Fierce Pharma

JULY 28, 2023

On Monday during a quarterly earnings call, when Biogen CEO Chris Viehbacher was asked about the company’s potential to execute M&A, he randomly offered “we’ve got, I think, about $7.3 billion | Biogen has revealed a proposal to acquire Reata Pharmaceuticals for $7.3 billion. The Texas-based rare disease specialist brings newly approved Skyclarys, the first treatment for the neurologic disorder Friedreich’s ataxia with peak sales potential of $1.5 billion.

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Sales Pharmaceutical 239

MedCity News

JULY 28, 2023

The food as medicine movement is gaining momentum, but there are several challenges, according to a PitchBook report. These challenges include resistance to diet restrictions and difficulty in tracking compliance.

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Food Medicine Medical 92

Fierce Pharma

JULY 28, 2023

Is AstraZeneca planning to peel off its China business? By CEO Pascal Soriot’s response to that question, it may only a contingency plan. | Is AstraZeneca planning to peel off its China business? By CEO Pascal Soriot’s response to that question, it may only be a contingency plan.

Sales 201

Sales 201

European Pharmaceutical Review

JULY 28, 2023

Publication of results of the Phase III SKYLARK study “is a pinnacle moment in treating postpartum depression ( PDD ),” stated Dr Kristina M Deligiannidis, Professor at the Institute of Behavioral Science at the Feinstein Institutes, the trial’s principal investigator, lead author of the paper. The study investigated oral 50mg, 14-day neuroactive steroid zuranolone pill as a treatment for perinatal or postpartum depression.

Food and Drug Administration 90

Food and Drug Administration Food Safety FDA 90

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Fierce Pharma

JULY 28, 2023

Teva’s CEO Richard Francis is adding to his constellation of new executives with a fresh business development hire from BeiGene. | Teva has enlisted BeiGene's Angus Grant, Ph.D, as its EVP of business development, the Israeli-American generics giant announced Friday. It was during Grant's tenure as chief business executive that BeiGene signed the high-profile PD-1 and TIGIT pacts with Novartis.

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Impetus Digital

JULY 28, 2023

A version of this article was previously published on PharmaPhorum. It has been many years since “ patient-centricity ” first started being thrown around by life science companies. However, it’s only recently that most companies are actually starting to prioritize patient engagement. The act of directly engaging with patients and patient advocates has quickly shifted from an occasional nice-to-have to a must-have if brands want to stay competitive in the increasingly crowded marketplace.

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Patients Education Pharma Competition 90

MedCity News

JULY 28, 2023

Biogen’s Reata Pharmaceuticals acquisition brings Skyclarys, the first and only FDA-approved therapy for the rare neuromuscular disease Friedreich’s ataxia. Biogen says Skyclarys complements the other neuromuscular drugs in its portfolio.

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Pharmaceutical FDA Biopharma Pharma 86

European Pharmaceutical Review

JULY 28, 2023

AstraZeneca has announced that Sharon Barr will succeed Mene Pangalos as Executive Vice President, BioPharmaceuticals R&D. Pangalos will step down from his role in early 2024 due to retirement. His length of service with the company totals almost fourteen years. Sharon Barr brings over 18 years of industry experience into her new role and will be responsible for discovery through to late-stage development.

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Medicine Patients Pharma Pharmaceutical 83

Pharmaceutical Technology

JULY 28, 2023

NS Pharma’s candidate would be the first to target Duchenne Muscular Dystrophy (DMD) patients amenable to exon 44 skipping therapy.

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Pharma Patients 98

MedCity News

JULY 28, 2023

Executives from Geisinger and UNC Health discussed the most impactful ways they have deployed predictive AI across their health systems during a recent virtual panel. At Geisinger, these predictive algorithms are reducing avoidable emergency department admissions, and at UNC, they are helping to identify sepsis before it becomes severe.

Management 79

Management Healthcare Healthcare 79

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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.

Safety

PharmExec

JULY 28, 2023

Pandemic preparedness and curbing PBMs among the pending legislation that will have to wait until after summer recess.

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PharmaVoice

JULY 28, 2023

Head honchos at the biggest pharma companies reporting second-quarter earnings dig into the topics du jour.

Pharma 96

Pharma 96

Pharmaceutical Commerce

JULY 28, 2023

CDMO’s Turku addition will span over 69,000 square feet and support the production of ATMPs.

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Manufacturing 98

Copyright Clearance Center

JULY 28, 2023

The Texas “Reader Act” requires book vendors to review any book that could be sold into a school.

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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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Pharmaceutical Commerce

JULY 28, 2023

The pharma and biotech exec will begin his role on Aug. 1.

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Pharma 98

PharmaTimes

JULY 28, 2023

Mage Biologics aims to progress a novel, orally administered monoclonal antibody - News - PharmaTimes

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Legacy MEDSearch

JULY 28, 2023

RIVANNA ® , developers of imaging-based medical solutions, announced that they have received funding totaling $30.5 million over 39 months from early execution of an option by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).

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Recruitment Medical FDA Management 52

PharmaTimes

JULY 28, 2023

The vital second batch represents a critical step on the candidate’s pathway to regulatory approval - News - PharmaTimes

Manufacturing 67

Manufacturing 67

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Safety

PharmExec

JULY 28, 2023

In this exclusive Q&A, Alice Valder Curran, life sciences regulatory expert and partner, Hogan Lovells LLP, shares her perspective on the biggest drug pricing challenges today, current efforts to lower drug pricing, and the Inflation Reduction Act.

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Pharmaceutical Technology

JULY 28, 2023

Senator Bernie Sanders has proposed price caps on drugs developed with federal funds, following a political career battling against high drug prices.

Pharma 52

Pharma 52

Pharmaceutical Commerce

JULY 28, 2023

Pandemic preparedness and curbing PBMs among the pending legislation that will have to wait until after summer recess.

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Pharmaceutical Technology

JULY 28, 2023

Bristol Myers Squibb has reported revenues of $11.2bn in the second quarter of 2023, versus $11.8bn in Q2 2022, indicating a drop of 6%.

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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 Commerce

JULY 28, 2023

William Fletcher brings his serialization and traceability knowledge to the healthcare solutions company.

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Healthcare Healthcare 52

Pharmaceutical Technology

JULY 28, 2023

InSilicoTrials has entered a partnership with Axoltis Pharma for the advancement of therapeutic solutions for neurological disorders.

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Pharma 52

Pharmacy Times

JULY 28, 2023

Author of the book The Journey’s End discusses how extending life at all costs takes away time that patients could be spending with their families during the last moments of their life.

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Patients 49

Pharmaceutical Technology

JULY 28, 2023

Carmell Therapeutics has entered a definitive agreement and plan of merger with the regenerative medicine company Axolotl Biologix.

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Medicine 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

Leads

Pharmacy Times

JULY 28, 2023

A new study indicates that adults with obesity or who are overweight with weight-related comorbidities can help manage their weight with lifestyle changes in conjunction with specified treatment.

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Management 49

Pharmaceutical Technology

JULY 28, 2023

Gilead Sciences has received approval from EC for Trodelvy, for pre-treated HR-positive, HER2-negative metastatic breast cancer.

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Pharmacy Times

JULY 28, 2023

It was previously undetermined whether the combination of IVIG and ICI would lead to patient complications or reduced efficacy of the cancer treatment, but 2 successful case reports dispel that belief.

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Patients Leads 49

Pharmaceutical Technology

JULY 28, 2023

As several economies deal with inflation, there has been a reduction in deals involving contract manufacturing organisations.

Manufacturing 52

Manufacturing 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.

Management