Latest Pharma and Biotech News
Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
Today's issue
Refine Search
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Pharmaceutical
Swiss drugmaker Idorsia was trading more than 10% higher by lunchtime on Wednesday. Idorsia earlier announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. 27 November 2024
Biosimilars
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
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
All news
Biotechnology
Shares of US biotech Cidara Therapeutics rose almost 20% to $1.81 in early trading as the company announced promising efficacy and safety data from a planned interim analysis of the ongoing Phase IIa trial evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain, as of a February 13, 2023 data cut-off. 1 March 2023
Pharmaceutical
Eager to boost the development of orphan drugs to treat rare diseases in India, the government is looking to offer incentives to drug companies in terms of faster approvals and extended periods of exclusivity. 1 March 2023
Biotechnology
Antibody-drug conjugate (ADC) company ImmunoGen is to license its technology to Vertex Pharmaceuticals. 1 March 2023
Pharmaceutical
The European Commission has granted marketing authorization for Nubeqa (darolutamide) alongside androgen deprivation therapy in combination with docetaxel, to treat metastatic hormone-sensitive prostate cancer (mHSPC). 1 March 2023
Biotechnology
Shanghai Junshi Biosciences had more positive news, this time on its monoclonal antibody (MAb) candidate ongericimab, adding to the successful trials results for its toripalimab in breast cancer last week. 1 March 2023
Biotechnology
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) yesterday voted that available data is adequate to support the safety and effectiveness of the respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF, from US pharma giant Pfizer. 1 March 2023
Biotechnology
Two late-stage trials testing Merck & Co’s class-leading immunotherapy Keytruda (pembrolizumab) have been discontinued. 1 March 2023
Biotechnology
In a second financing within one year, China-based Oricell Therapeutics has announced the close of a $45 million Series B1 investment round. This adds to the $125 million Series B fund that was raised in July 2022. 1 March 2023
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI) has attempted to show that there is a better way than the existing Voluntary Pricing and Access Scheme (VPAS). 1 March 2023
Generics
US generic drug-focussed drugmaker Viatris has announced that, as it prepares to enter Phase 2 of its previously revealed strategic plan in 2024, the appointment of pharma veteran Scott Smith to lead the execution of that plan as Viatris' new chief executive (CEO), effective April 1, 2023. 28 February 2023
Pharmaceutical
Werner Baumann, chairman of the board of management at the German life sciences major Bayer, presented his final set of annual financial results on Tuesday. 28 February 2023
Biotechnology
US precision medicines company Frontier Medicines today announced the addition of Christo Shalish to the leadership team as senior vice president (SVP) and head of business development. 28 February 2023
Biotechnology
Sino-American biotech BeiGene yesterday reported financial results, showing that revenues for the fourth quarter and full year 2022 was $380.1 million, missing consensus estimates of $345 million by 2%, and $1.4 billion, respectively, compared to $214.0 million and $1.2 billion in the prior-year periods. 28 February 2023
Pharmaceutical
New York-based central nervous system (CNS) specialist Axsome Therapeutics has hit a regulatory snag in the development of AXS-05 (dextromethorphan/bupropion). 28 February 2023
Biotechnology
The Biologics License Application (BLA) for Leqembi (lecanemab), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. 28 February 2023
Biotechnology
US CNS specialist Aptinyx saw its shares plunge more than 56% to $0.26, after it released Phase II clinical study results evaluating the effects of NYX-458 in patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies. 28 February 2023
Pharmaceutical
Russia may be facing a shortage of erectile dysfunction drug Viagra (sildenafil) – once the best-selling medicine in the country- due to the recent announcement by the USA’s Viatris about the suspension of supplies to the drug to the Russian market. 28 February 2023
Biotechnology
The Dutch business of Rhythm Pharmaceuticals has acquired Xinvento, a Netherlands-based biotech focused on therapies for congenital hyperinsulinism (CHI). 27 February 2023
Biosimilars
The need to guarantee a new regulatory category for ‘value-added medicines’ has been proposed by the Asociación Española de Medicamentos Genéricos (AESEG), the Spanish trade group representing generic and biosimilar medicine manufacturers. 27 February 2023
Pharmaceutical
Even as the US Food and Drug Administration’s (FDA) director of drug quality Carmelo Rosa recently emphasized the need for Indian pharmaceutical companies to continually strive to manufacture drugs of the highest quality, both domestically and internationally, the Indian government has gone into overdrive to ensure that the impeccable standards of its regulatory mechanisms can be maintained over the long-term, reports The Pharma Letter’s India correspondent. 27 February 2023
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze