Bio Pharma Dive
MAY 5, 2021
The influential watchdog group found the evidence supporting aducanumab "insufficient" to determine a health benefit and suggested the drug would be cost effective at up to $8,300 per year, well short of what some analysts are predicting.
NY Times
MAY 5, 2021
The Biden administration, siding with some world leaders over the U.S. pharmaceutical industry, came out in favor of waiving intellectual property protections for coronavirus vaccines.
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Bio Pharma Dive
MAY 5, 2021
Led by a former MyoKardia executive, Esker Therapeutics is developing a drug that could eventually compete with one of Bristol Myers Squibb's most closely watched candidates.
pharmaphorum
MAY 5, 2021
A medicine based on MDMA – the active ingredient in recreational drug ecstasy – is on the cusp of FDA approval as a treatment for post-traumatic stress disorder (PTSD), according to the organisation developing it. . The non-profit Multidisciplinary Association of Psychedelic Studies (MAPS) is leading the development of MDMA and has just reported top-line results from a phase 3 trial of the drug combined with psychotherapy that it says could form the basis of a marketing application to the US reg
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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
MAY 5, 2021
Months after leaving his post as Merck's top scientist, Perlmutter has become CEO of Eikon Therapeutics, which plans to use Nobel Prize-winning microscope technology to discover new drugs.
pharmaphorum
MAY 5, 2021
Pfizer expects revenues from its BioNTech-partnered COVID-19 vaccine to reach an eye-watering $26 billion this year, catapulting it to the top of the world’s biggest-selling medicines. . The company also said that it doesn’t expect the massive sales to be a one-off, as demand from governments around the world for coronavirus vaccines will continue to be strong in the coming years.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
MAY 5, 2021
While mix-and-match sounds more like a meal deal at your local fast-food chain, it’s now the colloquial term being used for the approach currently under study in the U.K. for administering two doses of different types of COVID-19 vaccines.
BioPharma Reporter
MAY 5, 2021
Takara Bio Europe has announced a licensing agreement with Denmarkâs PanCryos, a pre-clinical stage biotech company, for its clinical-grade human embryonic stem (hES) cell lines, starting material for cell therapy development.
BioSpace
MAY 5, 2021
Newly-published studies suggest currently authorized COVID-19 vaccines may be effective for protecting against new and emerging variants of the novel coronavirus, while booster doses of these vaccines may improve the overall efficiencies of these immunizations at combating these variants.
Drug Patent Watch
MAY 5, 2021
Annual Drug Patent Expirations for ARMONAIR+RESPICLICK Armonair Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are nineteen…. The post New patent for Teva Pharm drug ARMONAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
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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
BioSpace
MAY 5, 2021
Two new notable biotech/biopharma acquisitions were reported this week: Athenex has acquired Kuur Therapeutics, while Altasciences has acquired preclinical CRO Calvert Laboratories.
Scienmag
MAY 5, 2021
Researchers have mapped the gene activity of osteocytes to improve their understanding of skeletal disease Credit: Garvan Institute of Medical Research Research led by the Garvan Institute of Medical Research has for the first time mapped the unique genetic profile of the skeleton’s ‘master regulator’ cells, known as osteocytes. The study published today in Nature […].
BioSpace
MAY 5, 2021
Bluebird bio reported first-quarter earnings, the approval of Abecma, the first CAR-T therapy for relapsed or refractory multiple myeloma, and its spinout, 2seventy bio, and its leadership.
Scienmag
MAY 5, 2021
LANL scientists contribute to comprehensive sea-level rise projections Credit: (photo by Jeremy Harbeck, NASA Icebridge). LOS ALAMOS, N.M., May 5, 2021– A massive collaborative research project covered in the journal Nature this week offers projections to the year 2100 of future sea-level rise from all sources of land ice, offering the most complete projections created […].
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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.
pharmaphorum
MAY 5, 2021
Roche’s cancer immunotherapy Tecentriq has been granted a new use by European regulators, for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC). Tecentriq (atezolizumab) has now been used in Europe for adults with metastatic NSCLC whose tumours have high PD-L1 expression. The tumours must also have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.
