Sat.Apr 10, 2021 - Fri.Apr 16, 2021

US calls for pause in J&J coronavirus vaccine rollout after rare blood clotting cases

Bio Pharma Dive

The FDA and CDC recommended halting vaccinations while they investigate six cases of unusual blood clots in women given the company's shot

COVID-19: Some ignored facts

World of DTC Marketing

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Coronaviruses were first encountered in April 1930, when a strange respiratory disease ravaged poultry farms across North Dakota and Minnesota, killing tens of thousands of baby birds.

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2020 505(b)(2) NDA Approvals: A Year in Review, and What a Year It Was!

Camargo

In 2020, CDER approved 68 NDAs that used the 505(b)(2) pathway, representing important advances in patient care across a wide range of therapeutic areas. 505(b)(2) Drug Improvement Approvals by Year.

Moderna to take mRNA flu and HIV vaccines into Phase 1 trials this year

BioPharma Reporter

Moderna will take mRNA flu and HIV vaccines into Phase 1 trials this year, as well as beginning a pivotal Phase 3 study for its cytomegalovirus (CMV) vaccine candidate. Bio Developments

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5 takeaways from AACR, one of the year's top meetings on cancer drugs

Bio Pharma Dive

The American Association for Cancer Research's virtual conference featured new data on an emerging immunotherapy target, a new kind of cell therapy and a KRAS reboot

The internet enables misinformation on COVID

World of DTC Marketing

QUICK READ: Some deaths will occur during the COVID-19 vaccination rollout, but these deaths would have happened for other reasons and are unrelated to the vaccine.

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Marshall University researcher receives $400K NIH grant to study nervous system development

Scienmag

Credit: Marshall University Joan C. Edwards School of Medicine HUNTINGTON, W.Va. – W. Christopher Risher, Ph.D., an assistant professor of biomedical sciences at the Marshall University Joan C.

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FDA faces backlash after seeking more data on an experimental ALS therapy

Bio Pharma Dive

The ALS Association demanded the FDA "move with the urgency" other agencies have in reviewing a drug from Amylyx Pharmaceuticals

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Reaching HCPs online

World of DTC Marketing

QUICK READ: Recent research from Zoom Rx saying that digital interactions with HCPs are myopic and don’t apply to the heavily segmented HCP audience. The future of reaching HCPS is both on and off-line depending on the product, health condition, and specialty.

HIV has been had

Scienmag

Credit: Department of Medicinal Chemistry, TMDU Tokyo, Japan – A team of scientists led by the Institute of Biomaterials and Bioengineering at Tokyo Medical and Dental University (TMDU) have created novel molecules that prevent human immunodeficiency virus (HIV) particles from attacking immune cells.

mRNA Tech Used in COVID-19 Vaccines Could be Used to Cure HIV, Cancer and More

BioSpace

Researchers are leveraging the messenger RNA (mRNA) technology used to develop the Pfizer-BioNTech and Moderna COVID-19 vaccines for possible treatments for a range of other diseases, including HIV and cancer

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Lilly gene-targeted drug shows potential for use across cancers

Bio Pharma Dive

Study results presented at AACR showed Retevmo shrank tumors in nine different cancers, building a case for the type of tissue-agnostic label that only three other medicines have secured

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And so pharma profiteers again

World of DTC Marketing

QUICK READ: Pfizer has already announced a price increase to the EU for their Covid Vaccine. With a CEO who earns more than $20 million annually and the potential for billions in profit Pfizer is reminding us that Wall Street is once again their primary customer.

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Vaccines Won’t Protect Millions of Patients With Weakened Immune Systems

NY Times

Many cannot produce enough infection-fighting cells to fend off the coronavirus. But researchers are testing one therapy that may help: monoclonal antibodies.

Combining mask wearing, social distancing suppresses COVID-19 virus spread

Scienmag

Network model findings could shape public health policy for airborne viruses Credit: Anna Sawulska and Maurizio Porfiri WASHINGTON, April 13, 2021 — Studies show wearing masks and social distancing can contain the spread of the COVID-19 virus, but their combined effectiveness is not precisely known.

CDC panel delays decision on J&J vaccine, extending pause over rare side effect

Bio Pharma Dive

Advisers to the agency agreed to wait for more data before recommending new guidance, but aim to reconvene quickly to decide on whether vaccinations with J&J's should be resumed, and for whom

Should we be worried about pharma’s supply chain?

World of DTC Marketing

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives.

