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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
Intelligence company Evaluate predicts sales in the global pharmaceutical industry to grow by 6% per year between 2022 and 2028, according to its annual World Preview report. 21 October 2022
Pharmaceutical
Positive safety and efficacy data from a pivotal Phase III clinical trial have just been published in leading nephrology journal Kidney International, and lend further support to the recent European launch of Kinpeygo (budesonide; development name: Nefecon). 21 October 2022
Biotechnology
US immunology focussed biotech Immunic saw is shares plunge nearly 75% to $2.34 post-market yesterday, after it reported disappointing early-stage results for its psoriasis candidate. The overall trial is ongoing and remains blinded. 21 October 2022
Biotechnology
Thursday’s trading wiped more than 43% off the value of Talaris Therapeutics, a US cell therapy firm developing treatments in solid organ transplantation and severe immune and blood disorders. 21 October 2022
Biotechnology
US clinical-stage biotech Minerva Neurosciences (Nasdaq: NERV) has recently received a refusal to file letter from the Food and Drug Administration (FDA) regarding its new drug application (NDA) for roluperidone, which was filed in August, for the treatment of negative symptoms in patients with schizophrenia, is yet another obstacle to the drug’s development. 21 October 2022
Biotechnology
Belgian company Rewind Therapeutics, which is developing first-in-class treatments for demyelination-associated diseases, has named Irene Knuesel its new chief scientific officer (CSO). 21 October 2022
Biotechnology
In the first three quarters of the year, with investment activity accelerating in the three months leading to August 31, UK-based life sciences and biotech companies raised some £1.5 billion ($1.67 billion) in equity finance. 21 October 2022
Biotechnology
Shares in Parisian immuno-oncology specialist OSE Immunotherapeutics rose by around a third on Friday morning, after the firm provided an update on its neoepitope cancer vaccine Tedopi. 21 October 2022
Biotechnology
Following a Series A financing of $27 million a year ago, Singapore-based AUM Biosciences has entered into an agreement to merge with Mountain Crest Acquisition Corp, a publicly-traded special purpose acquisition company (SPAC). 21 October 2022
Pharmaceutical
USA-based CNS specialist Corium and Gurnet Point Capital have announced the acquisition of their manufacturing business and a $100 million equity investment by Webster Equity Partners. 21 October 2022
Biotechnology
Swiss pharma giant Roche has become the latest large biopharma company to team up with Austrian arenaviral technology firm Hookipa Pharma. 20 October 2022
Biotechnology
Data on Incyte’s Opzelura (ruxolitinib) cream from the pivotal Phase III TRuE-V clinical trial program have been published in The New England Journal of Medicine (NEJM). 20 October 2022
Biotechnology
While there has been a dearth mega-billion M&A activity in the pharma sector this year, smaller deals are coming through, now with US pharma major AbbVie announcing its second acquisition this year. 20 October 2022
Pharmaceutical
Japanese gastroenterology giant Takeda has inked a deal with German firms Zedira and Dr. Falk Pharma for the development of a celiac disease candidate, TAK-227. 20 October 2022
Generics
Swiss pharma giant Novartis has entered into a voluntary licensing agreement for its chronic myeloid leukemia (CML) drug with the Medicines Patent Pool (MPP), agreeing to the production of generics in low-and-middle income countries. 20 October 2022
Biotechnology
Bristol Myers Squibb has presented data that reinforces the benefits of its immuno-oncology blockbuster Opdivo (nivolumab) in the earlier stages of melanoma. 20 October 2022
Pharmaceutical
The US Food and Drug Administration’s (FDA) Obstetrics, Reproduction and Urologic Advisory Committee yesterday voted to recommend that the FDA pursue withdrawal of approval of privately-held Swiss drugmaker Covis Pharma’s Makena (hydroxyprogesterone caproate injection), the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth. 20 October 2022
Biotechnology
An alternative to mRNA-based coronavirus vaccines has received an Emergency Use Authorization in the USA, providing a new option for a first booster dose. 20 October 2022
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. 20 October 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has announced the Advancing Real-World Evidence (RWE) Program. 20 October 2022
All news
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
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
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