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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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Pharmaceutical
The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to 4.75 years from the time a drug receives approval from global health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), until it is approved by their local authority and is available on the market, writes The Pharma Letter's local correspondent. 28 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Pharmaceutical
Munich, Germany headquartered contract development and manufacturing organization (CDMO) Adragos Pharma has acquired Baccinex, a Swiss-based expert in aseptic fill-finish manufacturing. 28 November 2024
Pharmaceutical
The board of Spanish plasma-based medicines producer Grifols has announced the termination of discussions with Brookfield Capital Partners (UK) regarding a potential acquisition of Grifols shares. 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
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
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Pharmaceutical
A new collaboration will see precision oncology company Erasca working with the MD Anderson Cancer Center to evaluate multiple agents from the firm’s pipeline. 23 August 2022
Pharmaceutical
Japanese pharma major Takeda announced the company’s dengue vaccine, Qdenga (dengue tetravalent vaccine [live, attenuated]; formerly known as TAK-003), was approved by the Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), for the prevention of dengue disease caused by any serotype in individuals six years to 45 years of age. 23 August 2022
Pharmaceutical
Shares of Clinical stage US biotech Minerva Neurosciences were up more than 5% at $4.35 pre-market, after it said it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. 23 August 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a revised draft guidance for industry, which responds to frequently asked questions about FDA’s processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances in clinical trials or expanded access for treatment use. 23 August 2022
Pharmaceutical
Shares of US ophthalmic drugs specialist Aerie Pharmaceuticals shot up 34.55 to $15.00 pre-market, after it was announced it has entered into a definitive merger agreement through which Switzerland-headquartered eye-care company Alcon will acquire Aerie. 23 August 2022
Pharmaceutical
The Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund have announced the development of the Sputnik V vaccine specifically adapted against Delta and Omicron variants of coronavirus. 23 August 2022
Pharmaceutical
Global drugmakers have significantly reduced their investments and payments into Russia and its pharmaceutical market this year due to the ongoing military conflict between Ukraine and Russia and sanctions imposed on the latter, reports The Pharma Letter’s local correspondent. 23 August 2022
Biotechnology
Pharvaris, a Switzerland-based clinical-stage company, today announced that the US Food and Drug Administration (FDA) verbally informed Pharvaris that, based on its review of non-clinical data, the agency is placing a clinical hold on the clinical trials of PHA121 in the USA under two Pharvaris Investigational New Drug (IND) applications for the treatment of HAE. 23 August 2022
Generics
Russia plans to rebuild its pharmaceutical sector, which has been hit significantly by international sanctions and their consequences, that will be part of the recently announced state strategy of ensuring Russia’s national drug sovereignty by reducing the country’s dependence on the imports at all stages of drug production, from intermediates to the production of pharmaceutical substances. 23 August 2022
Pharmaceutical
CSL Vifor and Travere Therapeutics today announced that the European Medicines Agency (EMA) has accepted for review the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN, a rare kidney disorder and a leading cause of end-stage kidney disease (ESKD). 22 August 2022
Pharmaceutical
The European medicines regulator has started reviewing a submission from Japanese drugmaker Otsuka Pharmaceutical for its acute myeloid leukemia (AML) therapy ASTX727. 22 August 2022
Biotechnology
Following in the steps of US mRNA biotech Moderna, which last week gained a first regulator approval for its bivalent vaccine, now BioNTech and Pfizer say they have completed their submission to the US Food and Drug Administration (FDA) today requesting an Emergency Use Authorization of a 30µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years and older. 22 August 2022
Biotechnology
Singapore-based Tessa Therapeutics, a Temasek-backed clinical stage biotech company, today announced the appointment of Thomas Willemsen as its president and chief executive, effective October 1, 2022. 22 August 2022
Pharmaceutical
COVID-19 has changed the world during the past couple of years, and one of its lasting legacies will be the need for speed and agility in all spheres of healthcare. 22 August 2022
Pharmaceutical
PanTher Therapeutics, a clinical-stage oncology company developing next-generation targeted therapies for solid tumors, has received a $14.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). 22 August 2022
Pharmaceutical
Several multinational pharmaceutical companies and some domestic firms, as well as the trade group the Organization of Pharmaceutical Producers of India (OPPI), have expressed their opposition to the Indian government's plan to rationalize trade margins on novel or patentable medications which many drug firms tend to offer free to patients. 22 August 2022
Biotechnology
The BioInnovation Institute (BII), an international commercial non-profit foundation incubating and accelerating life science research set up by the Novo Nordisk Foundation, has announced its investment into three international start-up companies from the UK, Germany, and Finland. 22 August 2022
Biotechnology
Roche majority-owned Japanese drugmaker Chugai Pharmaceutical has entered into a license agreement for Noile-Immune Biotech’s proprietary PRIME (proliferation-inducing and migration-enhancing) CAR-T technology. 22 August 2022
Pharmaceutical
A regulatory submission from British firm Mundipharma, for the invasive candidiasis (IC) candidate rezafungin, has been accepted for review by the European Medicines Agency. 22 August 2022
Pharmaceutical
US central nervous system specialist Axsome Therapeutics saw its shares close up more than 40% at $59.55 on Friday, after it revealed that the US Food and Drug Administration (FDA) has approved its Auvelity (dextromethorphan HBr-bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. 22 August 2022
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