Bio Pharma Dive
DECEMBER 12, 2022
After outlasting rival suitors Sanofi and J&J in deal talks, Amgen agreed to a deal that values the Ireland-based maker of rare and inflammatory disease drugs at about $28 billion.
Pharmaceutical Technology
DECEMBER 12, 2022
Pipeline therapies within the cardiometabolic space have recently gathered interest following the 20th World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC) Hybrid Conference, which took place on 1–3 December. The spotlight was placed on many up-and-coming pharmacotherapies within the space, one of which was Amgen’s obesity therapy, AMG-133, following the company’s announcement of its Phase I therapy results last week, on 1 December.
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Bio Pharma Dive
DECEMBER 12, 2022
Roche’s subsidiary Spark has offered few updates on its hemophilia A treatment since being acquired in 2019. New data at ASH show the therapy can maintain levels of a key blood-clotting protein for years.
Pharmaceutical Technology
DECEMBER 12, 2022
Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. The alliance will utilise the capabilities of both firms, including international cell therapy leadership and manufacturing of Kite.
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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
Bio Pharma Dive
DECEMBER 12, 2022
The year’s biggest meeting on blood diseases kicked off this past weekend. Here are three of the most important storylines to emerge from the past few days of presentations.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 12, 2022
A systematic review of the scientific literature has found preliminary evidence that hearing aids could help keep the human brain young and fit as a person ages. When researchers in Singapore reviewed eight long-term studies on adults who are hard of hearing, they found participants who wore hearing aids were 19 percent less likely to […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 12, 2022
The Subject Expert Committee (SEC) for Reproductive and Urology, which advices the nation’s drug regulator on clinical studies and approvals, has recommended approval for the State-run HLL Lifecare Ltd to manufacture and market graphene condom, the next generation thinner; and stronger condom that is expected to improve the acceptability of the male contraceptive product.
Bio Pharma Dive
DECEMBER 12, 2022
The biotech is still waiting to treat its first commercial patient with Zynteglo, but says it has not seen insurers deny coverage for the beta thalassemia drug.
Pharmaceutical Technology
DECEMBER 12, 2022
In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Pharmaceutical companies often outsource different parts of the manufacturing process, including the production of small molecule active pharmaceutical ingredients (APIs) and parenteral packaging, to contract manufacturi
Bio Pharma Dive
DECEMBER 12, 2022
Perhaps best known for its marketed PARP inhibitor Rubraca, the cancer drugmaker is now in the process of reorganizing its debt and selling off assets.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
DECEMBER 12, 2022
Health Canada has granted approval for Swedish Orphan Biovitrum (Sobi) affiliate Sobi North America’s Empaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare hematologic ailment. The treatment is indicated for such patients with insufficient response to, or are not tolerant to, a C5 inhibitor. The latest development is based on the findings from the head-to-head Phase III PEGASUS clinical trial of Empaveli in PNH patients.
Bio Pharma Dive
DECEMBER 12, 2022
The pharmaceutical industry is dynamic and rapidly evolving. To compete, companies must learn to leverage the pace of change as an accelerator for both shareholder returns and patient outcomes.
Medical Xpress
DECEMBER 12, 2022
Reasons underlying hesitancy to get vaccinated against COVID-19 may be associated with increased risks of traffic accidents according to a new study in The American Journal of Medicine. Researchers found that adults who neglect these health recommendations may also neglect basic road safety. They recommend that greater awareness might encourage more COVID-19 vaccination.
Bio Pharma Dive
DECEMBER 12, 2022
This podcast series explores how to help small and mid-sized companies get innovative treatments to the people who need them.to help small and mid-sized companies get innovative treatments to the people who need them.
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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.
STAT News
DECEMBER 12, 2022
This Wednesday will mark two years since nurse Sandra Lindsay became the first person in the U.S. to receive a Covid-19 vaccine outside of a clinical trial. A study released Tuesday by the Commonwealth Fund shows that in those two years, the Covid vaccines have averted over 3 million deaths in the U.S. The Centers for Disease Control and Prevention estimates that more than 1 million Americans have died from Covid-19 since the onset of the pandemic.
Bio Pharma Dive
DECEMBER 12, 2022
What healthcare trends biopharma leaders should pay attention to in 2023 and how to set yourself up for success.
