Bio Pharma Dive
OCTOBER 4, 2022
Chroma Medicine, which launched last year with $125 million in funding, has drawn several high-profile biotech leaders to it, including ex-Alnylam CEO John Maraganore and deal maven George Golumbeski.
Pharmaceutical Technology
OCTOBER 4, 2022
Pfizer has acquired commercial-stage biopharmaceutical firm Biohaven Pharmaceutical for $148.50 for each share or a total consideration of nearly $11.6bn in cash. In May, Pfizer entered a definitive agreement to acquire all outstanding shares of Biohaven which were not previously held by the former. . With the takeover, Biohaven became a wholly-owned Pfizer subsidiary.
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Bio Pharma Dive
OCTOBER 4, 2022
AstraZeneca paved the way for PARPs in prostate cancer when it won an approval for Lynparza in advanced patients. Now Pfizer may have a combination treatment for earlier-stage disease.
Pharmaceutical Technology
OCTOBER 4, 2022
The type 2 diabetes (T2D) space recently witnessed a new approval: on 15 September, the European Commission (EC) authorised Eli Lilly’s Mounjaro (tirzepatide) for T2D patients. Mounjaro is a dual gastric inhibitory polypeptide (GIP)/glucagon-like peptide 1 (GLP-1) receptor agonist. This event is of paramount interest, and not only for T2D patients, as it could address vital unmet needs for other GIP/GLP-1 receptor agonist–treated diseases, including obesity.
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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
OCTOBER 4, 2022
Cellarity is the second Flagship company in as many months to raise a Series C round instead of filing to go public.
Pharmaceutical Technology
OCTOBER 4, 2022
Shionogi & Co and the United Nations (UN)-backed public health organisation Medicines Patent Pool (MPP) have entered a voluntary licence agreement for the former’s oral Covid-19 antiviral candidate ensitrelvir fumaric acid (S-217622). Signed at the headquarters of Shionogi in Osaka, Japan, the deal signifies a shared commitment of the parties to boost access to life-saving therapies for low- and middle-income countries (LMICs).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
OCTOBER 4, 2022
A little over a century ago, scientists working in laboratories discovered that microbes were the cause of many epidemics. Once they understood that, they began to put their faith more and more in laboratory science. This major transformation, called the bacteriological revolution, began in the 1880s. During this period, diphtheria was one of the leading causes of death among mostly poor children in New York City.
Bio Pharma Dive
OCTOBER 4, 2022
The acquisition, Incyte’s first of an entire company, hands the pharmaceutical company a potentially long lasting treatment for the skin disease vitiligo.
STAT News
OCTOBER 4, 2022
The press release issued by pharmaceutical companies Eisai and Biogen on Sept. 27 might someday be remembered as the beginning of a revolution in Alzheimer’s diagnosis and treatment. Years and years of failed Alzheimer’s trials created, and then fortified , doubts about whether drugs that attacked amyloid, a brain protein linked to Alzheimer’s disease, were a valid approach to its treatment.
Bio Pharma Dive
OCTOBER 4, 2022
The biotech terminated a Phase 2 study after treatment led to serious liver enzyme elevations in multiple patients with hereditary angioedema.
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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
STAT News
OCTOBER 4, 2022
After years spent building a seemingly slapdash set of medical initiatives, Verily seems to have a game plan. The Alphabet life sciences spinout is doubling down on the business of evidence generation , trying to build the tools and technical infrastructure that will help pharma and digital health customers run the next generation of clinical trials.
NPR Health - Shots
OCTOBER 4, 2022
A New York woman seeking to end a dangerous ectopic pregnancy in a fallopian tube finds the procedure more complicated and expensive than expected — even in a state with liberal abortion laws.
STAT News
OCTOBER 4, 2022
Looking for an actually concise explanation of a half-century’s worth of research and arguments about health care spending in the U.S.? You’re in luck: Government budget wonks, against all odds, condensed it down to a single PowerPoint slide. The slide is part of a broader report from the Congressional Budget Office that finds that capping the prices that hospitals, doctors, and other providers charge private health insurers would lower health care prices significantly more than ma
Rethinking Clinical Trials
OCTOBER 4, 2022
. Speakers. Marianne Chase. Senior Director Clinical Trial Operations. Neurological Clinical Research Institute. Massachusetts General Hospital. Jörg Goldhahn, MD. Medical Director. Director of Institute for Translational Medicine. ETH Zurich. Slides. Keywords. Clinical Trial Transformation Initiative (CTTI); Decentralized Clinical Trials (DCTs); Digital endpoints; Developing novel endpoints.
