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LATEST PUBLICATIONS



Reconfiguring COVID and influenza vaccines for long-term effectiveness

September 22, 2022

Category: Industry, Vaccines

Alexandre Le Vert, CEO and co-founder of Osivax, discusses the company’s breakthrough vaccine technology, oligoDOM, and how it’s driving the development of new influenza and SARS-CoV-2 vaccines that attack T-cells, providing a long-lasting effect. Currently, available vaccines for influenza and […]


The future of AI drug discovery & development in immunology and GPCR research

September 16, 2022

A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”. Now, Verily has announced that […]


Pfizer told by FDA to test additional Paxlovid course in patients with COVID-19 rebound

August 22, 2022

Via: PMLiVE
Category: Industry, Vaccines

The company must produce the initial results of a randomised controlled trial of a second course of the antiviral by 30 September next year, according to a letter from the regulator. The order follows reports of rebounding COVID-19 symptoms after […]


Mergers and Acquisitions

AstraZeneca to acquire gene editing biotech LogicBio

October 3, 2022

Via: Biopharma Dive

AstraZeneca’s rare disease unit Alexion will acquire gene editing specialist LogicBio Therapeutics in a small buyout deal, the companies announced Monday. Under the terms of the agreement, Alexion will acquire all of LogicBio’s outstanding shares for $2.07 each, representing a […]


Clinical Trials, Research and Development

Positive phase 3 results for Zealand Pharma’s glepaglutide

October 3, 2022

Via: Pharmaphorum

Biotech company Zealand Pharma A/S, an innovator in peptide-based medicines, announced the positive topline results from its phase 3 trial of glepaglutide on Friday. A total of 106 patients with short-bowel syndrome (SBS) who also experienced intestinal failure and dependency […]


News

Translarna not approved by NICE for DMD on NHS

October 3, 2022

Via: Pharmaphorum

In draft guidance published on Friday, it emerged NICE does not recommend PTC Therapeutics’ Translarna (ataluren) for the treatment of Duchenne muscular dystrophy (DMD) caused by a nonsense mutation. The decision came following a re-evaluation of Translarna in order to […]


Pricing, Regulations

Amylyx ALS drug draws criticism over $158,000 price tag

October 3, 2022

Via: Pharmaphorum

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 […]


Industry, Pharma

Hollywood and the Metaverse’s effect on pharma’s content

October 3, 2022

Via: Pharmaphorum

Pharma companies’ customer communication methods require reimagining as technology progresses. Kapoor says, now, pharma can learn from the on-demand nature of content distribution that Hollywood utilises and simultaneously prepare for future needs in content delivery. “One of our senior clients […]


FDA, Regulations

FDA Approves New ALS Drug Despite Uncertain Data

September 30, 2022

Via: Drugs.com

The U.S. Food and Drug Administration on Thursday gave its approval to a new drug for ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig’s disease. But approval of the drug, called Relyvrio, is bound to stir new questions, with […]


Mergers and Acquisitions

Vanda Pharmaceuticals, OliPass Enter ASO R&D Alliance

September 30, 2022

Via: Contract Pharma

Vanda Pharmaceuticals Inc. and OliPass Corp. have entered into a research and development collaboration to jointly develop a set of antisense oligonucleotide (ASO) molecules based on OliPass’ modified peptide nucleic acids. The partnership leverages the respective strengths of Vanda and […]


Cell and Gene Therapy, Industry

BioMarin resubmits its hemophilia gene therapy to the FDA

September 30, 2022

Via: Biopharma Dive

Roctavian’s road back to the FDA has been long, as BioMarin has had to gather additional data in support of its therapy. Delays and new safety concerns further hampered the company’s resubmission plans. The treatment is for people with severe […]


FDA, Regulations

Federal watchdog highlights flaws in speedy FDA approvals

September 30, 2022

Via: Biopharma Dive

The accelerated approval program was implemented as the U.S. grappled with the HIV crisis and was searching for a way to get medicines for the deadly infection to market more quickly. But its use has skyrocketed in recent years, with […]


Cell and Gene Therapy, Industry

Sarepta asks FDA to approve first gene therapy for Duchenne muscular dystrophy

September 29, 2022

Via: Biopharma Dive

Sarepta Therapeutics has asked the Food and Drug Administration to approve its gene therapy for Duchenne muscular dystrophy under accelerated review, the company said Thursday. The biotechnology company’s application for SRP-9001, also known as delandistrogene moxeparvovec, is primarily based on […]