Sat.Feb 04, 2023 - Fri.Feb 10, 2023

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Feinstein Institutes researchers discover new protein for sepsis treatment

Pharmaceutical Technology

Researchers at the Feinstein Institutes for Medical Research have discovered a new protein that can be a potential therapeutic target for lethal sepsis.

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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

RNA 358
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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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So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups

FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market.

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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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4D Molecular’s Fabry gene therapy program on FDA clinical hold

Pharmaceutical Technology

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310).

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Cigna restricts coverage of new ALS drug, deepening fears about access

Bio Pharma Dive

The health insurer’s national formulary considers Amylyx Pharmaceuticals’ Relyvrio to be "experimental, investigational or unproven for any use,” and now does not recommend covering it

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More Trending

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Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics

Fierce Pharma

Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics fkansteiner Tue, 02/07/2023 - 10:08

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Risk-sharing agreements are growing at a rate of 24%

Pharmaceutical Technology

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world.

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Eisai gives first glimpse into Alzheimer’s drug launch

Bio Pharma Dive

In the month since its U.S. approval, Leqembi has had its first sale, its first prescription written and its first administration to a patient

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Positive data from LEO Pharma’s delgocitinib cream trial

Pharma Times

Study involves the treatment of adults with moderate-to-severe chronic hand eczema

Trials 126
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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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Forxiga approved in the EU for the treatment of symptomatic chronic heart failure

The Pharma Data

First and only heart failure therapy with proven mortality benefit across the full ejection fraction range Forxiga (dapagliflozin) has been approved in the European Union to extend the indication for heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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Roche rival to AstraZeneca’s Soliris succeeds in late-stage testing

Bio Pharma Dive

The company said the experimental injection matched Soliris in a Phase 3 study and would soon be submitted to regulators around the world

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Vygon and University hospital of Wales in heart patient partnership

Pharma Times

Collaboration has created method for heart failure patients to receive at-home treatment

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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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BREAKING: Bayer taps Roche vet Anderson as its next CEO, pushing out Baumann

Fierce Pharma

BREAKING: Bayer taps Roche vet Anderson as its next CEO, pushing out Baumann esagonowsky Wed, 02/08/2023 - 11:28

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FDA grants approval to Gilead Sciences’ breast cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

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Astellas switches CEOs amid plans to pursue ‘aggressive’ growth

Bio Pharma Dive

Naoki Okamura, currently Astellas’ chief strategy officer, will replace current CEO Kenji Yasukawa as the company attempts to “further accelerate growth &rdquo

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Pharmacists to receive further mental health training

Pharma Times

The pathway is a programme designed to develop pharmacists’ knowledge of mental health among patients

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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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Novartis, Bayer marshal relief for Turkey and Syria following devastating earthquake

Fierce Pharma

Novartis, Bayer marshal relief for Turkey and Syria following devastating earthquake fkansteiner Wed, 02/08/2023 - 09:56

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AbbVie reports rise in full-year 2022 net revenues

Pharmaceutical Technology

AbbVie has reported full-year 2022 net revenues of $58.054bn, representing a 3.3% rise on a reported basis and 5.1% on an operational basis. The company reported an increase of 1.6% on a reported basis in global net revenues to $15.121bn for the fourth quarter (Q4) of 2022.

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GSK wins full approval for cancer immunotherapy, looks to expand use

Bio Pharma Dive

The drugmaker converted Jemperli’s accelerated approval in endometrial cancer, while outside advisers endorsed its plan to study the Keytruda rival in rectal tumors

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EU approves AstraZeneca Forxiga for use across the EU

Pharma Times

Milestone therapy concerns the treatment of patients with symptomatic chronic heart failure

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Excess Mortality Among US Physicians During the COVID-19 Pandemic

JAMA Internal Medicine

This cross-sectional study examines the death rates among active and nonactive physicians aged 45 to 84 years

Medicine 107
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UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]).

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Medicare to collect drug price rebates starting in 2025

Bio Pharma Dive

CMS laid out how it plans to implement a key provision of the Inflation Reduction Act, which requires drugmakers to pay rebates on price hikes within Medicare that are greater than inflation

Drugs 246
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Alvotech and Advanz link-up for Xolair drive

Pharma Times

Alvotech will be responsible for supply and Advanz will oversee commercialisation of biosimilar

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AstraZeneca's Forxiga nabs expanded heart failure approval in Europe

Fierce Pharma

AstraZeneca's Forxiga nabs expanded heart failure approval in Europe zbecker Tue, 02/07/2023 - 14:24

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Teva Pharmaceutical reports 5% fall in Q4 2022 revenue

Pharmaceutical Technology

Teva Pharmaceutical Industries has reported $3.9bn revenue in the fourth quarter (Q4) of 2022, representing a 5% decline in US dollars or a 1% increase in local currency terms, from $4.1bn in the same quarter of the previous year.

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Bayer begins key tests for closely watched blood thinner

Bio Pharma Dive

The company has begun enrolling patients in one of the largest Phase 3 programs in its history, a pair of trials that will test an anticoagulant it believes can be a future blockbuster

Trials 246
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Vital funding established for Evonetix projects

Pharma Times

Financing will allow company’s development of DNA synthesis chip technology to commercial scale

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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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ReviR Therapeutics partners with Asieris to develop new oncology therapies

Pharmaceutical Technology

ReviR Therapeutics has signed a research collaboration and option-to-license agreement with Asieris Pharmaceuticals to discover new oncology therapeutics.

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Another biotech IPO hits the market, as Mineralys raises $192M

Bio Pharma Dive

Mineralys, which is developing a hypertension drug, followed closely behind Structure Therapeutics in pricing an IPO, suggesting an opening investment window

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