Sat.Feb 25, 2023 - Fri.Mar 03, 2023

article thumbnail

Is the microbiome therapy hype up for a reckoning?

Pharmaceutical Technology

In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream.

Bacteria 278
article thumbnail

Viatris taps new CEO to lead second phase of business revamp

Bio Pharma Dive

Celgene veteran Scott Smith will take over for Michael Goettler on April 1 as the generic drugmaker prepares for a return to growth after divestitures and the addition of a new eye care division

318
318
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

New patent expiration for Dialysis Sups drug NORMOCARB HF 25

Drug Patent Watch

Annual Drug Patent Expirations for NORMOCARB+HF+25 Normocarb Hf 25 is a drug marketed by Dialysis Sups and is included in one NDA. There is one patent protecting this drug.

article thumbnail

Digital natives: are pharma companies ready?

Pharma Phorum

Engaging digitally native healthcare professionals requires companies to challenge existing business ethos and commit to the customer experience in an increasingly digital world. Life Sciences" HCP Digital

article thumbnail

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.

article thumbnail

US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients.

article thumbnail

Amid industry turbulence, Chroma raises fresh funding to edit the epigenome

Bio Pharma Dive

At a time when many startups have struggled to gain cash, the biotech has raised another $135 million to back its research, a new twist on genetic medicine

Genetics 308

More Trending

article thumbnail

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv

Fierce Pharma

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv kdunleavy Tue, 02/28/2023 - 18:55

Drugs 136
article thumbnail

Merck reports rise in group net sales in fiscal 2022

Pharmaceutical Technology

Merck has reported an increase in group net sales by 12.9% to €22.23bn in fiscal 2022 against €19.68bn in 2021. The growth in sales was driven by all regions and business sectors, particularly Life Science. Organically, the company generated an increase of 6.4% in group sales in fiscal 2022.

Sales 245
article thumbnail

FDA rejects Cytokinetics’ heart failure drug

Bio Pharma Dive

The biotech said the FDA was unconvinced by available study evidence and asked for data from an additional clinical trial, which the company currently does not plan to run

article thumbnail

Barroom (Promotional) Brawl

FDA Law Blog

By Charles D. Snow — As Benjamin Franklin once ( apocryphally ) stated: “Beer is proof that God loves us and wants us to be happy.” And what comes with such a heaven-sent, nourishing beverage? Mainly hangovers and beer bellies, but also fierce marketplace competition and gamesmanship.

article thumbnail

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.

article thumbnail

Hope for Parkinson’s disease and Lewy body dementia patients

Pharma Times

Research into modified RNA messages could help treat diseases and develop new therapies

RNA 129
article thumbnail

US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals and Sanofi ’s Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients.

article thumbnail

FDA clears Intellia to start US tests of ‘in vivo’ gene editing drug

Bio Pharma Dive

The announcement, which follows recent regulatory setbacks for some of Intellia’s peers, is a “big win” for the gene editing field, according to one analyst

article thumbnail

Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul

Fierce Pharma

Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul fkansteiner Wed, 03/01/2023 - 08:40

Insulin 116
article thumbnail

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.

article thumbnail

Amniotics’ PulmoStem receives positive safety data

Pharma Times

Treatment is a lung-specific stem cell therapy designed for hospitalised patients with respiratory infections

116
116
article thumbnail

Resolving challenges with product recovery in biopharma manufacturing

Pharmaceutical Technology

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs.

article thumbnail

Following another trial failure, a brain biotech considers ‘strategic alternatives’

Bio Pharma Dive

Aptinyx has joined a lengthy list of drugmakers looking to cut costs and explore strategic options after hitting setbacks in key clinical studies

Trials 295
article thumbnail

Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit

Fierce Pharma

Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit aliu Wed, 03/01/2023 - 10:03

116
116
article thumbnail

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.

article thumbnail

Positive CHMP opinion for Janssen’s AKEEGA

Pharma Times

If approved company’s prostate cancer therapy will be the first dual-action tablet available in EU

117
117
article thumbnail

FDA issues continuous manufacturing advice to build an agile pharma industry

Pharmaceutical Technology

On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing in drug production.

article thumbnail

Despite study setback, a biotech plans to push tremor drug into late-stage testing

Bio Pharma Dive

An experimental medicine from Praxis Precision Medicines missed the main goal of a Phase 2b trial. But there were also some positive findings, which have encouraged the company to press forward

Medicine 275
article thumbnail

Which pharmaceutical companies have the most drug patents in Serbia?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Serbia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Serbia?

Drugs 98
article thumbnail

Sequana Medical announces positive results for DSR 2.0 candidate

Pharma Times

Extensive phase 1 clinical trial evaluates safety of treatment among peritoneal patients

article thumbnail

The future of diagnosing and monitoring NAFLD/NASH could be noninvasive

Pharmaceutical Technology

The prevalence of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) continues to increase, compounded by risk factors such as advanced age, obesity, ethnicity, and type 2 diabetes mellitus (T2DM).

article thumbnail

Lilly to lower insulin prices by 70%

Bio Pharma Dive

The pharma company, along with its diabetes drug rivals Novo Nordisk and Sanofi, has long been under pressure over the high cost of insulin — scrutiny that has recently ramped up in the U.S.

Insulin 275
article thumbnail

After Historic Hemophilia B Approval, uniQure Targets Huntington’s and ALS

BioSpace

After Historic Hemophilia B Approval, uniQure Targets Huntington’s and ALS 2/27/2023

111
111
article thumbnail

Vital update for Valneva’s COVID-19 vaccine

Pharma Times

European Medicines Agency has issued a positive opinion for the use of VLA2001 among certain adults

Medicine 112
article thumbnail

Venture financing for APAC early-stage innovator drugs raises one-third less than US

Pharmaceutical Technology

Venture financing for early-stage innovator drugs for biotech companies based in the Asia-Pacific (APAC) region between 2018 to 2022 received three times less funding, at $23bn, than their US counterparts, at $72bn, according to GlobalData’s Pharma Intelligence Centre Deals Database.

Marketing 182
article thumbnail

Seagen reportedly in sales talks again, this time with Pfizer

Bio Pharma Dive

Citing people familiar with the talks, The Wall Street Journal reported over the weekend that Pfizer is trying to acquire Seagen and its suite of cancer therapies in a deal that could be worth more than $30 billion

Sales 275
article thumbnail

Sanders urges Sanofi, Novo Nordisk to be like Eli Lilly in reducing insulin prices

Fierce Pharma

Sanders urges Sanofi, Novo Nordisk to be like Eli Lilly in reducing insulin prices kdunleavy Fri, 03/03/2023 - 10:38

Insulin 105
article thumbnail

CN Bio launches single-organ higher throughput system PhysioMimix

Pharma Times

Tech was created to overcome adoption obstacles currently reducing the use of predictive human liver models

111
111
article thumbnail

KFA-115 by Novartis for Melanoma: Likelihood of Approval

Pharmaceutical Technology

KFA-115 is under clinical development by Novartis and currently in Phase I for Melanoma. According to GlobalData, Phase I drugs for Melanoma have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how KFA-115’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

article thumbnail

Vertex tiptoes further into Duchenne research with Tevard deal

Bio Pharma Dive

An alliance with the startup brings Vertex an RNA-based medicine for the disease, adding to a portfolio that already includes a gene editing treatment