Bio Pharma Dive
JUNE 23, 2021
A group of statisticians who had argued for rejection were overruled, internal memos show, as high-ranking agency officials got behind an accelerated clearance for Biogen's drug.
World of DTC Marketing
JUNE 23, 2021
SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. Source: Fierce Pharma If that enthusiasm pans out in the long run, it could mean at least 300,000 patients taking the drug, or $10 billion to $15 billion in peak Aduhelm from U.S. sales alone, which is above co
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Bio Pharma Dive
JUNE 23, 2021
Led by CEO Samantha Singer, Abata Therapeutics has $95 million to advance its plans to engineer regulatory T cells for treating autoimmune diseases.
Camargo
JUNE 23, 2021
While the COVID-19 pandemic has accelerated innovation in many areas, including clinical trial design, many recent advancements were already in motion before 2020 as sponsors and CROs sought to improve the patient journey and encourage trial participation. Traditional trials, especially those for pediatric populations, often place enormous burdens on patients and their families.
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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
JUNE 23, 2021
Under pressure from activist investors, the British drugmaker set lofty sales targets for a "new GSK" after a planned exit from consumer health. But shareholders will first face a dividend cut.
Pharma Mirror
JUNE 23, 2021
Vectura Group plc, an industry leading inhalation CDMO, today announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicines development company, to provide pre-clinical development services for IHL-216A, Incannex’s proprietary inhaled drug product for the treatment of traumatic brain injury (TBI). Under the terms of the agreement, Vectura will undertake formulation screening studies, manufacturing process optimisation studies and stability assessments
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JUNE 23, 2021
The two companies will assess the safety and immunogenicity of the vaccine candidate, which codes for the hemagglutinin protein in the A/H3N2 strain of the seasonal flu virus.
XTalks
JUNE 23, 2021
AstraZeneca scored a major win last week in a lawsuit launched by European Union (EU) officials that accused the drugmaker of failing to deliver on promised supplies of its COVID-19 vaccine. A Brussels court found that the European Commission has no exclusivity or right of priority over contracting parties, and also dismissed other measures being sought by the Commission.
BioSpace
JUNE 23, 2021
Concerns over vaccination links to heart inflammation are valid, a U.S. Centers for Disease Control and Prevention advisory committee announced this afternoon.
pharmaphorum
JUNE 23, 2021
GlaxoSmithKline’s pitch to shareholders kicked off this afternoon with an optimistic view of its late-stage pipeline – including some big sales predictions for products like its respiratory syncytial virus (RSV) vaccine and new blood cancer drug Blenrep. By 2031, the UK drugmaker expects sales to top £33 billion ($46 billion), despite facing a patent cliff for big-selling HIV drugs including dolutegravir towards the end of this decade, with double-digit profit growth expected over the next
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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
JUNE 23, 2021
As BioSpace releases its third annual 2021 U.S. Life Sciences Salary Report, there are hopeful surprises and unsettling truths.
Scienmag
JUNE 23, 2021
A new study identifies key linkages between rainfall occurring in the tropics and climate trends in Antarctica Credit: Zhen Fu Our planet is warming due to anthropogenic greenhouse gas emissions; but the warming differs from region to region, and it can also vary seasonally. Over the last four decades scientists have observed a persistent austral […].
BioSpace
JUNE 23, 2021
?The U.S. FDA has had a mix of announcements this week, from drug approvals to the acceptance of NDAs and INDs. Here’s a look.
BioPharma Reporter
JUNE 23, 2021
The company states that it will hire at least 155 new employees into manufacturing positions during 2021.
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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
JUNE 23, 2021
Strategy includes proposals for patients to easily access their test results, medication lists, procedures and care plans
pharmaphorum
JUNE 23, 2021
Merck & Co’s Keytruda has become the first checkpoint inhibitor to help patients with advanced cervical cancer live longer when used as alongside standard first-line drugs. Keytruda (pembrolizumab) was given an accelerated approval in 2018 as a second-line therapy for PD-L1-positive cervical cancer, but the new survival data – from the phase 3 KEYNOTE-826 trial – could extend the use of the drug.
