FDA approves first gene therapy for hemophilia B
Bio Pharma Dive
NOVEMBER 22, 2022
The treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5 million.
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AI will continue to attract investment in near future in the healthcare industry
Pharmaceutical Technology
NOVEMBER 25, 2022
Artificial intelligence (AI) was seen as one of the top current investment priorities and was thought to continue to attract investment in the healthcare sector in the upcoming two years, according to GlobalData's latest report ‘Digital Transformation and Emerging Technology in the Healthcare Industry - 2022 Edition’. In this survey-based report tracker, digital media was prioritised as a top current investment target, with 53% of surveyed respondents confirming that their companies are currentl
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2022 in review: Regulation starts to catch up with AI in pharma
Pharmaceutical Technology
DECEMBER 21, 2022
Artificial intelligence (AI) continued to stay in the news with several high-profile deals this year, as the pharmaceutical industry readily took to adopting AI models to improve drug discovery. But as the field grows in leaps and bounds, many authorities have prioritised the release of new guidelines, frameworks, and regulations to keep pace with these advances.
What to make of Eisai and Biogen’s latest Alzheimer’s drug data
Bio Pharma Dive
NOVEMBER 29, 2022
At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. However, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.
Running Decentralized Trials at Scale: Planning for Success
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
In surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial
Bio Pharma Dive
SEPTEMBER 28, 2022
The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s.
In Afghanistan, coal mining relies on the labor of children
NPR Health - Shots
DECEMBER 31, 2022
Since the return of the Taliban, Afghanistan's coal exports have increased — and so has child labor. At a coal mine in Baghlan province, boys earn between $3 and $8 for a day's work.
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Developing a digital marker for coronary artery disease
Medical Xpress
DECEMBER 20, 2022
Using machine learning and clinical data from electronic health records, researchers at the Icahn School of Medicine at Mount Sinai in New York constructed an in silico, or computer-derived, marker for coronary artery disease (CAD) to better measure clinically important characterizations of the disease.
UK digital health project aims to tackle dysfunctional breathing
pharmaphorum
DECEMBER 19, 2022
A collaboration between academic centres in the UK has won government funding for a digital approach to dysfunctional breathing or dyspnoea, a symptom that affects around 10% of the population. The Engineering and Physical Sciences Research Council (EPSRC) has set aside £400,000 (almost $490,000) for the project, which will help fund work at the Universities of Plymouth, Salford and Stirling, and the Glasgow School of Art.
Long-COVID personalized medicine enters Phase 2 trial
BioPharma Reporter
NOVEMBER 22, 2022
GeNeuro has recruited the first patients in a Phase 2 trial evaluating temelimab against long-COVID: assessing the efficacy of the treatment for improving cognitive impairment and fatigue.
Artificial intelligence stands to transform precision medicine: AiCure
Outsourcing Pharma
MAY 18, 2022
An expert from the AI-focused technology company shares insights as to how it can be harnessed to better interpret, and even predict, patient behavior.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Ocugen sniffs out COVID-19 vaccine opportunity, landing rights to nasal candidate with India authorization
Fierce Pharma
OCTOBER 4, 2022
Ocugen sniffs out COVID-19 vaccine opportunity, landing rights to nasal candidate with India authorization. ntaylor. Tue, 10/04/2022 - 05:33.
A Cancer Trial’s Unexpected Result: Remission in Every Patient
NY Times
JUNE 5, 2022
The study was small, and experts say it needs to be replicated. But for 18 people with rectal cancer, the outcome led to “happy tears.”.
Early cell therapy successes start to turn the tide in lupus
Pharmaceutical Technology
NOVEMBER 14, 2022
In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells.
Building a biotech in a downturn: 3 lessons from VCs and startup CEOs
Bio Pharma Dive
NOVEMBER 3, 2022
In a panel discussion hosted by BioPharma Dive, venture capitalists and CEOs discussed how startups can navigate a challenging market as well as possible ripple effects from the new U.S. drug pricing law.
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
ALS drug approved by FDA in closely watched decision, marking win for patients, developer
Bio Pharma Dive
SEPTEMBER 30, 2022
The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.
‘In vivo’ cell therapy: expanding beyond CAR-T
Bio Pharma Dive
OCTOBER 18, 2022
At least five startups have emerged with new ways to genetically modify immune cells within the body, an approach that, if successful, could widen the field of CAR-T treatment.
