Sat.Apr 24, 2021 - Fri.Apr 30, 2021

FDA panel largely backs speedy cancer drug approvals, forcing tough choice for agency

Bio Pharma Dive

Over three days of meetings, a group of FDA advisers discussed the tough trade-offs of accelerated immunotherapy approvals. Their decisions could escalate an already intense debate

Drugs 254

Pharma’s social irresponsibility

World of DTC Marketing

QUICK READ:There are times when I really want to quit working in the industry and the latest news about pharma is aiming at U.S. lawmakers to stop the global push to lift intellectual property through a waiver for Covid vaccines is just the latest.

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Using PK Modeling and Simulation to Plan Studies for Pediatric Patient Populations

Camargo

Conducting a clinical study in a pediatric patient population requires careful planning, as providing a benefit to a child without causing harm is a weighty responsibility.

Wasps are valuable for ecosystems, economy and human health (just like bees)

Scienmag

Credit: Professor Seirian Sumner, UCL Wasps deserve to be just as highly valued as other insects, like bees, due to their roles as predators, pollinators, and more, according to a new review paper led by UCL and University of East Anglia researchers.

Under pressure, Biogen will allow some patients early access to experimental ALS drug

Bio Pharma Dive

Biogen plans to start a compassionate use program in July that would let a small group of patients with rapidly progressing disease access its drug

Drugs 219

Pharma websites tracking visitors

World of DTC Marketing

WHAT”S UP WITH THAT: A quick analysis of two pharma websites shows that Facebook, and others, are tracking users. Does pharma even know or care? With the release of Apple’s latest updates, privacy has suddenly become a big issue, especially for Facebook.

Plant-based COVID-19 vaccine candidate starts rolling review with Health Canada

BioPharma Reporter

Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily. Bio Developments

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Pfizer buys infectious disease biotech Amplyx

Bio Pharma Dive

The deal is another sign of Pfizer's interest in infectious disease beyond COVID-19, following the pharma's participation in an industry investment fund

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Doctors don’t have time for digital

World of DTC Marketing

QUICK READ: Patients are returning to their doctor’s office, and it’s not uncommon for appointments, or routine visits, to be scheduled weeks or months in advance.

Millions Are Skipping Their Second Doses of Covid Vaccines

NY Times

Nearly 8 percent of those who got initial Pfizer or Moderna shots missed their second doses. State officials want to prevent the numbers from rising.

Death, Disability Among Side Effects of Chinese COVID-19 Vaccines, Leaked Documents Reveal

BioSpace

Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China

BioMarin partners with Allen Institute to develop gene therapies for the brain

Bio Pharma Dive

Far along in testing for a hemophilia treatment, BioMarin is expanding its gene therapy research into diseases of the central nervous system and aims to use some of the institute's technology

Jones receives $2.87 million for Gulf war illness study

Scienmag

Credit: UTHSC Memphis, Tenn. April 30, 2021) – The National Institute of Environmental Health Sciences has awarded Byron C. Jones, PhD, professor in the Department of Genetics, Geonomics, and Informatics at the University of Tennessee Health Science Center, $2.87

Jolly Good/Teijin Pharma develop VR digital therapeutics for depression

Pharma Phorum

Technology firm Jolly Good and Teijin Pharma have begun a partnership to develop virtual reality digital therapeutics (VR DTx) for major depressive disorder. The goal of the partnership for approval for the Japanese market from the Pharmaceuticals and Medical Devices Agency (PMDA).

AstraZeneca Hits Another Bump in the Road to COVID-19 Vaccine Approval in the US

BioSpace

AstraZeneca’s COVID-19 vaccine road to approval has been anything but smooth

Vertex moves pain drug into mid-stage testing

Bio Pharma Dive

VX-548 is Vertex's latest attempt to show that blocking a certain sodium channel can offer a new, non-addictive way to treat pain

Drugs 191

Team builds better tool for assessing infant brain health

Scienmag

Credit: Photo by Fred Zwicky CHAMPAIGN, Ill. — Researchers have created a new, open-access tool that allows doctors and scientists to evaluate infant brain health by assessing the concentration of various chemical markers, called metabolites, in the brain.

Not just COVID-19 vaccines: 5 things that cause blood clots

Pharma Phorum

Reports of COVID-19 vaccinations causing blood clots has caused alarm in the general population. However due to the rarity of incidences from vaccination, myGP explores the most common causes of blood clots and how we can prevent them.

