioepis and USA-based Organon have announced the interchangeable result of its Humira (adalimumab) biosimilar, SB5, based on a recently conducted Phase IV study. 3 August 2023
Biotechnology
US precision genetic rare diseases specialist Sarepta Therapeutics yesterday reported financial results for the second quarter 2023. 3 August 2023
Biotechnology
Switzerland-based biologics contract development and manufacturing organization (CDMO), Celonic Group has appointed Dr Samantha Cimitan as chief executive. 3 August 2023
Generics
Israeli generics giant Teva Pharmaceutical Industries made stock market gains of around 12% during Wednesday morning’s trading. 2 August 2023
Biotechnology
Japanese companies have been slow to progress COVID-19 vaccines, but today Daiichi Sankyo announced that it has received approval for the manufacturing and marketing of Daichirona for Intramuscular Injection (DS-5670). 2 August 2023
Biotechnology
US biotech Seagen, the subject of a $43 billion takeover by US pharma giant Pfizer, today reported financial results for the second quarter ended June 30, 2023, highlighting record net product sales, with significant year-over-year growth of 26% to $544 million 2 August 2023
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has issued a draft Appraisal Consultation Document recommending against CSL Behring’s Hemgenix (etranacogene dezaparvovec) for severe and moderately severe hemophilia B (congenital factor IX deficiency) patients without a history of Factor IX (FIX) inhibitors. 2 August 2023
Pharmaceutical
German family-owned drugmaker Grünenthal and Japan’s Kyowa Kiron today announced the successful completion of a deal to enter into a joint venture collaboration for Kyowa Kirin International's established medicines portfolio. 2 August 2023
Biosimilars
The end of exclusivity for AbbVie’s top-selling biologic Humira (adalimumab) has provided a key test of whether biosimilars are finally ready to deliver on their promise in the US biopharmaceutical market. 2 August 2023
Biotechnology
Dutch rare diseases biotech firm ProQR Therapeutics saw its shares rise 5% to $1.58 yesterday, after it announced an agreement to divest its late-stage ophthalmic assets, sepofarsen and ultevursen, to Laboratoires Théa. 2 August 2023
Pharmaceutical
Shares of UK clinical stage drug development company Evgen Pharma (AIM: EVG) were down more than 8% at 2.94 pence mid-morning, after it revealed that JuvLife Ltd, a division of Juvenescence, has terminated the patent and know-how license agreement for Evgen's Sulforadex sulforaphane stabilization technology. 2 August 2023
Pharmaceutical
US biopharma company Vertex Pharmaceuticals has reported consolidated financial results for the second quarter ended June 30, 2023 and updated its full year 2023 financial guidance. 2 August 2023
Biotechnology
US drugmaker EQRx, founded on the principle of developing and delivering innovative medicines to patients at radically lower prices, saw its share price leap more than 19% to $2.04 by mid-morning (having hit a high of $2.22), on news of a takeover bid. 1 August 2023
Pharmaceutical
While its work on the novel coronavirus swept Pfizer to the top of the world’s largest drugmakers by revenue, the firm must now find a way to manage a precipitous drop in sales, as countries move past the acute phase of the pandemic. 1 August 2023
Pharmaceutical
US pharma giant Merck & Co today announced financial results for the second quarter of 2023 that topped expectations on strong sales of its blockbuster cancer drug Keytruda (pembrolizumab) and HPV vaccine Gardasil. 1 August 2023
Pharmaceutical
Bimervax, the COVID-19 vaccine developed by Spanish company HIPRA Human Health, has today been authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 1 August 2023
Pharmaceutical
Belgian women’s healthcare company Mithra Pharmaceuticals saw its shares gain 13.9% to 1.96 euros, after it revealed it has signed licensing agreement with privately-held Canadian specialty pharma firm Searchlight Pharma for the Canadian rights to Donesta. 1 August 2023
Pharmaceutical
Age-related and autoimmune disease specialist MyMD Pharmaceuticals has announced positive Phase II data for its oral TNF-α inhibitor, MYMD-1. 1 August 2023
Biotechnology
UK-based industry accelerator the Cell and Gene Therapy Catapult (CGT Catapult) today announces that Jeanette Evans has been appointed chief business officer (CBO), taking over from Sharon Brownlow, with effect in August 2023. 1 August 2023
Generics
USA-based generics major Viatris and Kindeva Drug Delivery today announced the launch of Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of AstraZeneca's Symbicort with an Abbreviated New Drug Application (ANDA) approved by the US Food and Drug Administration (FDA). 1 August 2023
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