XTalks

APRIL 3, 2024

billion in sales in 2023, Ultomiris was approved in 2018 and generated $3 billion in revenue last year. In 2023, its second year on the market, the drug earned $91 million in sales. According to Jefferies analyst Peter Welford, Voydeya’s peak annual worldwide sales in PNH could hit $759 million.

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FDA Approval Sales Trials Development 102

Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Drug establishment licensing.

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Regulation Drugs Vaccination Vaccine 52

Pharma in Brief

MARCH 21, 2022

3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 ( IO No. 3 also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim orders. Interim Order No. 1 and IO No. 2 was set to expire on March 1, 2022. Links: Interim Orders.

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Sales Regulation Manufacturing Licensing 52

Pharmaceutical Technology

JANUARY 2, 2023

The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. It is developed based on MyoKardia's drug discovery platform.

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Drugs Pharmacy Production Development 100

The Pharma Data

JANUARY 18, 2021

For the study, researchers looked at young adults in Los Angeles County before and after retail sale of recreational marijuana was legalized in California. People with a higher number of licensed marijuana outlets within four miles of home were more likely to have used pot in the past month, the survey showed. © 2021 HealthDay.

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Licensing Licensing Sales Regulation 52

Pharma in Brief

JANUARY 19, 2023

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments ). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1 , is open until March 27, 2023. We previously reported on the IO here.

Drugs 52

Drugs Regulation Clinical Trials Clinical Trials 52

XTalks

JANUARY 29, 2021

Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Keytruda (Pembrolizumab) and Opdivo (Nivolumab).

Clinical Trials 104

Clinical Trials Clinical Trials Production Trials 104

pharmaphorum

JULY 25, 2022

AstraZeneca and Daiichi Sankyo will hear back from the FDA before the end of 2022 on their license application for Enhertu in HER2-low breast cancer – an indication which could drive the drug into multibillion-dollar sales territory.

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Sales Regulation Licensing Licensing 58

Pharmaceutical Technology

JANUARY 31, 2023

Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1). The regulator has also cleared the investigational new drug (IND) application for APB-102.

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Gene Therapy Licensing Licensing Gene 277

Pharma Business Blog

MAY 10, 2020

Animal nutrition company BIOMIN America was fined by more than $250’000 for coordinating sales of agricultural commodities to a company in Cuba without authorization from OFAC (US Office of Foreign Assets Controls). BIOMIN identified this structure as being consistent with the US sanctions regulations.

Compliance 52

Compliance Licensing Licensing Sales 52

pharmaphorum

APRIL 19, 2022

The US regulator has kicked off a priority review of Enhertu (trastuzumab deruxtecan) as a treatment for NSCLC with HER2 mutations after prior systemic therapy, setting up a decision in the third quarter of this year. billion licensing deal for the drug in 2019. That was more than double the amount made in the previous year.

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Sales Licensing Licensing Drugs 105

pharmaphorum

MAY 30, 2022

It has been eight years since Sanofi licensed rights to an over-the-counter version of erectile dysfunction (ED) drug Cialis from Eli Lilly, and the FDA has just thrown a spanner into its plans to bring it to market in the US. Terms of that license deal have not been disclosed.

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Licensing Licensing Marketing Sales 58

The Pharma Data

DECEMBER 13, 2020

. Relay Therapeutics will receive $75 million upfront and is eligible to receive an additional $25 million in near-term payments and $695 million in additional potential milestones, plus royalties on global net product sales. sales and up to $410 million in additional ex-U.S. CAMBRIDGE, Mass., About RLY-1971.

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Licensing Licensing Clinical Trials Clinical Trials 40

FDA Law Blog

FEBRUARY 4, 2022

Part 205 (Guidelines for State Licensing of Wholesale Prescription Drug Distributors). As the title suggests, the Proposed Rule sets national licensing standards for both federal and state licensure for WDDs and 3PLs. For the time being, WDDs and 3PLs with state licensing obligations should continue to renew their current licenses.

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Licensing Licensing Drugs Pharmacy 40

pharmaphorum

SEPTEMBER 23, 2022

At the same time, the US regulator has converted the earlier accelerated approval for Retevmo (selpercatinib) in NSCLC into a full license, making Lilly’s drug the first and only RET inhibitor to have a traditional approval in NSCLC, according to David Hyman, Lilly’s chief medical officer.

Drugs 58

Drugs Sales Regulation Licensing 58

pharmaphorum

DECEMBER 28, 2022

In turn, the acquiring company will help the novel drugs navigate the complexities and costs of regulations and benefit from market access and economies of scale. Companies must comply with the regulations, but how compliance is achieved can be somewhat different. Looking beyond balance sheets. Post-acquisition compliance.

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Compliance Regulation Manufacturing Licensing 118

The Pharma Data

MARCH 30, 2021

There can be no guarantee that the FAP targeting agents, including FAPI-46 and FAPI-74, will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time.

Protein 52

Protein Licensing Licensing Containment 52

Pharma in Brief

JULY 22, 2021

2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 ( IO No. 1 to facilitate expedited evaluations by Health Canada of abbreviated applications for the importation or sale of medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Medical Device Regulations , SOR/98-282.

