Latest Pharma and Biotech News
Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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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
All news
Pharmaceutical
Bill Anderson has been named the new chief executive of German life sciences major Bayer. 9 February 2023
Pharmaceutical
From July 1 this year in Australia, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by specifically authorized psychiatrists for the treatment of certain mental health conditions. 9 February 2023
Pharmaceutical
With analysts forecasting revenues to exceed $11 billion, British pharma major AstraZeneca delivered as expected in the final quarter, taking in $11.3 billion, making $44.3 billion for the full year. 9 February 2023
Biosimilars
Icelandic firm Alvotech and marketing partner German drugmaker STADA Arzneimittel today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab). 9 February 2023
Biotechnology
Belgian biotech Galapagos’ shares were down almost 10% at 36.73 euros this morning, after it revealed that top-line Phase III results of its already commercialized JAK inhibitor Jyseleca (filgotinib) fell short in the induction cohorts of a Crohn's disease trial. 9 February 2023
Biotechnology
French drugmaker Sanofi has announced the availability of its new Pompe disease drug Nexviadyme (avalglucosidase alfa) on the UK’s National Health Service (NHS). 8 February 2023
Biotechnology
US neurological diseases specialist Ovid Therapeutics is expanding its medical and development team with the respective appointments of industry veterans, Dr Manoj Malhotra as its chief medical officer (CMO) and Dr Toshiya Nishi as its head of epilepsy research. 8 February 2023
Biotechnology
The European Commission (EC) marketing authorization (MA) that was granted in December to US biotech Atara Biotherapies for Ebvallo (tabelecleucel) has been transferred to privately French drugmaker Pierre Fabre. 8 February 2023
Generics
Teva Pharmaceutical took in $3.9 billion in revenues in the fourth quarter, around what the majority of analysts had forecast, making for annual sales of $14.9 billion. 8 February 2023
Pharmaceutical
Britain’s AstraZeneca has secured a new European approval for heart med Forxiga (dapagliflozin), an innovative medicine known in the USA as Farxiga. 8 February 2023
Pharmaceutical
Relief Therapeutics has decided to voluntarily withdraw its planned initial public offering (IPO), the Swiss biopharma company announced today, when its shares dipped 1%. 8 February 2023
Biotechnology
US biopharma Vertex Pharmaceuticals has reported its fourth-quarter and full-year financial results. 8 February 2023
Biotechnology
Swedish Orphan Biovitrum, also known as Sobi, today released financial results for the fourth-quarter and full-year 2022. 8 February 2023
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued draft guidance, saying that it has not recommended the diabetes drug Jardiance (empagliflozin) for the treatment of adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction for use on the National Health Service (NHS). 8 February 2023
Pharmaceutical
Belgian drug major UCB’s shares were up 2% at 77.70 euros this morning, on the news that Fintepla (fenfluramine) oral solution has been approved by the European Commission for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. 8 February 2023
Generics
The number of clinical trials of drugs in Russia in 2022 significantly declined, according to latest data from the Russian Ministry of Health, reports The Pharma Letter’s local correspondent. 8 February 2023
Biotechnology
Industry analyst GlobalData has released research indicating that sales of COVID-19 vaccines are likely to decline significantly in coming years. 7 February 2023
Biotechnology
Boston, USA-based Garuda Therapeutics, a company creating off-the-shelf, durable blood stem cell-based cellular therapies, is $62 million richer. 7 February 2023
Pharmaceutical
The Russian pharmaceutical market has generally withstood the pressure of sanctions from West, as foreign companies stopped supplying only 8% of drug names to Russia, reports The Pharma Letter’s local correspondent. 7 February 2023
Biosimilars
Róbert Wessman, founder and chairman of Icelandic biosimilars company Alvotech and investment fund Aztiq, offers his vision for affordable global healthcare in an Expert View piece. 7 February 2023
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