Sat.Oct 16, 2021 - Fri.Oct 22, 2021

Biogen's closely watched ALS drug comes up short in late-stage study

Bio Pharma Dive

Though the study's primary goal was missed, Biogen claimed there were some signs its drug, tofersen, could slow the disease's progression. The company is now engaging with regulators to discuss tofersen's future

New FDA head needs to examine the accelerated approval program

World of DTC Marketing

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found.

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Regulatory Strategy for Combination Devices: Working with the FDA for Program Success

Camargo

As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents.

Maintaining balance in the brain

Scienmag

SAN FRANCISCO, CA—October 19, 2021—With the school year well on its way, we all recognize the importance of getting students energized. However, we also know that overstimulated children can wreak havoc on a classroom, leaving a teacher trying to regain control of their group.

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

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

Atea, Roche change plans for oral COVID-19 drug after trial setback

Bio Pharma Dive

A closely watched competitor to Merck's molnupiravir failed a Phase 2 study, prompting its makers to change their strategy in a move that could delay an answer on the drug's efficacy until late next year

Trials 258

Pharma buys politicians like candy

World of DTC Marketing

SUMMARY : (Financial Times) BioNTech/Pfizer and Moderna will dominate the Covid-19 vaccine market next year, generating a massive $93.2bn in combined sales and legislation allowing the government to negotiate drug prices for Medicare is all but dead.

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Crab found in 100-million-year-old amber is oldest modern-looking crab ever found

Scienmag

Looking at the ancient piece of amber, Javier Luque’s first thought wasn’t whether the crustacean trapped inside could help fill a crucial gap in crab evolution. He just, more or less, wondered what the heck is a crab doing stuck in fossilized tree resin?

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Bluebird, winding down in Europe, withdraws another rare disease gene therapy

Bio Pharma Dive

The biotech won EU approval for two gene therapies, Zynteglo and Syksona, both of which it's now said it will pull from market after difficulties negotiating reimbursement

COVID-19 has propelled the regulatory industry years ahead

Pharma Phorum

Janssen’s Saskia De Haes, VP EMEA Regulatory Affairs, looks at how the pandemic response has shaped tomorrow’s regulatory landscape. In my 26 years of industry experience, I’ve often found the regulatory process to have plenty of opportunities to become more efficient and faster.

F.D.A. to Allow ‘Mix and Match’ Approach for Covid Booster Shots

NY Times

The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.

Drugs 114

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

New study suggests that breastfeeding may help prevent cognitive decline

Scienmag

A new study led by researchers at UCLA Health has found that women over the age of 50 who had breastfed their babies performed better on cognitive tests compared to women who had never breastfed.

Sage, Biogen detail plans to get their newer depression drug approved

Bio Pharma Dive

Following discussions with the FDA, the companies plan to submit zuranolone for approval in major depressive disorder and postpartum depression over the next roughly year and a half

Drugs 235

‘Digital transformation’ requires enterprise-wide change: Rockwell Automation

Outsourcing Pharma

To fully reap the benefits of tech advances, a company leader advises, a life-sciences firm must embrace change and connection throughout the operation. Contract Manufacturing & Logistics

Use of digital tools for clinical trials triples during pandemic; survey

Pharma Phorum

A new poll of clinical trial sponsors has found that around nine out of 10 of them are running decentralised trials with the help of digital technologies, a big increase on pre-COVID-19 levels.

Mechanism underlying the emergence of virus variants unravelled

Scienmag

An international consortium, led by Delft University of Technology and the University of North Carolina, has for the first time succeeded in probing the molecular origins of recombination in RNA viruses.

RNA 83

Pfizer, in a first, shows booster shot strengthens COVID-19 protection in large study

Bio Pharma Dive

A third dose was 96% effective in preventing COVID-19 compared to a placebo in a Phase 3 trial of previously vaccinated adults. Missing details, however, leave some questions unanswered

Atsena Unveils Gene Therapy for Retinal Eye Disease with Promising Profile

BioSpace

While it has yet to reach clinical trials, preclinical results with the company’s specially-tailored adeno-associated virus have been fortuitously auspicious

FDA clears AI-powered digital test for early dementia

Pharma Phorum

The FDA has approved an artificial intelligence-based test for early detection of dementia that can be carried out on an iPad in five minutes.

