Sat.Dec 31, 2022 - Fri.Jan 06, 2023

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10 clinical trials to watch in the first half of 2023

Bio Pharma Dive

By the end of June, highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s disease, while a pair of high-priced acquisitions could be put to the test

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Cell therapies might revolutionise treatment for multiple sclerosis patients

Pharmaceutical Technology

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.

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Scope 3 Emissions – More Than Suppliers

Pharma Mirror

by Dr Torill Bigg, Chief Carbon Reduction Engineer at Tunley Engineering Businesses globally are looking to reduce their carbon footprints. A number of factors is driving this activity. It is a smart and ethical business practice to operate sustainably for the environment and for grand success.

Engineer 130
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Incurable liver disease may prove curable

The Pharma Data

Research led by Associate Professor Duc Dong, Ph.D., has shown for the first time that the effects of Alagille syndrome, an incurable genetic disorder that affects the liver, could be reversed with a single drug.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

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FDA approves Alzheimer’s drug from Eisai, Biogen in closely watched decision

Bio Pharma Dive

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

Last week, Novartis announced plans to pay $245 million to end a pay-for-delay legal battle that started in 2018. This settlement ends a packed year of legal rulings for the Swiss pharmaceutical giant.

Doctors 205

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Biogen Names Priya Singhal as Executive Vice President, Head of Development

The Pharma Data

Biogen Inc. Nasdaq: BIIB) announced that Priya Singhal, M.D., M.P.H.,

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Eisai, in pricing new Alzheimer’s drug, tries to sidestep controversy

Bio Pharma Dive

The pharma set the average annual cost of it and Biogen’s newly approved medicine Leqembi to $26,500, below the cost of the companies’ earlier drug Aduhelm but above one estimate of cost effectiveness

Medicine 261
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China’s NMPA clears Transcenta’s IND for solid tumour treatment

Pharmaceutical Technology

The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted clearance for Transcenta’s investigational new drug (IND) application for its TST003 to treat solid tumours. TST003 is a first-in-class Gremlin1 targeting humanised monoclonal antibody.

Antibody 205
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Google and DeepMind share work on medical chatbot Med-PaLM

Pharma Phorum

Google and DeepMind have developed an artificial intelligence-powered chatbot tool called Med-PaLM designed to generate “safe and helpful answers” to questions posed by healthcare professionals and patients.

Scientist 108
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

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FDA accepts nirsevimab application as first protective option against RSV disease for all infants

The Pharma Data

FDA accepts nirsevimab application as first protective option against RSV disease for all infants. Nirsevimab would be the first broadly protective option against RSV disease designed for all infants, if approved.

Trials 82
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Prevail, Capsida partner to develop gene therapies for nervous system diseases

Bio Pharma Dive

The Lilly-owned subsidiary will pay $55 million to gain access to Capsida’s AAV gene therapy technology in a deal aimed at central nervous system disorders

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Capsida Biotherapeutics and Prevail to develop CNS gene therapies

Pharmaceutical Technology

Capsida Biotherapeutics and Eli Lilly and Company ’s wholly owned subsidiary Prevail Therapeutics have announced a partnership for the development of non-invasive gene therapies for central nervous system (CNS) diseases.

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Valneva delivers additional data for COVID-19 booster vaccine

Pharma Times

Company has reported booster details from a study of its inactivated COVID-19 candidate

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Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

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Gilead and EVOQ Therapeutics Announce Collaboration to Advance Immunotherapies

The Pharma Data

Gilead Receives Rights to Exclusively License EVOQ’s NanoDisc Technology to Develop and Commercialize Immunotherapy Products for Rheumatoid Arthritis and Lupus –. Gilead Sciences, Inc. Nasdaq: GILD) and EVOQ Therapeutics , Inc.

