Pharmaceutical Technology

MAY 29, 2023

Lexicon senior vice president and chief medical officer Dr Craig Granowitz said: “With today’s FDA approval, Inpefa is now a valuable option for physicians to consider when treating patients transitioning out of the hospital and working to break the cycle of repeated hospitalisation.”

FDA Approval 246

FDA Approval Trials Medicine Drugs 246

Pharmaceutical Technology

AUGUST 8, 2022

A HER2-directed antibody-drug conjugate (ADC), Enhertu is co-developed and marketed by AstraZeneca and Daiichi Sankyo. In July, the companies received Priority Review for their supplemental Biologics License Application (BLA) from the US FDA for Enhertu to treat unresectable or metastatic HER2-low breast cancer.

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

Bio Pharma Dive

JANUARY 20, 2021

The drugmakers could face an uphill battle, however, to market the medicine, which showed a more modest benefit than expected in a key study.

FDA Approval 233

FDA Approval Medicine Drugs Marketing 233

Pharmaceutical Technology

JUNE 21, 2023

It can be used as a monotherapy or along with cholesterol-lowering medicines. It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. It has been designed to target residual inflammation as an underlying cause of ASCVD.

FDA Approval 246

FDA Approval Cardiology Clinical Trials Clinical Trials 246

XTalks

FEBRUARY 25, 2025

Mirum Pharmaceuticals, a biotech innovator known for developing therapies for rare metabolic disorders, now has FDA approval for its new treatment, Ctexli (chenodiol) tablets the first and only medication approved for cerebrotendinous xanthomatosis (CTX) in adults.

FDA Approval 59

FDA Approval Gene Therapy Gene Genetics 59

Pharmaceutical Technology

MAY 1, 2023

“The approval of Uzedy is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market. The regulatory approval is based on the data obtained from the Risperidone Subcutaneous Extended-Release Study (RISE) and the SHINE Phase III trials.

FDA Approval 189

FDA Approval Clinical Trials Clinical Trials Trials 189

Pharmaceutical Technology

JUNE 14, 2023

All six treatments are US Food and Drug Administration (FDA) approved. At market open, shares in Blue Water surged 90% higher than the previous day’s (13 June) market close. The company has a market cap of $20m. The six newly acquired medicines join Entadfi (finasteride and tadalafil) in Blue Water’s portfolio.

FDA Approval 130

FDA Approval Cardiology Marketing Vaccination 130

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). Ipsen is also seeking marketing approval from the European Medicines Agency, with a final decision expected in the second half of 2023.

FDA Approval 130

FDA Approval Genetics Trials Medicine 130

Pharmaceutical Technology

MARCH 27, 2023

It is claimed to be the first and only therapy to receive approval in the US for the treatment of APDS, a rare and progressive primary immunodeficiency. Leniolisib’s marketing authorisation application (MAA) is currently under review with the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA).

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Medicine 130

Pharmaceutical Technology

JULY 1, 2022

Blueprint Medicines has entered strategic financing partnerships for up to $1.25bn with life sciences-focused investors Sixth Street and Royalty Pharma. The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects.

Medicine 147

Medicine Business Development Sales Life Science 147

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

FDA Approval 264

FDA Approval Dermatology Sales Clinical Trials 264

Pharmaceutical Technology

OCTOBER 7, 2022

Additionally, the company granted Sanofi an exclusive right of first negotiation (ROFN) to attain international rights to market teplizumab for T1D indications for a one-time payment of $20m. The ROFN is exercisable by Sanofi until 30 June next year. An anti-CD3 monoclonal antibody, teplizumab is in the developmental stage to delay T1D.

FDA Approval 299

FDA Approval Licensing Licensing Antibody 299

STAT News

NOVEMBER 14, 2022

market in more than seven years, and the first approval of a wholly owned medicine in Immunogen’s 41-year history. The new drug, called Elahere, was developed by Immunogen, a biotech company based in Waltham, Mass. It’s the first new treatment option for advanced ovarian cancer to reach the U.S.

Medicine 98

Medicine FDA Approval Antibody Drugs 98

XTalks

MARCH 10, 2025

The FDA has approved Genentechs TNKase (tenecteplase) for the treatment of acute ischemic stroke in adults, marking a milestone as the first new stroke medicine approved in nearly three decades.

Medicine 59

Medicine Trials Pharmacy Clinical Trials 59

XTalks

JANUARY 21, 2025

The approval makes Datroway AstraZenecas eighth new medicine since 2020, the first US approval for Daiichi Sankyo and AstraZenecas TROP2-directed ADC and the second based on their proprietary DXd technology. The FDA approval sent Daiichi Sankyos shares soaring by 8.7% to 4,437 yen, reflecting investor confidence.

Antibody 105

Antibody FDA Approval HR Trials 105

Pharmaceutical Technology

APRIL 6, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. A recent wave of monoclonal antibodies, including the FDA-approved Eisai / Biogen ’s Leqembi (lecanemab), is expected to shake up the space.

