Fierce Pharma

APRIL 17, 2023

In Pfizer's $43B acquisition of Seagen, the biotech's patience paid off kdunleavy Mon, 04/17/2023 - 11:34

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MedCity News

APRIL 17, 2023

Innovaccer launched a new product called Sara, a conversational AI assistant designed to help executives at health systems and payers make better use of their data. It allows executives can ask complex questions about their organization’s patients or members and get immediate answers on clinical, financial or operational metrics.

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Fierce Pharma

APRIL 17, 2023

After going all-in on blood cancer therapy, Gamida Cell scores big win at FDA kdunleavy Mon, 04/17/2023 - 16:19

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MedCity News

APRIL 17, 2023

Talkiatry is now available to Horizon Healthcare Services’ commercial members at no additional cost, giving 3.6 million people access to the virtual mental health services. The company treats patients ages 5 years and older for conditions including anxiety, depression and bipolar disorder.

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Healthcare Healthcare Patients 106

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Fierce Pharma

APRIL 17, 2023

The end of an era: Regeneron chairman Roy Vagelos to retire after 29-year run aliu Mon, 04/17/2023 - 10:18

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Pharmaceutical Technology

APRIL 17, 2023

Merck has signed a definitive agreement to buy clinical-stage biotechnology firm Prometheus Biosciences for $10.8bn, strengthening its immunology pipeline. The company will buy all of Prometheus Biosciences’ outstanding shares for $200 a share through a subsidiary. Prometheus Biosciences uses precision medicine to discover, develop and commercialise new therapeutic and companion diagnostic products to treat immune-mediated diseases.

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Engineering Medicine Patients Leads 105

MedCity News

APRIL 17, 2023

The FDA approved Omisirge, an allogeneic cell therapy from Gamida Cell that could improve access to stem cell transplants as treatments for blood cancers. The biotech makes its therapy from umbilical cord blood.

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Fierce Pharma

APRIL 17, 2023

After period of tumult, Amarin names new interim CEO and board member zbecker Mon, 04/17/2023 - 11:20

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PharmExec

APRIL 17, 2023

J&J's Janssen Pharmaceutica NV collaborates with Pipeline Therapeutics in a $50 million licensing deal for oral MS drug PIPE-307, with potential earnings of up to $1 billion for Pipeline.

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MedCity News

APRIL 17, 2023

Clear, a company founded to help travelers breeze through airport security lines, is now pursuing partnerships with health systems. Georgia-based Wellstar Health System recently announced it will use the company’s identity verification technology to give patients secure and seamless access to their personal health information.

Patients 101

Patients 101

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Pharmaceutical Technology

APRIL 17, 2023

NKGen Biotech, a clinical-stage natural killer (NK) cell therapy firm, has signed a definitive agreement to combine its business operations with Graf Acquisition. NKGen Biotech will become a publicly traded company, while Graf will be rebranded as NKGen Biotech. Graf is also anticipated to be listed on the New York Stock Exchange, NYSE American and Nasdaq under the ticker symbol ‘NKGN’.

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MedCity News

APRIL 17, 2023

Express Scripts released several new solutions last week that aim to improve drug price transparency, including a cap on out-of-pocket costs for prescription drugs for consumers. The news comes amid increasing scrutiny against pharmacy benefit managers.

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Tribeca Knowledge

APRIL 17, 2023

I n our new report Market Access 2023, we consider how a rapidly changing market access environment presents the biopharm aceutical industry with complex challenges to launch success and enhanced patient outcomes. Without mastering these challenges, companies risk seeing potentially transformative products, nurtured through years of effort and investment, left stranded in limbo between market entry and uptake.

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Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). Serving as a joint meeting of the Psychopharmacologic Drugs AdCom and the Peripheral and Central Nervous System Drugs AdCom, experts from the committees voted nine against one in support of Rexulti’s supplemental New Drug

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FDA Safety Food Medicine 96

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Distribution

European Pharmaceutical Review

APRIL 17, 2023

Merck & Co. Inc has agreed to acquire Prometheus Biosciences for $10.8 billion. The agreement is set to help advance PRA023, a novel humanised monoclonal antibody (mAb), developed by Prometheus. Its chosen indications are ulcerative colitis (UC) and Crohn’s disease (CD) and other autoimmune conditions. Prometheus is a clinical-stage biotechnology company.

