Fierce Pharma

JUNE 21, 2023

After Merck and Bristol Myers Squibb took shots at the Inflation Reduction Act (IRA) in separate lawsuits, influential trade group Pharmaceutical Research and Manufacturers of America (PhRMA)—plus | Trade group PhRMA is the latest to go after the IRA in a lawsuit claiming violations of the Fifth and Eighth amendments. The suit follows similar legal efforts by Merck and Bristol Myers Squibb.

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European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital. It is the first anti-inflammatory cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with establ

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Food and Drug Administration Medicine FDA Food 121

Fierce Pharma

JUNE 21, 2023

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will vote this afternoon on recommendations for the use of new respiratory syncytial virus (RSV) | The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will vote this afternoon on recommendations for the use of new RSV shots from GSK and Pfizer.

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MedCity News

JUNE 21, 2023

A new startup named Zuri Fertility recently launched. Its platform provides resources for patients who are trying to conceive — including telehealth, at-home testing, prescriptions, mental health services, education and care coordination.

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Fierce Pharma

JUNE 21, 2023

The PARP inhibitor class is welcoming its second FDA approval in prostate cancer in the span of several weeks. The new approval, for Pfizer, is broader than the first but still limited. | The PARP inhibitor class is welcoming its second FDA approval in prostate cancer in the span of several weeks. The new approval, for Pfizer, is broader than the first but still limited.

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease. LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease.

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Food and Drug Administration FDA Prescription Food 98

MedCity News

JUNE 21, 2023

Oura — a company selling a ring that tracks peoples’ biometrics — announced new partnerships with three providers of continuous glucose monitors: January, Supersapiens and Veri. These companies will now be receiving sleep scores and other biometric data from Oura so they can see how these measurements affect users’ glucose levels and overall health.

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PharmaTimes

JUNE 21, 2023

Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes

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MedCity News

JUNE 21, 2023

While the average lifespan for Americans is 77.9 years, Americans are living only 65.9 years in good health. A new Deloitte report shows that if changes are made, Americans’ average lifespan could reach 90 years by 2040, with 85 of those years being in good health.

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Healthcare Healthcare 95

Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. The delivery candidate, called TPU-006, delivers dexmedetomidine for up to four days. Dexmedetomidine is a common non-opioid analgesic that activates alpha-2 receptors, which inhibits the release of noradrenaline and subsequent propagation of pain signals.

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Food and Drug Administration Pharma FDA Food 80

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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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MedCity News

JUNE 21, 2023

Scientists at Empress Therapeutics say molecules that co-evolved with humans over millennia are a promising source of new drugs. With its AI-driven technology platform, the Flagship Pioneering-founded startup finds them.

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PharmaTech

JUNE 21, 2023

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

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MedCity News

JUNE 21, 2023

Losing sight of organizational goals and priorities and operating without a clear, supported plan can lead to a scatter-shot approach to AI investment that may duplicate investments, misallocate resources, and cause stakeholders to become cynical about AI’s value and potential.

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PharmaTimes

JUNE 21, 2023

During research there were not any clinically-relevant adverse events or psychotomimetic effects - News - PharmaTimes

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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

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MedCity News

JUNE 21, 2023

Highmark Health has been launching a series of initiatives to support the “food as medicine” movement, including a program that provides some West Virginia residents with debit cards to purchase healthy food at Dollar General stores.

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Food Medicine 87

PharmExec

JUNE 21, 2023

Collaboration to focus on personalized medicine in the United Arab Emirates capital.

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Medicine 98

MedCity News

JUNE 21, 2023

I interview Punit Singh Soni, CEO of Suki and Niall O’Connor, CTO, Cohere Health to evaluate two areas where AI can have an outsize impact: clinical documentation and prior authorization.

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PharmExec

JUNE 21, 2023

Biopharma aims to strengthen field engagement with healthcare professionals.

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Biopharma Pharma Healthcare Healthcare 98

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Pharmaceutical Commerce

JUNE 21, 2023

Initiative to support developing manufacturers launch new products.

