Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials. A fully human anti-IL-7R?

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Development Clinical Trials Clinical Trials FDA Approval 130

pharmaphorum

NOVEMBER 10, 2021

The agreement includes a sizeable $500 million upfront payment, reflecting that Nurtec ODT (rimegepant) is already FDA-approved for treating acute migraine with and without aura in adults, and for prevention of episodic migraine in patients who suffer less than 15 headache days per month.

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Licensing Licensing Drugs Sales 52

Pharmaceutical Technology

JANUARY 19, 2023

While allogeneic hematopoietic stem cell transplants (HSCT) provide long-term benefit to a subset of AML patients, other cell therapy modalities such as natural killer (NK) cells or chimeric antigen receptor (CAR)-T cells have failed to show conclusive benefit in late-stage clinical trials.

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Marketing Gene Editing Production Sales 130

XTalks

MAY 29, 2024

The multiple myeloma drug recently received US Food and Drug Administration (FDA) approval in earlier treatment settings. Products like electrophysiology devices, contact lenses and surgical products were major drivers of sales in this area. billion on R&D in 2023, representing almost 18 percent of the year’s sales.

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Pharma Companies Sales FDA Approval Vaccination 52

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

FDA Approval 52

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

pharmaphorum

NOVEMBER 24, 2021

Takeda has scored the first-ever FDA approval of a treatment for refractory cytomegalovirus (CMV) infections in organ transplant patients, which can lead to an increased risk of complications and even death. Originally developed by GlaxoSmithKline, it was licensed to ViroPharma, which was subsequently bought put by Shire.

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Drugs Sales FDA Approval Licensing 105

Pharmaceutical Technology

OCTOBER 28, 2022

In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. Merck, known outside of the US and Canada as MSD, is developing its portfolio of pneumococcal vaccines , and has secured an FDA approval for the paediatric use of its 15-serotype vaccine Vaxneuvance in June.

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Vaccination Vaccine Marketing Bacteria 162

pharmaphorum

SEPTEMBER 15, 2021

If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who cannot or do not want to take hormone therapy, as well as options for those women happy to do so, according to ObsEva. If approved, ObsEva’s drug will add another once-daily competitor to the ring.

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Hormones Drugs FDA Approval Sales 98

pharmaphorum

AUGUST 24, 2021

One of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – chronic itching – now has an FDA-approved treatment. It’s also in line for up to $240 million in US sales-based milestones.

Drugs 105

Drugs Sales FDA Approval Licensing 105

pharmaphorum

OCTOBER 27, 2022

GSK has said it will not be able to move ahead with regulatory filings for otilimab as a treatment for rheumatoid arthritis (RA), after it failed to show the desired level of efficacy in two phase 3 trials. GSK licensed otilimab from German biotech MorphoSys in 2013 in a deal valued at up to €423 million, including around €23 million upfront.

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Sales Antibody FDA Approval Trials 97

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif.,

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

pharmaphorum

NOVEMBER 21, 2022

The US FDA approved the anti-CD3 antibody to delay the onset of stage 3 T1D in patients aged eight years and older who are currently diagnosed with stage 2 disease – a population estimated by Provention to be around 30,000 in the US. There is a much larger undiagnosed T1D stage 2 population that could number around 1.4

Drugs 116

Drugs Insulin FDA Approval Sales 116

pharmaphorum

JANUARY 9, 2023

Albireo secured approval in the US and Europe for the ileal bile acid transport inhibitor (IBATi) drug in 2021 for the treatment of pruritus (itching) in patients with rare disorder progressive familial intrahepatic cholestasis (PFIC), and has said sales should reach $24 million this year. billion deal. billion deal.

Licensing 52

Licensing Licensing Sales FDA Approval 52

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis added inclisiran to its pipeline after buying The Medicines Company – which had licensed the drug from Alnylam – for $9.7 It has a long way to go.

Drugs 105

Drugs Sales Antibody FDA Approval 105

pharmaphorum

MARCH 22, 2022

Bavarian Nordic has licensed rights to its respiratory syncytial virus (RSV) vaccine in China and certain other Asian markets to Shanghai’s Nuance Pharma in a $225 million deal. million tied to clinical, regulatory, and commercial milestones as well as royalties on sales if MVA-BN RSV is launched in those markets.

Vaccination 52

Vaccination Vaccine Marketing Trials 52

pharmaphorum

NOVEMBER 10, 2022

Clovis Oncology has said it may not have enough cash to fund continuing operations beyond January next year, as it struggles to reverse a decline in sales of PARP inhibitor Rubraca. Sales were around $140 million in 2019, and climbed to $165 million the following year, despite the impact of the pandemic.