NPR Health - Shots
DECEMBER 12, 2022
A KHN investigation found when some Medicare Advantage plans got a rare federal audit, they couldn't produce billing records for care they said they'd provided. Some blamed fire, flood — or doctors.
Bio Pharma Dive
DECEMBER 12, 2022
Learn about the investment landscape for life science companies, heading into 2023.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
NPR Health - Shots
DECEMBER 12, 2022
The pandemic put infectious diseases doctors in the spotlight. The 'Fauci Effect' raised the number of fellowship applicants in 2020, but this year almost half of the training programs went unfilled.
Bio Pharma Dive
DECEMBER 12, 2022
Two bispecific antibodies are “foundational” to the company’s plan to build an oncology business, according to a top executive. But Regeneron will have to surpass a crowd of competitors.
STAT News
DECEMBER 12, 2022
Type “Ehlers-Danlos syndromes” into a search engine, and multiple suggestions pop up. Is Ehlers-Danlos an autoimmune disease? Is EDS hereditary? Rare? Then, the algorithm might suggest: Is Ehlers-Danlos syndrome a disease?
Medical Xpress
DECEMBER 12, 2022
Researchers at UC San Francisco (UCSF) have engineered molecules that act like "cellular glue," allowing them to direct in precise fashion how cells bond with each other. The discovery represents a major step toward building tissues and organs, a long-sought goal of regenerative medicine.
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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.
NPR Health - Shots
DECEMBER 12, 2022
International aid groups are warning of a catastrophic food crisis, as Somalia faces what could be its worst drought in 40 years. Nearly 2 million children are suffering from malnutrition.
STAT News
DECEMBER 12, 2022
Curative rose to prominence during the throes of the pandemic, as people and governments across the country used its Covid-19 tests. But that business is now firmly in the past, and the company has switched to an even more regulated industry: health insurance. Last year, Curative had a cloud hanging over its head. It got into trouble with the Food and Drug Administration and states, which said the company’s tests led to too many false negatives, meaning the tests may have told patients th
NPR Health - Shots
DECEMBER 12, 2022
The winners confronted stigma and health equity in some countries with their tech ideas to help LGBTQI+ youth reach out for help and let women access private OB-GYN care.
STAT News
DECEMBER 12, 2022
A coalition of pharmaceutical industry and academic medical research associations based in Germany is calling for the indefinite suspension of a new European system to register clinical trials, citing “serious shortcomings” that need to be fixed. In a strongly worded statement released late last month, the organizations expressed concern that the clinical trial information system, or CTIS, suffers from “deficiencies” that have only worsened since it debuted this past
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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.
Medical Xpress
DECEMBER 12, 2022
Investigators from the Smidt Heart Institute at Cedars-Sinai validated the link between a debilitating heart condition and COVID-19 and, to a lesser extent, a novel link between the same condition and COVID-19 vaccination.
STAT News
DECEMBER 12, 2022
Amgen said Monday it would purchase Horizon Pharmaceuticals for $27.8 billion, marking the latest bet by a large pharmaceutical company on the lucrative market for treating a rare disease. The deal is the largest pharma merger announced this year, and it represents the most that Amgen has spent on an acquisition since its $16 billion purchase of Immunex in 2001.
Medical Xpress
DECEMBER 12, 2022
The incidence rate of infective endocarditis—a rare but often fatal inflammation of the heart valves—among patients with cocaine use disorder or opioid use disorder increased from 2011 to 2022, with the steepest increase occurring from 2021 to 2022, a new study reports. Study findings contribute to expanding evidence of endocarditis as a significant and growing health concern for people who inject drugs, and further demonstrate that this risk has been exacerbated during the COVID-19 pandemic.
pharmaphorum
DECEMBER 12, 2022
In a fresh update, Bloomberg has reported that US biotech Amgen Inc. has agreed to purchase Dublin-based Horizon Therapeutics Plc. for €24.7 billion ($26bn), in a deal which could yet see further delays or a breakdown in negotiations. Following Sanofi’s withdrawal from the running, stating that “transaction price expectations do not meet [their] value creation criteria” – for the purposes of Rule 2.12 of the Irish Takeover Rules in response to Horizon’s announcement under Rule 2.4 of the I
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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