Scienmag
MAY 5, 2021
Researchers simulate conditions necessary for planet’s unique magnetic field Credit: Ankit Barik/Johns Hopkins University New Johns Hopkins University simulations offer an intriguing look into Saturn’s interior, suggesting that a thick layer of helium rain influences the planet’s magnetic field. The models, published this week in AGU Advances, also indicate that Saturn’s interior may feature higher […].
NY Times
MAY 5, 2021
The Biden administration, siding with some world leaders over the U.S. pharmaceutical industry, came out in favor of waiving intellectual property protections for coronavirus vaccines.
Scienmag
MAY 5, 2021
Credit: Christopher Moore, Georgia Tech Granular materials, such as sand and gravel, are an interesting class of materials. They can display solid, liquid, and gas-like properties, depending on the scenario. But things can get complicated in cases of high-speed vehicle locomotion, which cause these materials to enter a “triple-phase” nature, acting like all three fundamental […].
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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.
Pharma Times
MAY 5, 2021
Checkpoint inhibitor specifically approved for patients with high PD-L1 expression
Scienmag
MAY 5, 2021
UD’s Singh and collaborators propose repurposing tabletop sensors to search for dark matter Credit: Photo by Evan Krape, photo composite by Jeffrey C. Chase Scientists are certain that dark matter exists. Yet, after more than 50 years of searching, they still have no direct evidence for the mysterious substance. University of Delaware’s Swati Singh is […].
Pharma Times
MAY 5, 2021
Managed access agreement treatment eligibility criteria extended following review
Scienmag
MAY 5, 2021
Black workers 50% more likely to stay in unwanted jobs than white workers Credit: West Health-Gallup Survey, March 2021 WASHINGTON, DC – MAY 6, 2021 – One out of every six adult workers (16%) in the United States are staying in jobs they might otherwise leave out of fear of losing their employer-sponsored health insurance, […].
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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.
BioSpace
MAY 5, 2021
Less than two weeks after receiving the greenlight for Zynlonta under accelerated approval, ADC Therapeutics has launched its treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Scienmag
MAY 5, 2021
Credit: The Hong Kong University of Science and Technology The emergence and spread of new forms of resistance remains a concern that urgently demand new antibiotics. Transcription is a vital process in bacterial cell, where genetic information in DNA is transcribed to RNA for the translation of proteins that perform cellular function. Hence, transcription serves […].
Pharma Times
MAY 5, 2021
Funds will be used to advance company's integrated physiological and digital biomarker platform
pharmaphorum
MAY 5, 2021
After an indifferent period Novo Nordisk has kicked off 2021 on the front foot, raising its financial forecast after posting better than expected Q1 earnings and sales. The world’s biggest manufacturer of diabetes drugs expects growth in constant currencies at between 6% and 10%, up from the previous forecast in the 5%-9% range. Operating profit is expected to be in constant currencies in the 5% to 9% range, up from the previous estimate of 4%-8%.
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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.
Pharma Times
MAY 5, 2021
New facility will fast-track vaccines for COVID-19 variants to “future-proof the country”
Scienmag
MAY 5, 2021
Marine scientists are calling on the EU to adopt a comprehensive plan to protect dolphins and porpoises from fisheries bycatch in European waters. Marine scientists are calling on the EU to adopt a comprehensive plan to protect dolphins and porpoises from fisheries bycatch in European waters. A team of conservation experts, including Newcastle University’s Professor […].
BioSpace
MAY 5, 2021
With Biogen’s potential treatment for Alzheimer’s, aducanumab, coming in weeks before a U.S. FDA decision, ICER wrote a punishing report slamming the drug for insufficient efficacy and recommending a low price point if approved.
Scienmag
MAY 5, 2021
R21/Matrix-M becomes the second malaria vaccine candidate ever to start a phase III licensure trial R21/Matrix-M becomes the second malaria vaccine candidate ever to start a phase III licensure trial This builds on the recent finding of high level efficacy of this vaccine in a phase IIb trial in children in Burkina Faso, published today […].
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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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