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Manufacturing 98

Scott’s Directories

JUNE 21, 2023

The healthcare industry is constantly evolving, with new technologies and advancements shaping the way medical professionals operate. For businesses operating in the health and wellness sector, it is crucial to stay updated with the latest trends and innovations to effectively reach their target audience. In today’s digital age, having a strong online presence is essential for success, and utilizing innovative B2B marketing tactics can give businesses a competitive edge.

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Pharma Leaders

JUNE 21, 2023

The US Food and Drug Administration (FDA) has accepted bluebird bio’s Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy and granted priority review for the product’s use in the treatment of sickle cell disease (SCD). Bluebird is seeking approval for treating a rare genetic disease, SCD, in patients aged 12 years and above having a history of vaso-occlusive events.

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Food and Drug Administration FDA Prescription Food 52

Rep-Lite

JUNE 21, 2023

Job interviews are crucial milestones in one’s career journey. They offer the opportunity to showcase your skills, experience, and passion for a particular role. At Rep-Lite, where we pride ourselves on talent sourcing for medical sales, clinical, and service teams, we understand the significance of job interviews in finding the perfect fit for both candidates and companies.

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Medical sales Medical Sales Recruitment 52

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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.

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Referral MD

JUNE 21, 2023

Referral management is a critical aspect of healthcare delivery, ensuring that patients receive timely and appropriate care from the right providers. However, the referral process can be complex and prone to errors, leading to delays, patient dissatisfaction, and increased healthcare costs. To address these challenges, healthcare organizations need to implement end-to-end referral management solutions that integrate referral tracking , prior authorization, patient notification, and provider cons

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Pharma Leaders

JUNE 21, 2023

Eli Lilly and Company has signed a definitive agreement to acquire a biopharmaceutical company DICE Therapeutics. Under the deal terms , Lilly will begin a tender offer to purchase all outstanding shares of DICE for an acquisition price of $48 per share in cash, which translates to a total of about $2.4bn that is payable at closing of the deal. This deal has secured approval from the boards of directors of both the companies.

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Clarivate

JUNE 21, 2023

The passage of the European Artificial Intelligence Act (AIA) is a huge step toward new compliance requirements for many medical devices. It also added to the daunting regulatory complexity the industry faces, coming on top of the new Medical Device Regulation (MDR) efforts and investment, which went into force in May 2021. The European Parliament passed draft AI Act legislation on June 14, despite the protestations of industry bodies such as MedTech Europe , the Confederation of European Busine

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Pharmaceutical Technology

JUNE 21, 2023

PharmaTher and Vitruvias Therapeutics have entered a collaboration deal to commercialise PharmaTher’s Ketarx (racemic ketamine) in the US. Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list.

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Distribution FDA Specialization Sales 52

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Clarivate

JUNE 21, 2023

Economic headwinds are forcing Intellectual Property (IP) legal teams to evaluate strategies and spend with more scrutiny, including their patent maintenance strategy. Within this blog, we highlight five strategies to help corporate teams make better patent portfolio decisions. In 2023, ongoing inflation and the potential of a recession are never far from mind.

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Pharmaceutical Technology

JUNE 21, 2023

The Drug Controller General of India (DCGI) has granted emergency use authorisation (EUA) for Gennova Biopharmaceuticals’ Omicron-specific mRNA-based Covid-19 booster vaccine, GEMCOVAC-OM. GEMCOVAC-OM was developed using indigenous platform technology. The project was supported under the Mission Covid Suraksha, which has been implemented by India’s Biotechnology Industry Research Assistance Council (BIRAC).

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PharmaTech

JUNE 21, 2023

PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.

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Manufacturing Pharmaceutical 52

Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted approval to Pfizer’s Talzenna (talazoparib) along with Xtandi (enzalutamide) for prostate cancer. The combination therapy is indicated to treat homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) in adult patients. Talzenna is an oral inhibitor of poly ADP-ribose polymerase (PARP) that plays a role in repairing DNA damage.

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Food and Drug Administration FDA Safety Food 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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