Sat.Jun 05, 2021 - Fri.Jun 11, 2021

In historic move, FDA approves a closely watched and controversial Alzheimer's drug

Bio Pharma Dive

With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives

A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company.

Drugs 168
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Niche Nonclinical Studies: Uncommon Routes of Administration and Animal Models

Camargo

Camargo Research Group , Camargo’s managed nonclinical solution, has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species.

Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug

NY Times

The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients. your-feed-science Alzheimer's Disease Drugs (Pharmaceuticals) Clinical Trials Aduhelm (Drug) Elderly Biogen Inc

Drugs 91

Vertex stops work on second rare disease drug after study results disappoint

Bio Pharma Dive

The biotech said its drug for alpha-1 antitrypsin deficiency wasn't potent enough to advance into further testing, but plans to move others into clinical trials next year

Novo’s obesity drug has serious warnings and barriers to overcome

World of DTC Marketing

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings.

Digital fabric could be used to measure health data

Pharma Phorum

Researchers in the US have developed a wearable fabric that can sense, store and analyse data that could be used to measure physiological functions or detect illness.

More Trending

'The lights are no longer green': Antitrust regulators reassess pharma deals

Bio Pharma Dive

The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues where they may look next

Obesity represents a catastrophic failure of government policy, public health, and medicine

World of DTC Marketing

SUMMARY: Obesity has many causes, and while we would like to think the answer is as easy as people exercising more and eating less, it isn’t that simple.

Aduhelm Approval Draws Mixed Reaction, Sparks New Controversy Over Pricing

BioSpace

Not everyone is so confident that Aduhelm will transform the Alzheimer’s drug development landscape

Drugs 80

Wisconsin Pharmacist Who Tampered With Vaccine Gets 3-Year Sentence

NY Times

The pharmacist, Steven R. Brandenburg, believed in conspiracy theories and thought vaccines were dangerous, the authorities said.

Biogen Alzheimer's approval could open the door for other similar drugs

Bio Pharma Dive

Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look

Drugs 180

Your HCP marketing just became harder, a lot harder

World of DTC Marketing

Key Points: Trust in the CDC and FDA has decreased dramatically during the COVID-19 pandemic among health care professionals, according to a new WebMD/Medscape poll. Out of nearly 450 U.S.

Spread of Misinformation About Face Masks and COVID-19 by Automated Software on Facebook

JAMA Internal Medicine

This cross-sectional study examines the spread of misinformation regarding the Danish Study to Assess Face Masks for the Protection Against COVID-19 Infection on Facebook

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F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

NY Times

Aducanumab is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some prominent experts say there’s not enough evidence it can address cognitive symptoms. Alzheimer's Disease Drugs (Pharmaceuticals) Food and Drug Administration Clinical Trials Biogen In

A first-of-its-kind Alzheimer's drug raises heavy questions around who will and won't get it

Bio Pharma Dive

Biogen priced its newly approved medicine Aduhelm at an average cost of $56,000 a year, adding affordability to other barriers patients may face

The perfect storm is coming for pharma

World of DTC Marketing

SUMMARY: One area where Republicans and Democrats agree is that drug pricing is out of control. Retail price increases for widely used brand name prescription drugs consistently exceeded the rate of general inflation between 2006 and 2020.

Ensuring accessibility: Crossing the digital divide in healthcare

Pharma Phorum

“Rarely does the answer come from the boardroom” – what can user experience teach us about building accessible digital health? No one should be left behind as the world embraces digital healthcare say leading user experience voices.

Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense

NY Times

Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare. Drugs (Pharmaceuticals) Alzheimer's Disease Health Insurance and Managed Care Clinical Trials Biogen Inc

Drugs 78

As trials progress, FDA weighs COVID-19 vaccine authorizations for children

Bio Pharma Dive

An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean vaccination of kids under 12 is unnecessary

Trials 153

Using the Internet to reach doctors, numbers don’t matter. What you have to say and how you say are more important.

World of DTC Marketing

SUMMARY: Several online providers promise that they can reach physicians with your message, but I would argue that numbers are only important if they can be measured against key brand objectives. Ask your target audience what THEY use and how they use it to understand each platform’s relevance.

