XTalks

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. It is the first FDA-approved SGLT2 inhibitor for any animal species. What is the Animal Drug Regulatory Process?

FDA Approval 52

FDA Approval Drugs Life Science Cosmetics 52

Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn.

Sales 130

Sales Insulin Marketing FDA Approval 130

pharmaphorum

JANUARY 28, 2021

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. million patients.

Marketing 119

Marketing Insulin HR Production 119

XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. In the US, it is estimated that 1.45 million people are currently living with type 1 diabetes.

Insulin 97

Insulin Drugs FDA Approval Immune Response 97

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

Drug Discovery World

JULY 7, 2023

It’s been a fascinating week in drug discovery, as AstraZeneca announced that its Phase III trial of datopotamab deruxtecan did not meet its second primary endpoint and saw an 8% drop in its stock market value as a result. The post This week in drug discovery (3-7 July) appeared first on Drug Discovery World (DDW).

Drugs 52

Drugs FDA Approval Insulin Gene 52

pharmaphorum

NOVEMBER 21, 2022

The company argues that the cost is justified as Tzield (teplizumab) is the first drug that can delay the onset of type 1 diabetes, fending off the time when they become highly reliant on insulins and at risk of the serious complications that can accompany advanced T1D. It also has an option on global marketing rights to the drug.

Drugs 116

Drugs Insulin FDA Approval Sales 116

Drug Discovery World

JULY 10, 2023

It’s been a fascinating week in drug discovery, as AstraZeneca announced that its Phase III trial of datopotamab deruxtecan did not meet its second primary endpoint and saw an 8% drop in its stock market value as a result. You can listen below, or find The Drug Discovery World Podcast on Spotify , Google Play and Apple Podcasts.

Insulin 52

Insulin FDA Approval Drugs Trials 52

Drug Discovery World

JULY 10, 2023

It’s been a fascinating week in drug discovery, as AstraZeneca announced that its Phase III trial of datopotamab deruxtecan did not meet its second primary endpoint and saw an 8% drop in its stock market value as a result. You can listen below, or find The Drug Discovery World Podcast on Spotify , Google Play and Apple Podcasts.

Insulin 52

Insulin FDA Approval Drugs Trials 52

FDA Law Blog

AUGUST 12, 2021

Koblitz — About two weeks ago, FDA made an exciting announcement (and it remains exciting even if we’re late posting about it): FDA approved the first interchangeable biosimilar. Thus, though Semglee is not new to the market, it is for the first time substitutable for Lantus without intervention of a health care provider.

Insulin 98

Insulin Production FDA Approval Marketing 98

pharmaphorum

APRIL 1, 2022

Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their promising potential to usher in competition, increase access, and drive down costs for patients—and the U.S. market is just beginning to heat up. Innovator products working to maintain market share.

Marketing 59

Marketing Pharmacy FDA Approval Manufacturing 59

pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

pharmaphorum

FEBRUARY 21, 2022

Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival therapies from AstraZeneca and Johnson & Johnson.

Drugs 122

Drugs Trials Insulin FDA Approval 122

XTalks

FEBRUARY 21, 2024

Recently, Eli Lilly revealed promising results from a mid-stage trial, indicating that its popular drug, tirzepatide (marketed as Zepbound and Mounjaro for weight loss and diabetes, respectively), may be an effective treatment for the fatty liver disease metabolic dysfunction-associated steatohepatitis (MASH).

Clinical Trials 59

Clinical Trials Clinical Trials Trials Insulin 59

Pharmaceutical Technology

DECEMBER 22, 2022

AstraZeneca and Daiichi Sankyo win the Business Expansion award this year as their collaboration bears more fruit in terms of new approvals. Financing recognises companies and institutions that have raised significant capital during the research period whether it be through corporate finance, the capital markets or fund raising.

Insulin 130

Insulin Production Development Genetics 130

XTalks

NOVEMBER 3, 2022

Eli Lilly is finding itself in an enviable position with its newly launched diabetes injection Mounjaro (tirzepatide) and blockbuster diabetes med Trulicity due to temporary shortages of competitor Novo Nordisk’s diabetes drug Ozempic (semaglutide). Lilly is also looking to pitch Mounjaro as an obesity drug and directly take on Novo’s Wegovy.

Sales 98

Sales FDA Approval Production Insulin 98

STAT News

NOVEMBER 18, 2022

The first therapy that delays the onset of type 1 diabetes received approval from the U.S. Food and Drug Administration , CNN tells us. The monoclonal antibody teplizumab, which will be marketed under the brand name Tzield and is from ProventionBio and Sanofi, is given through intravenous infusion. As of 2019, about 1.9

Insulin 98

Insulin FDA Approval Production Pharmacy 98

XTalks

OCTOBER 11, 2023

While the link between GLP-1 inhibitors and gastrointestinal side effects has been known for diabetics taking the drugs, this is the first study that was conducted among non-diabetics taking them for weight loss. Rybelsus is Novo’s third semaglutide product on the market, a tablet form of the drug used for the treatment of type 2 diabetes.