Scienmag
JUNE 23, 2021
Credit: Augusta University With age, a diet lacking in the essential amino acid tryptophan — which has a key role in our mood, energy level and immune response — makes the gut microbiome less protective and increases inflammation body-wide, investigators report. In a normally reciprocal relationship that appears to go awry with age, sufficient tryptophan, […].
BioSpace
JUNE 23, 2021
German biotechnology firm LEUKOCARE, which has operations in Milford, Connecticut, has announced the closing of $17.5 million financing round from New York investment firm Petrichor Healthcare Capital Management.
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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.
Scienmag
JUNE 23, 2021
Bacterium associated with antibiotic-induced colitis plays a role in weight control Credit: © CDC | Janice Carr Researchers from Charité – Universitätsmedizin Berlin and the University of California in San Francisco were able to show for the first time that a very low calorie diet significantly alters the composition of the microbiota present in the […].
BioPharma Reporter
JUNE 23, 2021
Bio-Thera Solutions recently initiated a Phase 3 trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe, making it the first subcutaneous golimumab biosimilar to do so in multiple countries, according to a report from GlobalData.
Scienmag
JUNE 23, 2021
Credit: Zach Laubach Best known for its presence in house cats and a tendency to infect and alter the behaviors of rodents and humans, the parasite Toxoplasma gondii (T. gondii) is also associated with bold behavior among wild hyena cubs and risk of death during interactions with lions, finds new research from the University of […].
pharmaphorum
JUNE 23, 2021
Digital health company Pear Therapeutics has foregone the traditional initial public offering (IPO) route to a stock exchange listing in favour of a merger with a “blank cheque” company. By combining with special purpose acquisition company (SPAC) Thimble Point Acquisition, Pear gets a Nasdaq listing, a cash injection of around $400 million gross, and a pro forma equity value of around $1.6 billion.
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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.
Pharma Times
JUNE 23, 2021
Partnership will advance the early clinical development of CAR-T cell engager candidate ALETA-001
BioSpace
JUNE 23, 2021
With COVID-19 ducking for cover and going into an almost full retreat across the U.S., Americans are throwing caution – and masks – to the wind. But many are still nervous, and wondering: How do we protect ourselves in this brave new normal?
Scienmag
JUNE 23, 2021
Credit: Canterbury Museum It’s one of the iconic images of early Antarctic exploration: the heroic explorer sledging across the icy wastes towed by his trusty team of canine companions. But new research analysing a century-old dog biscuit suggests the animals in this picture were probably marching on half-empty stomachs: early British Antarctic expeditions underfed their […].
BioSpace
JUNE 23, 2021
Fulcrum achieved what the company is calling a clinical first. Data showed that using losmapimod slowed the progression of FSHD and demonstrated improved function in patients.
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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.
Scienmag
JUNE 23, 2021
Berkeley Lab researchers are developing a family of cathode materials that have all of the advantages of conventional lithium batteries but without the supply constraints Credit: Marilyn Sargent/Berkeley Lab In our future electrified world, the demand for battery storage is projected to be enormous, reaching to upwards of 2 to 10 terawatt-hours (TWh) of annual […].
BioSpace
JUNE 23, 2021
EQRX is pushing forward with its goal of developing more affordable novel medications that can sustain healthcare systems.
Drug Patent Watch
JUNE 23, 2021
Annual Drug Patent Expirations for SOOLANTRA Soolantra is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from three suppliers. There are eleven…. The post New patent for Galderma Labs drug SOOLANTRA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 23, 2021
Credit: Photo: Tristan Eckerter How many tree species are there in the forest? How are the trees scattered throughout? How high are the individual tree crowns? Are there fallen trees or hollowed-out tree trunks? Forest scientists characterize forests according to structural factors. “Structural richness is very important for biodiversity in forests.
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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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