Changing the paradigm: Microbiome modulation may become the next ‘pillar’ in cancer treatment

BioPharma Reporter

Insights have been gained into the role of the microbiome in disease states such as cancer, and strategies to manipulate the microbiome are quickly emerging, though optimal approaches are not yet known, said experts during an AACR 2021 event this week. Bio Developments

Japanese-European research team discovers novel genetic mitochondrial disorder

Scienmag

Team of Japanese and European scientists identify a novel genetic mitochondrial disorder by analyzing DNA samples from three distinct families Credit: Fujita Health University DNA ligase proteins, which facilitate the formation of bonds between separate strands of DNA, play critical roles in the replication and maintenance of DNA.

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Moderna watches for 'waning immunity' as new data show durable vaccine protection

Bio Pharma Dive

Updated study results show Moderna's coronavirus vaccine was strongly protective against COVID-19 through six months. But executives outlined contingency plans in case those effects fade

Pharma agency challenges and opportunities

World of DTC Marketing

QUICK READ: According to Setup 30% of Brand marketers say they’re likely/somewhat likely to switch Agencies in the next 6 months. While the consolidation of agencies may be a priority for some pharma companies a good digital agency can add a lot of value.

Thermo Fisher Scientific snaps up PPD in $17.4b acquisition deal

Outsourcing Pharma

The science service and technologies firm plans to bring the CRO under its Laboratory Products and Services Segment umbrella after the deal is completed. Markets & Regulations

USU researchers develop power converter for long-distance, underwater electric grids

Scienmag

Credit: Photo by Steve Johnson News Release — Logan, UT — Apr. 16, 2021 — A team of researchers from Utah State University’s Power Electronics Lab have developed a DC current-to-DC voltage power converter.

Lilly asks FDA to revoke clearance of first COVID-19 antibody drug

Bio Pharma Dive

The request comes less than six months after the FDA authorized Lilly's bamlanivimab, reflecting the spread of virus variants that can elude the drug

COVID-19 Infection After Vaccine is Rare But Possible, CDC Says

BioSpace

The U.S. CDC said up to 5,800 people who have been fully vaccinated against coronavirus disease 2019 (COVID-19) have been infected by the novel coronavirus following vaccination

AXA partners Microsoft on ‘all-in-one’ digital health platform

Pharma Phorum

European insurance giant AXA has stepped up an alliance with Microsoft to develop an international digital health platform on the back of successful pilots in Germany and Italy last year. .

Volcanic pollution return linked to jump in respiratory disease cases

Scienmag

Credit: Dr Evgenia Ilyinskaya Respiratory disease increased markedly following one of Iceland’s largest volcanic eruptions, a new study has found.

Gilead stops Veklury study, citing enrollment challenges, changing treatment

Bio Pharma Dive

The company said a multi-day infusion treatment that must be administered in healthcare settings no longer addresses an unmet need of non-hospitalized COVID-19 patients

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Genentech and Novartis Win FDA Approval for Self-Injectable Form of Xolair

BioSpace

The U.S. Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company

Protected: Health Psychology – the Solution to First Fill Abandonment?

Pharma Marketing Network

This content is password protected. To view it please enter your password below: Password: The post Protected: Health Psychology – the Solution to First Fill Abandonment? appeared first on Pharma Marketing Network. Articles Events

Conservationists may be unintentionally spreading pathogens between threatened animal populations

Scienmag

Credit: David Aldridge Moving endangered species to new locations is often used as part of species conservation strategies, and can help to restore degraded ecosystems. But scientists say there is a high risk that these relocations are accidentally spreading diseases and parasites.

Merck, in latest COVID-19 setback, scraps one drug and pins hopes on another

Bio Pharma Dive

The decision to end development of a medicine acquired in a $425 million deal last November is another disappointment for Merck's coronavirus effort, which once involved multiple drugs and vaccines

Pacira Takes ASA to Court in Defense of Non-Opioid Painkiller

BioSpace

With its only approved drug product on the line, Pacira Biosciences is fighting back against what it's calling “misrepresentation of the clinical effectiveness” of its non-opioid pain reliever Exparel

Tune In: Key Learnings and Insights from Leaders in Native Advertising

Pharma Marketing Network

Native advertising may mean something different to you depending on what part of the industry you’re in whether it be in advertising or publishing. .

On the pulse of pulsars and polar light

Scienmag

Reimagined telescopes may fill the void left by Arecibo’s collapse Credit: Robert Schwarz Faced with the tragic loss of the Arecibo observatory in Puerto Rico and the often prohibitive cost of satellite missions, astronomers are searching for savvy alternatives to continue answering fundamental questions in physics.

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Relay buys AI startup to aid unorthodox drug discovery quest

Bio Pharma Dive

The $85 million acquisition is an unusual and early step for a company like Relay, which went public last July and only just began clinical testing of its lead drugs last year

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Celularity Gains FDA Orphan Drug Status on Strength of Placental Stem Cell Trials

BioSpace

On Tuesday, Celularity received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its off-the-shelf natural killer cell therapy for malignant gliomas