Sat.Sep 04, 2021 - Fri.Sep 10, 2021

FDA halts tests of BioMarin drug amid heightened focus on gene therapy safety

Bio Pharma Dive

On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice

Medicare savings won’t make a dent in healthcare costs

World of DTC Marketing

SUMMARY: Allowing Medicare to negotiate drug prices is popular with voters because the media has been focused on the high price of some drugs, but this measure won’t lead to lower healthcare costs.

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In the News: August 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Some Drugs May Require Reclassification to Devices.

How serotonin curbs cocaine addiction

Scienmag

Contrary to common thinking, cocaine triggers an addiction only in 20% of the consumers. But what happens in their brains when they lose control of their consumption?

Moderna expands mRNA vaccine supply in deal with new biotech producer

Bio Pharma Dive

The company has previously said it could make up to three billion vaccine doses in 2022, depending on how booster shots are authorized

Of course, ageism exists in pharma

World of DTC Marketing

SUMMARY: Those working in pharma know that ageism exists, especially in the sales force. Pharma has been purging older employees for some time, and when you reach the magic age of 50+, you’re going to be pushed to take “early retirement.”

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Pharmacists must be mobilised to mitigate health impacts of air pollution

Pharma Mirror

The Hague, Pharmacists must be allowed to do more to manage respiratory conditions in communities if the urgent need to address the harmful effects of air pollution on health is to be met, the International Pharmaceutical Federation (FIP) said today.

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More Trending

Biden pushes forward on Medicare price negotiation

Bio Pharma Dive

But opposition from the drug industry and congressional Republicans could make the Democrats' signature proposal an uphill battle

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The drug industry can’t fight change

World of DTC Marketing

SUMMARY: John F. Kennedy said, “Change is the law of life, and those who look only to the past and present are certain to miss the future”. Change is coming for one simple reason; our country can’t sustain the current costs of healthcare.

Drugs 203

Remote Patient Monitoring Industry

Pharma Mirror

Increasing burden of chronic diseases and rising awareness about necessity of early warning signs are fuelling the demand of remote patient monitors With the COVID-19 pandemic, health systems or hospitals rapidly adopted remote patient monitoring technology to maintain social distancing and thereby control viral spread.

How land birds cross the open ocean

Scienmag

Researchers at the Max Planck Institute of Animal Behavior and University of Konstanz in Germany have identified how large land birds fly nonstop for hundreds of kilometers over the open ocean—without taking a break for food or rest.

Sanofi drug for rare skin disease, acquired in buyout, fails in late-stage trial

Bio Pharma Dive

The French drugmaker bought Principia Biopharma last year for two therapies that block a protein called BTK. The second targets a much bigger disorder, multiple sclerosis

Mandating vaccinations is the right decision

World of DTC Marketing

SUMMARY: Marci Hamilton, a professor at the University of Pennsylvania Constitution, said, “The Constitution is not a suicide pact guaranteeing a right to harm others.

AI could be used to guide drug therapy for heart failure

Pharma Phorum

UK researchers have used artificial intelligence (AI) to develop a way to identify patients with heart failure who would benefit from treatment with beta blockers, by interrogating data from nine landmark clinical trials.

Cost, Confusion Proving Potentially Prohibitive in Aduhelm Rollout

BioSpace

Biogen CEO Michel Vounatsos admitted Thursday that the company’s rollout of Aduhelm (aducanumab) for Alzheimer’s disease has been “slower than we anticipated

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Roche bets big on off-the-shelf cancer cell therapy with Adaptimmune deal

Bio Pharma Dive

Long a bystander in the race to develop so-called allogeneic treatments, the cancer drugmaking giant has joined the fray with a wide-ranging alliance that could be worth up to $3 billion

JCVI does not recommend COVID-19 vaccination for all 12 to 15-year-olds

Pharma Times

UK’s chief medical officers will now provide ‘further advice’ on COVID-19 vaccination in this age group

How blockchain can revolutionise medical records and save lives

Pharma Phorum

Balancing medical privacy with ease of access for healthcare professionals is a challenge, but technology could provide the solution, says Aleph Zero Foundation’s Matthew Niemerg.