Sales 59

Sales FDA Approval Licensing Licensing 59

pharmaphorum

APRIL 10, 2022

The jury in the US District Court for the Eastern District of Texas agreed with the biotech that the infringement was wilful, awarding it a sum based on past royalties that should have been paid on Enhertu sales in the US to date. billion licensing deal for the drug in 2019. That could be a sizeable sum.

Sales 52

Sales Antibody FDA Approval Drugs 52

pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). Tasigna made sales of $1.56 Scemblix could beef up Novartis’ CML portfolio, which remains a big earner for the company.

Drugs 115

Drugs FDA Approval Trials Licensing 115

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. At its peak sales, Qalsody is expected to generate around $300 million for Biogen. The recommended dosage of Qalsody is 100 mg (15 mL) per administration. What is SOD1 -ALS?

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FDA Approval Gene Genetics Protein 89

pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Symbicort brought in worldwide sales of $2.7 billion last year, with $1.1

FDA Approval 59

FDA Approval Generic Drugs Marketing Drug Delivery 59

pharmaphorum

APRIL 5, 2022

AstraZeneca’s take on the PCSK9 inhibitor – an antisense drug licensed from Ionis six years ago – has cleared a proof-of-concept trial in high-risk patients with high blood cholesterol, but it remains to be seen where it will fit into the increasingly busy category. billion in sales by 2027, ahead of Repatha at $2.2

Drugs 52

Drugs Antibody Sales FDA Approval 52

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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Development Bioequivalency Generic Drugs Production 242

The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. In addition, Sosei Heptares will be eligible to receive tiered royalties on net sales of products resulting from the collaboration. Vlad Coric , M.D.,

Licensing 40

Licensing Licensing Production Development 40

pharmaphorum

NOVEMBER 23, 2022

In trials, it cut the annualised bleed rate for patients, as well as reducing their need for regularly injected Factor IX replacement therapies. We are incredibly proud to announce the FDA approval of the world’s first #genetherapy for #hemophiliaB. link] pic.twitter.com/QWy0WgNGQu.

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Gene Therapy Gene FDA Approval Trials 59

pharmaphorum

MAY 24, 2021

While there are plenty of EGFR-targeting drugs on the market for NSCLC, Rybrevant is the first to be FDA-approved for patients with exon 20 mutations, and also represents Janssen’s first lung cancer therapy. billion last year from its approved indications in EGFR-mutated NSCLC.

FDA Approval 52

FDA Approval Antibody Drugs Marketing 52

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

Antibody 52

Antibody Trials Production Clinical Trials 52

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

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Licensing Licensing FDA Approval Clinical Trials 111

pharmaphorum

FEBRUARY 2, 2021

At the moment, there are no FDA-approved treatments for patients who have progressed after first-line chemo for this “historically neglected, yet important, tumour,” according to Icyte’s head of immuno-oncology Lance Leopold. Despite SCAC being a rare disease, its incidence is increasing and its impact is profound,” he added.

FDA Approval 40

FDA Approval Drugs Trials Licensing 40

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. REGN-COV2 was well tolerated in the trial. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

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Antibody Trials Production Clinical Trials 40

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). Product Sales Performance. Key results include: Total revenues increased 5% to $6.5

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Sales Production Antibody Development 52

The Pharma Data

NOVEMBER 5, 2020

net sales increased 11% to $1.32 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints.

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Sales Production Manufacturing Antibody 52

FDA Law Blog

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. That did not happen.

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Production Drugs FDA Approval Compliance 59

pharmaphorum

SEPTEMBER 8, 2022

Last year, the company signed two deals in quick succession, which saw it form a licensing deal worth $1.3 billion acquisition of Endocyte in 2018 , with estimations that sales could reach $600 million in this first indication alone. billion with Artios Pharma and with iTheranostics for a number of diagnostic radiopharmaceuticals.

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Manufacturing Development Drugs Antibody 105

Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1.

Medicine 52

Medicine Scientist Production Regulation 52

XTalks

DECEMBER 29, 2022

As of December 16, 2022, there are seven US Food and Drug Administration (FDA) approved gene therapies. In 2022 alone, the US regulator approved four new gene therapies, showing the high interest in getting these therapies to market. In 2023, a number of gene therapies are expected to get the FDA green light.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52

XTalks

NOVEMBER 28, 2023

Samsung Bioepis was the first company to receive FDA approval for both high-concentration and low-concentration formulations of adalimumab biosimilar. However, it is important for all stakeholders to realize that the FDA interchangeability designation is a legal distinction, not a clinical one.

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