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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.
Pharma Times
OCTOBER 4, 2022
University of Lincoln and the University of Sheffield are researching how DNA could be repaired
STAT News
OCTOBER 4, 2022
When CAR-T therapy works against blood cancer, it can work spectacularly, but cancer still returns for many patients. In lymphoma, scientists are just beginning to work out why over half of treated patients don’t experience lasting remission, depending on the product. Now two separate research teams have identified a possible culprit in the mix of engineered immune cells created as part of CAR-T therapy.
pharmaphorum
OCTOBER 4, 2022
The life sciences company Solid Biosciences is merging with the privately-held gene therapy company AavantiBio in a deal which is expected to result in a combined sum of $215 million in cash and investments – projected to be enough for funding into 2025. AavantiBio, a precision genetic medicine company that was bankrolled by Solid’s rival Sarepta back in 2020, focuses on neuromuscular and cardiac rare diseases.
Pharma Times
OCTOBER 4, 2022
Treatment involves adult patients with severe alopecia areata
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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.
STAT News
OCTOBER 4, 2022
Nearly 60 years ago, Johns Hopkins Hospital opened a first-of-its-kind clinic to provide gender-affirming surgery. The Gender Identity Clinic blazed a new trail, with more than a dozen new clinics opening across the country in the decade that followed. But in 1979, the clinic shut its doors. And while the institution claimed for years that the decision was made based on the evidence — which, they argued, showed such surgeries didn’t benefit patients — new research by a Johns
pharmaphorum
OCTOBER 4, 2022
The FDA has approved Swiss pharmaceutical company Roche’s first companion diagnostic for identifying those patients with HER2 low-metastatic breast cancer who are eligible for ENHERTU. The approval brings hope to many, with breast cancer having surpassed lung cancer to become the most commonly diagnosed cancer in the world: there are approximately 2.3 million new cases each year, and each year over 620,000 breast cancer patients will die.
NPR Health - Shots
OCTOBER 4, 2022
There is a lot of information about coronavirus vaccines out there, and some of it seems vague or contradictory. We talked to experts to help answer some of the most common and confusing questions.
STAT News
OCTOBER 4, 2022
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday.
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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.
BioPharma Reporter
OCTOBER 4, 2022
Kibow Biotech is celebrating its 25th anniversary as the company pivots toward developing a drug based on its proprietary probiotic strains that benefit kidney disease suffers.
XTalks
OCTOBER 4, 2022
Recently, Mallinckrodt announced that Terlivaz (terlipressin) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function. HRS is a life-threatening condition involving rapid reduction in kidney function in patients with advanced liver disease. HRS affects 30,000 to 40,000 Americans every year.
NPR Health - Shots
OCTOBER 4, 2022
The National Federation of Infectious Diseases and the CDC are urging people to get flu shots. Both groups say the flu is likely to come back after a two-year hiatus, and it could be a bad year.
XTalks
OCTOBER 4, 2022
Just when it seemed like more and more plant-based meat companies were popping up, JBS pulled the plug on Planterra Foods only two years after it made its retail debut. The plant-based meat brand has permanently ceased operations in Lafayette, Colorado, closing its manufacturing facility and laying off its entire staff consisting of approximately 120 employees.
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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.
Drug Channels
OCTOBER 4, 2022
Last month, IQVIA quietly released a fascinating new report on discount cards. (Link below.) The research was sponsored by the Association for Accessible Medicines (AAM). Below, I highlight three unexpected findings from the data regarding GoodRx’s market position, when people use discount cards, how much they save, and why PBMs should still be worried about this market.
XTalks
OCTOBER 4, 2022
The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) injection. Rolvedon is a leukocyte growth factor administered to help prevent infection due to chemotherapy-induced neutropenia. Rolvedon is indicated to lower the chance of infection from febrile neutropenia (the development of fever, often with other signs of infection, in patients with a very low number of neutrophil granulocytes in the blood) in adult patients with non-myeloid malig
BioPharma Reporter
OCTOBER 4, 2022
Genezen has completed another expansion phase at its viral vector process development and cGMP vector production facility in Fishers, Indiana.
Outsourcing Pharma
OCTOBER 4, 2022
The company announces further measures against a counterfeiting network it accused of being responsible for selling illegitimate Gilead HIV medications.
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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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