Atomic Scale “lasagna” keeps heat at bay

Scienmag

Tokyo, Japan – Researchers from Tokyo Metropolitan University have found new ways of controlling how heat flows through thin materials by stacking atomically thin layers of atoms into van der Waals heterostructures.

Boehringer Ingelheim takes next step in development of cystic fibrosis gene therapy

Bio Pharma Dive

Drugs from Vertex can effectively treat the lung disease in as much as 90% of patients. Gene therapy could be a solution for the remaining 10%, but the path forward is challenging

Intellia’s Milestone In Vivo CRISPR Therapy Granted FDA Orphan Drug Designation

BioSpace

The experimental drug, NTLA-2001, is being developed for the treatment of transthyretin (ATTR) amyloidosis

A test of NICE’s resolve: clinical guidelines for Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

Pharma Phorum

The work of the UK’s HTA body, the National Institute for Health and Care Excellence (NICE), is often heatedly debated, and this time it’s for holding back a clinical guideline. Leela Barham looks into the controversy. Updating a previous clinical guideline.

Infant planet discovered by UH-led team using Maunakea telescopes

Scienmag

One of the youngest planets ever found around a distant infant star has been discovered by an international team of scientists led by University of Hawai?i i at M?noa noa faculty, students, and alumni. Credit: Subaru Telescope and Gaidos, et al.

Esperion lays off nearly half its workforce as heart drug sales disappoint

Bio Pharma Dive

The company hopes a "streamlined" sales force can turn around a drug launch that's failed to meet expectations amid tough competition from rival medicines

Sales 223

Research Roundup: Regrowing Nerve Cells in Spinal Cord Injuries and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones

What HCPs think about medical tweetorials

Pharma Phorum

Twitter has been used by health professionals for over a decade to share medical knowledge and education. Until late-2018 they had only 140 characters to do this, increasing to 280 at that time.

The introduction of perennial plants among rainfed almond trees helps to mitigate climate change

Scienmag

Agriculture and the change in soil use produce 23% of the total emissions of greenhouse gases of anthropogenic origin.

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Biden administration rolls out plan for vaccinating kids as FDA weighs clearance

Bio Pharma Dive

The plan is dependent on FDA authorization and CDC recommendation of Pfizer's vaccine for children aged 5 to 11, expected by early next month

New asthma drug approved on NHS branded a ‘wonder drug’

Pharma Times

Dupilumab (also known as Dupixent) will be available to patients through injections

Biogen’s Aduhelm rollout goes from bad to worse

Pharma Phorum

Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug seems to be going into reverse.

Virginia Tech researchers garner NSF grant to connect AI with urban planning to improve decision making and service delivery

Scienmag

Tom Sanchez, professor of urban affairs and planning, and Chris North, professor of computer science and associate director of the Sanghani Center for Artificial Intelligence and Data Analytics, have been awarded a planning grant from the National Science Foundation’s Smart and Connected Communities program.

Gates Foundation pledges $120M to bring Merck COVID-19 drug to lower-income countries

Bio Pharma Dive

Anticipating regulatory clearance of the pill, the group aims to speed access by investing in the manufacturing of generic versions of the drug

Is mRNA the Future of Drug Development?

BioSpace

The idea of using mRNA has been around for some time, but only in recent years has it become practical. The COVID-19 pandemic provided the opportunity for the technology to push ahead

Roche scores early adjuvant lung cancer approval for Tecentriq

Pharma Phorum

Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage cases that can be treated with surgery.

Traces of an ancient road in a lake

Scienmag

Anyone traveling from the German city of Brandenburg via Berlin to Frankfurt an der Oder at the Polish-German border does so along an ancient route that reaches far into Poland.