February, 2021

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Bristol Myers finally wins FDA approval for cancer cell therapy

Bio Pharma Dive

Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors.

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Pfizer/BioNTech to trial COVID-19 vaccine in pregnant women and children

BioPharma Reporter

Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.

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Pfizer Accused of Holding Some Countries to “Ransom” Over COVID-19 Negotiations

BioSpace

Pfizer has been accused of bullying governments in Latin America over coronavirus disease 2019 (COVID-19) vaccine negotiations, a recent investigative article revealed.

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White paper reveals pathway for digital therapeutics use in Italy

pharmaphorum

A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month. The book features insights and recommendations from 40 leading experts in the field, who hope that Italy will begin to follow in the footsteps of early adopters of digital therapeutics such as Germany, France and

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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New analysis backs safety, efficacy of AZ/Oxford COVID-19 jab

Pharma Times

The data show 100% protection against severe disease, hospitalisation and death, greater vaccine efficacy with an inter-dose interval of 12 weeks or more, and the potential for reduced asymptomatic transmission

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Climate impacts drive east-west divide in forest seed production

Scienmag

Western forests may be less able to regenerate following large-scale diebacks Credit: USGS DURHAM, N.C. — Younger, smaller trees that comprise much of North America’s eastern forests have increased their seed production under climate change, but older, larger trees that dominate forests in much of the West have been less responsive, a new Duke University-led […].

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First look inside BioNTech's Marburg site as it starts production for COVID-19 vaccine

BioPharma Reporter

BioNTech announced this morning it has started the production of mRNA at its new facility in Marburg, Germany: which will become one of the largest mRNA manufacturing sites in Europe.

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Bristol Myers Takes $470 Million Write-off and Scraps Orva-Cel CAR-T Program

BioSpace

The company’s head of drug development, Samit Hirawat, told analysts in a conference call last week that the decision was about working with the best drugs, particularly in a crowded field like BCMA.

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Not every cough is COVID – MSD UK’s lung cancer campaign

pharmaphorum

For World Cancer Day, David Long, business unit director of Oncology at MSD UK tells pharmaphorum about the company’s ‘Do It Yourself’ campaign launched in the North East to raise awareness of lung cancer symptoms. As COVID cases surged last year, lung cancer referrals dropped in the UK, causing alarm to the UK Lung Cancer Coalition (UKLCC), an alliance of the UK’s leading lung cancer experts, senior NHS professionals, charities, and healthcare companies.

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Family cancer experience informs eHealth company

Outsourcing Pharma

The founder of Andaman7âs leukemia diagnosis, and his sonâs experience with bone cancer, have helped inform the firm's tech and patient-centric approach.

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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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Pharma Rivals Step Up to Assist with COVID-19 Vaccine Production

XTalks

As COVID-19 vaccines continue to be in short supply around the world, pharma giants such as Bayer (Nasdaq: BAYRY ) are stepping up to help fulfill the need. Bayer has agreed to assist in the manufacturing of an mRNA-based coronavirus vaccine, CVnCOV, developed by fellow German biopharma company CureVac (Nasdaq: CVAC ). In early January, Bayer also struck an agreement with the company to support the further development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate.

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Gilead partners with a cancer biotech, seeking to develop an HIV immunotherapy

Bio Pharma Dive

Gritstone Oncology, known for its cancer research, is drawing attention in infectious disease, signing a deal with Gilead two weeks after announcing plans to develop a coronavirus vaccine.

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Clinical trial set to test efficacy of mixing Sputnik V and COVID-19 Vaccine AstraZeneca

BioPharma Reporter

Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.

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University of Oregon Campus Could Be Cornerstone of New Biotech Hotspot

BioSpace

A new biotech hotspot could be on the horizon in Oregon thanks to a $500 million gift to the University of Oregon from Nike co-founder Phil Knight, an alumnus of the university.