Trial finds Orion digital therapeutic helps chronic pain sufferers

Pharma Phorum

A digital therapeutic aimed at people with chronic lower back pain based on virtual reality (VR) has shown encouraging results in a clinical trial, helping patients manage the fear of movement that can reduce their activity and impede recovery.

F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

NY Times

Aducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some experts say there’s not enough evidence it can address cognitive symptoms.

Beigene expands into cancer cell therapy with Shoreline pact

Bio Pharma Dive

The fast-growing biotech will work with Shoreline to develop cancer treatments using natural killer cells, an emerging alternative to T-cell based therapies

Deep learning with SPECT accurately predicts major adverse cardiac events

Scienmag

Credit: Image created by Singh et al., Cedars-Sinai Medical Center, Los Angeles, CA. Reston, VA (Embargoed until 6:15 p.m.

Quidel Receives Amended Emergency Use Authorization for New Sofia® Q Rapid Antigen Test Device

BioTech 365

Quidel Receives Amended Emergency Use Authorization for New Sofia® Q Rapid Antigen Test Device Quidel Receives Amended Emergency Use Authorization for New Sofia® Q Rapid Antigen Test Device Sofia® Q device features a miniaturized, AI-powered design Quidel plans initial release … Continue reading → Business Wire

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“Ethno-pharma” Opportunities in India

Pharma Mirror

US bets $1.2B on Merck's last hope for a COVID-19 drug

Bio Pharma Dive

Though most of Merck's COVID-19 efforts have come up short, its antiviral pill could still have a role, as signaled by the U.S. government's sizable financial commitment

Drugs 149

Big data: IPK researchers double accuracy in predicting wheat yields

Scienmag

Credit: IPK/ Christoph Martin The enormous potential of Big Data has already been demonstrated in areas such as financial services and telecommunications.

Cybin to Present at the H.C. Wainwright Psychedelics in Psychiatry and Beyond Virtual Conference on June 17th

BioTech 365

Cybin to Present at the H.C. Wainwright Psychedelics in Psychiatry and Beyond Virtual Conference on June 17th Cybin to Present at the H.C. Wainwright Psychedelics in Psychiatry and Beyond Virtual Conference on June 17th TORONTO–(BUSINESS WIRE)–Cybin Inc.

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Future Trials Conference: Decentralized, Direct-to-Patient & Virtual Clinical Trials

ERT

The Evolving Role of Sites in Decentralized Clinical Trials.

The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.

Bio Pharma Dive

Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it

Promising ovarian cancer treatment proves effective and efficient

Scienmag

Credit: Image provided by Abdullah Metebi, PhD Student at the Institute for Quantitative Health Science and Engineering, Michigan State University. Reston, VA (Embargoed until 11:00 a.m.

EY Names G.F. Sigurjonsson of Kerecis as an Entrepreneur Of The Year® 2021 Mid-Atlantic Award Finalist

BioTech 365

EY Names G.F. Sigurjonsson of Kerecis as an Entrepreneur Of The Year® 2021 Mid-Atlantic Award Finalist EY Names G.F. Sigurjonsson of Kerecis as an Entrepreneur Of The Year® 2021 Mid-Atlantic Award Finalist Founder of medical fish skin company part of … Continue reading → Business Wire

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An Update on Global Availability of COVID-19 Vaccines from Editor of The Lancet

Pharma R&D Today

In the U.S., the COVID-19 vaccine roll-out has moved at a strong pace, with about half of Americans now having received at least one shot. While many of the most motivated people have been able to get vaccinated by now, plenty of others still have questions.

Novo keeps price in line with FDA approval of second obesity shot

Bio Pharma Dive

Wegovy, a weekly drug, joins daily Saxenda in the pharma's portfolio, which could soon be under pressure from an experimental Lilly medicine

Effects of ‘Fenton-like’ reactions of ferric oxalate on atmospheric oxidation processes and radiative forcing

Scienmag

Credit: Yu Wang The Fenton reaction is a chemical transition involving hydrogen peroxide (H2O2) and the ferrous (iron) ion, which acts as a catalyst. This process is used to destroy hazardous contaminants in wastewater through oxidation.