Mon.Mar 14, 2022

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FDA clears AstraZeneca, Merck drug to treat some genetic breast cancers early

Bio Pharma Dive

Lynparza is the first drug targeting BRCA mutations to be approved for use in early breast cancer, a decision that could lead to more genetic testing.

Genetics 308
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Are small biotechs in trouble?

World of DTC Marketing

It’s not only getting harder for small biotechs to find funding; too many have scaled up operations by adding employees too quickly, forcing them to lay off people as the path to new drug approvals gets more complicated. With two of its prized gene therapies on clinical hold, Bluebird, a small biotech company in Cambridge, is going through some hard times.

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BridgeBio looks for comeback with trial results for muscular dystrophy drug

Bio Pharma Dive

Positive signs for the experimental treatment could help shore up investor confidence in BridgeBio after the December study failure of a drug for a rare heart condition.

Drugs 266
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FDA says no to AZ’s Fasenra for nasal polyp indication

pharmaphorum

AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal polyps, after the FDA rejected its marketing application. The US regulator has asked for additional clinical data, according to AZ, which said it remains committed to brining the drug to patients with the inflammatory condition, which results in the growth of nasal polyps in the nose that can sometimes require surgical intervention.

Sales 115
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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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Not all medical insights require a committee

Bio Pharma Dive

Most medical affairs teams have an insight generation program that includes collecting insight data during 1:1 KOL engagements, submitting them into a centralized system, and reviewing them as a team to identify potential impact to strategy. However, not all insight requires a committee.

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Moderna takes HIV trimer mRNA vaccine into clinical trials

BioPharma Reporter

The first participant has been dosed in a Phase 1 clinical trial of HIV trimer mRNA vaccine candidate mRNA-1574.

More Trending

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Enveric taps University of Calgary to study psychedelic therapy in cancer-related distress

Outsourcing Pharma

The pharma company and academic institution will explore the viability of a psychedelic treatment to help patients suffering from cancer-related distress.

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Implementing value-based care to drive success for life sciences companies

Bio Pharma Dive

Value-focused solutions can help life sciences groups make the switch to value-based contracting.

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COVID-19 infections seeing spike across UK

Pharma Times

In the coming months, an additional vaccine booster will be offered to those over 75, care home residents and to those over 12 who are most vulnerable

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Russia: Pfizer stops clinical trials, Bayer halts investment projects

BioPharma Reporter

Pfizer Inc says it will maintain its supply of medicines to Russia but it will not initiate new clinical trials in the country, while Bayer is suspending investment projects and new-business development in that market.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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These Alt Meat Companies are Suing Each Other Over Intellectual Property

XTalks

Meati Foods and The Better Meat Co. , two fungi-based alt meat companies, are embroiled in a legal battle over their alt meat intellectual property (IP). Meati has accused Better Meat of stealing its mycelium harvesting tech, while Better Meat has accused Meati of damaging its reputation and fundraising efforts in a separate lawsuit. Founded in 2015, Colorado-based Meati claims that a former employee, Augustus H.

Protein 98
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From healthcare to human care: Shaping a healthier society

pharmaphorum

Janssen’s Roz Bekker, VP Commercial Strategy for Infectious Diseases & Vaccines at Janssen EMEA, looks at how COVID-19 has reinforced the value of connecting with people, and how healthcare systems need ongoing reform to deliver more holistic, human-centric care. The connecting effect of COVID-19. No matter where you are in the world, COVID-19 has had an impact.

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Ken Nowak selected as Reclamation’s Research and Development Office program manager

Scienmag

The Bureau of Reclamation has selected Kenneth Nowak, Ph.D., as the Research and Development Office program manager. Nowak will oversee several programs within the office, including the Desalination and Water Purification Research Program, Science and Technology Program, Open Water Data, and Reclamation geographical information systems. Credit: Bureau of Reclamation The Bureau of Reclamation has selected […].

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Pharma leaders should step up on artificial intelligence: ConcertAI

Outsourcing Pharma

An executive from the AI specialist discusses how recent advances have provided opportunities for industry professionals to champion new ways of thinking.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Sandoz bulks up ahead of possible sale with Coalesce buy

pharmaphorum

Novartis may be planning to sell off its generics business Sandoz, but that hasn’t stopped it investing in the unit ahead of a decision on its future later this year. This morning, Sandoz announced it has acquired medical and drug delivery device specialist Coalesce Product Development, bolstering its capabilities for the development of respiratory medicines and ‘complex’ generics.

Sales 91
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Scientists look for answers to taste loss with COVID

Scienmag

AUGUSTA, Ga. (March 15, 2022) – Up to 80% of individuals who’ve had COVID-19 report temporary or lasting changes in their sense of taste, and scientists are working to better understand the biological basis of why, including whether our taste buds are a direct virus target. Credit: Michael Holahan, Augusta University AUGUSTA, Ga. (March 15, 2022) – […].

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State-of-the-art R&D facilities to be developed in Oxford city centre

Pharma Times

Site will include creating space for student accommodation, offices, retail outlets and restaurants

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Apple Developer Academy opens in Pohang

Scienmag

Korea’s first Apple Developer Academy held its first class online on March 14. The Apple Developer Academy is an education program for developers in the making. The nine-month course will be conducted online to start, with in-person classes at POSTECH at a later date. On the first day of classes, both the students and the mentors […].

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The New Age of Decentralized Clinical Trials

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.

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New US Preventive Services Task Force Recommendations on Screening for Eating Disorders

JAMA Internal Medicine

Eating disorders are conditions characterized by disturbances in eating behaviors that impair physical and psychosocial functioning and include, but are not limited to, anorexia nervosa, binge eating disorder, bulimia nervosa, avoidant/restrictive food intake disorder, and other specific feeding and eating disorders, including atypical anorexia nervosa (Table).

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Fast-melting alpine permafrost may contribute to rising global temperatures

Scienmag

From the ancient sludge of lakebeds in Asia’s Tibetan Plateau, scientists can decipher a vision of Earth’s future. That future, it turns out, will look very similar to the mid-Pliocene warm period – an epoch 3.3 million to 3 million years ago when the average air temperature at mid-latitudes rarely dropped below freezing. It was […].

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Sanofi takes a hit as hotly tipped breast cancer drug fails trial

pharmaphorum

Shares in Sanofi were on the slide this morning after the drugmaker revealed that one of its top pipeline prospects – selective oestrogen receptor degrader (SERD) amcenestrant – stumbled in a mid-stage breast cancer trial. The phase 2 AMEERA-3 trial was testing amcenestrant in women aged 18 and over with hormone receptor-positive, HER2-negative advanced breast cancer, and showed no benefit in progression-free survival for the drug compared to physician’s choice endocrine therapy.

Trials 64
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Warning: Objects in driverless car sensors may be closer than they appear

Scienmag

DURHAM, N.C. – Researchers at Duke University have demonstrated the first attack strategy that can fool industry-standard autonomous vehicle sensors into believing nearby objects are closer (or further) than they appear without being detected. Credit: Spencer Hallyburton, Duke University DURHAM, N.C. – Researchers at Duke University have demonstrated the first attack strategy that can fool […].

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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New patent for Therapeuticsmd Inc drug IMVEXXY

Drug Patent Watch

Annual Drug Patent Expirations for IMVEXXY Imvexxy is a drug marketed by Therapeuticsmd Inc and is included in one NDA. It is available from one supplier. There are fourteen patents…. The post New patent for Therapeuticsmd Inc drug IMVEXXY appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Microbes and minerals may have set off Earth’s oxygenation

Scienmag

For the first 2 billion years of Earth’s history, there was barely any oxygen in the air. While some microbes were photosynthesizing by the latter part of this period, oxygen had not yet accumulated at levels that would impact the global biosphere. But somewhere around 2.3 billion years ago, this stable, low-oxygen equilibrium shifted, and […].

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New patent for Catalyst Pharms drug FIRDAPSE

Drug Patent Watch

Annual Drug Patent Expirations for FIRDAPSE Firdapse is a drug marketed by Catalyst Pharms and is included in one NDA. It is available from one supplier. There are two patents…. The post New patent for Catalyst Pharms drug FIRDAPSE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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UTSW study finds cognitive decline key factor in predicting life expectancy in Alzheimer’s disease

Scienmag

DALLAS – March 14, 2022 – Cognitive decline is the biggest factor in determining how long patients with Alzheimer’s disease will live after being diagnosed, according to a new study from researchers at UT Southwestern. The findings, published in the Journal of Alzheimer’s Disease, are a first step that could help health care providers provide reliable prediction […].

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How Machine Learning Drives Clinical Trial Efficiency

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.

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New patent for Alk Abello drug OTIPRIO

Drug Patent Watch

Annual Drug Patent Expirations for OTIPRIO Otiprio is a drug marketed by Alk Abello and is included in one NDA. It is available from one supplier. There are six patents…. The post New patent for Alk Abello drug OTIPRIO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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COVID-19 variants can’t hide from Variabel

Scienmag

HOUSTON – (March 14, 2022) – Details about variants hiding in the deluge of genetic SARS-CoV-2 sequences would be good to know, if only researchers can get to them. Credit: Illustration courtesy of the Treangen Lab/Rice University HOUSTON – (March 14, 2022) – Details about variants hiding in the deluge of genetic SARS-CoV-2 sequences would […].

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Sour taste for Nektar as bempegaldesleukin flunks ph3 test

pharmaphorum

Four years ago, Bristol-Myers Squibb paid $1.85 billion upfront to claim rights to Nektar’s bempegaldesleukin, setting it up to be companion drug to its cancer immunotherapy Opdivo. Now, that hope is looking like a bust. The PIVOT IO-001 trial of Opdivo (nivolumab) plus bempeg as a first-line treatment for advanced melanoma showed no improvement over Opdivo alone on progression-free survival and the objective response rate at the final analysis, or overall survival on an interim assessment

Trials 52
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Sharks sleep with eyes wide open

Scienmag

New Zealand and Australian researchers studied seven draughtsboard sharks from the Hauraki Gulf, off Auckland, New Zealand to explore how and why the animals sleep. The sharks could sleep with their eyes open and, in common with other animals, sleep was associated with lying flat and a lowered metabolic rate, they wrote in the journal Biology Letters.The […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.