Latest Pharma and Biotech News
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.
Today's issue
Refine Search
Biotechnology
Confirming that there are still plenty of investors ready to wager on attractive biotechnology prospects, France’s Mablink Biosciences today announced it has raised a 31 million-euro ($30 million) Series A funding round to advance its lead candidate to the clinic and to build a pipeline of antibody-drug conjugates (ADCs) using its proprietary platform technology. 14 October 2022
Biotechnology
The European Medicines Agency (EMA) today announced recommendations made by its human medicines committee (CHMP) following its October 2022 meeting. 14 October 2022
Pharmaceutical
US clinical-stage firm Reata Pharmaceuticals edged up 2.6% to $25.05 yesterday, when it puzzled investors with the news that the US Food and Drug Administration (FDA) has decided not to hold an advisory committee (AdCom) meeting in connection with its review of the company’s New Drug Application (NDA) for omaveloxolone for the treatment of patients with Friedreich’s ataxia. 14 October 2022
Biotechnology
After just a year in the role of chief medical officer and head of global clinical development at Californian biotech BioMarin, Harold Bernstein has taken a new job elsewhere. 14 October 2022
Biotechnology
US neurology company Otonomy saw its shares plunge nearly 54% to $0.12, a far cry from its height of more than $39 in mid-2015, after releasing disappointing data for its hearing loss candidate OTO-413. 14 October 2022
Biotechnology
Troubled Boston, USA-based rare disease specialist Imara saw its shares rise 4.4% yesterday and a further 17% to $3.01 pre-market today, after a planned merger with fellow USA-based Enliven Therapeutics was revealed. 14 October 2022
Biotechnology
New data from Pfizer and BioNTech’s Comirnaty program show the firms’ updated jab produces antibodies against the latest variants of the coronavirus. 14 October 2022
Pharmaceutical
The Russian pharmaceutical sector is steadily developing despite the ongoing military conflict in Ukraine and the ever-tightening sanctions pressure against the country, according to recent statements by some leading local pharma analysts and Russian media, reports The Pharma Letter’s local correspondent. 14 October 2022
Biotechnology
Russia has been faced with a shortage of Oncaspar (pegaspargase), a drug from French independent pharma major Servier, which is designed for the treatment of leukemia in children. 14 October 2022
Biotechnology
A significant late stage trial win lifted GSK stock by around 1.5% in early morning trading on Friday, with the company hailing the result as “truly exceptional.” 14 October 2022
Biotechnology
Late-stage US biotech Relmada Therapeutics’ shares sank 78% to $7.00 by mid-morning, after it revealed that its RELIANCE III study (REL-1017-303), evaluating REL-1017 in the monotherapy setting for major depressive disorder (MDD), did not achieve its primary endpoint. 13 October 2022
Biotechnology
Australian drug discovery company AdAlta and venture-backed Korean biotech GPCR Therapeutics have announced a collaboration. 13 October 2022
Pharmaceutical
The migraine market has seen the introduction of a large number of highly effective monoclonal antibody (Mab) drugs for the prevention of the condition, leading to expectations for the overall therapy sector to grow from $4.7 billion in 2020 to $12 billion in 2030 across the seven major markets. 13 October 2022
Biotechnology
US biotech Novavax has reported potentially important results on its COVID-19 vaccine NVX-CoV2373. 13 October 2022
Biotechnology
Sino-American biotech BeiGene shot up on Wednesday, after the company's chronic lymphocytic leukemia (CLL) treatment was shown to beat out a blockbuster drug from Johnson & Johnson. 13 October 2022
Biotechnology
Shares of US biotech Moderna leapt almost 12% to $134.96 yesterday, after it announced that pharma giant Merck & Co has opted to develop a personalized cancer vaccine based on messenger RNA technology. 13 October 2022
Biotechnology
Updated results from the Phase I/II STAAR trial are good enough for Sangamo Therapeutics to trigger the expansion phase of the study. 13 October 2022
Biotechnology
The US Food and Drug Administration yesterday said it has amended the emergency use authorizations (EUAs) for two COVID-19 vaccine, bivalent to authorize their use as a single booster dose in younger age groups. 13 October 2022
Biosimilars
An Expert View from Mark Samuels, chief executive, British Biosimilars Association. 12 October 2022
Pharmaceutical
French therapeutic peptides for rare endocrine and metabolic diseases company Amolyt Pharma today announced positive Phase IIa safety and efficacy data from the second cohort of its ongoing clinical trial evaluating its lead candidate, AZP-3601, in patients with hypoparathyroidism. 12 October 2022
All news
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
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze