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.

Drugs 100

Drugs Pharmacy Production Development 100

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.

Sales 104

Sales Licensing Licensing Drugs 104

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.

Compliance 117

Compliance Regulation Manufacturing Licensing 117

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 104

Drugs Sales Antibody FDA Approval 104

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

pharmaphorum

JULY 6, 2021

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. Novartis added inclisiran to its pipeline after buying The Medicines Company, which had licensed the drug from Alnylam, for $9.7

RNA 104

RNA Manufacturing Sales Marketing 104

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

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 104

Drugs Sales FDA Approval Licensing 104

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. Qulipta hasn’t been approved in Europe yet but is following hard on Vydura’s heels, setting up what is expected to be a closely fought battle in the market.

Drugs 98

Drugs Marketing Compliance Licensing 98

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 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).

Licensing 52

Licensing Licensing Sales Production 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.

Development 242

Development Bioequivalency Generic Drugs Production 242

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

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.

Gene Therapy 277

Gene Therapy Licensing Licensing Gene 277

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.

Sales 52

Sales Gene Therapy Marketing Drugs 52

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.

Sales 109

Sales Medicine Drugs Marketing 109

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.

Contamination 145

Contamination Clinical Trials Clinical Trials Protein 145

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

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.

Licensing 52

Licensing Licensing Hormones Drugs 52

pharmaphorum

MAY 4, 2021

Early life science pioneers in foreign markets earned a reputation for lax ethical behaviour, making them a prime target for regulators. When companies target new markets, most will ensure their distribution partners sign legal agreements stating they won’t engage in corrupt practices. . No excuses. Get control back.

Life Science 109

Life Science Compliance Regulation Marketing 109

pharmaphorum

JUNE 16, 2021

Biogen has also come in for steep criticism for its decision to price Aduhelm at $56,000 a year, and gets a broadside from the advocacy group as well, which says the company and its shareholders “undoubtedly are ecstatic about their soon-to-be-reaped windfall profits from sales of the…exorbitantly priced but ineffective drug.”

Clinical Trials 92

Clinical Trials Clinical Trials Marketing Drugs 92

Drug Discovery World

FEBRUARY 1, 2023

It is estimated that there will be 340,000 medicinal cannabis users in Europe in 2022 alone, and the overall market is estiated to grow over 500% over the next three years – with the market value in Germany alone poised to hit over €7 billion by 2027 1. Only with more evidence-backed indications will the medicinal market boom.

Clinical Trials 52

Clinical Trials Clinical Trials Medicine Trials 52

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.

Trials 138

Trials Development Licensing Licensing 138

pharmaphorum

NOVEMBER 30, 2022

As an industry, pharma has specific needs; it is driven by targeted regulations and rules and has not been well served by technology. Prioritisation and the evolution of the sales, medical, and marketing triumvirate. Together with Matt Wallach, Gassner began with the life sciences, and they never looked back.

Life Science 98

Life Science Pharma Companies Sales Marketing 98

pharmaphorum

APRIL 16, 2021

The launch environment was directly impacted by the COVID-19 pandemic, which hit two key drivers of launch uptake particularly hard: the dynamic market, i.e. new and switch prescriptions, and face-to-face interactive engagement with healthcare professionals. We measured the pandemic impact on the launch of NAS at four levels.

Sales 95

Sales Marketing Medicine Doctors 95

pharmaphorum

MAY 14, 2021

This article appears in our digital magazine, Deep Dive: Market Access 2021. Long headquartered in London, the EU drug regulator is now severed from the country both physically and systematically, with its base now in Amsterdam and the UK now assessing drugs through its own regulatory agency, MHRA. appeared first on.

Marketing 57

Marketing Regulation Medicine Life Science 57

Creogenic Pharma

APRIL 15, 2023

This includes knowledge of whether they are looking for specific products or are open to negotiation on prices, their professional background and experience in the pharmaceutical industry, their plans for starting a business, and their sales turnover if they are already associated with other pharma franchise companies.

Production 40

Production Sales Doctors Doctor 40

FDA Law Blog

AUGUST 17, 2022

Thus, only self-fitting hearing aids need to be cleared by FDA prior to marketing; regular OTC hearing aids—ones that are customizable based on user preference—do not, and consumers must rely on FDA postmarket enforcement activities to ensure safety and effectiveness of OTC hearing aids (more on that later).

Licensing 40

Licensing Licensing Regulation Marketing 40

Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

Medicine 52

Medicine Scientist Production Regulation 52

pharmaphorum

APRIL 24, 2022

Biogen has given up on seeking approval for its Alzheimer’s disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it clear the current data for the drug is not sufficient to get it past the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Drugs 52

Drugs Regulation Clinical Trials Clinical Trials 52

pharmaphorum

MAY 25, 2022

Vtama (tapinarof) – originally developed by GlaxoSmithKline – is a first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) and has been approved by the US regulator with a broad label spanning mild, moderate, and severe psoriasis and an unlimited duration of use.

Drugs 52

Drugs FDA Approval Licensing Licensing 52

pharmaphorum

DECEMBER 7, 2021

The Commission is however thought to be the first regulator to award full regulatory approval to the IL-6 inhibitor. Sales in the first nine months of the year rose by 30% to CHF 2.69 Sales in the first nine months of the year rose by 30% to CHF 2.69 In the same period of 2019, before the pandemic, sales were CHF 1.7

Sales 52

Sales Drugs Medicine Licensing 52

pharmaphorum

DECEMBER 16, 2022

There are already rules that dictate how countries should react against public health events that have the potential to traverse country borders, through the International Health Regulations.

Vaccination 96

Vaccination Vaccine Production Licensing 96

FDA Law Blog

DECEMBER 21, 2021

AAM argued that AB 824 violates the dormant Commerce Clause by regulating out-of-state conduct; is preempted by federal patent law in view of FTC v. in which none of the parties, the agreement, or the pharmaceutical sales have any connection with California,” in violation of the doctrine. Actavis , 510 U.S.

Sales 40

Sales Regulation Manufacturing Drugs 40

FDA Law Blog

DECEMBER 21, 2021

AAM argued that AB 824 violates the dormant Commerce Clause by regulating out-of-state conduct; is preempted by federal patent law in view of FTC v. in which none of the parties, the agreement, or the pharmaceutical sales have any connection with California,” in violation of the doctrine. Actavis , 510 U.S.

Sales 40

Sales Regulation Manufacturing Drugs 40

The Pharma Data

OCTOBER 27, 2020

Pharmaceutical-Grade Hand Sanitizer Available for Sale Across Canada. For bulk / commercial sales of DermSafe please contact one of our Canadian distributors or email us directly at info@ovationscience.com. According to Statista.com in late 2019, e-commerce retail trade sales amounted to almost 1.85 Forward-Looking Statements.

Sales 52

Sales Production Drug Delivery Development 52

XTalks

DECEMBER 29, 2022

This highlights potentially new marketing trends that life science companies may have to start looking into if they haven’t already. In 2022 alone, the US regulator approved four new gene therapies, showing the high interest in getting these therapies to market. 4. Social Media Marketing.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52