FDA Approval 264

FDA Approval Licensing Licensing Antibody 264

Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). The rarity of disease – 1.36

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

pharmaphorum

NOVEMBER 24, 2020

The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with an infectious person. Xofluza has already been on the market for two years, and already had licensed uses to treat uncomplicated flu and those at high risk of complications.

FDA Approval 105

FDA Approval Medicine Licensing Licensing 105

Pharmaceutical Technology

OCTOBER 1, 2022

Indicated for use as a monotherapy or along with currently approved therapies, Relyvrio can be administered orally by mixing a packet in eight ounces of water. The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

FDA Approval 244

FDA Approval Pharmacy Doctors Doctor 244

pharmaphorum

MAY 16, 2022

GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. The post Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval appeared first on.

FDA Approval 115

FDA Approval Insulin Drugs Hormones 115

Fierce Pharma

FEBRUARY 16, 2024

People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades.

Allergies 119

Allergies FDA Approval Marketing Medicine 119

XTalks

NOVEMBER 27, 2024

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation.

FDA Approval 99

FDA Approval Drugs Gene Trials 99

XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

FDA Approval 105

FDA Approval Protein RNA Clinical Trials 105

XTalks

OCTOBER 16, 2024

Stelara now has a new biosimilar option on the market, as Dong-A ST’s Imuldosa (ustekinumab-srlf) has received approval from the US Food and Drug Administration (FDA) for the treatment of several autoimmune conditions. If approved, the biosimilar will be marketed in the European Union (EU).

FDA Approval 103

FDA Approval Marketing Pharmacy Development 103

XTalks

APRIL 3, 2024

While Soliris had its market launch 17 years ago with $3.2 billion in sales in 2023, Ultomiris was approved in 2018 and generated $3 billion in revenue last year. Competitors in the PNH market include Novartis, which won approval for its factor B inhibitor Fabhalta (iptacopan), the first oral pill for PNH treatment, late last year.

FDA Approval 102

FDA Approval Sales Trials Development 102

XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

FDA Approval 101

FDA Approval Trials Clinical Trials Clinical Trials 101

XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. Duvyzat received Priority Review, Orphan Drug and Rare Pediatric Disease designations from the FDA.

FDA Approval 105

FDA Approval Genetics Gene Therapy Gene 105

XTalks

JUNE 3, 2024

First approved in 2011, Eylea’s market value was estimated to be $8.79 Biocon and Biogen haven’t shared what their interchangeable biosimilars will cost, nor when they will be launched in the US market. In the US, Biogen will market Yesafili. It was also approved in the UK in November 2023.

FDA Approval 98

FDA Approval Sales Clinical Trials Clinical Trials 98

STAT News

OCTOBER 1, 2022

Food and Drug Administration approved a new medicine for ALS from Amylyx Pharmaceuticals, providing a desperately needed new treatment option for a devastating disease , STAT writes. The In a rare commitment, the company has promised to remove the drug from the market if that study is not successful. But be safe.

Medicine 98

Medicine FDA Approval Drugs Clinical Trials 98

Pharmaceutical Technology

JUNE 29, 2022

For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications. However, extended market exclusivity is often associated with high drug pricing and limited patient access.

Drugs 246

Drugs FDA Approval Development Marketing 246

BioSpace

JUNE 11, 2024

Ipsen and Genfit’s elafibranor will now be marketed as Iqirvo and is the first new medicine approved in nearly a decade for the treatment of the rare liver disease, according to the companies.

FDA Approval 90

FDA Approval Medicine Marketing 90

Pharmaceutical Technology

FEBRUARY 10, 2023

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 Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US.

Gene Therapy 263

Gene Therapy Marketing Gene Drugs 263

STAT News

SEPTEMBER 23, 2022

Market share is often held up as the most relevant metric for the success of a biosimilar class. As I write this, there are 38 FDA-approved biosimilars ; 22 of them are commercially available. As I write this, there are 38 FDA-approved biosimilars ; 22 of them are commercially available. In the U.S.,

Marketing 98

Marketing FDA Approval Medicine Production 98

World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

Clinical Trials 234

Clinical Trials Clinical Trials FDA Approval Trials 234

World of DTC Marketing

MARCH 10, 2022

market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech. AbbVie won dozens of additional patents — what critics call a “patent thicket” — that extended the exclusive market for the drug. Sales of Humira earned AbbVie $20.7 The executives at AbbVie make over $300 million.

FDA Approval 205

FDA Approval Drugs Branding Sales 205

XTalks

JANUARY 13, 2023

According to Polarean, Xenoview is the first and only inhaled hyperpolarized MRI contrast agent to reach the market. FDA approval represents achievement of a major milestone for Polarean’s technology.

FDA Approval 105

FDA Approval Packaging Packaging Clinical Trials 105

Pharmaceutical Technology

JULY 28, 2022

The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The therapy received FDA approval in October last year.

Marketing 130

Marketing Gene Therapy FDA Approval Development 130