Pharmaceutical Technology

MARCH 31, 2023

It will also receive an additional $15m in milestone payments, upon receipt of US FDA approval for an additional indication. in sales-related milestone payments, along with tiered royalties on sales across all indications. The company will receive up to $245.5m Additionally, GSK will pay up to $242.5m

Sales 130

Sales FDA Approval Clinical Trials Clinical Trials 130

XTalks

DECEMBER 18, 2024

Ingrezza (valbenazine), first approved in 2017 for tardive dyskinesia, received a key label expansion in 2023 to include the treatment of chorea in patients with Huntingtons disease. Neurocrines hit drug generated $613 million in sales during the third quarter and is projected to reach $2.3 billion in revenue by 2024.

Genetics 116

Genetics Hormones Trials Drugs 116

pharmaphorum

AUGUST 18, 2021

Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. . TALi is also in line for royalties on sales.

Licensing 64

Licensing Licensing Sales FDA Approval 64

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.

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

AUGUST 16, 2022

Q32 will also receive tiered royalty payments on net sales. In July, the US Food and Drug Administration (FDA) approved Horizon’s supplemental Biologics License Application for Krystexxa (pegloticase) plus methotrexate, to aid uncontrolled gout patients attain a complete response to treatment. A fully human anti-IL-7R?

Development 130

Development Clinical Trials Clinical Trials Regulation 130

pharmaphorum

NOVEMBER 15, 2022

Lantheus’ pipeline-building drive in radiopharma has continued with a $260 million upfront deal to license rights to two oncology candidates from POINT Biopharma. billion in milestone payments to POINT if the two radiotherapeutics get FDA approval and meet commercial objectives, plus royalties on net sales.

Licensing 52

Licensing Licensing FDA Approval Trials 52

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.

Vaccination 162

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. Linzagolix is not currently approved anywhere in the world.

Hormones 98

Hormones Drugs FDA Approval Sales 98

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.

Licensing 52

Licensing Licensing Drugs Sales 52

Pharmaceutical Technology

JANUARY 19, 2023

However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000. NiCord’s biologics license application is currently being investigated by the FDA with a review date set by May 2023.

Marketing 130

Marketing Gene Editing Production Sales 130

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

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. It also has an option on global marketing rights to the drug.

Drugs 116

Drugs Insulin FDA Approval Sales 116

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

Pharmaceutical Technology

JANUARY 6, 2023

This class-action litigation specifically focused on a 2011 licensing agreement between the two companies. Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic.

Doctors 242

Doctors Doctor Drugs Sales 242

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. Related Articles: Danyelza (naxitamab-gqgk) FDA Approval History. NEW YORK, Nov. Source link.

FDA Approval 52

FDA Approval Production Clinical Trials Clinical Trials 52

Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. This figure represents a 2.4% increase over the 2016–2020 period average.

Drugs 130

Drugs Pharma Companies Medicine Production 130

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 Containment 115

XTalks

JULY 10, 2023

“Ignoring drug-approval requirements provides the defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Novo’s FDA-approved prescription semaglutide products include Wegovy for chronic weight management, and Ozempic and Rybelsus for type 2 diabetes.

Pharmacy 90

Pharmacy FDA Approval Licensing Licensing 90

XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. The GLP-1 drug market is on its way to becoming one of the most lucrative pharmaceutical markets.

Pharmacy 104

Pharmacy Drugs Production Sales 104

pharmaphorum

OCTOBER 27, 2022

It’s a disappointing outcome for a programme that GSK said in 2021 could potentially generate £1 to £2 billion in peak sales because of the serious unmet need in RA patients. GSK licensed otilimab from German biotech MorphoSys in 2013 in a deal valued at up to €423 million, including around €23 million upfront.

Sales 97

Sales Antibody Drugs Trials 97

XTalks

JULY 6, 2021

As part of the deal with Nestlé, Seres will receive license payments of $175 million up front with an additional $125 million upon FDA approval of the drug. The agreement also includes sales target milestones which, if achieved, could total up to $225 million, Seres outlined in a news release from the company.

Marketing 105

Marketing Drugs Bacteria FDA Approval 105

pharmaphorum

SEPTEMBER 26, 2022

In May, the Delaware court sided with Hospira and ruled that three patents Astellas is relying on for Lexiscan market exclusivity in the US – 8,106,183; 8, 524,883; and RE47301 – are not infringed by Hospira’s generic, which was submitted for FDA approval in 2018. It was first launched in the US in 2008.

Production 52

Production FDA Approval Licensing Licensing 52

The Pharma Data

DECEMBER 9, 2020

.–( BUSINESS WIRE )– Advanced Bionics (AB) , a global leader in cochlear implant technology, in collaboration with Phonak, a leading provider of life-changing hearing solutions, receives FDA approval and announces it is bringing Marvel hearing technology to Advanced Bionics cochlear implant wearers. Life is on. Gifford, R.

FDA Approval 52

FDA Approval Production Development Licensing 52

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 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 Drugs FDA Approval 52

XTalks

JUNE 12, 2023

Abbott Laboratories reported that the sales from its Diagnostics and Medical Device divisions in 2022 surpassed the company’s initial forecast. The remarkable performance in 2022 was driven largely by the sales of COVID-19 testing kits, including the BinaxNOW COVID-19 Ag test and its at-home self-test version. percent from $27.06

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

pharmaphorum

JANUARY 4, 2023

The Japanese pharma and Gilead Sciences – which licensed US rights to Lexiscan to the Japanese company – won a temporary reprieve against the launch of the generic back in the autumn, winning a temporary stay on launch until 6 December. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

FDA Approval 59

FDA Approval Sales Marketing Licensing 59

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

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

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. Vlad Coric , M.D.,

Licensing 40

Licensing Licensing Production Development 40

pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder.

Drugs 52

Drugs FDA Approval Licensing Licensing 52

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

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

pharmaphorum

NOVEMBER 23, 2022

We are incredibly proud to announce the FDA approval of the world’s first #genetherapy for #hemophiliaB. The approval keeps uniQure in pole position over its closest rival in the haemophilia B gene therapy race, Pfizer/Roche, whose fidanacogene elaparvovec candidate is in the BENEGENE-2 trial, due to generate results in 2023.

Gene Therapy 59

Gene Therapy Gene FDA Approval Trials 59

FDA Law Blog

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. 353b(a). Section II at 2. Draft Guidance III.B.2(e)

Drugs 52

Drugs Production Manufacturing Licensing 52

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.

FDA Approval 40

FDA Approval Drugs Trials Licensing 40

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.

Production 98

Production Marketing Development Pharmacy 98