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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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Why we need the human element of remote clinical trials

pharmaphorum

Over the last year, we’ve noticed that “connectivity” doesn’t always equate to “connected” – and that’s just as true in the realm of clinical trials as it is in our personal lives. Amanda Barrell reports from a panel at the Patients as Partners Europe conference on remote clinical trials. Decentralised trials have been growing in popularity in recent years, and the COVID-19 pandemic has served to accelerate that progress.

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McKinsey Settles for $573 Million Over Role in Opioid Crisis

NY Times

The consulting firm has reached the agreement with 47 states because of its advice to drugmakers, including Purdue Pharma, the manufacturer of OxyContin.

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Synairgen’s inhaled COVID-19 treatment included in US trial

Pharma Times

Trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID)

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Lilly wagers almost $1B on Rigel's drugs for immune and nervous systems

Bio Pharma Dive

For $125 million up front, Lilly secures rights to a drug about to enter mid-stage testing for autoimmune and inflammatory diseases, as well as preclinical assets targeting the central nervous system.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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'Vaccines are working': UK unveils real-world data from vaccination campaign

BioPharma Reporter

Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions.

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South Africa Pauses AstraZeneca Vaccine Rollout Over Small but Dismal Study Results

BioSpace

South Africa has delayed the distribution of the AstraZeneca-University of Oxford COVID-19 vaccine after data suggested it “provides minimal protection” against mild disease from the South African variant.

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Early data back J&J and AC Immune’s Alzheimer’s jab

pharmaphorum

Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial. . ACI-35.030, partnered with Johnson & Johnson, is designed to stimulate the body to generate antibodies against tau protein, one of the factors though to play a role in the development of AD dementia.

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Johnson & Johnson Will Test its Vaccine in Infants

NY Times

The company’s coming trials will also involve pregnant women and people whose immune systems are compromised.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Antibiotic Research UK calls for clear guidance on the use of antibiotics and COVID-19 vaccines

Pharma Times

Charity has urged the UK government to provide clarity on whether people receiving antibiotics can receive a COVID-19 vaccination

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FDA review supports safety, efficacy of J&J coronavirus vaccine

Bio Pharma Dive

Agency scientists noted the shot's strong protection against severe COVID-19, even for the virus variant first detected in South Africa and known to weaken vaccine potency.

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How CureVac is creating a ‘broad pipeline’ of both first and second generation COVID-19 vaccines

BioPharma Reporter

CureVac aims to bring together expertise from both its own company and other stakeholders to provide âbroader and faster protection against current and future viral threatsâ: through collaborations with the UK Government, Bayer and GSK all announced this month.

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COVID-19 Long-Hauler Therapy Space Beginning to Take Shape

BioSpace

While the space is just beginning to emerge, therapies for long-haul COVID-19 patients are still very much an unmet need.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Almirall, Happify partner on digital tool for psoriasis mental health

pharmaphorum

It’s well recognised that people with psoriasis can develop depression or anxiety, particularly in moderate or severe cases where a sizeable part of the body can have skin lesions. Now, drugmaker Almirall and digital health firm Happify are working on a tool to support mental health in these patients. Almirall is a specialist in psoriasis therapies with drugs like Skilarence (dimethyl fumarate) and Ilumetri (tildrakizumab), while Happify’s app is designed to drive away negative thoughts through

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Say ‘NO’ to bad contracts

Drug Patent Watch

Are you tired of having to naviagate complicated contracts to access the information you need? Let DrugPatentWatch free you from weeks of negotiating complex contracts and let you focus on…. The post Say ‘NO’ to bad contracts appeared first on DrugPatentWatch - Make Better Decisions.

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Jazz Pharmaceuticals to acquire GW Pharma for $7.2bn

Pharma Times

Jazz will add GW's plant-derived cannabinoid treatment Epidiolex to its roster

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FDA authorizes J&J's one-shot coronavirus vaccine

Bio Pharma Dive

The agency's emergency clearance makes J&J's vaccine the third available in the U.S., adding much-needed reinforcements at a critical time.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time