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Pharmaceutical
27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
According to a report from industry analyst DelveInsight, the market for Down syndrome treatments in the USA is now valued at almost $250 million. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
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
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Pharmaceutical
California, USA-based Opiant Pharmaceuticals saw its shares skyrocket 111.6% to $20.10 by close of trading yesterday, as it announced a definitive agreement to be acquired by UK drugmaker Indivior. 15 November 2022
Biotechnology
Chinese biotech company Hutchmed is evolving its business strategy, targeting a faster path to profitability amid turbulent economic conditions. 15 November 2022
Pharmaceutical
The demand for insulin in Russia is steadily growing, which provides some opportunities for global majors operating in this market segment, reports The Pharma Letter’s local correspondent. 15 November 2022
Pharmaceutical
An Expert View from Fiona Maini, principal, global compliance and strategy at Medidata Solutions, a Dassault Systèmes company. 14 November 2022
Pharmaceutical
Radiopharmaceuticals company POINT Biopharma has inked a deal with diagnostics specialist Lantheus Holdings, giving the latter exclusive worldwide rights to POINT’s candidates PNT2002 and PNT2003. 14 November 2022
Biotechnology
With the aim of advancing its pipeline of Precision Endocrine Peptides (PEPs) therapeutic candidates to tread a wide array of endocrine disorders, Indiana, USA-based MBX Biosciences today announced the closing of a Series B financing. 14 November 2022
Pharmaceutical
Imophoron, a biopharma developing nanoparticle products that is based in Bristol, UK, has announced the appointment of Richard Bungay as chief executive. 14 November 2022
Pharmaceutical
Positive results have been reported from the Phase III FRUTIGA trial of fruquintinib, a candidate under development by Sino-American cancer specialist Hutchmed, in partnership with Eli Lilly. 14 November 2022
Pharmaceutical
Israel-headquartered clinical-stage diabetes specialist Oramed Pharmaceuticals saw its shares rise as much as 3.3% to $7.82 in early trading, after it revealed signing an exclusive commercial distribution agreement for South Korea with Medicox Co. 14 November 2022
Biotechnology
Swiss pharma giant Roche was trading nearly 4% lower early Monday afternoon. 14 November 2022
Pharmaceutical
Switzerland’s Relief Therapeutics was up 6.5% this morning after it announced definitive settlement agreements with NRx Pharmaceuticals to resolve their pending litigation. 14 November 2022
Pharmaceutical
UK pharma major GSK’s shares closed down 6% at 1,323.60 pence on Friday, as it said that it would only recommend its ovarian-cancer treatment Zejula (niraparib) as a secondary maintenance treatment to a subgroup of patients in the US who carry a specific genetic mutation connected to breast cancer, known as BRCA. 14 November 2022
Pharmaceutical
The European Commission (EC) has granted approval for the marketing authorization application for Livtencity (maribavir) that was submitted by Japan’s largest drugmaker Takeda. 14 November 2022
Pharmaceutical
The Europe biodefense market size is projected to reach a valuation $6.3 billion by 2028, according to a recent study from market research firm Graphical Research. 14 November 2022
Pharmaceutical
Notable research news last week included UK pharma major GSK releasing disappointing Phase III trial results for its already approved multiple myeloma drug Blenrep. Also, French drugmaker Ipsen presented positive new Phase III data on its Onivyde in pancreatic cancer. M&A developments saw significant change of focus for generic drugmaker Viatris, which plans to establish an ophthalmic franchise through the acquisition of Oyster Point Pharma and Famy Life Sciences for around $700-$750 million. Also of note, France’s Sanofi entered into an agreement with artificial intelligence (AI) firm Insilico Medicines, potentially worth $1.2 billion to the latter. 13 November 2022
Pharmaceutical
Following a four to zero vote for the action, the US Federal Trade Commission (FTC) has filed an amicus brief with the US District Court for the District of Delaware in the case of US drugmaker Jazz Pharmaceuticals versus Ireland-incorporated Avadel Pharmaceuticals 12 November 2022
Biosimilars
As with every sector, the biopharmaceutical field has its own lingo—a world of jargon and buzz words that develop alongside industry trends and wider societal changes, some carrying significant meaning and others representing little more than the hype of marketers. 11 November 2022
Biosimilars
Following its November 2022 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four medicines for approval, one a biosimilar, two generics and the other a coronavirus vaccine. 11 November 2022
Biotechnology
A dose of reality appears to have brought about a change at EQRx. 11 November 2022
Biotechnology
Harbour BioMed saw its shares close up 12% at HK$1.30 today, on the news that its subsidiary Nano Biosciences has entered into a license and collaboration agreement with US biotech Moderna, a pioneer of messenger RNA (mRNA) therapeutics and vaccines. 11 November 2022
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