CAR-T pioneer Carl June on founding biotech startups and cell therapy’s next act
Bio Pharma Dive
OCTOBER 18, 2022
The University of Pennsylvania immunologist and inventor of Kymriah spoke with BioPharma Dive about working with pharma, starting companies and the future of the cell therapy field.
Bluebird gene therapy approved by FDA for rare blood disease
Bio Pharma Dive
AUGUST 17, 2022
The regulator cleared the biotech’s medicine Zynteglo for transfusion-dependent beta thalassemia, giving patients a powerful new treatment option. But it will come at a very high cost of $2.8 million in the U.S.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Ferring wins FDA approval for bladder cancer gene therapy
Bio Pharma Dive
DECEMBER 19, 2022
The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the second half of next year, however.
Centerview grows role as go-to adviser for biopharma dealmaking
Bio Pharma Dive
NOVEMBER 8, 2022
Over the past several years, the investment firm has served as a financial adviser on biopharma acquisitions worth more than $200 billion in total, with the latest announced Monday.
Alnylam drug succeeds in key heart disease study, boosting company
Bio Pharma Dive
AUGUST 3, 2022
The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application.
A Versant-backed biotech emerges to take on ‘overlooked’ cancer targets
Bio Pharma Dive
OCTOBER 6, 2022
Nested Therapeutics touts a deep bench of scientific leaders and advisers, including Kevan Shokat, whose work drugging KRAS — a cancer-related gene once thought to be undruggable — helped lead to the development of Amgen’s Lumakras.
Mandatory COVID Vaccination Policy Template
Advertiser: Aggregage
New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!
Moderna and UK government sign deal to establish mRNA facility
Pharmaceutical Technology
DECEMBER 21, 2022
Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year. This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure.
Prime Medicine raises $175M in one of the year’s largest biotech IPOs
Bio Pharma Dive
OCTOBER 20, 2022
The gene editing startup is one of less than two dozen biotech companies to debut on Wall Street this year, as the pace of IPOs remains far off last year’s trajectory.
AstraZeneca to acquire gene editing biotech LogicBio
Bio Pharma Dive
OCTOBER 3, 2022
Shares in LogicBio had lost nearly all their value since a 2018 IPO, bringing the company to the brink of Nasdaq delisting. The buyout deal represents a premium of over 600%.
Sangamo presses ahead with Fabry disease gene therapy
Bio Pharma Dive
SEPTEMBER 2, 2022
Preliminary results from a Phase 1 study show Sangamo’s treatment to be safe and suggest it is working as intended, leading the biotech to move into the trial’s next phase.
Pfizer study results show Paxlovid benefit less clear in lower-risk patients
Bio Pharma Dive
JUNE 15, 2022
A closely watched study missed its goal, failing to prove the antiviral pill’s benefit in a broader population than the high-risk individuals for which it’s currently cleared.
Biotech veteran Jeff Jonas on leaving Sage, guiding new biotechs and his ‘personal odyssey’
Bio Pharma Dive
DECEMBER 6, 2022
In an interview with BioPharma Dive, the longtime industry executive discussed becoming a biotech investor and his plans for Abio-X, a new incubator with $150 million to spend on startups.
Sarepta asks FDA to approve first gene therapy for Duchenne muscular dystrophy
Bio Pharma Dive
SEPTEMBER 30, 2022
The application comes a year earlier than previously had been expected, as company says drug reviewers are open to accelerated review based on data from early-stage trials.
How environmental factors could influence disease and drugs
Pharmaceutical Technology
SEPTEMBER 20, 2022
The study of lifetime exposures, also known as the “exposome”, is providing a new perspective on how environmental and social factors affect disease pathways and general wellbeing, and could influence the way pharma researches drugs. The Centers for Disease Control and Prevention (CDC) define the exposome as “the measure of all the exposures of an individual in a lifetime and how those exposures relate to health”.
Bluebird wins FDA approval of gene therapy for rare brain disorder
Bio Pharma Dive
SEPTEMBER 17, 2022
The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million.
Narcan developer to be acquired by Indivior
Bio Pharma Dive
NOVEMBER 14, 2022
The deal, which could carry a total value of roughly $145 million, is in large part focused on a nasal formulation of the opioid overdose drug nalmefene.
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