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Ensoma buys a startup to advance ‘in vivo’ cell therapy work

Bio Pharma Dive

The Takeda-backed biotech revealed it’s raised $85 million in new funding alongside announcing the acquisition of gene editing startup Twelve Bio

In-Vivo 252
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Inflation, drug pricing and reimbursement constraints will challenge pharma sector

Pharmaceutical Technology

The swift development of COVID-19 vaccines was an unprecedented scientific and collaborative achievement by government, regulators, research institutions, and the pharmaceutical industry.

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Transgene receives approval to begin oncolytic virus trial

Pharma Times

Study will evaluate the intravenous administration of company’s multi-armed immunotherapy

Trials 105
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Pfizer, GSK, AbbVie and many more celebrate New Year with price hikes: report

Fierce Pharma

Pfizer, GSK, AbbVie and many more celebrate New Year with price hikes: report. esagonowsky. Wed, 01/04/2023 - 10:21

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Fate, two other cell therapy biotechs lay off staff, restructure research

Bio Pharma Dive

The cuts at Fate, Century Therapeutics and TCR2 Therapeutics signal a longer road in the companies’ plans to develop next-generation cell therapies for cancer

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US FDA accepts AstraZeneca’s BLA for nirsevimab to prevent RSV

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted AstraZeneca ’s nirsevimab biologics licence application (BLA) for review to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in children aged up to 24 months.

Antibody 141
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SanegeneBio and Orbit join forces to establish targeting peptides

Pharma Times

Agreement covers cell-based studies, with an additional option to further develop screening activities

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Opus acquires two compounds for inherited retinal diseases

BioPharma Reporter

Last week saw Opus Genetics announce it had acquired the rights to two preclinical-stage adeno-associated virus (AAV)-based gene therapy product candidates for inherited retinal diseases (IRDs) from Iveric Bio. Markets & Regulations

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Bluebird bolsters balance sheet with sale of second regulatory fast pass

Bio Pharma Dive

The gene therapy developer will receive $95 million from Bristol Myers Squibb, slightly less than it got in the recent sale of another priority review voucher

Sales 248
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Adcendo and Duality Biologics sign license deal for ADC platform

Pharmaceutical Technology

Danish biotech company Adcendo has entered into a licence agreement with Duality Biologics on the next-generation antibody-drug conjugates (ADC) platform.

Licensing 130
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Janssen submits marketing application for talquetamab

Pharma Times

European Medicines Agency will consider therapy for the treatment of patients with multiple myeloma

Medicine 101
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COVID-19 tracker: AstraZeneca workers who were fired for refusing vaccine file lawsuit

Fierce Pharma

COVID-19 tracker: AstraZeneca workers who were fired for refusing vaccine file lawsuit. kdunleavy. Tue, 01/03/2023 - 10:31

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Pharma companies boost drug prices to start year, but hikes lag inflation

Bio Pharma Dive

Analysts noted hundreds of wholesale price increases, including dozens by Pfizer. Many checked in around 5%, roughly in line with hikes taken in recent years

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Synaffix and Amgen sign agreement for advanced ADCs development

Pharmaceutical Technology

Dutch biotechnology company Synaffix and Amgen have entered a licensing agreement for the development of next-generation antibody-drug conjugates (ADCs).

Licensing 130
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Orion and Alligator reveal second stage of immuno-oncology research collaboration

Pharma Times

Second study will develop a bispecific antibody with potential applications in solid tumours

Antibody 101
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UK partners with BioNTech on clinical trials of mRNA cancer therapies

Pharma Phorum

The UK has formed an partnership with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies, in another example of the country embracing the mRNA technologies that underpinned COVID-19 vaccines.

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Belharra debuts with $130M in funding, Genentech partnership

Bio Pharma Dive

The Versant-backed company emerged from stealth with technology it says can help it better identify small molecule drugs for any target on any protein

Protein 246
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Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

Pharmaceutical Technology

Formulating products that have the proper composition, viscosity, texture, and stability, and can also be shown to be safe and effective, is both a science and an art.

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Mission Therapeutics concludes clinical assessment for lead DUB inhibitor

Pharma Times

Safety, tolerability and pharmacokinetic endpoints for MTX652 have been successfully met

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