Sales 52

Sales Regulation Licensing Licensing 52

pharmaphorum

AUGUST 24, 2021

The US regulator has cleared Cara Therapeutics’ Korsuva (difelikefalin) as an injectable treatment for chronic itching, also known as pruritus, in these patients after a priority review. It’s also in line for up to $240 million in US sales-based milestones.

Drugs 105

Drugs Sales FDA Approval Licensing 105

pharmaphorum

DECEMBER 23, 2021

The US regulator issued Novartis with a complete response letter (CRL) for inclisiran a year ago, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy. It will be launched in the US in January, said Novartis. It has a long way to go.

Drugs 105

Drugs Sales Antibody FDA Approval 105

pharmaphorum

JULY 16, 2021

French drugmaker Ipsen has made another foray into the Parkinson’s disease category, licensing rights to an oral dopamine D3 receptor antagonist from Sweden’s IRLAB for $28 million upfront. . It is due to readout in the first half of next year.

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Licensing Licensing Cosmetics Drugs 89

pharmaphorum

DECEMBER 22, 2021

CFI regulates the activity of the complement immune system which is over-activated in GA. Last year, it also signed a licensing deal with Dyno Therapeutics for its AAV capsid-based gene delivery technology focused on ocular diseases. It has been fast-tracked by the FDA.

Gene Therapy 105

Gene Therapy Gene Licensing Licensing 105

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks.

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pharmaphorum

JULY 6, 2021

The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy. Analysts at EvaluatePharma have suggested it could make $2 billion a year in 2026.

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RNA Manufacturing Sales Marketing 105

The Pharma Data

NOVEMBER 4, 2020

Bactiguard’s growth strategy for the coming five-year period up to 2025 is based on a continued roll-out of Bactiguard’s technology, with a focus on new license agreements and a broader product portfolio. We have several interesting licensing projects ongoing and see new, exciting business opportunities. unchanged).

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Licensing Licensing Sales Production 52

pharmaphorum

JANUARY 4, 2022

Spinal muscular atrophy (SMA) therapy Spinraza has been a key earner for Biogen in recent years, but with sales now heading into reverse, the company is looking to extend its franchise. The arrival of Zolgensma was followed by a decline in Spinraza’s sales during 2020, particularly in the US.

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Sales Gene Therapy Marketing Drugs 52

pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront.

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Drugs Licensing Licensing Trials 75

pharmaphorum

AUGUST 16, 2022

Immunomedics had licensed the rights to the drug in Asian markets to Everest in 2019 for $65 million upfront and with up to $710 million in potential milestones, including $65 million due on US approval. The new deal means that the licensing deal has been terminated, and the Chinese pharma is no longer on the hook for any remaining payments.

Licensing 52

Licensing Licensing Hormones Drugs 52

pharmaphorum

JULY 26, 2022

Regulators in the US and Europe have started to review Novartis’ biosimilar version of Biogen’s big-selling multiple sclerosis therapy Tysabri, which could reach the market next year. The subcutaneous version still needs to be administered by a healthcare professional.

Sales 52

Sales Marketing Drugs Licensing 52

The Pharma Data

NOVEMBER 17, 2020

Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . Humans as well as cats and dogs can be affected. . “We Source link.

Immune Response 52

Immune Response Licensing Licensing Sales 52

pharmaphorum

MARCH 19, 2021

The company said that Microtox BT already satisfies many of the criteria set out in a document published by the UK regulator, setting out standards for COVID-19 breath tests. It has licensed in a patented breathalyser, the analysts noted.

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Contamination Clinical Trials Clinical Trials Protein 145

pharmaphorum

APRIL 20, 2021

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . billion in sales in 2028. billion by 2028. While it requires a clinic visit, Ocrevus only has to be administered twice a year.

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Sales Medicine Drugs Marketing 110

pharmaphorum

OCTOBER 27, 2022

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. “We look forward to working closely with US regulators to advance vamorolone towards approval,” he added.

Drugs 98

Drugs Marketing Licensing Licensing 98

pharmaphorum

JUNE 1, 2021

Novo Nordisk – which is already active in stem cell therapies with a candidate in early development for type 1 diabetes – is on the hook for up to $598 million in total licensing and milestone payments plus royalties on sales if HS-001 reaches the market. Other readouts give grounds for optimism.

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Trials Development Licensing Licensing 138

Druggist

FEBRUARY 28, 2021

In other words, melatonin acts as a biological clock that regulates sleep. Melatonin, therefore, can be used to promote and regulate sleep (Wagner et al., In the UK, licensed forms of melatonin are prescribed either for the management of insomnia in adults over 55 years of age or to help with jet lag. Can buy melatonin abroad?

Pharmacy 98

Pharmacy Licensing Licensing Medicine 98

Drug Discovery World

SEPTEMBER 14, 2023

Excluding Covid-19 medicines, total revenue increased 16% and product sales increased 15%. For Sanofi, second quarter 2023 sales growth of 3.3% AstraZeneca saw total revenue reach $22,295m, up 4% despite a decline of $2,181m from Covid-19 medicines. at CER and business EPS growth of 8.1% Specialty care grew 11.8% Vaccines were up 9.1%

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Drugs Vaccination Vaccine Medicine 59

pharmaphorum

APRIL 28, 2022

billion licensing deal with Biohaven for rights to oral migraine drug rimegepant is approaching a payoff after the European Commission approved the drug. Pfizer’s $1.2

Drugs 98

Drugs Marketing Compliance Licensing 98