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MedCity News

APRIL 17, 2023

Merck is acquiring Prometheus Biosciences and a lead drug candidate in development for inflammatory bowel disorders. The deal comes as Merck looks for drug prospects that could make up for revenue declines facing blockbuster seller Keytruda, which faces patent expirations in coming years.

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European Pharmaceutical Review

APRIL 17, 2023

A report on automation in the biopharma industr y has shown that the market is projected to grow at a compound annual growth rate (CAGR) of 5.7 percent during the forecast period 2023-2033. The market’s overall world revenue value will exceed $1,855.0 million in 2023, according to the data. Factors impacting the automation in the biopharma industry market The report found that 75 percent of pharmaceutical organisations want to use automated solutions more frequently.

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Biopharma Manufacturing Pharmaceutical products Marketing 92

MedReps

APRIL 17, 2023

It always helps to be prepared when heading into an interview for a medical sales job. Those who want to have all of their bases covered should definitely be ready to answer the following ten questions. All of them have appeared in medical sales interviews in the past and are common enough to be asked in the future. So, what are these top ten questions?

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Medical sales Sales Medical Medical sales reps 86

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Safety

European Pharmaceutical Review

APRIL 17, 2023

The combination treatment allowed the optimal numbers of stem cells to be harvested in over 92 percent of patients after two collection procedures.” When used in combination with standard stem cell therapy, motixafortide significantly increased the number of stem cells that can be harvested, results from an international Phase III trial for multiple myeloma (MM) suggest.

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Pharmaceutical Technology

APRIL 17, 2023

Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The vaccine will be used to prevent lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in adults aged 60 and above. Immunising pregnant women will also prevent these diseases in infants from birth up to six months.

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Food and Drug Administration Government Medicine Food 64

Copyright Clearance Center

APRIL 17, 2023

The post London Book Fair Takes Climate Action appeared first on Copyright Clearance Center.

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PharmaTimes

APRIL 17, 2023

Efti’s targeting activation of antigen-presenting cells delivers an adaptive immunity to fight cancer

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Specialization

Pharmaceutical Technology

APRIL 17, 2023

US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. STS101 combines Satsuma’s nasal powder formulation and Shin Nippon Biomedical Laboratories’ (SNBL) delivery device technology, which was licensed by Satsuma.

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Food and Drug Administration FDA Food Pharmaceutical 59

PharmaTimes

APRIL 17, 2023

Group B streptococcus vaccine study will involve adult groups with and without underlying conditions

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Pharmaceutical Technology

APRIL 17, 2023

Akthelia Pharmaceuticals and the University of Iceland have received a €6m European Union (EU) Horizon Grant for the IN-ARMOR project. The project aims to combat antimicrobial resistance (AMR), identified as one of the top 10 global health challenges by the World Health Organisation (WHO). AMR and multi-drug resistance are said to result in the deaths of more than five million people per year.

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Safety Medicine Pharma Medical 59

Scott Burrows

APRIL 17, 2023

According to the latest market research data, the current valuation of the U.S. oral care market is around $34 billion with a projected valuation of somewhat over $51 billion by 2030. As a motivational dental sales keynote speaker, I know most observers might say, “A growth rate of nearly 5.5% is pretty darn good.

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Sales Marketing Medical sales Medical 52

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Legacy MEDSearch

APRIL 17, 2023

Precision Optics Corporation, Inc. (NASDAQ: POCI ), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, today announced the appointment of medical device and aerospace/defense industry manufacturing veteran, Mahesh Lawande, as the Company’s Chief Operating Officer effective April 24, 2023.

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Engineering Manufacturing Electronics Medical 52

PharmaVoice

APRIL 17, 2023

Gain a deep understanding of the analytical challenges that gene therapy developers face, and how a strategic partnership with a specialized CRO can offer a competitive advantage in accelerating timelines and improving program success.

Specialization 52

Specialization Competition 52

Pharmaceutical Technology

APRIL 17, 2023

Australian pharmaceutical company Incannex has appointed Quest Pharmaceutical Services (QPS) to advance CannQuit-N (Nicotine), CannQuit-O (Opioid) and Renecann Products in the USA and the European Union (EU). QPS was established in 1995 to provide bioanalytical LC-MS/MS contract services. The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases.

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Food and Drug Administration Management Food Pharmaceutical 52

Pharma Leaders

APRIL 17, 2023

Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease. Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease.

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FDA Pharmacology Medicine Leads 52

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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