Ocugen-Bharat Biotech Vaccine Shows Efficacy Against B.1.617 Variant

BioSpace

A new study published online has provided some hope for the citizens in India, with researchers suggesting that the Covaxin vaccine, developed by Bharat Biotech and Pennsylvania-based Ocugen, could neutralize the SARS-CoV-2 variant leading the second wave in the country

FDA gives first citation to biotech for failure to report clinical trial details

Bio Pharma Dive

The agency threatened to fine Acceleron for not posting study results to clinicaltrials.gov. Whether the action is a sign of a larger crackdown is unclear

A milestone in muscular dystrophy therapy

Scienmag

Credit: Spuler Lab, ECRC Muscle stem cells enable our muscle to build up and regenerate over a lifetime through exercise. But if certain muscle genes are mutated, the opposite occurs. In patients suffering from muscular dystrophy, the skeletal muscle already starts to weaken in childhood.

Gene 66

Can your typing patterns reveal if you have Alzheimer’s?

Pharma Phorum

The neuroQWERTY technology can analyse people’s typing for signs of motor conditions like Parkinson’s disease – and now the team behind it is looking to expand into the notoriously-difficult area of dementia.

Sanofi Partners With Moderna to Answer Global Demand for COVID-19 Vaccines

BioSpace

Sanofi will use its manufacturing capabilities to support the development of 200 million doses of the Moderna COVID-19 vaccine beginning in September

Wall Street fears Amgen's tough first quarter is just the start

Bio Pharma Dive

Product sales fell by 5% in the first quarter, keeping the pressure high for Amgen to deliver on expectations for its KRAS cancer drug Lumakras

Sales 177

‘Twisting’ atomic materials may convert light into electricity

Scienmag

US Army grant to UC Riverside will support the study of the science of light and its interaction with matter Credit: Stan Lim, UC Riverside. RIVERSIDE, Calif.

Apixaban vs warfarin: rise of newer anticoagulant

Druggist

Apixaban (Eliquis®) and warfarin are two popular prescription-only drugs classified as anticoagulants, commonly known as blood thinners. Warfarin has been used as an anticoagulant for a very long time.

Biden Proposes New $6.5 Billion Advanced Research Agency to End Cancer

BioSpace

Cancer doesn’t care if you’re Democratic, Republican, Libertarian or Green. It strikes without prejudice or consideration. As President Joe Biden said Wednesday night in his first major speech to Congress, “I know of nothing that is more bipartisan

Merck, GSK vaccine sales hit by pandemic as competitors' business booms

Bio Pharma Dive

Both companies blamed the impact of COVID-19 on sharp declines in sales of their shingles, pneumonia and HPV shots

Sales 173

International study: Humans accelerate the change of biodiversity

Scienmag

Humans have significantly altered biodiversity in all climate zones of the Earth. This has been shown by a study published in “Science” Credit: © Manuel Steinbauer. Humans have significantly altered biodiversity in all climate zones of the Earth.

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Oxford Immunotec’s COVID-19 test to be used in ‘mix and match’ UK vaccine trial

Pharma Times

Test will be used for T cell testing in study, which is evaluating different combinations of COVID-19 vaccines

Introducing the 2020-21 HBA Honorable Mentor and STAR Awardees

Pharma Marketing Network

Introducing the recipient of the 2020-21 HBA Honorable Mentor Award, Dr. Rod MacKenzie , Chief Development Officer and EVP, Pfizer and the recipient of the 2020-21 HBA STAR Award, Susan Torroella , Chief Operating Officer, ArmadaHealth. What is the Honorable Mentor Award?

A serious side effect puts a biotech's eye gene therapy in limbo

Bio Pharma Dive

Adverum Biotechnologies has unmasked a Phase 2 study in which a trial participant suffered severe inflammation and vision loss — a finding that could threaten the program’s future in multiple eye diseases

eNeuro publishes commentaries on upcoming documentary “In Silico”

Scienmag

Special collection provides additional perspective on brain modelling and collaborative neuroscience Credit: eNeuro 2021 eNeuro is publishing a special collection of commentaries on April 30, 2021 on the neuroscience documentary In Silico.

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First UK-based clinical trial focused viral vector manufacturer announces launch

Pharma Times

ViroCell Biologics will meet the growing demand for viral vectors in clinical trials

Health Care in the U.S., as Seen From Abroad

NY Times

We asked eight people around the world what they thought. It didn’t go well. Health Insurance and Managed Care United States Regulation and Deregulation of Industry Prices (Fares, Fees and Rates) Drugs (Pharmaceuticals

Emergent CEO defends company from criticism of error that ruined vaccine doses

Bio Pharma Dive

The company expects to respond within days to a long list of findings FDA officials made in a nine-day inspection of Emergent's Baltimore plant earlier this month

Meteorite amino acids derived from substrates more widely available in the early solar system

Scienmag

Credit: JAXA Scientists have recreated the reaction by which carbon isotopes made their way into different organic compounds, challenging the notion that organic compounds, such as amino acids, were formed by isotopically enriched substrates.