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COVID-19 Update: Super-Immunity, Booster Shots, Mu and Moderna

BioSpace

Heading into fall, with the COVID-19 pandemic surging again and researchers tracking new variants, there’s plenty of news. Here’s a look

Biogen offered a window into what's holding up Aduhelm. Investors didn't like what they saw.

Bio Pharma Dive

At Morgan Stanley’s healthcare conference, executives detailed how the launch of their Alzheimer’s drug has been slower than expected, due in large part to lingering questions about clinical trial data and insurance coverage

Novavax begins COVID-19, flu combination vaccine trial

Pharma Times

The trial will aim to enrol 640 healthy adults, aged 50- to 70-years-old

AI ‘could help diagnose lung cancer a year earlier’

Pharma Phorum

An artificial intelligence algorithm was able to detect signs of lung cancer on CT scans a year earlier than with traditional methods, according to a new study.

Collab Worth Up to $3 Billion for Off-the-Shelf T-Cell Cancer Therapies

BioSpace

Adaptimmune will be responsible for developing clinical T-cell candidates for the two companies through its induced pluripotent stem cell (iPSC) derived allogeneic platform

'The sky is not falling.' Cautious optimism follows FDA meeting on gene therapy risks

Bio Pharma Dive

Wall Street analysts expect little impact on biotech developers after an inconclusive discussion last week. Yet the FDA still appears wary, as shown by a new hold on a BioMarin rare disease treatment

Recent FDA COVID-19 actions and updates

Outsourcing Pharma

The US agency continues to oversee vaccine and drug development, and to share information and advice for life-sciences professionals and civilians alike. COVID-19

4 ways emerging pharma companies can harness marketing content

Pharma Phorum

Rapid creation of compliant marketing content is increasingly important and there are ways emerging pharma companies can stay ahead of the game – despite having fewer resources than bigger firms.

Lucerna is Illuminating the Mysteries of RNA to Solve Disease

BioSpace

The company aims to make RNA molecules visible and druggable – opening the door to study RNA-based diseases

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Jennifer Doudna-founded CRISPR biotech raises new cash to broaden drug development work

Bio Pharma Dive

Formed as a diagnostics developer, Mammoth Biosciences, which Doudna started with two of her former students at the University of California, has accelerated plans to make gene editing medicines as well

Qualified mobile research nurses key to DCT success: Illingworth

Outsourcing Pharma

A leader from Illingworth Research Group outlines exactly what makes a good mobile research nurse and what their duties in decentralized trials are. Patient centricity

Moderna to develop mRNA therapeutic for very rare disease

BioPharma Reporter

Moderna and the nonprofit Institute for Life Changing Medicines (ILCM) are collaborating to develop a new messenger RNA (mRNA) therapeutic (mRNA-3351) for Crigler-Najjar Syndrome Type 1 (CN-1), an ultra-rare disease. Markets & Regulations

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Introducing Cas7-11—A New Addition to the CRISPR Toolkit

BioSpace

The new bacterial enzyme has the ability to cut and modify RNA with the exquisite precision that has only been possible so far for DNA editing

RNA 91

Lilly joins RNA editing race with ProQR deal

Bio Pharma Dive

An agreement with the Dutch biotech, which could be worth as much as $1.3 billion, expands Lilly's work in genetic medicine research

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Startup Neuroglee raises $10m for virtual neurology clinics

Pharma Phorum

A digital health company focusing on neurodegenerative disorders – Neuroglee Therapeutics – has raised $10 million in first-round funding to roll out a virtual neurology clinics for people with cognitive problems caused by dementia.

Government launches OHID to tackle health inequalities

Pharma Times

New government body will be co-led by deputy chief medical officer Jeanelle de Gruchy

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Creating Your Non-Negotiable List While Job Searching

BioSpace

Non-negotiables are the factors that you decide must exist or must not exist in order for you to say yes to a position

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Venture capital pours more money into RNA medicines with the launch of Replicate

Bio Pharma Dive

The company, which focuses on self-replicating RNA, comes equipped with $40 million from Apple Tree Partners and a stamp of approval from the former research head at Biogen

RNA 211

Intelligent digitalization can maximize manufacturing ROI: ACG

Outsourcing Pharma

A leader from ACG Engineering shares insight on how âsmartâ drug manufacturing, accelerated by COVID-19, can best be put to work now and in months to come. Contract Manufacturing & Logistics