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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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Biotechnology
Acelyrin, a late-stage clinical biopharma company focused on accelerating the delivery of transformative medicines in immunology, has announced a $300 million Series C financing to fund izokibep Phase III development in psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA). 13 September 2022
Pharmaceutical
The USA’s medicines cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of treatment of amyotrophic lateral sclerosis (ALS). 13 September 2022
Pharmaceutical
Israeli diabetes specialist Oramed Pharmaceuticals edged up 3% to $8.46 pre-market today, as it announced positive Phase II results from its double-blind, fully randomized, placebo-controlled, multicenter trial to assess the safety and efficacy of its oral insulin candidate (ORMD-0801), to reduce liver fat content in type 2 diabetes (T2D) patients with non-alcoholic steatohepatitis (NASH). 13 September 2022
Pharmaceutical
Scientists have worked to develop a vaccine for respiratory syncytial virus (RSV) for over half a century, but there is no currently approved vaccine. 13 September 2022
Biotechnology
The value of Californian biotech Akero Therapeutics could double on Tuesday, with its shares already up by 89% in pre-market trading. 13 September 2022
Generics
A breakthrough on the litigation front will extend exclusivity for certain of Gilead Sciences’ HIV meds by around six or seven years. 13 September 2022
Biotechnology
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. 13 September 2022
Generics
Fast-growing contract development and manufacturing organization (CDMO), Bora Pharmaceuticals, has completed the acquisition of fellow Taiwan based TWi Pharmaceutical, a technology-based company specializing in development and commercialization of niche generic drugs. 13 September 2022
Biotechnology
Yesterday, Nuvaxovid (NVX-CoV2373) COVID-19 vaccine was granted expanded conditional marketing authorization (CMA) in the European Union (EU) for use as a booster vaccine for adults aged 18 and older by the European Commission. 13 September 2022
Pharmaceutical
Sophisticated products in the form of biologics and large molecules, produced by living materials from humans, animals, plants, or microorganisms, are increasingly prevalent in today’s market. These types of drugs may include cell and gene therapy (CGT) products typically produced in low numbers. 13 September 2022
Biotechnology
French biotech GenSight Biologics, which is developing gene therapy for rare and neurodegenerative diseases of the eye, is adding to its management team in anticipation of the European commercialization of Lumevoq (lenadogene nolparvovec). 13 September 2022
Generics
Indian drugmaker Zydus Lifesciences has been granted approval by the US Food and Drug Administration (FDA) to market lenalidomide capsules. 13 September 2022
Pharmaceutical
American president Joe Biden has announced his intent to appoint Dr Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health (ARPA-H), a new agency established to drive biomedical innovation that supports the health of all Americans. 13 September 2022
Pharmaceutical
Danish diabetes giant Novo Nordisk and tech behemoth Microsoft have entered a new multi-year strategic collaboration. 12 September 2022
Biotechnology
Having recently announced that it is slashing its global workforce by around 8,000, and a plan for a new organizational structure and operating model in April of this year that is expected to result in savings of at least a billion dollars, Swiss pharma giant Novartis has today revealed it is investing around $300 million in next-generation biotherapeutics. 12 September 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) filing from Chiesi Global Rare Diseases, and granted priority review designation for velmanase alfa, an investigational enzyme replacement therapy for the treatment of alpha-mannosidosis. 12 September 2022
Pharmaceutical
Breakthroughs in the mental health space that deliver for patients have been few and far between in the past 30 years, but this is not the time to be too depressed for those affected, nor for investors. 12 September 2022
Pharmaceutical
With the final presentations of this year’s meeting of the European Society of Medical Oncology (ESMO 22) in full swing, there is a lot for the scientific community to digest, including many potential catalysts for future research and development. 12 September 2022
Biotechnology
The final analysis of the Phase III LEAP-002 trial investigating Lenvima (lenvatinib), discovered by Japan’s Eisai plus US pharma giant Merck & Co’s mega blockbuster Keytruda (pembrolizumab) versus Lenvima monotherapy, was inconclusive for the combination as first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). 12 September 2022
Biotechnology
A research note from GlobalData suggests that AstraZeneca, the British pharma major responsible for the coronavirus vaccine Vaxzevria and antibody therapy Evusheld, can expect positive uptake for the latter in Japan. 12 September 2022
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