Drugs 59

Drugs Insulin Hormones FDA Approval 59

STAT News

DECEMBER 5, 2022

Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK, Roche, and others to remake plans for their drugs or pull them from the market , The Wall Street Journal notes. Food and Drug Administration. ” And the U.S.-based

Insulin 52

Insulin Manufacturing Medicine Drugs 52

pharmaphorum

FEBRUARY 18, 2021

Drug prices to plummet in wave of expiring patents”. These are just three headlines that come up when you Google “drug patent expiry”. It’s no wonder “loss of exclusivity (LOE)” or “the patent cliff” is an ominous prospect for drug manufacturers – shrouded in the threat of job losses and falling share prices.

Branding 52

Branding Insulin Sales FDA Approval 52

The Pharma Data

AUGUST 17, 2021

approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020.

Insulin 52

Insulin FDA Approval Doctors Doctor 52

Roots Analysis

FEBRUARY 22, 2022

Further, in order to improve the quality of life in these patients, companies have developed novel devices capable of delivering a variety of formulations of different drugs / therapies, in an efficient and relatively simple manner. Autoinjector As Emerging Drug Delivery Device. Rising Need of Autoinjectors – Roots Analysis.

Drug Delivery 52

Drug Delivery Production Marketing Development 52

The Pharma Data

DECEMBER 28, 2020

Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. Jack Zhang, commented: “This approval is yet another milestone for the Company and marks the first-ever FDA approval of a generic version of rDNA Glucagon.

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

Roots Analysis

JANUARY 14, 2024

With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally. Like all drugs, biologics are regulated by the FDA.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Protein Bacteria 40

XTalks

NOVEMBER 9, 2022

Glucagon-like peptide-1 (GLP-1) receptor agonists are a newer class of diabetes drugs that have the potential to double as weight loss drugs, widening their lucrative market potentials. While weight loss effects can vary depending on the drug, studies show that all GLP-1 meds can result in an average weight loss of about 10.5

Insulin 98

Insulin Hormones FDA Approval Sales 98

pharmaphorum

MARCH 3, 2022

Non-profit drugmaker Civica Rx has said it will launch biosimilars of three big-selling insulin products in the US by 2024 to help diabetic patients struggling with the cost of the drugs. Cheaper options are meanwhile becoming available.

Insulin 52

Insulin Production Generic Drugs FDA Approval 52

XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

Drug Discovery World

JULY 13, 2023

Following the death of a cancer patient after they were given an unlicensed drug, Diana Spencer unpacks the practice of prescribing unlicensed and off-label medicines. This month, a cancer patient died and three others were hospitalised in the UK after they were administered an unlicensed version of the chemotherapy drug cabazitaxel.

Drugs 94

Drugs Medicine Regulation Licensing 94

pharmaphorum

MARCH 23, 2022

The US Senate will vote in the coming weeks on whether to introduce a $35 cap on the monthly cost of insulin to patients that was endorsed by President Joe Biden in his 2022 State of the Union address. Assuming the bill is later passed by the Senate and signed into law by President Biden, the insulin cap would take effect beginning in 2023.

Insulin 75

Insulin Generic Drugs Production FDA Approval 75

Camargo

OCTOBER 14, 2020

The second guidance, “ ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs ,” deals with the not uncommon situation wherein an ANDA application has received tentative approval because of a Paragraph III patent certification in the original application.

Development 196

Development Insulin Drug Delivery Production 196

XTalks

FEBRUARY 2, 2023

Amgen’s Amjevita, the first biosimilar version of AbbVie’s blockbuster arthritis injection Humira (adalimumab), has finally hit the market this week after fetching US Food and Drug Administration (FDA) approval back in 2016. Sandoz’s Hyrimoz will follow suit in September.

Marketing 52

Marketing FDA Approval Branding Drugs 52

XTalks

SEPTEMBER 17, 2020

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. In the case of the former, pharmaceutical and biologics companies would be eligible for approval of their product through traditional regulatory pathways; the latter could support accelerated approval.

Trials 98

Trials Gene Hormones Clinical Trials 98

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. 2022 Revenue: Pfizer reported an annual revenue of $100.33 Pfizer Inc.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Drug Discovery World

JANUARY 11, 2023

Supported by landmark clinical data from a Phase III trial, next-in-class anti-Aβ monoclonal antibody (MAb) lecanemab appears poised for full US FDA approval and ex-US launches. Part of a set of emerging therapies with novel mechanisms of action, it will contribute to the growing market share held by these therapies. .

Drugs 52

Drugs Development Trials Antibody 52

XTalks

JUNE 12, 2023

The US Food and Drug Administration (FDA) granted approval to four of Medtronic’s cardiovascular product offerings, further expanding the company’s foothold in this sector. Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor. It also plans to launch these products in the US.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

pharmaphorum

OCTOBER 19, 2021

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention.

Sales 40

Sales Production Insulin FDA Approval 40

Pharmacy Checkers

OCTOBER 9, 2020

There is no end to my fascination over the new authorized pathways for wholesale and personal importation of lower cost drugs from Canada and many other counties. Last week, I wrote about the request for proposals from HHS on personal drug importation; the week prior, about the certification of Section 804 for wholesale imports from Canada.

Insulin 85

Insulin Manufacturing FDA Approval Drugs 85