2023

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At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders

Bio Pharma Dive

Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells

Protein 353
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Dawn of a new indication: how to study drugs for aging 

Pharmaceutical Technology

For a long time, aging biology and research have been enigmatic areas that biotechs hoped to capitalise on due to their market potential.

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Pharma Mirror Q&A with Jane Myles, Vice President of Clinical Trial Innovation at Curebase

Pharma Mirror

The White House Office of Science & Technology Policy (OSTP) convened a listening session January 11.

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FDA pulls AZ’s Evusheld for COVID, citing lack of efficacy

Pharma Phorum

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

This webinar will go over the FDA's guidance on pharmacological and toxicological considerations for optimizing doses for prescription drugs.

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QMSR Harmonization Curiously Missing from Spring 2023 Regulatory Agenda

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ).

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Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license

Fierce Pharma

Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18

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Moderna opts for Oxfordshire in quest for innovation

Pharma Times

Vaccines developed at the facility will cover a wide range of respiratory diseases

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Celebrating Black History Month 

Intouch Solutions

EVERSANA INTOUCH is once again celebrating Black History Month this February!

Nurses 98
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Disruptive Factors Shape RA Landscape

Pharmaceutical Commerce

As the range of treatment options for rheumatoid arthritis (RA) continues to grow and biosimilars are poised to enter the arena, the need for expert strategies to improve therapy selection and address the access, affordability, and adherence challenges patients face is coming into sharper focus.

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Pharma Marketers Need AI Now: How to deliver a truly personalized, omnichannel experience for your patients, with William Grambley, CEO of Allazo Health

Pharma Marketing Network

Marketing in the era of consumer-driven healthcare requires new tools and techniques. If you want patients to initiate therapy, you need to connect across more channels, more personally, and in the ways consumers prefer to be engaged.

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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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J&J-backed startup launches with $100M to build better brain drugs

Bio Pharma Dive

Rapport Therapeutics aims to find new so-called receptor-associated proteins that could serve as targets for neurological disease medicines. Its most advanced drug is already in early-stage human testing

Protein 362
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The impact of climate change on the pharma supply chain

Pharmaceutical Technology

Pharmaceutical supply chains are extremely vulnerable to the effects of climate change and face many challenges from sourcing to distribution.

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Can You Sue Your Doctor for Blindness Caused by Elmiron®?

Pharma Mirror

The Janssen Pharmaceuticals-produced medication Elmiron® is used to treat interstitial cystitis. Elmiron may be connected to eye damage that results in vision loss or other negative effects like blurry vision, according to some studies.

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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 136
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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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He Slimed Me: FTC Hits GoodRx Over Unauthorized Use of Consumer Data

FDA Law Blog

By Jeffrey N. Wasserstein — GoodRx is a digital health platform familiar to many, and a prime example of a single player that operates in several different realms of the evolving and growing digital health marketplace.

Radiology 105
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Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit

Fierce Pharma

Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit kdunleavy Tue, 02/14/2023 - 10:29

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New patent for Optinose Us drug XHANCE

Drug Patent Watch

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. It is available from one supplier. There are thirteen… The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions. Patent Added

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Trio of COVID-19 treatments receive NICE nod

Pharma Times

Final draft guidance from NICE ensures people at highest risk will have access to COVID-19 therapies

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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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A Day in the Life of a Senior Art Director

Intouch Solutions

M eet Meg Bradley, Senior Art Director at EVERSANA INTOUCH. Meg has been with EVERSANA INTOUCH for more than 5 years and has held a variety of positions.

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GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

Bio Pharma Dive

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more

Protein 360
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A new generation of biotech leaders is emerging. Can they change how drug startups are built?

Bio Pharma Dive

Through social media, virtual meetings and mentorship programs, a growing group of entrepreneurs is looking for new ways to build drug companies

Drugs 363
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Pfizer begins plan to challenge Shingrix with an mRNA vaccine

Bio Pharma Dive

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine

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Health Canada gives approval to Enhertu for breast cancer treatment

Pharmaceutical Technology

Health Canada has granted approval to Enhertu (trastuzumab deruxtecan) to treat unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.

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FIP advances sustainable health systems by providing new guidance for self-managing reflux symptoms

Pharma Mirror

The Hague, 25 January 2023 — Managing symptoms of reflux is the topic of new quick reference guidance for pharmacists published by the International Pharmaceutical Federation (FIP) today.

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A new dawn of the genomic age: five areas set to be transformed in 2023

Pharma Phorum

2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA.

Genome 129
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HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval

FDA Law Blog

Hyman, Phelps & McNamara, P.C.’s s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy.

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J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Fierce Pharma

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

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New patent for Vertex Pharms drug ORKAMBI

Drug Patent Watch

Annual Drug Patent Expirations for ORKAMBI Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. It is available from one supplier. There are twenty… The post New patent for Vertex Pharms drug ORKAMBI appeared first on DrugPatentWatch - Make Better Decisions. Patent Added

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Amvuttra recommended by NICE for amyloidosis

Pharma Times

Therapy is among the first to receive a positive draft recommendation under streamlined pilot process

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Biotech startup Structure pulls off rare IPO, raising $161M

Bio Pharma Dive

The company’s lead drug could be an oral alternative to marketed diabetes and obesity drugs from Novo Nordisk and Eli Lilly

Drugs 360
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Large study of J&J’s HIV vaccine stopped after shot found ineffective

Bio Pharma Dive

The result from the nearly 4,000-person trial is the latest setback in a long-running effort to develop a safe and effective shot for HIV infections

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Three VCs launch Dimension, a new firm with plans to fuel biotech’s ‘digitization’

Bio Pharma Dive

The veteran investors see the marriage of tech and life sciences as the “largest opportunity in venture today,” said co-founder and former Lux Capital general partner Adam Goulburn

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5 FDA decisions to watch in the first quarter

Bio Pharma Dive

An Alzheimer’s drug from Eli Lilly, BioMarin’s hemophilia gene therapy and a new type of breast cancer treatment are among the top decisions on the agency’s docket through the end of March